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The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock.

Indications include:

• Hallux valgus or Hallux limitus
• Hallux rigidus
• Unstable or painful metatarsallphalangeal (MTP) joint

The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component (four sizes for each component) designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. The implants are made from Cobalt Chrome per ASTM F-1537.

This document is a 510(k) summary for the Montross Extremity Medical Hemi Implant System, a medical device. The document describes the device, its intended use, indications for use, and a summary of nonclinical testing performed to demonstrate substantial equivalence to predicate devices. However, the document does NOT contain information pertaining to AI/ML device performance or studies with acceptance criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods typically associated with such studies.

Therefore, I cannot extract the requested information using the provided text. The device described is a physical implant, not an AI-powered diagnostic or predictive tool, and thus the acceptance criteria and study information requested (e.g., related to multi-reader multi-case studies, standalone algorithm performance, ground truth establishment) are not applicable to this submission.

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