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It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. ESR Control-HC™ is a bi-level hematology control designed to document and monitor values obtained from HiChem Mini-VES and VES-Matic automated erythrocyte sedimentation rate analyzers.

ESR Control-HC™ is an in vitro diagnostic reagent composed of mammalian erythrocytes suspended in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of monitoring the performance of HiChem Mini-VES and VES-Matic automated ESR analyzers. Overall performance of the entire system is monitored including the analyzer, disposable equipment, and technique. ESR Control-HC™ is available in two levels and is run in the same manner as patient specimens.

The provided document K972170 is a 510(k) Pre-Market Notification for the ESR Control-HC™ Hematology Control. This document is a submission for a quality control device, not a diagnostic device that directly "performs" with clinical data or generates diagnostic outputs that would have detailed performance metrics like sensitivity, specificity, or AUC based on patient data.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

The "performance data" discussed in this 510(k) is related to the stability of the control material itself, ensuring it remains consistent and reliable for its intended purpose of monitoring automated ESR analyzers. The acceptance criteria relate to the control values falling within an "Expected Range" over time.

Here's a breakdown based on the information available:

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

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

• Sample Size for Test Set: Not explicitly stated in the provided document. The studies were focused on the stability of the control material, not on a diagnostic test applied to patient samples.
• Data Provenance: Not specified, but likely internal laboratory testing performed by R&D Systems, Inc. (USA). The nature of the device (a quality control material) suggests prospective in-house testing rather than retrospective data from a specific country's patient population.

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)

• Not Applicable. The "ground truth" for a hematology control is its expected value range and stability over time, determined by internal validation and adherence to established quality control principles, not by expert interpretation of images or patient data.

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

• Not Applicable. Adjudication methods are typically used for clinical endpoints or diagnostic interpretations, which are not relevant to the performance assessment of a quality control material.

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

• Not Applicable. This device is a hematology control, not an AI-powered diagnostic tool. MRMC studies are not relevant to its regulatory submission.

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

• Not Applicable. This device is a physical reagent (hematology control), not an algorithm or AI system.

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

• The "ground truth" indirectly refers to the expected range of values for the erythrocyte sedimentation rate (ESR) that the control material is designed to demonstrate when run on automated ESR analyzers. This "Expected Range" would be established internally by the manufacturer through rigorous testing and validation, typically against reference methods or established quality control standards, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

• Not Applicable. This device is a physical reagent, not an algorithmic model that requires training data.

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

• Not Applicable. (As above, no training set for a physical control material).

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