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The Responsive Arthroscopy Knotless Push-In Suture Anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

Hip: Capsular Repair, Acetabular Labral Repair.

The Responsive Arthroscopy (RA) Knotless Push-In Suture Anchor System is an updated version of the RA Knotless Push-In Suture Anchor System previously cleared under K180951. The RA Knotless Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone. The system includes a variety of anchors made of polyetheretherketone per ASTM F2026 (PEEK) along with repair suture tape, inserters, drills, broaches, and guides.

The only differences in the subject device are regarding suture geometry, anchor body geometry, and internal screw geometry. The RA Knotless Push-In Suture Anchor System anchors are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies. RA Knotless Push-In Suture Anchor System anchors range in diameter from 3.5mm to 4.75mm and are either pre-loaded with or accept #2 suture or 2.5mm suture tape.

The RA Knotless Push-In Suture Anchor System anchors are pre-loaded on inserters and provided sterilized with ethylene oxide. The RA Knotless Push-In Suture Anchor System reusable instruments are non-sterile and are to be sterilized by the end user.

The provided text describes a 510(k) premarket notification for a medical device, the "Responsive Arthroscopy Knotless Push-In Suture Anchor System." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets acceptance criteria in a clinical study. Therefore, several of your requested points related to clinical study design, ground truth establishment, expert involvement, and reader studies are not applicable to this type of regulatory submission.

The FDA 510(k) process for Class II medical devices like this one typically relies on bench testing and comparison to predicate devices, not extensive clinical trials with human subjects to prove performance metrics in the way you've outlined for diagnostic AI.

Here's a breakdown of the information that is available and a note on what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The submission demonstrates substantial equivalence through various performance tests, but it does not specify explicit "acceptance criteria" in a numerical sense as one would expect for a diagnostic AI study (e.g., AUC > 0.9, sensitivity > 90%). Instead, the "acceptance criteria" for a 510(k) are generally that the new device performs as well as or better than the predicate device, or at least does not introduce new safety or effectiveness concerns, for its intended use. The performance reported aims to support this substantial equivalence.

Study Proving Substantial Equivalence:

The provided document describes a 510(k) Pre-Market Notification submission, which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The "study" in this context refers to the collection of bench testing and risk assessments performed to support this claim.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated numerically for each test. Bench testing involves a certain number of samples, but these are material/device samples, not patient data.
• Data Provenance: The "data" comes from bench testing (laboratory mechanical tests) of the device components and system. It is not clinical data from patients, so concepts like "country of origin" or "retrospective/prospective" patient data do not apply.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This is not a diagnostic AI study involving expert radiologists/pathologists. The "ground truth" for bench testing is derived from established engineering and materials science principles, industry standards (e.g., ASTM F2026 for PEEK), and comparison to the predicate device's known performance.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation of data in the sense of a diagnostic study that would require adjudication. Bench test results are quantitative measurements.

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 not a study of AI assistance or human reader performance.

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

Not applicable. This device is a mechanical surgical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this regulatory submission is based on:

• Performance standards and literature: Established engineering principles, material properties (e.g., ASTM F2026 for PEEK), and industry standards for surgical implants.
• Predicate device performance: The performance of the Responsive Arthroscopy Suture Anchor System (K180951) serves as the primary benchmark.
• Risk assessment: Evaluation against known biological and mechanical risks associated with similar devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of Device and Regulatory Context:

The "Responsive Arthroscopy Knotless Push-In Suture Anchors" are intended for surgical fixation of soft tissue to bone in various joints (shoulder, foot/ankle, hip, knee, hand/wrist, elbow). Key features mentioned are:

• Made of PEEK (polyetheretherketone) per ASTM F2026.
• Available in 3.5mm to 4.75mm diameters.
• Pre-loaded with or accept #2 suture or 2.5mm suture tape (ultra-high molecular weight polyethylene).
• Introduces changes in "suture geometry, anchor body geometry, and internal screw geometry" compared to its predicate.
• Sterilized with ethylene oxide (anchors). Reusable instruments are non-sterile and sterilized by the end-user.

The FDA's determination of substantial equivalence for this Class II device means that, based on the submitted information (primarily bench testing and comparison to the predicate), the new device is as safe and effective as a legally marketed predicate device. This pathway does not typically require clinical trials in the sense of demonstrating new clinical efficacy or diagnostic accuracy with human subjects.

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The Responsive Arthroscopy Large Screw-In Suture Anchors are intended to fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures.
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

The Responsive Arthroscopy Large Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

The Responsive Arthroscopy Small Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures.
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair.

The Responsive Arthroscopy Knotless Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures.
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Bicens Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair,

The Responsive Arthroscopy (RA) Suture Anchor System is a family of suture anchors for the fixation of soft tissue to bone. The system includes a variety of suture anchors made of polyether ether ketone per ASTM F2026 (PEEK) along with repair sutures, inserters, taps, punches, drills, and quide tubes.
The suture anchors are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies. RA Suture Anchors range in diameter from 2.5mm to 5.5mm and are either pre-loaded with or accept #2 suture.
The RA Suture Anchor System implants are pre-loaded on inserters and provided sterile, RA Suture Anchor System single-use instruments are provided sterile, and the RA Suture Anchor System reusable instruments are non-sterile and are to be sterilized by the end user. All RA Suture Anchor System implants and single-use instruments are sterilized with ethylene oxide (EO).

The provided text describes a 510(k) premarket notification for the Responsive Arthroscopy Suture Anchor System. This document outlines the device's indications for use, technological characteristics, and performance testing to demonstrate substantial equivalence to legally marketed predicate devices.

However, the provided text DOES NOT contain information about a study proving the device meets acceptance criteria related to an AI/ML-driven medical device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance (for an AI model).
• Sample sizes, data provenance, expert numbers, adjudication methods, MRMC studies, or standalone algorithm performance, as these are related to the evaluation of AI/ML models.
• Details on ground truth establishment for AI training or test sets.

The document focuses on the substantial equivalence of a physical medical device (suture anchors) based on its mechanical performance and material properties. The performance testing mentioned ("Suture Characterization," "Insertion Torque Testing," "Static & Fatigue Pullout Force Testing," "Suture Locking Force Testing," "Bacterial endotoxin testing") are engineering and biocompatibility tests typical for a physical orthopedic implant, not studies for an AI/ML algorithm.

Therefore, I cannot fulfill the request as it is predicated on the assumption that the provided text describes an AI/ML device and its validation. The content of the document is solely for a physical medical device.

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