(365 days)
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
| Stage | N | Sensitivity (%) |
|---|---|---|
| Ta | 108 | 59 |
| T1 | 38 | 92 |
| ≥T2 | 50 | 88 |
| Tis | 18 | 67 |
| Grade | N | Sensitivity (%) |
| 1 | 53 | 53 |
| 2 | 56 | 68 |
| 3 | 96 | 72 |
| Overall | 216 | 72 |
Specificity Results of the Bard BTA TRAK test by Disease State (Mean - U/mL)
| Category | N | Mean - U/mL |
|---|---|---|
| Healthy Subjects | 212 | 4.1 |
| Male > 50 years | 21 | 2.7 |
| Female > 50 years | 67 | 93 |
| M/F 35 - 50 years | 164 | 4.5 |
| Non-Genitourinary (GU) Benign Diseases | 52 | 2.0 |
| Genitourinary Diseases | ||
| BPH | 26 | 9.0 |
| Benign Renal Disease | 32 | 78.7 |
| Misc. GU Disease | 94 | 26.3 |
| UTI/Cystitis | 30 | 61.8 |
| STD | 24 | 11.2 |
| Other | 40 | 8.8 |
| Genitourinary Trauma | 54 | 1031.9 |
| Genitourinary Cancers | ||
| Prostate Cancer | 45 | 64.4 |
| Renal Cancer | 7 | 1039.0 |
| Other Cancers | 25 | 3.3 |
| Active Bladder Cancer A | ||
| Grade I | 53 | 212.4 |
| Grade II | 56 | 543.0 |
| Grade III | 96 | 913.9 |
| Stage Tis | 18 | 68.4 |
| Stage Ta | 108 | 316.7 |
| Stage T1 | 38 | 851.0 |
| Stage T2 - T4 | 50 | 1250.5 |
| No Evidence of Disease B | 107 | 31.8 |
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.
- Sample Size:
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.
§ 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.