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COULTER® ALT TRON Cell Control is intended For In Vitro Diagnostic Use as a control to monitor the performance of the CBC parameters on COULTER® A · T Series Systems. Instrument performance is monitored using the assigned ranges on the TABLE OF EXPECTED RESULTS and reagents designed by Coulter for these systems.

The product is a Hematology Quality Control Mixture which like the predicate device, COULTER® 4C® PLUS Cell Control, is used to monitor the performance of Coulter hematology analyzers. COULTER® A °T TRON Cell Control is prepared from stabilized erythrocytes and a red chromophore so that repeated measurements can be made to monitor daily performance of the instrument system. Assigned values are confirmed by multiple analyses of the control product.

The provided text describes the COULTER® A.T TRON Cell Control, a hematology quality control mixture, and its nonclinical testing. However, it does not contain a detailed study report that would allow for a comprehensive description of acceptance criteria and a study proving device performance in the way typically expected for a medical device clinical trial or performance study on patient data.

The document is a 510(k) summary for a diagnostic control product, which focuses on demonstrating substantial equivalence to a predicate device based on its intended use, technological characteristics, and performance for its specific function (monitoring instrument accuracy). The "study" mentioned here refers to nonclinical testing of the control solution itself, not a clinical study involving patient samples or human readers.

Here's an attempt to extract and present the information based on the provided text, acknowledging its limitations for certain categories:

Acceptance Criteria and Device Performance for COULTER® A.T TRON Cell Control

The COULTER® A.T TRON Cell Control is a hematology quality control mixture intended for In Vitro Diagnostic Use as a control to monitor the performance of CBC parameters on COULTER® A.T Series Systems. The "study" described is nonclinical testing focused on the performance characteristics of the control solution itself, specifically its homogeneity and stability.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical acceptance criteria for precision (e.g., CV% less than X%).
• Specific numerical acceptance criteria for stability (e.g., drift within Y% over Z days).
• Details of the "Table of Expected Results" (e.g., target values and ranges for various CBC parameters).

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

• Sample Size: Not explicitly stated for the nonclinical testing. The text mentions "replicate measurements" for precision and "recovery of values" for stability, implying multiple tests were performed on the control solution.
• Data Provenance: Not applicable in the context of a clinical study with patient data. This is nonclinical testing of a manufactured control product.

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

• Not Applicable. The "ground truth" for this product is its own inherent stability and precision as a manufactured control, defined by its expected ranges and performance characteristics. There is no human expert "ground truth" generation for diagnostic interpretations in this context, as it's a quality control material, not a diagnostic device interpreting patient data.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human experts interpreting results and no diagnostic decisions being made, an adjudication method is irrelevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study is for evaluating the reader performance of diagnostic devices (e.g., AI algorithms for image analysis) and comparing human performance with and without AI assistance. The COULTER® A.T TRON Cell Control is a quality control substance for hematology analyzers, not a diagnostic device for human interpretation, thus an MRMC study is not relevant or performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• N/A (Not an algorithm). This device is a biochemical control solution, not an algorithm. Standalone performance studies typically refer to the performance of AI algorithms without human intervention.

7. Type of Ground Truth Used

• The "ground truth" for this product's performance is established by assigned values and expected ranges derived from extensive testing during its development and manufacturing, likely using reference methods or highly calibrated instruments. The product itself is the control 'truth' against which analyzer performance is measured. The text mentions "Assigned values are confirmed by multiple analyses of the control product."

8. Sample Size for the Training Set

• Not Applicable. This device is not an AI algorithm that requires a "training set" of data.

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

• Not Applicable. As there is no training set mentioned, this question is not relevant.

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