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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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: The document does not specify the number of screws or test specimens used for the mechanical testing (Static Torsion, Insertion/Removal Torque, Axial Pullout). It mentions "representative Tenodesis Screw System components."
• Data Provenance: The data is generated from laboratory mechanical testing of the device components, not from patient studies. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable in the context of this device's testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is a mechanical implant, not an AI/SaMD requiring ground truth established by medical experts for diagnostic accuracy. The "ground truth" for mechanical testing is based on engineered specifications and material science, verified through standardized testing methods (e.g., ASTM F543) conducted by qualified engineers/technicians in a laboratory setting.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are relevant for clinical studies or studies involving human judgment (like image interpretation). This device's performance is verified through objective mechanical measurements, not subjective human assessment needing adjudication.

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 not an AI/SaMD device. No MRMC study was conducted or is relevant for this type of mechanical implant.

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

• Not Applicable. This is not an AI/SaMD device. There is no algorithm to test for standalone performance.

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

• The "ground truth" for this device's performance is established by engineering standards (e.g., ASTM F543) and material properties. The device is expected to meet specific quantifiable mechanical performance metrics (e.g., torque, pullout strength) as stipulated by these standards and comparison to the predicate device. It's based on objective physical measurements rather than clinical or pathological "ground truth."

8. The sample size for the training set

• Not Applicable. This is not an AI/SaMD device. There is no "training set" as it does not involve machine learning.

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

• Not Applicable. This is not an AI/SaMD device. There is no training set or associated ground truth establishment methods relevant to AI.

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