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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 ZIPE® Knotless Tissue Repair and Attachment Devices are intended for fixation of tissue to bone and tissue to tissue.

This product is intended for the following indications:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-● Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction
• . Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
• . Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair
• . Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

The ZipE® Knotless Tissue Repair and Attachment Devices are implantable soft tissue fixation and suture retention devices comprising of a resorbable pledge('button disc ("suture capture"), a titanium screw or biocomposite bone anchor ("plug"), an ultra-high polyethylene (UHMWPE) braided #2 suture having pre-tied half hitched protuberances along its length, a nitinol wire capture holder and a nitinol wire suture shuttle. All components are preloaded onto a stainless steel insertion driver having a TPE tip protector and a silicone O-ring encircling the diameter of the handle to hold the system in place. The implantable elements of the system are the bone anchor, suture and capture; the other components are part of the driver insertion system.

The capture is designed to interact with the knotted suture by locking with the protuberances on the suture so that once advanced across the protuberance, it cannot move backward. Once the anchor is inserted into the bone, the pushed down with the stainless steel driver, traveling forward over the knotted suture, preventing movement in the reverse direction, and thereby locking the repair tissue to the underlying tissue.

The ZipE® Knotless Tissue Repair and Attachment Devices come with all components pre-assembled into the insertion driver and ready to be operated by the user. Products may be sold separately.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the typical format of a medical device submission beyond the non-clinical testing listed. The document is an FDA 510(k) clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a clinical study with an AI component.

Here's a breakdown of what can be extracted and what is missing:

Information that can be extracted from the provided text:

• Device Name: ZipE® Knotless Tissue Repair and Attachment Devices
• Non-clinical Testing Performed:
  • Bench testing (Static pullout testing, Cyclic pullout testing, Degradation testing, Insert Torque testing)
  • Biocompatibility testing (Systemic toxicity, Reverse mutation, Intracutaneous injection, Kligman maximization, Micronucleus assay, Lymphoma mutagenesis, Intramuscular implantation, Pyrogen test, Systemic injection test, MEM elution test, Neutral red uptake test)
  • Sterilization validation (Bioburden, EO residual testing, Endotoxin (LAL) Validation)
  • Package and transportation testing (Transportation validation, Packaging testing, Accelerated aging)

Information that is not available in the provided text, as it pertains to AI-enabled device studies and clinical performance:

• A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, AUC thresholds) or report device performance against such criteria. The reported performance is only a list of non-clinical tests.
• Sample sized used for the test set and the data provenance: Not applicable as no clinical study or AI performance evaluation is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Testing: None provided as a basis for substantial equivalence."
• 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 an AI algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

This document describes a traditional 510(k) clearance for a physical medical device (tissue repair and attachment devices), not an AI-enabled medical device. Therefore, the questions related to AI-specific performance criteria, ground truth, expert review, and clinical study designs (like MRMC) are not addressed by this submission. The "acceptance criteria" for this device were likely based on the successful completion of the listed non-clinical tests, demonstrating that the device meets safety and performance standards equivalent to predicate devices within an engineering context (e.g., pullout strength exceeding a certain threshold), rather than statistical performance metrics for diagnostic or prognostic accuracy.

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