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The Axis Charcot Fixation System in diameters of 4.5 to 8.5mm is indicated for reconstruction procedures, non-unions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).

The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloy fixation beams and accessories used for midfoot reconstruction. The modified device adds additional sizes, 4.5 and 8.5mm cannulated, titanium alloy fixation beams, previously cleared under Extremity Medical's 4.5 to 8.5 Screw System (K171018). The additional sizes offer the surgeon options for placement based on patient anatomy.

The provided text is a 510(k) summary for the Axis Charcot Fixation System, a medical device. It does not include information about AI/ML device performance, acceptance criteria, or studies involving human readers, as it describes a bone fixation system.

Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device evaluation.

However, based on the provided text, I can infer the following:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative manner typical for AI/ML performance. Instead, it refers to "engineering analyses evaluating mechanical strength" and "pullout strength". The performance determined was "substantially equivalent to the predicate devices for the intended use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The testing described is mechanical, not involving patient data or a "test set" in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The "ground truth" for this device would be established through engineering standards and physical measurements, not expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Mechanical testing does not involve adjudication.

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

No such study was performed or is relevant to this device. This device is a physical bone fixation system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. This device is a physical bone fixation system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on engineering standards and physical measurements of mechanical properties (strength, pullout force).

8. The sample size for the training set

This information is not applicable and not provided. There is no AI/ML model being "trained" for this device.

9. How the ground truth for the training set was established

This information is not applicable and not provided. There is no AI/ML model being "trained" for this device.

In summary, the provided document describes a 510(k) submission for a physical medical device (bone fixation system) and does not contain information related to AI/Machine Learning device performance or ground truth establishment in the context of diagnostic or interventional AI.

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Axis Charcot Fixation System:
The Axis Charcot Fixation System in diameters of 5.5, 6.5 and 7.5mm is indicated for reconstruction procedures, non-unions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthopathy (Charcot).
4.5 to 8.5 Screw System:
The 4.5 to 8.5mm Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints.

Axis Charcot Fixation System
The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloy fixation beams and accessories used for midfoot reconstruction.
4.5 to 8.5 Screw System
The 4.5 to 8.5 diameter screws consists of cannulated, titanium alloy fixation screws for use in bone reconstruction, osteotomy, arthrodesis and fracture repair and fixation in the foot.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document is a 510(k) premarket notification for the "Axis Charcot Fixation System, 4.5 to 8.5mm Screw System." It's important to note that 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than de novo approval requiring extensive clinical efficacy studies. Therefore, the "acceptance criteria" here are framed around demonstrating comparable performance to existing, legally marketed devices.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document explicitly states: "No clinical testing was performed." Therefore, there is no "test set" in the sense of patient data.

• Sample Size for Mechanical Testing: Not explicitly stated in the summary, but typical for bench testing, multiple samples of each device configuration would be tested.
• Data Provenance: Not applicable as no clinical data was collected. The bench testing would have been conducted by Extremity Medical, LLC or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical testing was performed, there was no ground truth to establish from patient data using expert review. The "ground truth" for the mechanical testing would be the raw data collected from the testing equipment, and the comparison point would be the performance of the predicate device (likely from published data or internal testing).

4. Adjudication method for the test set

Not applicable. No expert adjudication of clinical data was performed.

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. This device is a bone fixation system (screws), not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance in image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical testing:

• Ground Truth: The physical properties and performance measurements (e.g., pull-out force, bending stiffness, fatigue life) derived directly from the bench tests.
• Comparison Basis: The performance characteristics of the identified predicate devices, likely obtained through literature, publicly available predicate device information, or internal testing for comparison purposes.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. The design and manufacturing processes are informed by engineering principles, material science, and the performance characteristics of existing devices, rather than a "training set" in the context of data-driven models.

9. How the ground truth for the training set was established

Not applicable. See point 8.

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