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Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.

The SCARF Thread-Head Screw is a threaded bone fixation screw that is 3.0mm in diameter and 10 to 34mm in length (in 2mm increments). It is made of titanium alloy and is cannulated with a threaded head.

The provided text is a 510(k) premarket notification for a medical device called the SCARF Thread-Head Screw. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and device performance.

Therefore, the document does not contain the information requested regarding:

• Acceptance criteria and reported device performance
• Sample sizes for test sets or training sets
• Data provenance
• Number of experts or their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used or how it was established

The document primarily focuses on:

• Device Description: A threaded bone fixation screw, 3.0mm in diameter, 10-34mm in length, made of titanium alloy, cannulated with a threaded head.
• Intended Use/Indications: Fixation of fractures, fusion of a joint, or bone reconstruction of the mid-foot, metatarsals, and phalanges of the foot. (Note: The "Indications for Use" enclosure on Page 3 lists "phalanges, metacarpals and carpals of the hand," which appears to be a discrepancy or an initial proposed indication that was then changed or clarified in the main document. For this response, I'll use the main document's stated indications).
• Predicate Devices: Landos SCARF Thread-Head Screw, Zimmer Herbert-Whipple Bone Screw, and Osteomed M3 Screw.
• Regulatory Classification: Class II, product code 87HWC.
• Substantial Equivalence Determination: The FDA determined the device is substantially equivalent to predicate devices.

Summary of what can be extracted from the document:

The provided text describes a 510(k) submission for a medical device (SCARF Thread-Head Screw). In a 510(k) pathway, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to conduct studies that prove specific performance metrics against pre-defined acceptance criteria as would be typical for a novel high-risk device or an AI/software as a medical device (SaMD) study.

Therefore, the document does not contain a table of acceptance criteria and reported device performance because the submission method relies on demonstrating equivalence to existing devices rather than meeting new, explicit performance thresholds based on a study of the device itself.

The document does not contain the following requested information:

1. A table of acceptance criteria and the reported device performance: Not relevant for a 510(k) submission focused on substantial equivalence to predicate devices, where performance is implicitly similar to predicates.
2. Sample sized used for the test set and the data provenance: No test sets or associated data are described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth for a test set is described.
4. Adjudication method for the test set: Not applicable.
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, as this is a physical implant device, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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