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K Number
K991409
Device Name
K-ASSAY RHEUMATOID FACTOR
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
1999-06-09

(48 days)

Product Code
DHR
Regulation Number
866.5775
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The K-ASSAY Rheumatoid Factor is intended to be used for the quantitative determination of human rheumatoid factor in human serum by immunoturbidimetric assay.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "K-ASSAY Rheumatoid Factor." This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information required to answer the questions about acceptance criteria and a study proving device performance in the manner requested.

The FDA 510(k) process primarily evaluates a new device's "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as an already legally marketed device. It does not typically require the submission of detailed clinical trials with specific acceptance criteria and outcome measures as one might find in a Premarket Approval (PMA) application or a comprehensive scientific publication.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the document:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The letter states the device is "substantially equivalent" to predicate devices, but it does not provide specific performance metrics or acceptance criteria used in the equivalence determination.

  2. Sample size used for the test set and the data provenance: This information is not present. The type of study (if any, beyond equivalency testing) and details about the test set (sample size, origin, retrospective/prospective) are not provided.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present. Ground truth establishment details are not part of this regulatory letter.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present.

  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: This information is not applicable or present. The device is an in vitro diagnostic (IVD) for quantitative determination of rheumatoid factor, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device appears to be a standalone in vitro diagnostic assay for laboratory use, but the details of its "standalone" performance (e.g., sensitivity, specificity, accuracy) are not provided in this regulatory letter. The performance data would have been part of the 510(k) submission, but is not detailed here.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present. For IVDs, ground truth typically involves reference methods or established clinical diagnoses, but the specifics are not in this letter.

  8. The sample size for the training set: This information is not present. IVDs are typically "trained" through assay development and validation, not in the same way an AI algorithm has a distinct "training set."

  9. How the ground truth for the training set was established: This information is not present.

In summary, this document is a regulatory approval and confirms the device's substantial equivalence to existing devices. It does not provide the underlying technical and clinical study details that would address the requested questions about acceptance criteria and performance studies. Those details would typically be found in the full 510(k) submission or associated technical documentation, which is not provided here.

§ 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).