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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, Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair), 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 plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle indications.

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.

The provided text appears to be an FDA 510(k) summary for a medical device called the "GRAPPLER Suture Anchor System." It outlines the device's intended use, description, and the performance testing conducted to demonstrate its substantial equivalence to a predicate device.

However, the provided document does not contain information about an AI/ML-based device or a study proving its performance against acceptance criteria in the context of AI/ML. It focuses on a mechanical medical device (suture anchor system) and its physical and mechanical properties.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML-based device, a comparative effectiveness study with human readers, or details regarding training/test sets for an AI model, as this information is not present in the provided text.

The document discusses performance testing for a physical device, which includes:

• Torsional Yield per ASTM F543
• Insertion and Removal Torque per ASTM F543
• Pullout Strength per ASTM F543
• Analysis for Suture Abrasion
• USP Monograph (including USP and USP )
• Suture Tape Relaxation Evaluation
• Fatigue Testing according to FDA Guidance Bone Anchors - Premarket Notification (510(k)) Submissions
• Device shelf life validation (seal strength, visual inspection, dye penetration, pressurization evaluations)
• Device sterility validation (bioburden testing)
• Pyrogenicity verification (bacterial endotoxin (LAL) testing)

The document states that "All performance testing conducted for the GRAPPLER Suture Anchor System met the predetermined acceptance criteria or were otherwise considered acceptable." However, it does not detail what those specific numerical acceptance criteria were for each test.

To summarize, based solely on the provided text, I cannot answer your request as it pertains to an AI/ML device. The document describes a traditional medical device submission.

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The Parcus Actiflip is used for fixation of bone or soft tissue to bone, and is intended as a fixation post, 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 repari (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

The Parcus ActiFlip is also intended for fixation of suture (soft tissue) to bone in the foot and ankle for midfoot reconstruction and hindfoot reconstruction with the following procedures: FHL Tendon Transfer, Posterior Tibialis Tendon Transfer, Anterior Tibialis Tendon Transfer.

The Parcus ActiFlip device consists of a titanium implantable button that is mounted onto an inserter shaft that allows for placement and deployment of the button. ActiFlip is available in three (3) configurations, with or without UHMWPE suture – Naked (without suture), CINCH, WHIP.

The provided text is a 510(k) summary for the Parcus ActiFlip device. It outlines the device's indications for use, its characteristics, and how its substantial equivalence to predicate devices was established. However, it explicitly states that "Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices" and that "Performance was established based on acceptance criteria with the rationale that the new specific indications...do not introduce a worst-case for mechanical performance of the subject device."

This type of submission for a medical device (a 510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance through a clinical trial with specific performance metrics and acceptance criteria for algorithm-based diagnostic or prognostic devices.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-driven diagnostic devices. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance: No such table or performance metrics are provided. The "performance" mentioned refers to mechanical performance, not diagnostic accuracy.
2. Sample size used for the test set and data provenance: No test dataset details are given.
3. Number of experts used to establish ground truth and qualifications: Not applicable as there's no clinical data or ground truth establishment for a diagnostic study.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was performed or is mentioned.
6. Standalone (algorithm-only) performance: Not applicable as this is a physical implant, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as there's no algorithm training mentioned.
9. How ground truth for the training set was established: Not applicable.

The document describes a physical medical device (a fixation fastener), not an AI/ML-driven diagnostic or image analysis tool. The "performance" mentioned is mechanical validation (implicitly, by showing it's not a 'worst-case' scenario compared to predicates), not the type of performance evaluation relevant to AI diagnostics.

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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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