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K Number
K063452
Device Name
MA 55 MAESTRO
Manufacturer
MAICO DIAGNOSTICS (DIAGNOSTIC GROUP LLC)
Date Cleared
2007-03-29

(134 days)

Product Code
EWO
Regulation Number
874.1050
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MA55 system is intended to be used for the detection and diagnosis of suspected hearing loss.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for an audiometer, the MA55 "Maestro" Audio PC System. The provided document is a letter from the FDA determining substantial equivalence to a predicate device and the indications for use statement. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document includes:

  • Manufacturer: MAICO Diagnostics
  • Device Name: MA55 "Maestro" Audio PC System
  • Regulation Number: 21 CFR 874.1050 (Audiometer)
  • Regulatory Class: Class II
  • FDA Product Code: EWO
  • 510(k) Number: K063452
  • Date of FDA letter: March 29, 2007
  • Indications for Use: "The MA55 system is intended to be used for the detection and diagnosis of suspected hearing loss."

The document does not contain the following information that you requested:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method for the test set
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance. (Note: This device is an audiometer, not an AI diagnostic device so this section would likely not be relevant even if a study was present.)
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (Note: Similar to point 5, this is an audiometer, not an AI algorithm.)
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

For an audiometer, performance testing typically involves verifying the accuracy and precision of the sound output levels, frequency generation, and attenuation, as well as the calibration and stability of the device according to international standards (e.g., ANSI S3.6, IEC 60645-1). These details would usually be found in the special controls documentation or a detailed testing report, which is not part of this FDA letter.

§ 874.1050 Audiometer.

(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.