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The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm.

The SINEFIX is a PEEK implant which can be used to re-attach a ruptured rotator cuff tendon to the humerus of the shoulder. The implant can be used to re-attach complete or partially ruptured tendons up to 2 cm to facilitate the healing of the natural bone-tendon interface. The implant consists of a baseplate with a lateral and a medial anchor. The baseplate is placed over the tendon and attached to the humerus with the anchors. The medial anchor goes through the tendon, while the lateral anchor goes directly into the bone, lateral of the tendon.

The provided document is a 510(k) summary for a medical device called SINEFIX, a PEEK implant for soft tissue to bone reattachment in rotator cuff repairs. This document does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the non-clinical testing of a physical implant.

Therefore, many of the requested categories for AI/ML device studies cannot be answered from this document. However, I can provide information based on the non-clinical testing for the physical SINEFIX device.

Here's a breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test and then provide the exact performance results in a consolidated table. Instead, it lists the types of tests performed and concludes that the results demonstrate substantial equivalence.

Implied Acceptance Criteria (based on the type of tests performed and the conclusion of substantial equivalence):

• Mechanical Performance: The device must perform comparably to predicate devices in terms of mechanical strength, pullout strength, and response to cyclic loading. This would imply meeting or exceeding the mechanical properties of the predicate devices or relevant ASTM/ISO standards.
• Biocompatibility: The device must be biocompatible, meaning it does not cause adverse biological reactions. The acceptance criterion is compliance with ISO 10993-1.
• Sterilization: The device must be able to be effectively sterilized to a sterility assurance level (SAL) of 10^-6. Acceptance criterion is compliance with ISO 11137-1/2.
• Packaging: The packaging must maintain sterility and product integrity for the stated shelf life. Acceptance criterion is compliance with ISO 11607-1/2.
• Reprocessing (for reusable instruments): Reusable instruments (if any are associated with the implant) must be able to be reprocessed effectively. Acceptance criterion is compliance with the FDA guidance on reprocessing medical devices.

Reported Device Performance:

The document states: "Results of the performed tests demonstrate that the SINEFIX are substantially equivalent to legally marketed predicate devices." This is the overarching reported performance. Specific numerical results are not provided in this summary.

2. Sample size used for the test set and the data provenance

For the non-clinical tests (insertion, pullout, cyclic loading, static tensile, dynamic testing, pyrogenicity, endotoxins, packaging, biological evaluation, sterilization validation, reprocessing validation), the sample sizes are not specified in this 510(k) summary. These tests are performed in a laboratory setting (not on human data), so terms like "country of origin of the data" or "retrospective/prospective" are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the tests are non-clinical (mechanical, biological, sterility, etc.) and do not involve "ground truth" derived from expert interpretation of medical images or patient data. The interpretation of results would be done by laboratory personnel according to established scientific and engineering standards and protocols.

4. Adjudication method for the test set

Not applicable, as there is no "test set" in the context of human data or expert review. Non-clinical tests follow laboratory protocols and standards.

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 for a non-AI/ML physical implant, not a diagnostic or prognostic AI tool.

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

Not applicable. This is for a non-AI/ML physical implant.

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

Not applicable for a physical implant's mechanical or material performance. "Ground truth" for these types of tests refers to established physical properties, chemical composition, and performance against defined standards (e.g., maximum load at failure, sterility assurance level).

8. The sample size for the training set

Not applicable. This is for a non-AI/ML physical implant, so there is no "training set."

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

Not applicable. This is for a non-AI/ML physical implant, so there is no "training set" or "ground truth" in that context.

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The Arthrex TensionLocTM System is indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.

The Arthrex TensionLocTM System is a two-component system comprised of a polyetheretherketone (PEEK) plug and a mating collar for suture fixation within a bone tunnel.

The primary differences between the Arthrex TensionLocTM System and the predicate device are the geometry and material. The proposed Arthrex TensionLocTM System contains a ribbed outer edge collar and plug as opposed to the predicate geometry of a double spiked plate and cannulated post. The Arthrex TensionLocTM System is also manufactured of PEEK material whereas the predicate is manufactured from titanium. The Arthrex Tension LocTM System will offer external diameters of 11, 14, and 16 as opposed to the 13-22 mm range of the predicate. The Arthrex TensionLocTM System is 9.1 mm in length as opposed to the various lengths of the predicate (24-40 mm).

