(50 days)
The C.f.a.s. PAC is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
The C.f.a.s. PAC is a lyophilized product consisting of human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.
The provided document is a 510(k) summary for a medical device called "C.f.a.s. PAC," which is a calibrator for automated systems. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement that you requested.
The document states under "Performance Characteristics":
- "The C.f.a.s. PAC was evaluated for value assignment and stability."
This phrase indicates that a study was performed, but the results, methodology, acceptance criteria, and other specifics of that study are not included in this summary. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study report.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information (Table of acceptance criteria and reported performance, sample sizes, data provenance, number and qualifications of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and training ground truth establishment) is not present in this document.
§ 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.