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The Stat Profile pHOx Plus L Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage for the quantitative determination of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl- (or Ca++), Glu and Lac in heparinized whole blood and Na+, K+, Cl- (or Ca++), Glu and Lac in serum and heparinized plasma.

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The provided text is a 510(k) premarket notification approval letter for the "Stat Profile pHOx Plus L. Analyzer". This document indicates the device has been found substantially equivalent to a predicate device for its stated indications for use.

However, this letter does NOT contain the detailed information necessary to answer your questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses on the regulatory approval process, confirming that the device can be marketed in the US. It does not include the technical study reports that would detail the performance data and the methods used to generate that data.

To answer your questions, one would typically need access to:

• The actual 510(k) submission document, specifically the sections dealing with performance testing.
• Validation reports from Nova Biomedical for the Stat Profile pHOx Plus L. Analyzer.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner you've requested. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. Multi-reader multi-case comparative effectiveness study information.
6. Standalone performance information.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Stat Profile pHOx Plus L Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage for the quantitative determination of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl-(or Ca++), Glu and Lac in heparinized whole blood.

Not Found

This document is an FDA 510(k) clearance letter for the "Stat Profile pHOx Plus L Analyzer" and does not contain the detailed study information required to answer the prompt thoroughly. The letter confirms substantial equivalence to a predicate device and allows marketing, but it does not include the acceptance criteria, reported device performance, sample sizes, ground truth establishment, or details of a comparative effectiveness study.

Therefore, I cannot extract the specific information requested in your prompt based on the provided text. The document is a regulatory approval, not a scientific study report.

Ask a specific question about this device