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K Number
K053004
Device Name
MSAS-VANTAGE
Manufacturer
BIOMERIDIAN, INT.
Date Cleared
2006-01-13

(79 days)

Product Code
GZO
Regulation Number
882.1540
Type
Special
Panel
NE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MSAS -- Vantage intended use is for the measurement of Galvanic Skin Response.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "MSAS - Vantage." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this letter does not contain the information required to answer your specific questions about acceptance criteria and study details.

Here's why and what you would typically look for in such a document or related submissions:

  • Acceptance Criteria and Reported Device Performance: This letter only confirms that the device is "substantially equivalent" but does not detail the specific performance metrics used for that determination or the achieved results against acceptance criteria. A 510(k) submission would typically include a comparative analysis of the new device to a predicate device, often using metrics relevant to the device's function. For a galvanic skin response measurement device, this might include measures of accuracy, precision, or repeatability compared to a standard.
  • Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone, Training Set): None of this information is available in the provided FDA clearance letter. These details would be found in the actual 510(k) submission, specifically in the sections detailing the studies performed to demonstrate substantial equivalence.

In summary, based only on the provided text, I cannot complete the table or answer the specific questions. The document is a regulatory approval, not a technical report on the device's performance study.

§ 882.1540 Galvanic skin response measurement device.

(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.