(203 days)
For In Vitro Diagnostic use only.
Multichem IA Plus is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
The Multichem IA Plus control is prepared from human serum to which purified biochemical material (extracts of human and animal origin), chemicals, drugs, preservatives and stabilizers have been added. The control is used in liquid form for convenience.
The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices. Three levels of control are available to allow performance monitoring within the clinical range.
Multichem IA Plus controls are prepared from human serum with added constituents of human and animal origin, chemicals, therapeutic drugs, stabilizers and preservatives. The control is provided in liquid form for convenience.
Each donor unit used in the preparation of the control material was tested by United States Food and Drug Administration (FDA) approved methods and found to be negative for antibodies to HIV and HCV, and non-reactive for HBsAg.
This document is a 510(k) premarket notification for a quality control material (Multichem IA Plus), not an AI/ML medical device. Therefore, the information requested in your prompt regarding acceptance criteria and studies proving an AI/ML device meets them (e.g., sample size, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable or present in this document.
The document discusses the substantial equivalence of the "Multichem IA Plus" control to a previously marketed predicate device (K132091). The "study" referenced is primarily performance data related to product stability (open vial stability and shelf-life) for various analytes, which are typical for quality control materials in in-vitro diagnostics, not AI/ML algorithms.
Here's what can be extracted from the document relevant to its specific context:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" for an AI/ML device's performance metrics like accuracy, sensitivity, or specificity. Instead, it details stability claims for a quality control material.
| Acceptance Criteria (Product Claim) | Reported Device Performance (Stability Studies) |
|---|---|
| Open Vial Stability (at 2 to 8°C): | Achieved (based on claims stated by manufacturer) |
| - All analytes (general) | 10 days |
| - C-Peptide, Homocysteine, Calcitonin & Troponin T | 7 days |
| - PTH Intact, Troponin I & 25OH Vitamin D | 4 days |
| - Folate | 2 days |
| - ACTH | 8 hours |
| - BNP | 1 hour |
| Storage (Unopened)/Shelf-Life: | Achieved (based on claims stated by manufacturer) |
| - At -20° to -80°C | 36 months |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of "samples" for each stability test. The document mentions "Stability studies have been performed," but does not quantify the number of batches or measurements.
- Data Provenance: The studies were performed by the manufacturer, Technopath Manufacturing Ltd. No information about country of origin of the data beyond the manufacturer's location (Fort Henry Business Park, Ballina, Co. Tipperary, Ireland) is provided. These are laboratory studies for product stability, not clinical data sets.
- Retrospective or Prospective: These would typically be prospective stability studies, where the product is tracked over time under specified conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to the type of device described. Ground truth for a quality control material's stability is established through analytical testing against known reference methods or specifications, not through expert consensus on images or clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective interpretations of data, typically in diagnostic imaging or clinical assessments, not for quantitative chemical measurements of control materials.
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 is a laboratory quality control material, not a diagnostic imaging AI with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a reagent/control material, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance (stability) would be based on:
- Analytical Chemistry Measurements: Direct measurement of analyte concentrations over time using validated analytical methods.
- Pre-defined Specifications: The manufacturer's internal specifications for acceptable recovery of analytes and stability limits.
8. The sample size for the training set:
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. No training set.
In summary, the provided document is a 510(k) for an in vitro diagnostic quality control material, not an AI/ML medical device. Therefore, the requested information regarding AI/ML device validation is not present. The "performance data" refers to the stability of the chemical control material.
§ 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.