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The GRAPPLER™ Suture Anchor System is intended for the fixation of soft tissue to bone including:

Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC

Foot/Ankle: Lateral Stabilization (Brostrom-Gould, Chrisman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid Repair, Spring Ligament Reconstruction), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair

Hip: Capsular Repair, Acetabular Labral Repair

The GRAPPLER™ Suture Anchor System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The anchors are provided in PEEK, titanium, and suture materials in multiple sizes and lengths. Each anchor is accompanied by round suture or suture tape composed of UHMWPE and PGLA.

This document is for a medical device called the "GRAPPLER™ Suture Anchor System," which is a physical device used to fix soft tissue to bone. It is not an AI/ML powered device, and therefore, does not have the types of acceptance criteria and study designs that would typically apply to such devices (e.g., diagnostic performance metrics like sensitivity, specificity, AUC, or MRMC studies for human-in-the-loop performance).

The document details the substantial equivalence determination for this device, comparing it to legally marketed predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and material testing to ensure the device performs as intended and is safe, rather than clinical performance studies measuring diagnostic accuracy or reader improvement.

Analysis of Acceptance Criteria and Device Performance (Based on Provided Text):

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not present the acceptance criteria in a formal table with specific numerical values or targets. Instead, it describes the types of tests performed and states that "All performance testing conducted for the GRAPPLER™ Suture Anchor System met the predetermined acceptance criteria or were otherwise considered acceptable."

Here's an interpretation based on the text:

Notes:

• The document states: "The device performance was characterized via torsional strength, insertion/removal torque, pullout testing and tensile testing."
• "Device shelf life was validated through real time and accelerate aging events assessed with seal strength, visual inspection, dye penetration, pressurization evaluations."
• "Device sterility was validated through bioburden testing. Pyrogenicity was verified through bacterial endotoxin (LAL) testing."

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

• Sample Size: The document does not specify the sample sizes (e.g., number of anchors tested) for each of the performance tests (torsional strength, tensile, etc.). It only mentions that "All testing was performed on finished devices."
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The data provenance refers to the results of in-house or contracted laboratory mechanical and material testing. The country of origin of this testing data is not specified. It is inherently "prospective" in the sense that the tests were conducted specifically for this submission.

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

• Not applicable. This is a physical device, and its acceptance criteria are based on engineering and material performance standards, not on expert consensus for clinical interpretations or diagnoses.

4. Adjudication Method for the Test Set:

• Not applicable. Ground truth for mechanical testing is established by direct measurement against engineering specifications, not through expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is typically performed for AI-powered diagnostic devices to assess how the AI assists human readers. This device is a physical surgical implant, so an MRMC study is not relevant.

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

• Not applicable. This is not an algorithm. The "standalone performance" refers to the mechanical and material performance of the device itself (e.g., its tensile strength, resistance to torque), which was indeed assessed through the tests mentioned.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's acceptance is based on engineering specifications and established material and mechanical testing standards. For example, a suture anchor must withstand a certain pullout force, or its material must have a certain tensile strength. These are objective, measurable criteria, not subjective interpretations.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. As there is no training set for an AI/ML model, there is no corresponding ground truth establishment process.

Summary for this Specific Device:

The provided document is a 510(k) clearance letter for a physical medical device (suture anchor). The "acceptance criteria" and "study" described pertain to engineering and material performance testing, rather than clinical diagnostic performance or AI model validation. The FDA granted clearance based on the device demonstrating substantial equivalence to existing predicate devices, supported by data showing it meets relevant mechanical, material, sterility, and shelf-life requirements. The type of information requested in the prompt (e.g., MRMC studies, training/test sets for AI, expert adjudication) is typically relevant only for AI/ML-powered medical devices.

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The HEALIX ADVANCE Anchor is indicated for use in soft-tissue-to-bone fixation in association with postoperative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

The proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a line extension to the currently marketed HEALIX ADVANCE™ Anchor family. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is available in absorbable BR and non-absorbable PEEK materials. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is provided sterile and is for single use only.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study of acceptance criteria and performance for a novel AI/software device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not present in the provided text. The document describes a traditional medical device (suture anchor) and its non-clinical testing for safety and effectiveness, not a computational device with performance metrics typically found in AI/software submissions.

Specifically, the document states:

• Non-clinical Testing: "Device safety and effectiveness is supported by non-clinical testing performed on the proposed device and / or its predicate. Performance testing included straight and knot tensile strength, suture approximation force, anchor fixation post cyclic loading and sterility."
• Safety and Performance: "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. Based on similarities in the indications for use, technological characteristics, and performance in comparison to the predicate devices, the proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act."

This indicates that the "acceptance criteria" were essentially demonstrating equivalence to existing predicate devices through mechanical performance testing relevant to a physical suture anchor, as opposed to accuracy, sensitivity, or specificity metrics for an AI system.

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