(71 days)
For in vitro diagnostic use in the calibration of the ADVIA 1650 Technicon RA-500, Technicon RA-1000, Technicon RA-XT, Technicon RA-2000, opeRA chemistry systems specific protein methods.
The Bayer Specific Protein Reference Serum are for one absolute value of calibrator material prepared in human serum with nonserum constituents added.
All the analytes currently in the calibrator material are: C4 IgA IgG IgM Transferrin Alpha-1-Acid Glycoprotein Alpha-1-Antitrypsin Haptoglobin
The intention of this submission is to add the assigned values to the labeling claims for use in the US for: Haptoglobin
As with the predicate device, the calibrator materials are a human serum concentrate and dilution is needed with the Specific Protein Sample Diluent provided. These calibrators are for use on the Bayer ADVIA 1650, Technicon RA-1000, Technicon RA-XT, Technicon RA-500, Technicon RA-2000, opeRA chemistry analyzers.
The provided text describes a "Specific Protein Reference Serum" device, which is a calibrator material used for in vitro diagnostic purposes. This type of device does not typically have "acceptance criteria" in the same way that a diagnostic assay or an AI algorithm would. Instead, its regulatory clearance is based on demonstrating "substantial equivalence" to a predicate device.
The document explicitly states:
"The Specific Protein Reference Serum are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Specific Protein Reference Serum. The only difference in these calibrators is the addition of the assigned values in the labeling of one new analyte: Haptoglobin."
Therefore, the concept of a study proving the device meets "acceptance criteria" in the context of performance metrics (like sensitivity, specificity, F1 score, etc.) does not apply here. The criteria for acceptance for this calibrator material would revolve around its manufacturing quality, stability, and the accuracy of the assigned Haptoglobin values, which are inherent to its function as a calibrator.
Based on the provided information, I can answer the following points:
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A table of acceptance criteria and the reported device performance: Not applicable. This is a calibrator material, not a diagnostic device with performance metrics like sensitivity or specificity. Its "performance" is its ability to accurately calibrate other devices, which is demonstrated by ensuring the assigned values are correct and stable. The document focuses on substantial equivalence rather than performance against a set of predefined acceptance criteria in the context of diagnostic accuracy.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a calibrator material. There is no "test set" in the sense of patient data for evaluating diagnostic performance.
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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): Not applicable. Ground truth for a calibrator material would involve highly controlled laboratory methods for assaying the concentration of the analytes (Haptoglobin in this case). This is not typically established by clinical experts in the same way as diagnostic imaging or pathology.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 not an AI-assisted device or a diagnostic device requiring human reader interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a chemical calibrator, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the Haptoglobin values added to the calibrator, the "ground truth" would be established through robust analytical validation studies, likely using reference methods and highly accurate laboratory measurements to determine the precise concentration of Haptoglobin in the calibrator material. This is an analytical "ground truth," not a clinical one.
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The sample size for the training set: Not applicable. Calibrator materials do not have "training sets" in the context of machine learning.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is for a medical device (a calibrator material) that is cleared based on "substantial equivalence" to a predicate device. The information requested (acceptance criteria, test sets, expert ground truth, MRMC studies, AI performance, etc.) is typically associated with diagnostic devices, particularly those involving image analysis or disease detection algorithms, and is not relevant to this specific product.
§ 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.