This document outlines the FDA's 510(k) clearance for the Arthrex TensionLocTM System, a medical device for orthopedic procedures. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of an AI/ML product's performance against acceptance criteria. Therefore, most of the requested information regarding AI/ML study design, acceptance criteria, multi-reader studies, and ground truth establishment is not applicable or cannot be extracted from this document.

However, I can extract information related to the device's performance testing from the "Performance Data" section of the 510(k) Summary.

Here's the relevant information that can be extracted:

• Device Name: Arthrex TensionLocTM System
• Purpose: Fixation of soft tissue (tendons and ligaments) to bone in orthopedic procedures.
• Predicate Device: K994202: Acufex® Washer System

Since this is a mechanical device clearance and not an AI/ML product, the questions related to AI/ML specific study design (e.g., sample size for test/training set, number of experts, MRMC studies, ground truth establishment for AI) are not directly addressed.

The "Performance Data" section details the studies conducted to demonstrate safety and effectiveness for this type of medical device:

1. Acceptance Criteria and Reported Device Performance (Table):

Performance Conclusion: "The submitted mechanical testing data demonstrates that the performance of the proposed devices meets or exceeds the predicate device for the desired indications."

2. Sample size used for the test set and the data provenance: Not explicitly stated for each test, but typically, these tests involve a defined number of device samples manufactured under controlled conditions. The data provenance is internal to the manufacturer (Arthrex Inc., Naples, FL). The study is prospective in the sense that the tests are designed and executed specifically for this regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical and biocompatibility testing of a physical medical device, "ground truth" is established through standardized testing protocols, material specifications, and comparison to predicate device performance, not expert human interpretation.

4. Adjudication method for the test set: Not applicable. Testing results are quantitative and objective, not subject to human adjudication in the context of diagnostic interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML diagnostic device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not a software algorithm.

7. The type of ground truth used:
* Mechanical Performance: Comparison to "predicate device performance" (implied "gold standard" of a previously cleared device) and meeting specified mechanical properties.
* Biocompatibility: Adherence to ISO 10993-1 standards, which involve in vitro and in vivo tests for cytotoxicity, sensitization, irritation, etc.
* Sterilization: Adherence to ISO 11135:2014 standards, ensuring a specified sterility assurance level (SAL).
* Pyrogenicity: Meeting bacterial endotoxin limits specified by pharmacopeial standards (EP/USP).

8. The sample size for the training set: Not applicable. This is not an AI/ML product that undergoes a "training" phase with data.

9. How the ground truth for the training set was established: Not applicable. No training set is used for this type of device.

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The Responsive Arthroscopy Interference Screws are intended to be used for fixation of tissue including ligament, tendon, soft tissue, or bone to bone. Interference fixation with PEEK or Titanium Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, and hand/wrist where the sizes offered are patient appropriate. Specifically, screws are intended for use 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, Anterior Shoulder Instability

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle, Bunionectomy

Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, 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, Lateral Epicondylitis Repair

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint

The Responsive Arthroscopy (RA) Interference Screw System is a family of interference screws for the reattachment and fixation of tissue including ligament, tendon, soft tissue, or bone to bone. The system includes cannulated interference screws in both polvether ether ketone (PEEK) per ASTM F2026 and Ti-6AI-4V ELI titanium alloy per ASTM F136, along with drivers, taps, and guide wires for screw insertion.

The screws are available in a variety of sizes to accommodate various procedures and patient anatomies. RA PEEK Interference Screws are offered with diameters from 7-12mm and lengths from 20-35mm. RA Titanium Interference Screws are offered with diameters from 7-10mm and lengths from 20-35mm.

The RA Interference Screw System implants are provided sterile, and the RA Interference Screw System instruments are non-sterile and are to be sterilized by the end user. The RA PEEK Screws are sterilized with ethylene oxide (EO). The RA Titanium Interference Screws are sterilized with gamma radiation.

The provided text describes the 510(k) premarket notification for the "Responsive Arthroscopy Interference Screw System." This document is a regulatory submission to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. It focuses on the device's design, materials, indications for use, and performance testing to support this claim.

However, the text does not contain the specific information requested about acceptance criteria and study details related to an AI/ML device. The document is about a mechanical surgical screw system, not an AI/ML-driven diagnostic or treatment device. Therefore, I cannot provide the requested details using the provided input.

The sections for acceptance criteria, study design, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information are not applicable to the submitted document.

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