(33 days)
The MAS® chemTRAK® · H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK .. II with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges us a means of assuring consistent performance of reagent and instrument.
The DADE® Moni-Trol® • H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include DADE® Moni-Trolf · H with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
The OLYMPUS Chemistry Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Chemistry Control with patient serum specimens when assaying for any of the listed consititients. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
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The provided document is a 510(k) clearance letter from the FDA for several chemistry control materials (MAS® chemTRAK® H, DADE® Moni-Trol® H, and OLYMPUS Chemistry Control). This type of device is a "Quality control material (assayed and unassayed)" and is classified as Class I.
The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy or diagnostic performance in the way a medical diagnostic AI might. Therefore, the questions related to acceptance criteria for diagnostic performance, study design with test sets, ground truth establishment, expert adjudication, or MRMC studies are largely not applicable in the context of this specific regulatory document.
Here's how to address the questions based on the provided FDA letter:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary "acceptance criteria" for a 510(k) submission of a Class I quality control material is demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness profile as the predicate. For quality control materials, this would involve comparing their physical and chemical properties, stability, and control ranges to that of established controls. The specific quantitative acceptance criteria (e.g., within certain percentage of known values, specific coefficient of variation) are not detailed in this FDA letter but would have been part of the 510(k) submission.
- Reported Device Performance: The FDA letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This is the reported "performance" in the context of regulatory clearance – the device met the criteria for substantial equivalence to a predicate. The specific performance data (e.g., assay values, stability data, precision data) for these specific controls are not detailed in the public FDA letter but would be in the confidential 510(k) submission. The "Indications for Use" section mentions that "Assay values are provided for the specific systems listed" and that users can "compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument." This implies that the controls provide known, consistent values.
2. Sample size used for the test set and the data provenance
- Not applicable in this document. A "test set" in the context of diagnostic AI algorithms is for evaluating performance on unseen data. For a Class I quality control material seeking 510(k) clearance for substantial equivalence, the "testing" involves demonstrating the product's consistency, stability, and ability to provide known control values. The document does not specify sample sizes for such internal validation studies for these control materials. Data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable in this document. "Ground truth" in the context of a diagnostic algorithm refers to a definitive diagnosis or finding. For a quality control material, the "ground truth" or "known concentration" is established through analytical methods and manufacturing processes, not typically by expert interpretation of patient data.
4. Adjudication method for the test set
- Not applicable in this document. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies for establishing ground truth for diagnostic devices, especially those involving image interpretation. This is not relevant for the clearance of liquid chemistry 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. MRMC studies are used to evaluate the impact of a diagnostic tool (like AI) on human reader performance. This device is a quality control material, not a diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a chemical control; it's not an algorithm, so "standalone performance" of an algorithm is not relevant.
7. The type of ground truth used
- For quality control materials, the "ground truth" refers to the assigned values or expected ranges for various analytes (e.g., glucose, cholesterol) within the control material. These values are established through rigorous analytical testing and calibration processes during the manufacturing and initial validation of the control material, often against reference methods or certified reference materials. It's not "expert consensus," "pathology," or "outcomes data" in the diagnostic sense.
8. The sample size for the training set
- Not applicable. "Training set" is a concept for machine learning models. This device is a manufactured chemical product, not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. As explained in point 8, there is no "training set" in the context of these quality control materials. The establishing of "known concentrations" for the control materials themselves is through analytical validation, as described in point 7.
§ 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.