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K Number
K060386
Device Name
NEXA CARPO METACARPAL IMPLANT
Manufacturer
NEXA ORTHOPEDICS, INC.
Date Cleared
2006-05-10

(85 days)

Product Code
KYI
Regulation Number
888.3770
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb with limited range of motion.

Device Description

The Nexa Orthopedics CMI implant and surgical instruments are provided in 3 sizes. The device is intended to be implanted into the metacarpal of the thumb. The device is made of pyrocarbon. No new materials are used in the development of this implant.

AI/ML Overview

The provided text is a 510(k) summary for the Nexa carpometacarpal (CMI) implant. This document is a premarket notification to the FDA for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and device performance results.

Therefore, the information requested in your prompt (acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) is not available within the provided text.

The document states:

  • "Documentation is provided which demonstrated the device to be substantial equivalent to other legally marketed devices."
  • "The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device."

This indicates that the FDA's decision was based on a comparison to an already approved device, likely through engineering bench tests and a review of the device's design and materials, rather than a clinical trial with specific performance metrics against pre-defined acceptance criteria.

§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.

(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.