(24 days)
The Arthrex BioComposite SutureTak is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Specific indications are listed below and are size appropriate per patient needs:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, Digital Tendon Transfers.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot reconstruction.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
The Arthrex BioComposite SutureTak is a 2.0mm biocomposite suture anchor with a molded-in suture eyelet. The anchor is loaded on a driver and pre-loaded polyester suture.
The provided text describes a 510(k) submission for the Arthrex BioComposite SutureTak device. The study described focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not involve human readers, AI, or traditional clinical study methodologies for diagnostic accuracy.
Here's the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ultimate load strength of the proposed devices after 16 weeks of degradation meets or exceeds the minimum acceptance criteria. | "The submitted mechanical testing data demonstrated that the ultimate load strength of the proposed devices after 16 weeks of degradation meets or exceeds the minimum acceptance criteria." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes mechanical testing. The text does not specify the sample size for the mechanical testing (e.g., how many anchors were tested) nor the provenance of this testing data (e.g., which lab conducted it). It is implied to be a prospective mechanical test conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The study is a mechanical test of device performance, not a diagnostic accuracy study requiring expert human interpretation or ground truth establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method was described as this was a mechanical test.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was conducted. This device is a medical implant, and the study described focused on its mechanical properties for regulatory clearance, not on human-AI diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component to this device or study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth or evaluation metric was the "minimum acceptance criteria" for ultimate load strength after 16 weeks of degradation, which is a physical performance target derived from engineering and regulatory standards for medical implants, not clinical ground truth.
8. The sample size for the training set
Not applicable. There is no training set mentioned or implied for this mechanical validation study.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned or implied for this mechanical validation study.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.