(67 days)
Multicheck™ with metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Oximetry, Electrolytes, and Glucose and Lactate.
Multicheck™ with metabolite is a four level quality control system consisting of part numbers S5530, S5540, S5550, and S5560. Each level consists of 30 ampoules per box, 2 mL solution per ampoule.
The provided document is a 510(k) Summary for a medical device (Multicheck™ with metabolite) seeking clearance from the FDA. This document is related to quality control materials for laboratory analyzers, not a diagnostic device for patient care. Therefore, the concepts of acceptance criteria and studies as typically applied to medical imaging or diagnostic AI devices (e.g., sensitivity, specificity, reader studies, ground truth establishment by experts, sample sizes for test/training sets, etc.) do not directly apply in the same way.
The document focuses on demonstrating substantial equivalence to a predicate device (Multicheck™ with glucose), with the primary difference being the addition of a lactate analyte. The "study" here is the comparison of technological characteristics to show this equivalence for a quality control product.
However, if we interpret your request in the context of what would constitute "acceptance criteria" and "proof" for a quality control material gaining clearance, it would revolve around demonstrating that the new formulation (with lactate) performs comparably to the predicate for all intended analytes and that the lactate measurement is within acceptable ranges for quality control.
Here's an attempt to structure the information based on your request, understanding the limitations given the document's nature:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for QC Material) | Reported Device Performance (Implied from Substantial Equivalence Claim) |
|---|---|
| Ability to check precision and accuracy of analyzers for pH/Blood Gases, Oximetry, Electrolytes, and Glucose. | The device is substantially equivalent to the predicate device (Multicheck™ with glucose) for these parameters. |
| Ability to check precision and accuracy of analyzers for Lactate. | The device has the addition of the lactate analyte, implying it effectively serves as a control for lactate measurement as well. |
| Shelf-life and stability for all analytes. | Not explicitly stated, but implied as a quality control product would need to maintain stability over its stated shelf-life to be effective. The predicate device's established stability would likely be a benchmark. |
| Manufacturing quality and consistency. | Not explicitly stated, but implied through the regulatory submission process for a quality control material. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of patient data. For a quality control material, "test set" would refer to analytical runs or batches. The document does not specify the number of batches or analytical runs performed to establish equivalence.
- Data Provenance: Not applicable in the context of country of origin for patient data. The "testing" would involve laboratory analysis of the QC material itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For a quality control material, "ground truth" is established by the certified values of the analytes in the control solution itself. This is typically determined through metrologically traceable methods, not by expert human interpretation of medical data. The Radiometer team manufacturing and validating the product would involve analytical chemists and quality control specialists.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of medical images or diagnostic results. This is not relevant for a quality control material.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Done. MRMC studies are used to assess the impact of AI on human reader performance in diagnostic tasks. This device is a quality control material for laboratory analyzers, not a diagnostic AI device, so such a study is irrelevant.
6. Standalone Performance Study
- Not Applicable / Implied. For a quality control material, standalone performance would relate to its ability to maintain its specified analyte values and stability over time. While not detailed in this summary, such studies (e.g., stability studies, homogeneity studies) would be part of the product development and validation for a QC material to demonstrate it reliably provides the intended target values for calibration and quality assurance. The claim of "substantial equivalence" implies that these aspects were demonstrated to be comparable to the predicate.
7. Type of Ground Truth Used
- Certified Analyte Values: The "ground truth" for a quality control material is its assigned or certified values for each analyte (pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate). These values are determined through highly accurate analytical methods, often traceable to international reference materials.
8. Sample Size for the Training Set
- Not Applicable. "Training set" refers to data used to train machine learning models. This is a quality control material, not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See point 8).
In Summary:
The provided document is a regulatory submission for a quality control product. The "acceptance criteria" for such a device are primarily about demonstrating its ability to accurately and precisely check the performance of laboratory analyzers for specified analytes, and its "proof" comes from demonstrating substantial equivalence to a previously cleared product, with any new analytes (like lactate) being validated to perform as intended within the context of a quality control material. The frameworks for evaluating diagnostic AI or medical imaging devices (which heavily rely on expert consensus, clinical outcomes, and reader studies) are not applicable here.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.