(51 days)
The Arthrex Pec Repair Button, Large Pec Button, Biceps Button, and Proximal Biceps Button are used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The four proposed Arthrex suture buttons are titanium oblong buttons that consist of two eyelets each that allow the buttons to be threaded with a variety of suture options. The Arthrex Pec Button, Large Pec Button, Biceps Repair Button and Proximal Biceps Buttons are used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The provided text describes a 510(k) submission for several Arthrex suture buttons, focusing on demonstrating substantial equivalence to predicate devices through mechanical testing. The information required for a comprehensive AI device study report (e.g., training set details, expert ground truth adjudication) is not applicable or not present in this document, as the device is a physical medical implant, not an AI or software-based device.
Therefore, the following information is extracted or stated as not applicable based on the provided input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Tensile Strength | Met or exceeded acceptance criteria for proposed indications and the ultimate load to failure seen clinically for pectoralis repair. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified (mechanical testing, not a clinical data set).
- Data Provenance: Not applicable by country or retrospective/prospective as this describes mechanical testing in a lab setting, not human subject data.
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. Ground truth for a physical device's mechanical performance is typically based on established engineering standards and material science, not retrospective expert consensus on medical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is for mechanical testing, not clinical diagnosis consensus.
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
- Not applicable. This device is a physical implant, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an AI or software device. The study describes standalone mechanical performance of the device, but not in the context of an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground truth was based on established biomechanical and engineering standards for tensile strength and ultimate load to failure for soft tissue fixation, as well as clinical expectations for pectoralis repair.
8. The sample size for the training set
- Not applicable. This device is a physical implant, not an AI or software device. The concept of a "training set" is not relevant here.
9. How the ground truth for the training set was established
- Not applicable. See above.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.