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Indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus and an unstable or painful metatarsophalangeal joint. OsteoMed 1st MPJ Hemi Implants are intended for single use only.

The OsteoMed 1st MPJ Hemi Implant is a one piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to replace the distal base of the proximal phalanx and provide a smooth articular surface for the adjacent first metatarsal head. It is available in several sizes in direct per portion to the anatomic construct of the distal base of the proximal phalanx. Primary fixation is intended via a press fit bone implant interface. The OsteoMed 1* MPJ Hemi Implant is made of cobalt chromium (ASTM F-799) and may also be provided with a titanium plasma coated stem.

This document, K060536, is a 510(k) premarket notification for the OsteoMed 1st MPJ Hemi Implant System, a medical device. It is a submission to the FDA (Food and Drug Administration) for clearance to market the device. The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your request, highlighting what information is available and what is not typically found in a 510(k) summary for this type of device:

Key Takeaway: This 510(k) submission seeks clearance based on substantial equivalence to existing devices, not a clinical study proving new acceptance criteria. Therefore, the requested information about device performance, ground truth, expert review, and sample sizes for a study proving acceptance criteria will largely be absent because such a study was not conducted or required for this type of submission.

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

• Acceptance Criteria: Not explicitly stated as "acceptance criteria" in the context of a performance study with numerical targets. For a 510(k) based on substantial equivalence, the "acceptance criteria" are typically that the device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to predicate devices.
• Reported Device Performance: No clinical performance data is reported or provided in this 510(k) summary. The document states, "Due to the similarity of materials and design to the predicate devices, OsteoMed believes that the OsteoMed 1st MPJ Hemi Implant System does not present new safety or effectiveness issues." This indicates reliance on the established safety and effectiveness of the predicate devices.

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

• Not Applicable. No clinical test set or data provenance is mentioned as part of this 510(k) submission. This is typical for Class II devices seeking substantial equivalence through material and design similarity, especially when there are no new technological characteristics.

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)

• Not Applicable. As no clinical test set was used to establish an "acceptance criteria" for a new performance claim, there was no need for experts to establish ground truth in that context. The "ground truth" for this submission is established by the FDA's existing clearances for the predicate devices.

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

• Not Applicable. No clinical test set requiring adjudication was used.

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 passive, implantable orthopedic prosthetic (a hemi-implant for a toe joint), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant to this product.

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

• Not Applicable. This device is a physical implant, not an algorithm.

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

• Implicit Ground Truth: The "ground truth" in the context of this 510(k) is the established safety and effectiveness of the predicate devices (BioPro Hemi MP Joint (K041555), Kinetikos Medical, K2 Hemi Toe Implant System (K023770), and Fii tira BioMedical Metal Hemi Toe Implant (K971047)) as previously determined by the FDA. Its own safety and effectiveness are inferred by its substantial equivalence to those devices.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. This is a manufactured product, not a machine learning model.

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

• Not Applicable. As there is no training set mentioned, this question is not relevant to the information provided in the 510(k) summary.

Summary of what the K060536 document does provide:

• Predicate Devices: Clearly identifies three predicate devices for comparison.
• Intended Use: The intended use of the OsteoMed 1st MPJ Hemi Implant System is for "treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal joint."
• Materials: Made of cobalt chromium (ASTM F-799) and may also be provided with a titanium plasma coated stem, similar to the materials of predicate devices.
• Design and Operational Principle: Stated to be similar to predicate devices.

For a 510(k) based on substantial equivalence, the "study" demonstrating that the device meets "acceptance criteria" is typically the submission itself, arguing that the device is so similar to existing cleared devices that it inheres their safety and effectiveness profile, without requiring new clinical trials or performance studies.

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