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The RoG 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

• . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications:- Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
• Foot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
• t Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
• Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:

• Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications:- Scapholunate ligament reconstruction. .
• . Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
• Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure. extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is supplied non-sterile and is intended for sterilization by the user facility. It allows the user to secure a suture of his/her selection to the top of the anchor. The anchor is supplied with reusable taps and guides of corresponding sizes.

The provided document is a 510(k) summary for the RoG Suture Anchor, a medical device. It describes the device's technical specifications, intended use, and its equivalence to predicate devices, but it does not contain information about a study involving AI, human readers, or image analysis.

The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on design considerations, materials, performance characteristics (mechanical testing), and indications for use. It typically does not involve the kind of clinical or comparative effectiveness studies with human readers or AI that your request outlines.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI performance, human readers, or ground truth establishment in the way you described, because the provided document does not pertain to such a device or study.

The "Performance Characteristics" section explicitly states: "Both sizes of subject were evaluated in accordance with FDA's Guidance Document for Testing Bone Anchor Devices (4/20/96). Testing consisted of tapping and pull testing with comparison to the corresponding size of predicate devices. The subject device was found to be equivalent to the corresponding sizes of the predicate devices in such testing." This indicates the evaluation was purely mechanical and comparative to existing similar devices.

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The proposed Gryphon T and P BR Anchors are intended for:

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;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;

Hip: Capsular repair, acetabular labral repair.

The proposed Gryphon T and P BR Anchors are absorbable suture anchors manufactured of “Biocryl Rapide” material. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size #2 suture to bone. The suture option is provided without needles. The Gryphon T and P BR Anchors are provided as size 3.0 mm. Each Gryphon T or P BR Anchor is provided sterile and is for single patient use only.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Gryphon T and P BR Anchors:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the Gryphon T and P BR Anchors. Instead, it broadly states that "Results of performance and safety testing have demonstrated that the proposed devices are suitable for their intended use."

The performance testing mentioned is "pull-out performance testing of the sample anchors under real-time aged conditions out to 26 weeks to show that the device meets its product specifications."

Without specific numerical criteria (e.g., "minimum pull-out strength of X Newtons for Y weeks"), a direct comparison table cannot be created.

However, based on the description, a conceptual table would look like this:

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

• Sample Size for Test Set: The text mentions "pull-out performance testing of the sample anchors." It does not specify the exact number (sample size) of anchors used in this testing.
• Data Provenance: The data provenance is internal testing conducted by the manufacturer, DePuy Mitek. The provided document does not indicate the country of origin of the data beyond the company's location in Raynham, MA, USA. It is a prospective study (performance testing of the new device).

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

This section is not applicable to the provided information. The study described is a mechanical performance study (pull-out strength), not a study requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "ground truth" for this type of study is the measured physical performance (e.g., force required for pull-out).

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human expert interpretation to resolve discrepancies in diagnoses or assessments. Since this is a mechanical performance test, there is no human interpretation or adjudication involved in establishing the test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided information describes mechanical performance testing of the device itself, not a study comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device described is a physical bone anchor, not an AI algorithm. Therefore, "standalone algorithm" performance is irrelevant.

7. The Type of Ground Truth Used

The ground truth used for this performance study is objective physical measurement. Specifically, it refers to the measured pull-out performance of the anchors, compared against the "product specifications." This is a direct measurement of the device's mechanical properties, not a subjective assessment, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This section is not applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set" for an algorithm.

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

This section is not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.

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The Healix BR and Gryphon BR Anchors are intended for:
Shoulder: Rotor 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;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

The Healix BR and Gryphon BR Anchors are absorbable threaded suture anchors manufactured of "Biocryl Rapide" material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The Healix BR Anchor is provided in three sizes: one with an outer diameter of 4.5mm. another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The Gryphon BR Anchor is provided as size 3.0mm. The suture options may or may not include tapered needles to facilitate suture passage through tissue. The Healix BR and Gryphon BR Anchors are currently offered with absorbable Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.

1. Acceptance Criteria and Reported Device Performance:

The document provided does not specify explicit acceptance criteria for device performance based on quantitative metrics. Instead, the "Safety and Performance" section states: "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This implies that the acceptance criteria were met by demonstrating substantial equivalence to pre-existing, legally marketed devices.

Therefore, the table would reflect this:

2. Sample Size and Data Provenance:

The document does not provide details on the sample size used for any specific tests or studies. It also does not specify the provenance (e.g., country of origin, retrospective/prospective) of any data used for testing. The statement is general, referring to "performance and safety testing."

3. Number and Qualifications of Experts for Ground Truth:

This information is not provided in the document. The substantial equivalence claim is against predicate devices, not based on expert-established ground truth on a new dataset.

4. Adjudication Method:

This information is not provided in the document. As no specific "test set" with ground truth established by experts is mentioned, adjudication methods like 2+1 or 3+1 are not applicable here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The submission focuses on substantial equivalence to predicate devices rather than direct comparative effectiveness with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

This information is not applicable as the device is a physical bone anchor, not an algorithm or AI-based system. Therefore, an "algorithm only" performance study would not be relevant.

7. Type of Ground Truth Used:

The concept of "ground truth" as typically applied in AI/software evaluation (e.g., expert consensus, pathology, outcome data) is not directly relevant here. The "ground truth" in this context is implicitly the established safety and performance profile of the predicate devices to which this device is compared for substantial equivalence.

8. Sample Size for the Training Set:

This information is not applicable as the device is a physical bone anchor and does not involve AI or algorithms that require a "training set."

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

This information is not applicable as the device is a physical bone anchor and does not involve AI or algorithms that require a "training set."

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