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K Number
K980991
Device Name
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
Manufacturer
NOVA BIOMEDICAL CORP.
Date Cleared
1998-04-15

(29 days)

Product Code
CHL,GKF
Regulation Number
862.1120
Type
Traditional
Panel
Clinical Chemistry
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Stat Profile pHOx Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of pH, pCO2, pO2, Hct, Hb, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea/BUN, Creatinine, SO2%, and expired (exhaled) gases.

Device Description

Stat Profile pHOx Blood Gas Analyzer

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the "Stat Profile pHOx Blood Gas Analyzer." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information required to fulfill the request regarding acceptance criteria and a study proving those criteria were met for a device algorithm.

The letter explicitly states:

  • "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device's clearance was based on demonstrating substantial equivalence to a predicate device, rather than explicit performance against pre-defined acceptance criteria in a standalone clinical study as might be conducted for novel AI/ML devices.

Therefore, I cannot provide the requested information for the following reasons based on the provided text:

  1. Acceptance Criteria and Reported Device Performance: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present reported device performance metrics against such criteria.
  2. Sample Size and Data Provenance (Test Set): This information is not present.
  3. Number and Qualifications of Experts for Ground Truth (Test Set): This information is not present.
  4. Adjudication Method (Test Set): This information is not present.
  5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not describe such a study or any effect sizes related to human readers improving with AI assistance.
  6. Standalone Performance Study: The letter does not detail a standalone performance study with specific metrics. Its clearance is based on substantial equivalence.
  7. Type of Ground Truth Used: This information is not present.
  8. Training Set Sample Size: This information is not present, as the document relates to regulatory clearance rather than explicit algorithm development.
  9. Ground Truth for Training Set: This information is not present.

The document primarily focuses on the regulatory clearance process, specifically 510(k) approval based on substantial equivalence, and not on the scientific study details of algorithm development and performance validation.

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.