Search Results

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.

Ask a specific question about this device

The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

The Extremity Medical Calcaneal Osteotomy Device is a bone fixation device consisting of a bracket and lag screws and a set of instruments used for implant site preparation and delivery. The bracket is offered in height sizes of 6mm to 13mm. The Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

The provided document describes the FDA 510(k) premarket notification for the Extremity Medical Calcaneal Osteotomy Device. This device is a bone fixation device, not an AI/ML medical device, and therefore the concepts of acceptance criteria, device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable in the context of AI regulatory submissions.

The document indicates that the device's substantial equivalence was based on non-clinical testing, specifically bench testing for static and dynamic bending, which was performed and compared to a predicate device. No clinical testing was performed.

The relevant information regarding this device's "acceptance criteria" (though not explicitly stated as such in the AI/ML context) would be its ability to demonstrate substantial equivalence to legally marketed predicate devices through its design, material mechanical properties, indications for use, and performance in these non-clinical bench tests.

To answer your request based on the provided document and keeping in mind it's for a physical bone fixation device:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implied): Substantial equivalence to predicate device in terms of design, material mechanical properties, indications for use, and performance in static and dynamic bending bench tests.
   • Reported Device Performance: "Bench testing static and dynamic bending were performed and compared to the predicate device." (Specific numerical performance data is not provided in this summary document.)

2. Sample size used for the test set and the data provenance: Not applicable as this is a physical device and no "test set" in the context of data for AI/ML is mentioned. The testing refers to physical bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models is not relevant here.

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: No, this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" for this physical device's performance would be its mechanical properties measured in bench tests and compared to the predicate device.

8. The sample size for the training set: Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device