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Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201DM with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

The HemoCue Glucose 201 DM System consists of the HemoCue Glucose 201DM Analyzer and HemoCue Glucose 201 Microcuvettes. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Glucose 201DM Analyzer is only to be used with HemoCue Glucose 201 Microcuvettes.

The provided text is a 510(k) clearance letter from the FDA for the HemoCue® Glucose 201 DM System. It primarily addresses regulatory approval and does not contain detailed information about the acceptance criteria or a specific study proving the device's performance against those criteria. Therefore, most of the requested information cannot be extracted from this document.

Here's an attempt to answer based only on the provided text, with significant limitations:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided document. The document is a regulatory clearance letter, not a detailed study report.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not present in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not present in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not present in the provided document. The device in question is a glucose measurement system, not an AI-assisted diagnostic imaging tool, so an MRMC study with human readers assisting AI would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device is a "Glucose 201 DM System" which includes an analyzer and microcuvettes. This implies it is a standalone analytical system for measuring glucose. However, the document does not explicitly describe any standalone performance study details, only that it's a "quantitative determination of glucose."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a glucose test system, the ground truth would typically be established by a reference laboratory method (e.g., hexokinase method). However, this specific detail is not present in the provided document. The document mentions "quantitative determination of glucose in whole blood" and "instant blood glucose concentration," indicating a direct measurement, but not the gold standard used for comparison.

8. The sample size for the training set

This information is not present in the provided document.

9. How the ground truth for the training set was established

This information is not present in the provided document.

In summary, the provided FDA 510(k) clearance letter confirms the regulatory approval of the HemoCue® Glucose 201 DM System based on substantial equivalence to a predicate device. It does not contain the detailed technical performance data, study design, or ground truth methodology that would typically be found in a clinical study report or a more comprehensive submission document.

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