Table 1.
Radiation Oncology-related vs. All Other Class 2 Recall Characteristics
| Radiation Oncology Devices (n=502) Other | Class 2 Devices (n=9,534) | p-value | |
|---|---|---|---|
| Year | < .001* | ||
| 2002–2005 | 15 (3.0) | 1,396 (14.6) | |
| 2006–2010 | 162 (32.3) | 3,363 (35.3) | |
| 2011–2015 | 325 (64.7) | 4,775 (50.1) | |
| Device Product Categories | |||
| External Beam | 335 (66.7) | ||
| Planning System | 115 (22.9) | ||
| Brachytherapy | 42 (8.4) | ||
| Simulation System | 10 (2.0) | ||
| Recall Class | < .001* | ||
| Class 1 | 1 (0.2) | 424 (4.4) | |
| Class 2 | 490 (97.6) | 8,311 (87.2) | |
| Class 3 | 11 (2.2) | 799 (8.4) | |
| Time Since 510K Clearance (n=471, 8267) | |||
| Oldest: Mean # days (range) | 2,117 (32 – 10,301) | 2,842 (13 – 14,182) | |
| Average: Mean # days (range) | 2,294 (43 – 10,301) | 2,967 (13 – 14,182) | < .001† |
| Newest: Mean # days (range) | 2,480 (53 – 12,893) | 3,093 (13 – 14,182) | |
| Average: Recalls within 12 months | 47 (10.0) | 488 (5.9) | < .001* |
| Quantity in Commerce (n=480, 9184) | < .001† | ||
| Mean | 682 | 233,498 | |
| Median | 107 | 433 | |
| Range | 1 – 22,900 | 0 – 225,000,000 | |
| Time to Termination (n=438, 8294) | .04† | ||
| Mean | 470.9 | 497.7 | |
| Median | 335.5 | 315 | |
| Range | 0 – 2,639 | 0 – 47,46 | |
*
Pearson’s Chi-squared test
†
Two-sample Kolmogorov-Smirnov test