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The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

The Healix Compression Screw (HCS) System consists of cannulated, solid titanium allov. headless, headed screws and specialized instrumentation. This submission expands the Healix offering and includes longer screws ranging from 31 to 130mm in length for the 2.0 to 7.5mm diameters.

The provided text is a 510(k) summary for the Nvision Biomedical Technologies' Healix Compression Screw System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML or diagnostic performance.

Instead, this document is a regulatory submission for a physical medical device (bone fixation screws) and relies on mechanical performance characteristics and a comparison to existing predicate devices.

Therefore, I cannot extract the requested information (items 1-9) as it pertains to AI/ML device performance from the provided text. The document clearly states:

• "No FDA performance standards have been established for the Healix Compression Screw System."
• "The following was performed to demonstrate safety per methods of the previous submission: . Engineering analysis comparison of mechanical performance characteristics"
• "The results of the engineering analysis indicate that the Healix Compression Screw System is substantially equivalent to the predicate devices."

This indicates the evaluation was based on engineering analysis and comparison against physical predicate devices, not on a study proving a device meets acceptance criteria related to diagnostic performance, human-in-the-loop improvements, or ground truth establishment for AI/ML.

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The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

The Healix Compression Screw (HCS) System consists of 2.0mm to 8.5mm cannulated, solid titanium alloy, headless, headed screws and specialized instrumentation. The screw system has multiple lengths depending on diameter of the screws.

The provided text is related to a 510(k) premarket notification for the "Healix™ Compression Screw System." It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical testing.

However, the document does not contain information about:

• Acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) for a diagnostic or AI-driven device.
• A study that proves the device meets specific acceptance criteria in terms of clinical performance because this device is a bone fixation fastener, not an AI or diagnostic tool.
• Sample sizes used for test sets or training sets in the context of AI or diagnostic algorithms.
• Data provenance, expert qualifications, or adjudication methods for ground truth, which are relevant for AI/diagnostic studies.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• The type of ground truth used for AI/diagnostic algorithms.
• How ground truth for a training set was established.

Instead, the document focuses on non-clinical testing to demonstrate the safety and effectiveness of the bone fixation screw system, establishing its substantial equivalence to previously cleared predicate devices.

Here's what can be extracted and what is missing relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail values for specific performances, but implied as meeting industry standards and being comparable to predicate devices. The tests performed are described.
• Reported Device Performance:
  • Torsion, driving torque, and axial pullout (per ASTM F543)
  • Static and dynamic bending (per ASTM F1264)

The "results of these tests, as well as engineering analysis of device characteristics, indicate that the HEALIX Compression Screw System is substantially equivalent to the predicate devices." This implies that the device met the performance expected for these tests and was found to be comparable to or better than the predicate devices, thereby satisfying the implicit acceptance criteria of substantial equivalence.

2. Sample Size for Test Set and Data Provenance: Not applicable in the context of this device and testing. The testing described is mechanical (physical properties of the screws), not clinical data-based.

3. Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in this context, refers to the reference standard for clinical performance in AI/diagnostic studies. Here, the "ground truth" is adherence to established mechanical testing standards and comparison to predicate devices, assessed by engineers and regulatory bodies.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This is a mechanical device, not an AI or diagnostic reading system.

6. Standalone (Algorithm Only) Performance Study: No.

7. Type of Ground Truth Used: The ground truth for this device's evaluation is primarily based on engineering standards (ASTM F543, ASTM F1264) and comparison to the established performance of legally marketed predicate devices.

8. Sample Size for the Training Set: Not applicable. This document does not describe an AI/diagnostic device with a training set.

9. How the Ground Truth for the Training Set was Established: Not applicable.

In summary, the provided document describes a mechanical device (bone fixation fastener) and its regulatory clearance based on non-clinical physical testing and comparison to predicate devices, rather than a diagnostic or AI device and its clinical performance evaluation. Therefore, most of the requested information regarding acceptance criteria and studies that prove the device meets acceptance criteria for AI/diagnostic devices is not present.

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