(355 days)
The BTA stat test is indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy. This 510(k) is to expand the same indication to prescription home use of the product. The original 510(k) was K964151.
The BTA stat test for bladder tumor associated antigen is an immunochromatographic assay utilizing monoclonal antibodies to specifically detect the presence of bladder tumor associated antigen in urine. Patient urine is added to the sample well and allowed to react with a colloidal gold-conjugated antibody. If the antigen is present in the sample, an antigen conjugate complex is formed and a line in the patient (P) test zone appears.
Here's a breakdown of the acceptance criteria and study information for the BTA stat Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated as Study Objective) | Reported Device Performance (Study Results) |
|---|---|
| Lay users could read instructions and perform test acceptably well compared to laboratorians (Study 1). | No significant differences in accuracy and repeatability of BTA stat test results were observed between laboratorians and professional lay-persons at three sites. |
| Persons with a previous diagnosis of bladder cancer could perform the test accurately and comprehend "Instructions for Home Use" (Study 2). | The intended home user population can perform the test at the same level of accuracy observed in laboratory professionals in the first study, and the labeling is easily understood by bladder cancer patients. |
2. Sample Size Used for the Test Set and Data Provenance
- Study 1 (Comparison of Lay-persons vs. Laboratorians): Not explicitly stated, but implies multiple sites and "professional lay-persons."
- Study 2 (Home User Performance): Not explicitly stated, but refers to "persons with a previous diagnosis of bladder cancer" and "bladder cancer patients."
- Data Provenance: Not explicitly stated, but the submission is for the BTA Stat Test which is manufactured by Bion Diagnostic Sciences, Inc. in Redmond, WA. The studies were likely conducted in the US. The studies are prospective in nature, as they evaluate user performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" as it relates to expert consensus on clinical findings (like interpreting medical images) is not directly applicable here. This device detects a "bladder tumor associated antigen" in urine. The studies are evaluating the user's ability to perform and interpret the test correctly, rather than the test's diagnostic accuracy against a clinical ground truth.
For Study 1, "laboratorians" would be considered the expert standard for performing the test. Their qualifications are not explicitly stated, but it's implied they are trained laboratory professionals.
For Study 2, the ground truth relates to the correct performance and interpretation of the immunoassay by the home user.
4. Adjudication Method for the Test Set
Not applicable in the traditional sense. The studies focused on whether users could correctly perform and read the test, implying a comparison against an objective result (e.g., presence or absence of a line on the test strip) or against results obtained by trained laboratorians. There's no mention of a
multi-expert adjudication process for the test results themselves.
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 is not applicable. The BTA stat Test is an immunoassay, not an AI-powered diagnostic device requiring human interpretation in the context of images. The studies evaluate user performance with the device itself, not human performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The BTA stat Test is an immunoassay designed to be used by humans (either laboratorians or home users), who then interpret the visible result (a line on the test strip). There is no "algorithm only" component.
7. The Type of Ground Truth Used
As mentioned in point 3, the "ground truth" in these studies is the correct performance and interpretation of the BTA stat immunoassay.
- For Study 1, the ground truth for test performance was likely established by the "accuracy and repeatability" achieved by trained laboratorians.
- For Study 2, the ground truth for test performance and interpretation was established by comparing home user results to what the test should objectively show, likely based on known samples or comparison to laboratorian results from Study 1. The study also assessed comprehension of the "Instructions for Home Use," where correct comprehension would be the ground truth.
8. The Sample Size for the Training Set
The provided text does not mention a "training set" in the context of machine learning. The studies described are performance studies for the device and user's ability to operate it.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for machine learning.
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.