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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 KATOR Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repairs, 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

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

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

Hip: Capsular Repair, Acetabular Labral Repair.

The KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair suture tape within the implant.

The applicant is seeking 510(k) clearance for the KATOR Suture Anchor, a device designed to attach soft tissues to bone. The submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics comparison and nonclinical testing.

Here's an analysis of the provided information, structured to address your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for the individual nonclinical tests (Insertion, Pullout Strength, Cyclic Displacement, Pyrogenicity). It only mentions that "All testing was performed on test units representative of finished devices."

Data provenance is not explicitly stated as retrospective or prospective, but considering it's nonclinical testing of a device, it would inherently be prospective testing performed in a controlled laboratory environment. There's no mention of country of origin for the data, but the manufacturer is based in Logan, Utah, USA, suggesting the testing was likely conducted in the US or by a US-affiliated lab.

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

This question is not applicable to this submission. The KATOR Suture Anchor is a physical medical device, and its performance is evaluated through mechanical and biocompatibility testing, not through interpretations requiring expert consensus or ground truth derived from expert opinions (as would be the case for AI/software devices or diagnostic tools). The "ground truth" here is defined by engineering and biological standards.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons above. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human experts when establishing ground truth, typically in the context of diagnostic or interpretive tasks. The nonclinical tests here have objective pass/fail criteria based on predefined specifications.

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

An MRMC study was not applicable and therefore not performed. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging or similar fields where human interpretation is a key component. The KATOR Suture Anchor is a physically implanted medical device, and its safety and effectiveness are determined by objective mechanical and biocompatibility tests, not by human reader performance.

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

This question is not applicable. The KATOR Suture Anchor is a physical medical device, not an algorithm or software. Therefore, there is no "standalone algorithm performance" to evaluate.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the nonclinical tests conducted:

• Mechanical Tests (Insertion, Pullout Strength, Cyclic Displacement Testing): The ground truth is established by engineering specifications and industry standards. The device is subjected to forces and movements, and its response is measured against predefined thresholds for strength, displacement, and ease of insertion.
• Pyrogenicity (BET Test): The ground truth is established by biological safety standards for pyrogen limits. The test measures the presence of pyrogens, and the result is compared against a specified limit to determine if the device meets safety requirements.

8. The Sample Size for the Training Set

This question is not applicable. The KATOR Suture Anchor is a physical medical device, and its development and testing do not involve "training sets" in the context of machine learning. The design and manufacturing processes are based on engineering principles and material science, not data training.

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

This question is not applicable for the same reasons as #8. There is no training set for a physical medical device.

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