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The FiberTak® Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.

The FiberTak® Suture Anchors are intended for the following indications:

• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate 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, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• 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, Joint Capsule Closure
• Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.

The FiberTak® Suture Anchors are all-suture anchors intended to be used for soft tissue to bone fixation.

The provided text is a 510(k) Summary for a medical device (FiberTak® Suture Anchor) and does not contain the information requested about acceptance criteria and a study proving device performance as it relates to AI/ML or diagnostic performance.

The document describes performance data as:

• Ultimate load testing and cyclic displacement: Performed to demonstrate that differences in the subject device (a line extension) do not negatively impact mechanical strength compared to the predicate device.
• Bacterial endotoxin per USP : Conducted to demonstrate that the device meets pyrogen limit specifications.

These tests are standard for evaluating the mechanical and biocompatibility aspects of a physical medical device, not the diagnostic or predictive performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on this document.

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The FiberTak suture anchors are intended to be used for suture or tissue fixation in the foot, ankle, wrist, elbow, shoulder, and hip.
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure
• Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.

The Arthrex FiberTak® Suture Anchors are all-suture anchors intended to be used for soft tissue to bone fixation.

This document is a 510(k) summary for the "FiberTak Suture Anchor" and does not describe acceptance criteria or a study proving that an AI/device meets acceptance criteria in the context of AI performance. The document describes a new medical device (suture anchor) and its substantial equivalence to a previously cleared device, based on mechanical, material, and biocompatibility testing, not AI performance.

Therefore, I cannot extract the information required to populate the fields about AI/device performance, study design, ground truth establishment, or expert involvement as requested.

The document discusses the following types of performance data, which are not related to AI performance:

• Performance Data: "Ultimate load testing and cyclic displacement was performed on the subject device to demonstrate that the differences do not negatively impact mechanical strength." and "Bacterial endotoxin per USP was conducted to demonstrate that the device meets pyrogen limit specifications."

This is a clearance for a physical medical device, not a software or AI-driven device.

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The Arthrex Double Loaded Knotless FiberTak® Suture Anchor is intended to be used for suture (soft tissue) fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• 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, Joint Capsule Closure (Except Canada)
· Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair (Except Canada)

The Arthrex Double Loaded Knotless FiberTak Suture Anchor is an all-suture knotless anchor intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and hip. The Arthrex Double Loaded Knotless FiberTak Suture Anchor is a sterile, single use implant device constructed from a hollow braid of polyester (sheath) preloaded on an inserter with a double loaded suture component composed of UHMWPE and polyester.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device: the "Arthrex Double Loaded Knotless FiberTak® Suture Anchor." This document describes a surgical implant and its intended uses, asserting its substantial equivalence to a previously cleared device. It does not describe an AI/machine learning device, nor does it contain information about acceptance criteria or a study that proves an AI device meets acceptance criteria.

The information you are requesting, such as ground truth, sample sizes for training/test sets, expert adjudication methods, or MRMC studies, are concepts applicable to AI/ML device evaluations, particularly for diagnostic imaging or assistive technologies. Since this document describes a physical surgical implant (a suture anchor), these concepts are not relevant to its regulatory submission.

Therefore, I cannot extract the requested information from the provided text for an AI/ML device. The document explicitly states the "Performance Data" is "Cyclic pull-out testing was conducted on the proposed devices submitted in this Special 510(k). The test data demonstrates that the proposed devices perform statistically equivalent to the predicate device. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications." This type of testing is standard for mechanical implants, not AI.

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The Arthrex SutureLoc™ Implant is intended to be used for suture (soft-tissue) fixation to bone in the knee for meniscal root repair.

The SutureLoc™ Implant is a suture construct comprised of a polyester sheath with multiple sutures assembled through the sheath.

This FDA 510(k) summary is for a medical device (SutureLoc™ Implant) and primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data. It does not describe a study involving an algorithm's performance, human readers, or expert adjudication as would be relevant for an AI/ML-based device.

Therefore, many of the requested fields regarding acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies are not applicable or cannot be extracted from the provided text. The document describes performance testing for a physical implant, not a software algorithm.

Here's a breakdown of what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions performance data, but does not provide specific quantitative acceptance criteria or detailed reported performance values for each criterion in a table format. It generally states that testing was done to "demonstrate that the differences do not negatively impact mechanical strength" and that the device "meets pyrogen limit specifications."

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 does not provide details on the sample sizes used for the "ultimate load testing and cyclic displacement," "bacterial endotoxin," or "packaging testing." It does not mention data provenance (country of origin, retrospective/prospective).

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. This is a physical medical implant, not an AI/ML-based device requiring expert ground truth establishment for software performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 is a physical medical implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical testing, the "ground truth" would be the measured physical properties and performance characteristics against established engineering standards or against the predicate device's performance. For biocompatibility/safety, it's compliance with compendial standards like USP . For packaging, it's meeting defined integrity and sterility standards.

8. The sample size for the training set

Not applicable. This is a physical medical implant, not an AI/ML-based device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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