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The Synthes 1.0mm Ti. Cortex, Self-drilling screws are intended for fracture fixation in hand surgery and neurosurgery.

The 1.0mm Ti. Cortex Screws are self-drilling, have a flat head profile with rounded edges with a cruciform recess, and are available in lengths from 2 -- 4 mm.

This document is a 510(k) Summary and FDA clearance letter for a medical device, the Synthes 1.0mm Ti. Cortex, Self-drilling Screws. It does NOT contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) process for medical devices like this typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo study with acceptance criteria in the same way one might for a novel AI/software device.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on:

• Sponsor and Device Information: Synthes (USA), 1.0mm Ti. Cortex, Self-drilling Screws.
• Intended Use: Fracture fixation in hand surgery and neurosurgery.
• Classification: 21 CFR 888.3040 (Smooth or Threaded Metallic Bone Fixation Fastener), Class II.
• Predicate Devices: Synthes 1.0 / 1.2 mm Plusdrive Screws and KLS Martin 1.0mm System Center-Drive Screw System.
• Substantial Equivalence: The primary claim is that the device is substantially equivalent to existing legally marketed devices, meaning it has the same intended use, technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness.

There are no details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

These kinds of details are typically pertinent to the evaluation of software as a medical device (SaMD) or AI-based devices, which are not applicable to the physical bone screw described here.

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