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The Headless Compression Screw System Micro-2.8 screw fasteners are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

The Headless Compression Screw System Mini-3.9 screw fasteners are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation.

The screw fasteners are intended for single use only and may not be reused under any circumstances.

The system drills and guide wires are single use instruments.

The OsteoCentric Extremities Headless Compression Screw System within the product line of SMV Scientific Cannulated Screws consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided nonsterile. The subject headless compression screws are manufactured from Titanium per ASTM F136. The Headless Compression Screw System fasteners are offered in diameters of Ø2.8mm or Ø3.9mm and lengths from 12mm to 50mm.

This document describes a 510(k) premarket notification for a medical device, specifically the "Headless Compression Screw System." It does not contain information about software, AI, or diagnostic performance studies that would involve acceptance criteria, test sets, expert ground truth, or statistical analyses typically associated with AI/ML medical devices.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on the substantial equivalence of a physical medical device (screws) to legally marketed predicate devices based on identical or nearly identical technological characteristics, materials, principles of operation, and indications for use. Performance testing summarized here relates to mechanical testing (e.g., to ensure modifications introduce no new worst-case scenarios for mechanical performance), not diagnostic or interpretative performance.

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