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K Number
K993177
Device Name
SABRE
Manufacturer
SLE LIMITED
Date Cleared
1999-11-16

(85 days)

Product Code
GWJ
Regulation Number
882.1900
Type
Traditional
Panel
NE
Reference & Predicate Devices
K936093,K952080,K925648
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SABRE Auditory Brainstem Response Screener is a device that produces a sound stimulus for use in evoked response measurements. It is intended to be used by trained professionals in the evaluation of hearing function.

Device Description

The SABRE ABR Screener is an evoked potential device to be used in the evaluation of hearing function.

AI/ML Overview

The provided 510(k) summary for the SABRE Auditory Brainstem Response Screener does not contain information regarding detailed acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, expert qualifications, or comparative effectiveness with human readers. The document is primarily focused on establishing substantial equivalence to predicate devices based on intended use and technological characteristics.

Therefore, the following information cannot be extracted from the provided text:

  1. Table of acceptance criteria and reported device performance: Not available.
  2. Sample size used for the test set and data provenance: Not available.
  3. Number of experts used to establish the ground truth for the test set and their qualifications: Not available.
  4. Adjudication method for the test set: Not available.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not available.
  6. Standalone (algorithm-only) performance: Not available.
  7. Type of ground truth used: Not available.
  8. Sample size for the training set: Not available.
  9. How the ground truth for the training set was established: Not available.

The document states that the SABRE ABR device is "similar in its intended use to predicate devices and existent methodologies," implying that its performance is expected to be comparable to these established devices, rather than being demonstrated through a detailed independent study described within this summary.

§ 882.1900 Evoked response auditory stimulator.

(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).