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Fractures or Arthrodesis of Carpals and Metacarpals, Radial Head and Radial Styloid Fractures, Metatarsal Fractures and Osteotomies of the Forefoot, and Intra-articular arthrodesis in the wrist.

a series of titanium allov screws, commercially pure or TMZF allov, available in a 2.7mm diameter and lengths of 10mm to 40mm. The screws are available with or without washers(used to prevent the head of the screw from sinking into osteoporotic bone), and are cannulated, fully threaded, and self-tapping.

This appears to be a 510(k) summary for a medical device (Resch Fixation Screw) submitted in 1997. The information requested (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is typically associated with the evaluation of AI/ML-driven medical devices, particularly those involving diagnostic or prognostic algorithms.

The provided document describes a traditional medical device, a bone fixation screw, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as:

• Acceptance criteria table with reported device performance (in terms of AI metrics)
• Sample sizes for test sets, training sets, data provenance
• Number of experts, qualifications, adjudication methods for ground truth
• MRMC studies, standalone algorithm performance
• Type of ground truth (expert consensus, pathology, outcomes data)

do not apply to this specific device.

Instead, the "study" for a traditional device like the Resch Fixation Screw typically involves:

1. Bench Testing: Mechanical testing to ensure strength, fatigue resistance, and other physical properties meet established standards for orthopedic implants.
2. Biocompatibility Testing: Ensuring the materials are safe for implantation in the human body.
3. Sterilization Validation: Confirming the sterilization process effectively renders the device sterile.
4. Substantial Equivalence Argument: Comparing the device's design, materials, manufacturing, and intended use against legally marketed predicate devices to demonstrate it is at least as safe and effective. This is the primary "proof" for 510(k) clearance.

The provided document specifically states: "The substantial equivalence of the Resch Fixation Screw is based on an equivalence in design, materials, intended use, and operational principles to Synthes' 3.0mm & 3.5mm Cannulated Screw Systems, Alphatec's Mini Lag Screw System, and Howmedica's Alta Modular Small Bone Plating System and Cfx Intramedullary Rod and Screw System."

This sentence is the core of the "study" and "acceptance criteria" for this type of device in the context of a 510(k) submission. It's not about statistical performance metrics like sensitivity or specificity relative to a ground truth, but rather about demonstrating comparable safety and effectiveness to existing, legally marketed devices.

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