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In vitro test for the quantitative determination of total bilirubin in human serum and plasma on the cobas c 111 system.

Measurements of the levels of bilirubin and organic compound formed during normal and abnormal destruction of red cells, is used in the diagnosis of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block.

The Total Bilirubin Special reagent is intended for use on the cobas c 111 analyzer for the quantitative determination of total or direct bilirubin in serum and plasma.

The cobas c 111 analyzer is a partially automated, in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

The cobas c 111 instrument is a random access analyzer designed to be operated on a bench top in the professional environment using a combination of a photometric analysis unit and an optional ion selective electrodes (ISE).

Here's a breakdown of the acceptance criteria and study information for the Total Bilirubin Special reagent application to the cobas c 111 analyzer, based on the provided text:

Context: This submission is a Special 510(k) for a modification to an existing device. The modification involves applying the already cleared Total Bilirubin Special reagent to a new analyzer, the cobas c 111, which is itself a modification of the COBAS INTEGRA 400 plus. Therefore, the primary focus of the performance data is to demonstrate equivalence of the reagent's performance on the new analyzer compared to its performance on the predicate analyzer.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device. The performance characteristics of the modified device (on cobas c 111) are compared to the predicate device (on COBAS INTEGRA Total Bilirubin Special, K063543).

Note on Acceptance Criteria: For a Special 510(k) like this, the implicit acceptance criterion is that the performance of the modified device is substantially equivalent to the predicate device, meaning it performs as well or better for the critical parameters. The table demonstrates this comparable performance.

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: The document does not explicitly state the sample size used for the performance evaluation (precision, measuring range, detection limit, interference studies).
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a manufacturer's internal validation, likely conducted in a controlled lab environment.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This being an in-vitro diagnostic (IVD) chemistry analyzer, the "ground truth" for the test set is established by the reference method for total bilirubin (Doumas reference method, as mentioned in the traceability section) and highly controlled laboratory samples (e.g., control materials, spiked samples). There's no mention of human experts interpreting results in the way a radiologist interprets an image.

3. Adjudication method for the test set:

   • Not applicable in the context of an IVD chemistry analyzer. Results are quantitative outputs from the instrument.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This is a quantitative in-vitro diagnostic device, not an imaging device that requires human interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, this is an algorithm-only (analyzer-only) performance study. The analyzer performs the test and provides a quantitative result. There is no human interpretation component in the direct measurement of bilirubin by this device.

6. The type of ground truth used:

   • Reference Method: The device is standardized against the Doumas reference method for total bilirubin. This is the primary established ground truth for bilirubin measurement.
   • Control Materials: Performance is likely evaluated using assayed control materials (e.g., Precinorm U, Precipath U mentioned as quality controls) with known concentration values.

7. The sample size for the training set:

   • Not applicable as this is not a machine learning/AI algorithm that requires a "training set" in the conventional sense. This is an analytical chemistry device where the "training" would be the initial development and calibration of the reagent and instrument platform.

8. How the ground truth for the training set was established:

   • Not applicable. The "ground truth" for the development of such an IVD device is based on established clinical chemistry principles and standardization against internationally recognized reference methods (like Doumas). Calibrators are used to establish the measurement curve, and these calibrators are themselves traceable to a reference method.

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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):

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.

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Ask a specific question about this device