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The Tenodesis Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically: 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 Midfoot Reconstruction Metatarsal Ligament Repair Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction. Knee: Anterior Cruciate Ligament Repair Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Patellar Tendon Repair Posterior Oblique Ligament Repair Illiotibial Band Tenodesis Elbow: Biceps Tendon Reattachment Ulnar or Radial Collateral Ligament Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction Ulnar Collateral Ligament Reconstruction Radial Collateral Ligament Reconstruction Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) Carpal Ligament Reconstructions and repairs Ligament Reconstruction and Tendon Interposition.

The Tenodesis Screw System is composed of a screw manufactured from polyetheretherketone (PEEK). They are fully threaded, cannulated anchors with a flat head. The screws are provided in multiple lengths and sizes to accommodate variations in patient anatomy.

The provided text is a 510(k) summary for a medical device called the "Tenodesis Screw System." It describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence.

Based on the nature of this document (510(k) summary for a mechanical orthopedic implant), the information requested in your prompt regarding acceptance criteria and study design for an AI/Software as a Medical Device (SaMD) is largely not applicable. This document details the mechanical, material, and performance testing for a physical implant, not an AI-driven diagnostic or assistive tool.

Therefore, for aspects related to AI/SaMD studies (like sample size for test sets, expert consensus, MRMC studies, training set details, etc.), the answer will be that this information is not relevant or not present in the provided document, as it deals with a different type of medical device.

I will address each point of your query based on the information available in the provided text.

Acceptance Criteria and Study for the Tenodesis Screw System

The "Tenodesis Screw System" is a mechanical implant designed for soft tissue reattachment, primarily fixation of ligament and tendon graft tissue. Its performance is evaluated through mechanical testing, not clinical studies involving AI or human interpretation of images.

1. A table of acceptance criteria and the reported device performance

The document states:
"All necessary testing has been performed on representative Tenodesis Screw System components to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished Tenodesis Screw System implants. The device performance was characterized via Static Torsion, Static Insertion and Removal Torque, and Static Axial Pullout Testing per ASTM F543. Clinical data are not needed to support the safety and effectiveness of the subject devices."

The specifics of acceptance criteria (e.g., minimum torque values, maximum displacement) and reported device performance (e.g., actual measured values) are not explicitly provided in this 510(k) summary table. This summary states that the device meets the criteria (by demonstrating substantial equivalence) but does not list the numerical targets or results. The testing was conducted according to ASTM F543, which is a standard specification for metallic medical bone screws. Compliance with this standard implies that specific mechanical properties were tested and met, but the precise numbers are proprietary and typically found in the full submission, not the public summary.

Additionally, a "Bacterial Endotoxin Test has been conducted on the subject device and it meets the specified 20 EU/Device limit." This is an acceptance criterion for biocompatibility.

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The Tenodesis screws are intended for soft tissue reattachment procedures in foot surgery.

The system is indicated for soft tissue reattachment procedures in foot surgery, such as tendon reconstructions and tendon transfers.

The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.

The Tenodesis screw system is intended for soft tissue reattachment procedures in foot surgery. The screws are made of titanium alloy Ti-6AI-4V (ASTM F136). They are threaded, fully cannulated anchors.

The implants are offered in various sizes. The implants are provided non-sterile and single-use only.

The Tenodesis instruments are non-sterile and reusable.

Based on the provided text, the device in question is a "Tenodesis screw system." This document is a 510(k) submission, which focuses on demonstrating substantial equivalence to pre-existing predicate devices rather than proving performance against specific acceptance criteria in a traditional clinical study format for a novel device. Therefore, many of the requested categories for a study proving acceptance criteria will not be directly applicable or available in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, formal "acceptance criteria" for a novel device performance study are not explicitly stated. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through mechanical testing and biocompatibility.

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

The document does not specify the exact sample sizes for the mechanical and biocompatibility tests. It states that "Biocompatibility testing on the plates was conducted and evaluated per ISO 10993-1" and "Self-tapping performance, driving, torsional properties and axial pullout strength of the Tenodesis screw system and the predicate devices resulted in similar mechanical properties and performance." The data provenance is from the manufacturer's internal testing as part of the 510(k) submission. No information on country of origin of data or retrospective/prospective status is available for these non-clinical tests.

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

This information is not applicable. The evaluations (biocompatibility and mechanical properties) rely on established international standards (ISO 10993-1) and direct physical measurements, not expert interpretation of data points that require a "ground truth" established by human experts in the sense of a clinical trial.

4. Adjudication method for the test set

Not applicable, as this is not a human-adjudicated clinical study. The evaluations are based on objective test results against established mechanical and biological performance parameters.

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 a medical device (screw system), not an AI diagnostic or assistance tool. Therefore, an MRMC study and AI improvement metrics are not relevant.

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

Not applicable. This is a physical medical device.

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

For biocompatibility, the ground truth is compliance with the requirements of ISO 10993-1. For mechanical properties, the "ground truth" is measured physical properties that are comparable to those of the predicate devices, implying that the established performance of the predicate serves as the benchmark. No clinical "ground truth" (pathology, outcomes data) was used or required for this 510(k) submission.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

Not applicable, for the same reason as point 8.

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