XLTEK EMU40 EEG HEADBOX, MODEL PK1072

• K Number: K053386
• Device Name: XLTEK EMU40 EEG HEADBOX, MODEL PK1072
• Manufacturer: EXCEL TECH. LTD.
• Date Cleared: 2006-04-21 ( 137 days)
• Product Code: GWQ , GWO
• Regulation Number: 882.1400
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K980214

Intended Use

The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}.

The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.

The EMU40 Headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.

Device Description

The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}. The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "XLTEK EMU40 EEG Headbox". It doesn't contain information about acceptance criteria or a study proving the device meets acceptance criteria, as it's primarily a regulatory approval document.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria and Device Performance Table: The document states that the device is "substantially equivalent" to legally marketed predicate devices. This is a regulatory finding based on comparison to existing devices, rather than a detailed performance study with specific acceptance criteria.
2. Sample Size and Data Provenance: This information would be found in a study report, which is not part of this 510(k) letter.
3. Number and Qualifications of Experts: Again, this would be part of a study design and not typically included in a 510(k) clearance letter.
4. Adjudication Method: Not applicable or present in this regulatory document.
5. MRMC Comparative Effectiveness Study: The letter does not mention a comparative effectiveness study.
6. Standalone Performance Study: The letter does not describe a standalone performance study.
7. Type of Ground Truth: Not applicable or present.
8. Training Set Sample Size: Not applicable as this is not a study report.
9. Ground Truth for Training Set: Not applicable.

In summary, this document is a regulatory approval for market clearance, not a technical report detailing performance criteria or study results. Therefore, it does not contain the information required to answer your request.

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).