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Quantitative determination of hemoglobin in capillary, venous and arterial whole blood. The HemoCue® Hb 201 Microcuvettes are intended for use in the HemoCue® Hb 201 201 Analyzer. The HemoCue® Hb 201 DM System is used for the quantitative determination of hemoglobin in blood using specially designed analyzer, the HemoCue® Hb 201 DM Analyzer and specially designed microcuvettes, the HemoCue® Hb 201 Microcuvettes. The HemoCue Hb 201 DM Analyzer is only to be used with HemoCue® Hb 201 Microcuvettes. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Hb 201 DM Analyzer is only to be used together with HemoCue Hb 201 Microcuvettes. The use of any other device in the HemoCue Hb 201 DM Analyzer except the HemoCue 201 Microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequence. The HemoCue Hb 201 microcuvettes are for in vitro use only.

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This document is a 510(k) premarket notification from the FDA, which primarily focuses on establishing substantial equivalence to a predicate device. While it generally refers to performance, it does not provide detailed acceptance criteria and a study demonstrating the device meets those criteria in the way a clinical study report would.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document only states the device is "substantially equivalent" to legally marketed predicate devices. It does not list specific performance metrics or their acceptance thresholds.
• Sample size used for the test set and the data provenance: There is no mention of a test set, its size, or its origin.
• Number of experts used to establish the ground truth for the test set and their qualifications: Ground truth establishment details are absent.
• Adjudication method for the test set: No test set means no adjudication method described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No such study is mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The HemoCue Hb 201 DM System is an automated hemoglobin system, inherently operating in a standalone manner for measurement, but the document doesn't detail performance studies.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No information on how ground truth was established for any performance comparison.
• The sample size for the training set: There is no mention of a "training set" as this is a medical device clearance, not an AI model approval with a distinct training phase.
• How the ground truth for the training set was established: Not applicable, as no training set is discussed.

Information that can be inferred or directly stated from the document:

• Device Name: HemoCue® Hb 201 DM System
• Intended Use: Quantitative determination of hemoglobin in capillary, venous, and arterial whole blood.
• Regulatory Status: Cleared by FDA via 510(k) as substantially equivalent (K041234).
• Nature of the device: An automated hemoglobin system using a specific analyzer (HemoCue® Hb 201 DM Analyzer) and microcuvettes (HemoCue® Hb 201 Microcuvettes).

To answer the requested questions about acceptance criteria and study details, a different type of document, such as a clinical study report or detailed device validation report, would be required. The provided FDA 510(k) clearance letter confirms regulatory approval based on substantial equivalence, but it does not delve into the specifics of performance studies as requested.

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