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The Advia 120 Cn-free Hgb method is intended to quantitatively measure hemoglobin concentration in a sample of whole blood.

The ADVIA 120 Cn-free Hgb Method consists of the following optional changes to the ADVIA 120 Hematology System:

1. A reformulated reagent used to measure hemoglobin without the use of potassium cyanide.
2. A special cap and straw for the reagent bottle that restricts air exchange with the reagent.
3. A modified colorimeter that measures the hemoglobin reaction at 565 nm.
4. Modified software to implement the algorithms necessary to calculate hemoglobin concentration when using the optional reagent and hardware for the method.

The provided text describes the ADVIA 120 Cn-free Hgb Method, a cyanide-free hemoglobin determination option for a hematology analyzer, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study that proves the device meets those criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide specific quantitative acceptance criteria or detailed numerical performance data. Instead, it states that the new method is "Equivalent to predicate method" for several performance characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "The test results included in this submission demonstrate that the ADVIA 120 Cn-free Hgb Method has equivalent accuracy, precision, linearity, and carryover similar to the ADVIA 120 predicate method."

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a quantitative measurement instrument. The "ground truth" would typically refer to a reference method or a highly accurate established measurement of hemoglobin concentration, rather than expert judgment.

4. Adjudication Method for the Test Set

Not applicable, as this involves objective quantitative measurements and comparison to a predicate device/reference method, not subjective expert assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic aids where multiple human readers interpret cases with and without AI assistance. This device is an automated quantitative analyzer.

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

Yes, the study described is a standalone performance assessment of the ADVIA 120 Cn-free Hgb Method. It evaluates the device's ability to measure hemoglobin concentration without human intervention in the measurement process, against the performance of a predicate device.

7. The Type of Ground Truth Used

The "ground truth" for this type of device would implicitly be the results obtained by the ADVIA 120 cyanide containing Hgb predicate method (K971998) and/or other established, accurate reference methods for hemoglobin measurement. The study aimed to demonstrate equivalence to this predicate.

8. The Sample Size for the Training Set

Not applicable. This document describes a modification to an existing analytical instrument and its reagents, not a machine learning algorithm that requires a "training set" in the conventional sense. The "modified software to implement the algorithms" likely refers to analytical algorithms, not machine learning algorithms trained on large datasets.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set for a machine learning algorithm.

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