(25 days)
N Protein Standard PY is intended to be used for the establishment of reference curves.
The proposed calibrator, N Protein Standard PY is a calibrator prepared from human serum (lyophilized) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer Systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer II K943997) for the calibration of the following tests:
Fibrinogen Antithrombin II Prothrombin Plasminogen alpha1-Antitrypsin C1 Inhibitor
The provided text describes a 510(k) summary for the N Protein Standard PY, a calibrator. It focuses on demonstrating substantial equivalence to a predicate device and includes information on the device's intended use, composition, and basic performance characteristics like precision and stability.
However, the document does not contain the following information required to answer your request:
- Acceptance Criteria Table and Reported Device Performance: While "Precision and reproducibility" and "Stability" are mentioned, no specific acceptance criteria (e.g., "CVs must be less than X%") are provided, nor is a direct comparison in a structured table format against such criteria.
- Sample size and data provenance for a test set: The document mentions "one lot of N Protein Standard PY" for precision studies, but this isn't a "test set" in the context of device performance validation against ground truth. There's no information on data provenance (country, retrospective/prospective).
- Number of experts and qualifications for ground truth: No experts are mentioned, as the device is a calibrator, not a diagnostic tool requiring expert interpretation of results.
- Adjudication method for the test set: Not applicable, as there's no test set requiring adjudication.
- MRMC comparative effectiveness study: Not applicable. The device is a calibrator, not a diagnostic algorithm that would be compared with human readers.
- Standalone (algorithm only) performance: Not applicable. This is a physical calibrator, not an algorithm.
- Type of ground truth used: For a calibrator, the "ground truth" would typically refer to the assigned values of the standards, which are established through a metrological traceability chain, not expert consensus, pathology, or outcomes data. This information is not detailed here.
- Sample size and how ground truth was established for the training set: Not applicable, as this is a calibrator, not an AI model that undergoes "training."
In summary, the provided submission is for a calibrator (a laboratory reagent) and therefore does not contain the type of clinical performance validation studies, ground truth establishment, or AI-related metrics that your request assumes for a diagnostic device or AI algorithm. The information needed to fill out most of your table is not present in the document because it's relevant to a different type of medical device submission.
§ 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.