LogoFDA 510(k) Search
K Number
K971080
Device Name
MAICO MA52
Manufacturer
BERNAFON-MAICO, INC.
Date Cleared
1997-06-06

(73 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 indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.

Device Description

Not Found

AI/ML Overview

The provided documents are a 510(k) clearance letter and an Indications For Use statement for the Maico MA52 device. These documents do not contain information about acceptance criteria, device performance studies, or details regarding ground truth establishment, expert qualifications, or sample sizes.

The 510(k) clearance letter (Document 0) states that the FDA has reviewed the submission and determined that the Maico MA52 is "substantially equivalent" to devices marketed prior to May 28, 1976. This determination indicates that the device met the regulatory requirements for showing substantial equivalence to a predicate device, but it does not delve into the specifics of performance criteria or clinical study results for the device itself.

The "Indications For Use" statement (Document 1) simply specifies that the device "would be for the detection and diagnosis of a suspected hearing loss."

Therefore, based on the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not available in the provided documents.
  2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available. The device is an audiometer, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. The device is an audiometer, which typically involves a human operator.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
  8. The sample size for the training set: Not available.
  9. How the ground truth for the training set was established: Not available.

§ 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.