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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

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.

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The Bard BTA TRAK Test is an in vitro diagnostic assay indicated for the quantitative detection of bladder tumor associated antigen in human urine. This test is intended for use as an aid in management of bladder cancer patients in conjuction with cystoscopy.

The BTA TRAK test for bladder tumor associated antigen is an enzyme immunoassay utilizing monoclonal antibodies to specifically detect the presence of bladder tumor associated antigen in urine.

Here's a breakdown of the acceptance criteria and the study details for the Bard BTA TRAK™ Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds that the device had to meet to be considered effective. Instead, it presents the device's sensitivity results (performance data) and claims substantial equivalence to predicate devices. The implicit acceptance criteria are that the device demonstrates comparable or acceptable sensitivity for detecting bladder cancer, stratified by stage and grade, and acceptable specificity across various disease states.

Here's the reported performance:

BTA TRAK Test Sensitivity by Stage and Grade

Specificity Results of the Bard BTA TRAK test by Disease State (Mean - U/mL)

2. Sample Size Used for the Test Set and Data Provenance

• Sensitivity Test Set:
  • Sample Size: 220 patients with biopsy-proven bladder tumors.
  • Data Provenance: Samples were "collected from diverse geographic locations" and stored frozen until tested. It does not explicitly state if it was retrospective or prospective, but the description of biopsy-proven cases and prior collection suggests a retrospective or a pre-collected cohort analysis.
• Specificity Test Set:
  • Sample Size:
    • Healthy Subjects: 212
    • Non-Genitourinary Benign Diseases: 52
    • Various Genitourinary Diseases: 26 (BPH), 32 (Benign Renal), 94 (Misc. GU), 30 (UTI/Cystitis), 24 (STD), 40 (Other)
    • Genitourinary Trauma: 54
    • Various Genitourinary Cancers (excluding active bladder cancer): 45 (Prostate), 7 (Renal), 25 (Other)
    • No Evidence of Disease (history of bladder cancer): 107
  • Data Provenance: Not explicitly stated, but similar to the sensitivity set, the nature of disease states suggests collected samples rather than a real-time prospective study for this broad specificity analysis.

3. Number of Experts and Qualifications for Ground Truth

The summary states that the sensitivity results were determined using "biopsy proven bladder tumors." This implies that the ground truth for bladder cancer presence and its stage/grade was established through histopathological examination by medical professionals (pathologists). The number of pathologists or their specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth. The sole mention of "biopsy proven" suggests that a single, definitive pathological diagnosis was considered sufficient for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This study focuses on the standalone performance of the BTA TRAK test as an aid in management, rather than evaluating its impact on human reader performance with or without AI assistance.

6. Standalone Performance

Yes, a standalone (algorithm only) performance study was performed. The data presented in the tables (Sensitivity and Specificity) represent the direct output and performance of the BTA TRAK test itself, without human intervention in interpreting the test result as part of a diagnostic pathway. The intended use as an "aid in management... in conjunction with cystoscopy" highlights its role as a standalone diagnostic tool whose results are then considered by clinicians.

7. Type of Ground Truth Used

The primary ground truth for the presence and characteristics of bladder cancer was pathology (specifically, "biopsy proven bladder tumors" and "biopsy" for those with no evidence of disease if applicable). For other conditions mentioned in the specificity section (e.g., BPH, UTI, other cancers), the ground truth would likely be based on standard clinical diagnosis, imaging, and/or other laboratory tests.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This type of regulatory submission (510(k)) for an in vitro diagnostic device often focuses on verification and validation data from a pre-defined test set, rather than detailing the development (training) phase of the assay. For an immunoassay, the "training" would involve assay development and optimization rather than machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Since no training set details are provided, the method for establishing its ground truth is also not mentioned.

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The BTA stat test is an in vitro diagnostic immunoassay indicated for the qualitative detection of bladder turnor associated antigen in urine of persons diagnosed with bladder cancer. This test is indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy.

The BTA stat test is a qualitative test indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy.

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 Bard BTA stat™ Test, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The 510(k) summary for the Bard BTA stat™ Test does not explicitly state pre-defined acceptance criteria (e.g., "device must achieve X sensitivity and Y specificity"). Instead, it presents the device's performance metrics and implicitly asks the FDA to accept these results as substantially equivalent to the predicate device. The performance is primarily evaluated through clinical sensitivity and clinical specificity.

Study Details

Here's the breakdown of the study components:

1. Sample sizes used for the test set and the data provenance:

   • Clinical Sensitivity:
     • Initial cohort: 220 patients with histologically confirmed bladder cancer.
     • Subset for comparison with Bard BTA test: 181 patients from the sensitivity cohort.
     • Subset for comparison with Voided Urine Cytology (VUC): 131 patients (with histologically confirmed bladder cancer).
     • Data Provenance: Samples were "collected from 5 different may and the no have you intelles. United States." (This phrasing is a bit ambiguous, but suggests multiple sites within the US, prospectively collected for the study). Samples were stored frozen (-80°C) until tested.
   • Clinical Specificity:
     • No history of bladder cancer cohort: 555 individuals.
     • History of bladder cancer - No Evidence of Disease cohort: 107 patients. This cohort's no evidence of disease was confirmed by cystoscopy and/or biopsy.
     • Data Provenance: Samples were "collected from 5 different may and the no have you intelles. United States." (as above). Stored frozen (-80°C).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The primary ground truth for clinical sensitivity was histological confirmation of bladder cancer. This implies that pathology reports from pathologists were used. The number of pathologists involved is not specified, but it's standard practice in clinical studies for a pathologist to confirm diagnosis.
   • For the "History of Bladder Cancer - No Evidence of Disease" specificity cohort, ground truth was established by cystoscopy and/or biopsy. The experts performing these procedures (e.g., urologists) and interpreting the results (e.g., pathologists for biopsies) are not explicitly quantified or qualified in this summary.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • The summary does not explicitly mention an adjudication method for the final diagnosis (ground truth). The reliance on "histological confirmation" and "cystoscopy and/or biopsy" suggests that these established diagnostic methods served as the definitive ground truth, implying standard clinical practice for diagnosis rather than a specific multi-reader adjudication process for the test device interpretation. The device itself is a qualitative assay with a direct positive/negative result.

4. 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:

   • No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned. This device is an in-vitro diagnostic (IVD) assay designed for direct interpretation (presence/absence of a line), not an AI-powered image analysis tool requiring human reader interpretation in comparison.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, this entire study is a standalone performance evaluation of the Bard BTA stat™ Test as an algorithm/device only without a human-in-the-loop component for interpretation. The device provides a direct qualitative result (positive or negative based on line appearance).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Pathology: "Histological confirmation" was the primary ground truth for bladder cancer diagnosis (clinical sensitivity).
   • Clinical Outcomes/Procedures: "Cystoscopy and/or biopsy" confirmed "no evidence of disease" for defining part of the specificity cohort.

7. The sample size for the training set:

   • The document describes performance studies, which are equivalent to test set evaluations. It does not specify a separate training set for the development of the Bard BTA stat Test itself. This is typical for IVD devices where the analytic and clinical performance are assessed once the device's formulation and design are finalized. The device operates based on a fixed immunological reaction rather than a machine learning algorithm that requires a separate training phase.

8. How the ground truth for the training set was established:

   • As there's no mention of a separate "training set" for the device's development in the context of machine learning, this question isn't directly applicable. The device's "training" or development involved optimizing the immunochromatographic assay components, which would have been done using known positive and negative samples, but these are not described as a "training set" in the sense of a machine learning model.

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