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The Solana Surgical LLC, Metatarsal Decompression Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, 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) or Titanium, intended to replace the articulating surface of the metatarsal bone at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes to match the geometry of the metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends proximally in the intramedullary canal of the distal 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.

The provided text is a 510(k) summary for the Solana Surgical Metatarsal Decompression Implant. It details the device's description, indications for use, and a comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I cannot fulfill your request for that specific information based on the provided text.

The document primarily focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed clinical or performance study results against predefined acceptance criteria.

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The Solana Surgical LLC, Hemi Phalangeal Implant System is intended for use as a hemi-arthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, 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 phalangeal bone at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes (3) to match the geometry of the metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends distally in the intramedullary canal of the proximal phalanx. 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.

The provided text describes a medical device, the Solana Surgical Hemi Phalangeal Implant System, and its substantial equivalence to predicate devices, but it does not contain any information regarding acceptance criteria, device performance, or a study proving it meets acceptance criteria.

The document is a 510(k) summary and an FDA clearance letter, which focuses on establishing substantial equivalence based on similarities in:

• Intended use: Hemi-arthroplasty implant for the metatarsophalangeal joint to treat degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and unstable/painful MTP joint.
• Device description: One-piece device made of Cobalt Chromium (with titanium plasma spray coated stem).
• Materials: Industry standard materials, no new materials.
• Design features: Articulating surface and a stem extending distally into the intramedullary canal.
• Sizes: Available in a range of 3 sizes.
• Usage: Single use, with or without bone cement.

Therefore, I cannot provide the requested table or details about a study demonstrating acceptance criteria, as this information is not present in the provided text. The document is about regulatory clearance for a medical implant, not a performance study of an AI/software device.

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Hemi arthroplasty implant for first metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions; hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

The CAP™ Great Toe Resurfacinq Hemi-arthroplasty implant is a cobalt chrome alloy, 2-piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to provide a smooth surface for the first metatarsophalangeal joint as a the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions; hallux valqus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

The CAP™ Great Toe Resurfacing Hemi-arthroplasty implant consists of two components, a taper post component and an articular component, that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

The first implant component is a Taper Post manufactured of a Ti-6AI-4V ELI alloy per ASTM F136. The Taper Post has a tapering distal tip, a full-length cannulation, and a proximal female taper bore.

The second implant is an articular component manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The articular component has a bone contact surface that is coated with a CP Titanium coating and a polished articular bearing surface.

The provided text describes the safety and effectiveness of the CAP™ Great Toe Resurfacing Hemi-arthroplasty implant. It is a medical device, and the information presented here pertains to its mechanical performance and substantial equivalence to previously marketed devices, not to the performance of a software or AI/ML-based device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document describes non-clinical mechanical testing of the device components. It does not mention a "test set" in the context of patient data or clinical data.
• The sample sizes for the mechanical tests are not explicitly stated in the provided text.
• Data provenance is not applicable as this relates to mechanical testing, not patient data.

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)

• This is not applicable as the study involves mechanical testing of an implant, not a diagnostic or prognostic device requiring expert interpretation of data. The "ground truth" here is the physical and mechanical properties of the device as measured against established engineering standards.

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

• This is not applicable since the testing is mechanical and does not involve adjudication of expert opinions.

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

• This is not applicable as the device is an orthopedic implant, not an AI-assisted diagnostic tool.

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

• This is not applicable as the device is a physical implant, not an algorithm.

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

• The "ground truth" for this device, in the context of the described testing, is adherence to established industry standards and guidelines for mechanical properties and material performance (e.g., ASTM F1814, ASTM F897, ISO 7206-9, and relevant CDRH Guidance Documents for implants).

8. The sample size for the training set

• This is not applicable; there is no "training set" as this is a physical medical device, not an AI/ML algorithm.

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

• This is not applicable.

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