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Hemi-Arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or 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 HemiCAP® MTP Resurfacing Hemi-Arthroplasty System-Phalangeal HemiCAP® incorporates an articular resurfacing component and a cancellous taper post fixation 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 enclosed phalangeal base HemiCAP® implant is intended for hemiarthroplasty only. Do not use in conjunction with metallic metatarsal implant.

The present device modification includes the addition of modified phalangeal base (concave) implants and a corresponding taper post to the existing system.

This document pertains to the 510(k) premarket notification for the HemiCAP® MTP Resurfacing Hemi-Arthroplasty System. It describes a medical device, specifically a hemi-arthroplasty implant for the metatarsophalangeal joint. The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way this request is framed. This document, being an FDA 510(k) clearance letter, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria as might be expected for an AI/software device.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document describes:

• Device Name: HemiCAP® MTP Resurfacing Hemi-Arthroplasty System
• Intended Use: Hemi-Arthroplasty implant for the metatarsophalangeal joint for treatment of degenerative and post-traumatic arthritis in the metatarsal joint with good bone stock, hallux valgus or hallux rigidus, and unstable/painful MTP joint.
• Device Description: Incorporates an articular resurfacing component and a cancellous taper post fixation component that mate via a taper interlock. The modification includes modified phalangeal base (concave) implants and a corresponding taper post.
• Substantial Equivalence: The device is considered substantially equivalent to previously cleared predicate devices based on having the same Indications for Use, operating principle, manufacturing materials, shelf life, packaging, and sterilization processes.
• Non-clinical Tests: Comparative Engineering Analyses and Comparative Mechanical Testing (Assembly and Disassembly Testing, Resistance to Torsion Testing, Cyclic Fatigue Testing, Fretting Corrosion Testing, Pull-out Strength Testing, Finite Element Analysis) were performed to demonstrate safety, effectiveness, and substantial equivalence.

Without a detailed clinical or performance study report, or specific quantifiable acceptance criteria for a software/AI device, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement.

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