(73 days)
As a consistent test sample of known concentration for monitoring the performance of RF immunoturbidimetric assays.
The KAMIYA RF Control is a lyophilized, human serum-based, assayed control for use as a consistent test sample of known concentration for monitoring the performance of RF immunoturbidimetric assays. Two levels of the KAMIYA RF Control are provided. The human serum used to manufacture this product is tested and found negative for the presence of HBsAg and antibody to HCV and HIV. The assigned RF values are traceable to the WHO International Reference Preparation of Rheumatoid Arthritis Serum. This product is stable for at least 1 year (unopened) and 2 weeks (after reconstitution).
This document is a 510(k) summary for the KAMIYA RF Control Set, an in vitro diagnostic device used to monitor the performance of RF immunoturbidimetric assays. The submission focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, de novo clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML devices. Therefore, a direct mapping to all requested fields for AI/ML device studies is not possible.
Here's an analysis based on the provided text, addressing the relevant points and noting where direct information is unavailable due to the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Sigma Immunology Control, K851202) | Exhibits similar "within run and between day precision and reaction characteristics for the analyte" as the predicate device. |
| Consistency as a test sample of known concentration | The device is described as "a consistent test sample of known concentration." Specific quantitative data on consistency is not provided beyond the precision and reaction characteristics. |
| Traceability of assigned RF values | Assigned RF values are traceable to the WHO International Reference Preparation of Rheumatoid Arthritis Serum. |
| Stability | Stable for at least 1 year (unopened) and 2 weeks (after reconstitution). |
| Negative for HBsAg, HCV, and HIV antibodies in human serum | Human serum used is tested and found negative for these analytes. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" sample size in the context of a traditional clinical study with patient samples. The evaluation is based on the performance of the control material itself in laboratory settings.
- Sample Size: Not explicitly stated for testing precision or reaction characteristics.
- Data Provenance: Not explicitly stated, however, the product is from KAMIYA BIOMEDICAL COMPANY in Seattle, WA, USA. The testing would have been conducted internally as part of the validation for the 510(k) submission. This is a retrospective evaluation against an existing predicate device rather than a prospective study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in this context. The "ground truth" for a control material is its assigned value and its performance characteristics (precision, linearity, etc.) when tested against a reference method or predicate device. This isn't a diagnostic device requiring expert interpretation of results on patient samples to establish ground truth.
4. Adjudication method for the test set
Not applicable. There is no "adjudication" in the sense of resolving discrepancies in expert interpretations of patient data. The evaluation is based on laboratory measurements against a predicate device.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for the KAMIYA RF Control is its assigned RF values, traceable to the WHO International Reference Preparation of Rheumatoid Arthritis Serum, and its demonstrated precision and reaction characteristics in comparison to the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).