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510(k) Data Aggregation
(63 days)
SUPER STAPLE(TM) CLASSIC
The Super™ Staple is intended for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
The Super Staple™ is a two leg U-shaped staples fabricated from nitinol alloy with an S-shaped bridge design. These U-shaped compressive staples range in width from 9 to 30 millimeters. Staple prong length ranges from 7 to 30 mm and staples have prongs of equal and unequal length.
This is a summary of the performance data for the Super Staple™ Classic, based on the provided 510(k) summary.
1. Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Corrosion Testing (ASTM F2129) | Acceptable corrosion behavior, substantially equivalent to predicate devices. | The corrosion behavior of the Super Staple™ was acceptable for all samples tested and substantially equivalent to the predicate devices. |
| Staple Compression | Substantially equivalent compression force compared to predicate staples. | Compression tests showed that the Super Staple™ has a substantially equivalent compression force when compared to the predicate staples tested. |
| Pull-out | Substantially equivalent pull-out force compared to predicate staples. | Pull-out tests showed that the Super Staple™ had a substantially equivalent pull-out force when compared to the predicate staples tested. In this test, the performance of the Super Staple™ meets the performance of the predicate devices. |
| Ultimate Strength (Failure Load, Stiffness, Deflection) | Substantially equivalent to the predicate device. | Strength of the Super Staple™ in failure load, stiffness, and deflection was measured and found substantially equivalent to the predicate device tested. |
| Fatigue Strength (S-N curves) | Substantially equivalent or better load at run-out compared to the predicate device. | Fatigue testing S-N curves and their characteristic equations showed that the Super Staple™ withstands substantially equivalent load at run-out when compared to the tested predicate device. Thus, the fatigue performance of the Super Staple™ is substantially equivalent or better than the predicate devices. |
2. Sample Size and Data Provenance
The document does not specify the exact sample sizes (number of staples) used for each individual test. It refers to "all samples tested" for corrosion and "predicate staples tested" for other mechanical tests. The data provenance is not explicitly mentioned (e.g., country of origin). Based on the nature of the tests (mechanical and corrosion), this would be laboratory-generated data, not human patient data.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a mechanical implant, and its performance evaluation relies on objective physical and mechanical testing, not a ground truth established by human experts.
4. Adjudication Method for the Test Set
Not applicable. The performance evaluation is based on objective measurements from physical tests, not human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a medical device (surgical staple) and not an AI/imaging diagnostic device. Therefore, a multi-reader multi-case comparative effectiveness study with human readers assisting with AI is not relevant.
6. Standalone (Algorithm Only) Performance Study
No. This is a mechanical medical device, not an algorithm or software. Therefore, a standalone performance study in the context of AI algorithms is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective physical and mechanical measurements against defined engineering standards and comparison to legally marketed predicate devices. This includes:
- Corrosion resistance specified by ASTM F2129.
- Measured compression force.
- Measured pull-out force.
- Measured ultimate strength parameters (failure load, stiffness, deflection).
- Measured fatigue strength (S-N curves and load at run-out).
8. Sample Size for the Training Set
Not applicable. This device is a mechanical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a mechanical device.
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