EXCEL AV STIM 1000

• K Number: K972157
• Device Name: EXCEL AV STIM 1000
• Manufacturer: EXCEL TECH. LTD.
• Date Cleared: 1998-01-30 ( 235 days)
• Product Code: GWJ
• Regulation Number: 882.1900
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

AUDITORY TO PROVIDE VISUAL AND RECORDING FOR STIMULI EVOKED POTENTIAL S

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or a study proving that a device meets the acceptance criteria. The document is a clearance letter from the FDA for a device called "Excel AV Stim 1000" (later referred to as "Excel AV Stim 4000" in the Indications For Use section), stating that it is substantially equivalent to legally marketed predicate devices.

The document includes:

• Trade Name: Excel AV Stim 1000 (and 4000)
• Regulatory Class: II
• Product Code: GWJ
• Indications For Use: "AUDITORY TO PROVIDE VISUAL AND RECORDING FOR STIMULI EVOKED POTENTIAL S"

However, it does not provide any information about:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. Standalone performance of an algorithm.
7. The type of ground truth used.
8. Sample size for a training set.
9. How the ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided text.

Regulation Number and Section

§ 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).