GALIX ECG PROFESSIONAL STATION

• K Number: K051163
• Device Name: GALIX ECG PROFESSIONAL STATION
• Manufacturer: GALIX BIOMEDICAL INSTRUMENTATION, INC.
• Date Cleared: 2006-01-31 ( 271 days)
• Product Code: DPS
• Regulation Number: 870.2340
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The GALIX ECG Professional Station system is intended for 12 Channel ECG recording and monitoring (running the ECG-PS software module) and 12 channel cardiac stress testing (running the ERGO-PS software). It is indicated for use:

• with Male/Female Pediatric to Adult population
• in Hospital, Clinic and Physician´s office
• under prescription by a physician

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the "GALIX ECG Professional Station, Models ECG-PS and ERGO-PS". It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria or an associated study report detailing device performance against such criteria.

The 510(k) clearance letter is a regulatory approval document, not a detailed technical study report. It states the indications for use and classification but typically doesn't include the raw data, methodology, or results of performance testing that would be submitted to the FDA during the review process.

Therefore, I cannot provide the requested information based solely on the text provided. The document itself does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
6. Results of a standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

To obtain this information, one would typically need to review the full 510(k) submission summary or associated clinical/performance study reports, which are not part of this clearance letter.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).