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The OsteoMed Metatarsal Resurfacing Implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful MTP joint.

The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement.

The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.

The OsteoMed Metatarsal Resurfacing Implant is a one piece implant designed to replace the distal head of the metatarsal and provides a smooth articular surface for the adjacent phalangeal base. The implant is available in several sizes in direct proportion to the anatomic construct of the metatarsal head. Primary fixation is intended to be used with bone cement or press fit without bone cement.

The provided text is a 510(k) summary for the OsteoMed Metatarsal Resurfacing Implant System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not found in this type of submission. This 510(k) summary does not describe a clinical study with performance endpoints, ground truth, or expert review for a medical imaging or AI device.

Here's an breakdown of what can be extracted and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The 510(k) summary for this device does not present specific performance acceptance criteria or report performance metrics in the way a study for a diagnostic or AI device would. The core of this submission is to demonstrate equivalence based on:

• Intended use
• Materials
• Design
• Operational principle

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

Not applicable. There is no "test set" in the context of a clinical performance study described for this implant.

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

Not applicable. There is no ground truth establishment for a test set described.

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

Not applicable. This is not an AI or diagnostic imaging device.

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

Not applicable. This is not an AI or diagnostic imaging device.

7. The type of ground truth used

Not applicable. No ground truth is described.

8. The sample size for the training set

Not applicable. There is no "training set" for an algorithm described.

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

Not applicable.

Summary of the Acceptance Criteria and Study (as defined by this 510(k) submission):

The "acceptance criteria" for the OsteoMed Metatarsal Resurfacing Implant System, within the context of this 510(k) submission, are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices.

The "Study" that proves the device meets these "acceptance criteria":

The "study" or justification provided is a comparison to several predicate devices. The submission asserts that due to the "similarity in intended use, materials, design and operational principle to the predicate devices, OsteoMed believes that the OsteoMed Metatarsal Resurfacing Implant System does not raise any new safety or effectiveness issues."

Predicate Devices:

• Arthrosurface CAP Great Toe Resurfacing Hemi- Arthroplasty Implant (K031859)
• CAP Prosthetic 7.0mm MTP Resurfacing Hemi- arthroplasty (K063370)
• Vilex Met-Head Resurfacing Hemi- Arthroplasty Implant (K070052)
• OsteoMed 1st MPJ Hemi Implant System (K060536)
• ReFlexion Great Toe System (K922211)
• BioPro Hemi MPJoint (K041595)

Therefore, the "proof" is the argument for substantial equivalence based on these comparisons, rather than a clinical performance study with statistical endpoints specific to the device's function as an implant.

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