(63 days)
For use in the calibration of Roche lipid methods on automated clinical chemistry analyzers.
The Calibrator for Automated Systems (C.f.a.s.) consists of liquid human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.
The provided text describes a 510(k) summary for a medical device called "Calibrator for Automated Systems (C.f.a.s.) Lipids." This document focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in terms of performance metrics.
Here's an analysis based on the provided text, addressing your points where possible, and noting where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the C.f.a.s. Lipids device itself. Instead, it focuses on demonstrating substantial equivalence to a predicate device, "Roche Diagnostic Calibrator for Automated Systems (C.f.a.s.) HDL/LDL-C plus (K974825)".
The "acceptance criteria" in this context are implicitly that the proposed device:
- Shares the same intended use as the predicate.
- Has similar features (format, stability, levels, matrix).
- Differences in features (constituent analytes) do not raise new questions of safety or effectiveness.
Table of Substantial Equivalence Comparison (from the provided text):
| Feature | C.f.a.s. Lipids (Proposed) | C.f.a.s. HDL/LDL-C plus (Predicate Device) |
|---|---|---|
| Intended Use | For use in the calibration of Roche lipid methods on automated clinical chemistry analyzers. | For use in the calibration of homogeneous Roche methods for the quantitative determination of HDL-cholesterol and LDL-cholesterol on automated clinical chemistry analyzers. |
| Format | Pooled human sera with constituents added as required to obtain component levels. | Pooled human sera with constituents added as required to obtain desired component levels. |
| Stability | Lyophilized calibrator at 2-8°C until expiration date. Reconstituted: 8 hours at 15-25°C, 5 days at 2-8°C, 1 month at -20°C. | Lyophilized calibrator at 2-8°C until expiration date. Reconstituted: 1 day at 15-25°C, 5 days at 2-8°C, 1 month at -20°C. |
| Levels | Single Level | Single Level |
| Matrix | Lyophilized | Lyophilized |
| Constituent Analytes | Apolipoprotein A1, Apolipoprotein B, Cholesterol, HDL-cholesterol, LDL-cholesterol, Phospholipids, Triglycerides | HDL-cholesterol, LDL-cholesterol |
The "reported device performance" in this document is effectively the demonstration that the features and intended use are sufficiently similar to the predicate device, and where there are differences (e.g., additional analytes), these differences are acceptable for substantial equivalence. No specific numerical performance results (like accuracy percentages or coefficients of variation) for the new device are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. This type of summary focuses on the comparison of the device's characteristics with a predicate device, not on specific clinical or analytical studies that would involve test sets and data provenance. For a calibrator, studies typically involve testing its ability to consistently calibrate instruments across a range of values, but details of such studies are absent here.
3. 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)
This information is not applicable and not provided. This device is a calibrator, not a diagnostic tool requiring expert interpretation of images or patient data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As a calibrator, it doesn't involve subjective interpretations that would require adjudication.
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
This information is not applicable and not provided. This device is a calibrator, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a chemical calibrator; it does not involve an algorithm in the sense of AI or image processing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a calibrator, the "ground truth" would typically be derived from highly accurate reference methods or certified reference materials used to assign target values to the calibrator vials. The document states that "Values for constituent analytes are provided in product labeling," implying that these values are established and accepted as accurate. However, the method for establishing this "ground truth" (e.g., using a traceability chain to a primary reference method) is not detailed in this summary.
8. The sample size for the training set
This information is not applicable and not provided. As a calibrator, there isn't a "training set" in the context of machine learning or classification algorithms.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as point 8.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.