(126 days)
HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.
HemoTrol® WB is an assayed hemoglobin quality control material intended for professional use in the verification of the precision and accuracy of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® WB contains bovine red blood cells with hemoglobin lysates in MetHb and additional stabilizers. For daily quality control, three physiological relevant levels are available.
HemoTrol® WB solutions are filled in reclosable plastic primary containers. Each bottle contains 1.1 g of HemoTrol® WB solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.
The provided text is a 510(k) summary for a medical device (HemoTrol® WB) and focuses on establishing substantial equivalence to a predicate device. It describes performance data related to stability testing of the quality control material itself, rather than a clinical study evaluating the performance of an AI-powered diagnostic device in a patient population.
Therefore, the information required to answer your query about acceptance criteria and study proving a device meets acceptance criteria, specifically for an AI/diagnostic device, is not present in the provided text. The document describes:
- Device: HemoTrol® WB (a quality control material for hemoglobin measurement, not an AI diagnostic device).
- Purpose: To demonstrate substantial equivalence to a predicate quality control device (Eurotrol HemoTrol).
- Performance Data: Focuses on stability of the quality control material (open-vial and closed-vial stability), not diagnostic performance metrics like sensitivity, specificity, or reader improvement in an MRMC study.
Here's a breakdown of why I cannot fulfill your request based on this document:
- Acceptance Criteria for AI/Diagnostic Performance: The text does not mention any acceptance criteria for sensitivity, specificity, AUC, or other typical metrics for an AI or diagnostic device. The "acceptance criteria" presented here implicitly relate to demonstrating stability within acceptable ranges for a quality control material.
- Study Proving Acceptance Criteria: The studies described ("Open Stability" and "Closed Stability") are designed to show how long the quality control material remains stable, not to evaluate the performance of an AI or diagnostic device against a ground truth in a clinical setting.
- Sample Size (Test Set): Not applicable in the context of an AI/diagnostic test set. For stability testing, the sample size was "n=6" for open stability and "n=8" for closed stability.
- Data Provenance: Not relevant for these stability tests. The "samples used were produced according the regular production process of HemoTrol® WB."
- Experts for Ground Truth: Not applicable. Ground truth for stability is measurement against a known reference method for hemoglobin on specific analyzers (HemoCue® Hb 301 and HemoCue® Hb 801 systems).
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Study: Not performed, as this is a quality control material, not a diagnostic device for human interpretation.
- Standalone (Algorithm Only) Performance: Not applicable.
- Type of Ground Truth: For stability, the ground truth is the measured hemoglobin value on the specified HemoCue systems.
- Training Set Sample Size: Not applicable, as this is not an AI/machine learning device requiring a training set.
- Ground Truth for Training Set: Not applicable.
To answer your detailed questions, you would need a document that describes the clinical performance evaluation of an AI-powered diagnostic device in a patient population.
§ 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.