(58 days)
C.f.a.s. (Calibrator for automated systems) PUC (Proteins in Urine/CSF) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
The Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC) consists of a buffered aqueous solution with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.
The provided information does not contain any data regarding acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
This document is a 510(k) summary for a Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC), a biochemical calibrator. The summary focuses on demonstrating "substantial equivalence" to a predicate device, which is a regulatory pathway for certain medical devices that allows them to be marketed without undergoing the full premarket approval (PMA) process.
Here's why the requested information about acceptance criteria and a performance study for an AI/ML device is not present:
- Device Type: The device described, C.f.a.s. PUC, is a calibrator. Its function is to establish calibration curves for quantitative Roche methods on clinical chemistry analyzers. This is a chemical product used for laboratory testing, not an AI/ML algorithm or software for image analysis, diagnosis, or prediction.
- Regulatory Pathway: The 510(k) pathway for this type of device relies on demonstrating substantial equivalence to a previously legally marketed predicate device. This typically involves comparing physical characteristics, intended use, technological characteristics, and safety/effectiveness data if significant differences exist that could impact safety or effectiveness. For a calibrator, performance evaluation usually revolves around its ability to accurately calibrate the target assay, stability, and absence of interferences. It does not involve AI/ML performance metrics like sensitivity, specificity, AUC, or reader studies.
- Content of the Summary: The document details the submitter, device name, description, intended use, and a detailed comparison with a predicate device (C.f.a.s. Proteins). The comparison highlights similarities and differences, primarily in matrix composition (buffered aqueous solution vs. stabilized human serum) and constituent analytes. This is typical for a calibrator 510(k), focusing on the chemical and physical properties relevant to its function.
- Lack of AI/ML-specific terms: There is no mention of algorithms, machine learning, AI, training data, test sets, ground truth, expert readers, or any other terminology associated with AI/ML device validation.
Therefore, I cannot provide the requested information based on the given input. The input describes a different type of medical device and a different regulatory evaluation process.
§ 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.