(45 days)
ESR Control-M™ is a bi-level hematology control designed to document and monitor values obtained from manual ESR procedures.
ESR Control-M™ 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 manual ESR procedures. Overall performance of the entire system is monitored including disposable ESR tubes, technique, and important environmental factors. ESR Control-M™ is available in two levels and is run in the same manner as patient specimens.
The provided text describes the ESR Control-M™ Hematology Control, a device designed to monitor the performance of manual Erythrocyte Sedimentation Rate (ESR) procedures.
Here's an analysis based on the given information:
- Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability by recovery of values within the Expected Range through the life of the product | Met acceptance criteria. The shelf life is established as 45 days from shipment. Open-vial stability is 14 days, provided proper handling. This implies that the device's values remained within the expected range for these specified periods. |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample size used for the stability testing.
- It does not specify the data provenance (country of origin, retrospective/prospective). The study was likely conducted by R&D Systems, Inc. in Minneapolis, MN, USA.
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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):
- The document does not provide information on the number of experts or their qualifications for establishing ground truth. The 'ground truth' here refers to the "Expected Range" for ESR values, which would typically be established based on standardized laboratory methods and potentially expert consensus on what constitutes an acceptable range for a control.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hematology control material, not an AI-powered diagnostic device, so such a study would not be applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical control reagent, not an algorithm, so a standalone algorithm performance study is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth referred to as "Expected Range" for the ESR values of the control. This "Expected Range" would likely be established through internal validation studies, reference to predicate devices, and adherence to established clinical laboratory standards for hematology controls. It's an internal standard for the expected performance of a well-functioning manual ESR procedure when using the control.
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The sample size for the training set:
- The concept of a "training set" is not applicable to this device, as it is a physical control reagent and not a machine learning model.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
Study Proving Device Meets Acceptance Criteria:
The device's performance is proven through stability studies. The document states:
"Results of studies met acceptance criteria for stability tested by recovery of values within the Expected Range through the life of the product. The shelf life for this product is established as 45 days from shipment and the open-vial stability is 14 days provided that the product is properly handled according to the package insert instructions."
This indicates that R&D Systems, Inc. conducted internal testing which demonstrated that the ESR Control-M™ maintained its expected ESR values for the claimed shelf life and open-vial stability periods. The study would have involved storing the control material under specified conditions and then measuring its ESR values at various time points to ensure they remained within the pre-defined "Expected Range." This type of study is standard for in vitro diagnostic reagents to establish their stability and shelf life.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.