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To amplify and transmit sound to the ear

Programmable behind-the-ear hearing instrument. Substantially equivalent to other programmable behind-the-ear hearing instruments

This document (K961622) is a "Summary of Safety and Effectiveness Information" for a medical device submitted to a regulatory body (likely the FDA based on the K-number format). It outlines the device's characteristics and intended use.

However, the provided text does not contain any information about acceptance criteria, performance studies, or clinical evaluation data in the way you've requested for AI/ML device assessment.

Here's why and what's missing:

• Device Type: The device described, "Phonak Piconet2 P2 AZ," is a programmable behind-the-ear hearing instrument. This is a conventional medical device, not an AI/ML powered one. The regulatory submission process for such devices typically relies on demonstrating substantial equivalence to a predicate device and adherence to technical standards (like ASA/ANSI S3.2-1987, as mentioned).
• Content: The document focuses on:
  • Device name and type
  • Intended use
  • Key features
  • Assembly
  • Technical characteristics (compliance with a standard)
  • Fit (customization to audiogram)
  • Controls
  • Power source
    It explicitly states "Technical specifications comply with ASA/ANSI S3.2 - 1987," which is how its performance is likely "proven" for regulatory purposes, rather than through a dedicated performance study with acceptance criteria as one would conduct for an AI algorithm.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/ML device because this information is not present in the provided text. The document describes a traditional hearing aid, not an AI-powered diagnostic or assistive tool.

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