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The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal joints.

The EXTREMITY MEDICAL Midfoot Screw System

This document is a 510(k) Premarket Notification for the Extremity Medical Midfoot Screw System. It declares substantial equivalence to predicate devices and describes the intended use and technological comparison. However, it does not contain information about specific acceptance criteria or a study proving that the device meets such criteria because it's a submission for a medical device, not an AI/ML algorithm.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Summary of available information from the provided text:

Device: EXTREMITY MEDICAL Midfoot Screw System

Intended Use: Fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal joints.

Basis for Clearance: Substantial equivalence to predicate devices (EXTREMITY MEDICAL Midfoot Screw System K082934 and 3.5 Fully Threaded Screw, Synthes K050683). The statement of technological comparison notes that the device and its predicate devices have the same indications for use, similar design, similar materials, and equivalent mechanical properties. The conclusion is based on indications for use, materials, design, test data, and principles of operation.

Note: While "test data" is mentioned, the specific details regarding what tests were performed, what the acceptance criteria for those tests were, and the results of those tests are not included in this summary document. This 510(k) summary focuses on demonstrating substantial equivalence, not on detailing a performance study against specific acceptance criteria in the way one would for an AI/ML device.

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The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints

The EXTREMITY MEDICAL Midfoot Screw System

The provided 510(k) summary for the EXTREMITY MEDICAL Midfoot Screw System (K082934) does not contain information about acceptance criteria or a study demonstrating device performance against such criteria for AI/ML device functionalities.

The document describes a medical implant system, which are physical devices used for fixation and arthrodesis of foot joints, not an AI/ML-driven device. Therefore, the requested information points, which are primarily relevant to AI/ML device validation, are not applicable or available within this 510(k) submission.

Specifically:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence to predicate devices based on design, materials, indications for use, and mechanical properties.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No test set for AI/ML performance is mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for AI/ML is mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) 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.
• 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.

The document indicates that the device's substantial equivalence was based on:

• Indications for use: Same as predicate devices.
• Materials: Similar to predicate devices.
• Design: Similar to predicate devices.
• Test data: Implies mechanical testing data, but specific acceptance criteria and detailed results are not provided in this summary.
• Principles of operation: Similar to predicate devices.

This 510(k) establishes substantial equivalence for a conventional medical device, not an AI/ML product.

Ask a specific question about this device