(60 days)
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.
| Acceptance Criterion Type | Specific Acceptance Criterion (from document) | Reported Device Performance (from document) |
|---|---|---|
| Mechanical Performance | Meet requirements of ASTM F543 for: | "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." (Implies acceptance criteria were met, but specific values are not disclosed in this summary) |
| - Static Torsion | ||
| - Static Insertion and Removal Torque | ||
| - Static Axial Pullout Testing | ||
| Biocompatibility | Bacterial Endotoxin Limit: |
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.