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The Solana Surgical LLC, Lesser Metatarsal Head Implant System is intended for use as a hemiarthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux limitus, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is intended for single use to be used with bone cement or press fit without bone cement.

The Solana Surgical Implant is a one-piece device made of Cobalt Chromium (with titanium plasma spray coated stem) intended to replace the articulating surface of the metatarsal bone at the lesser metatarsal phalangeal (MTP) joint. The implant is available in a range of sizes (3) to match the geometry of the lesser metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends proximally in the intramedullary canal of the distal lesser metatarsal. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.

This looks like a 510(k) premarket notification for a medical device called the "Lesser Metatarsal Head Implant System." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance as would be expected for a novel device or a PMA.

Therefore, the information requested in your prompt related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone performance studies is not typically found in a 510(k) summary like this one.

Here's a breakdown of why and what information is available:

Response to your Request:

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

• Not Applicable. This 510(k) summary does not include specific acceptance criteria for a device performance study in the way a clinical trial or performance study for an AI/diagnostic device would. The "performance" being evaluated is primarily the mechanical strength and material properties in comparison to predicate devices, not clinical efficacy or diagnostic accuracy.
• The summary states: "An engineering analysis was performed to evaluate the mechanical strength of subject and predicate device implant stems." and "The titanium plasma spray coating process as applied to the Solana Surgical device has been thoroughly evaluated for morphological and strength characteristics." These are the "reported device performance" aspects, but without specific quantitative acceptance criteria disclosed in this summary.

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

• Not Applicable / Not Provided. No clinical test set data from actual patients is described or used in this 510(k) summary to prove performance against specific clinical acceptance criteria. The evaluation is focused on engineering analysis and comparison to predicate devices.

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. No ground truth establishment by experts is described, as there are no clinical test sets or diagnostic performance claims requiring expert interpretation.

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

• Not Applicable. No test set requiring expert adjudication is described.

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 mechanical implant, not an AI software or diagnostic tool. No MRMC study was conducted.

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

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

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

• Not Applicable. No clinical ground truth is established or used for performance evaluation in this 510(k) summary. The "ground truth" for the engineering evaluation would be established engineering principles, material science standards, and comparison with the known properties of the predicate devices.

8. The sample size for the training set

• Not Applicable. This is a mechanical implant; there is no "training set" in the context of machine learning or AI.

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

• Not Applicable. No training set exists for this type of device submission.

Summary of Available Information from the Provided Text:

• Device Name: Lesser Metatarsal Head Implant System
• Purpose: Hemiarthroplasty implant for the metatarsophalangeal joint.
• Materials: Cobalt Chromium (with titanium plasma spray coated stem).
• Design: One-piece device with an articulating surface and a stem for intramedullary canal insertion.
• Comparison Basis: Substantially equivalent to predicate devices (OsteoMed: K073065, Vilex: K102401) based on:
  • Similar materials
  • Similar indications for use
  • Comparable sizing
  • Similar intended use (single use, surgical implantation longer than 30 days)
  • Engineering analysis of mechanical strength (comparison of subject and predicate device implant stems).
  • Evaluation of the titanium plasma spray coating process for morphological and strength characteristics.

This document serves to demonstrate that the new device is as safe and effective as a legally marketed predicate device, primarily through engineering comparisons and material analysis, rather than extensive clinical efficacy studies with predefined acceptance criteria.

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