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The NMP22 BladderChek Test is indicated for professional and prescription home use as an aid in monitoring bladder cancer patients, in conjunction with standard diagnostic procedures.

The NMP22 BladderChek Test for nuclear matrix protein NMP22 is an immunochromatographic assay utilizing monoclonal antibodies in a lateral flow strip encased in plastic. Two different antibodies are used, one as a capture and one as a reporter antibody. Unprocessed patient urine is added to the sample well of the cartridge and allowed to react with the colloidal gold conjugated reporter antibody. If the antigen is present in urine, it will interact with the reporter conjugate to form an immune complex. The reaction mixture flows through the membrane, which contains zones of immobilized antibodies. In the Test (T) zone, antigen-conjugate complexes are trapped by the capture antibody, forming a visible line if the concentration of antigen in urine is elevated. The procedural Control (C) zone contains an immobilized goat anti-mouse IgG-specific antibody that will capture the conjugated antibody independently of the presence or absence of the antigen, thereby always producing a visible line in the Control window. This procedural control assures the operator that each device is working properly.

Here's a summary of the acceptance criteria and study details for the NMP22 BladderChek™ Kit, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Although explicit "acceptance criteria" (numerical thresholds that must be met for approval) are not directly stated in the summary, the overall performance goals are implied by successful demonstration of substantial equivalence to the predicate device and satisfactory clinical performance. The table below presents the clinical performance metrics reported for the NMP22 BladderChek™ Test and, for comparison, the predicate device.

Summary of the Study Proving Acceptance Criteria:

The device's performance was evaluated through non-clinical and clinical studies to demonstrate substantial equivalence to the predicate device, BTA Stat.

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

• Clinical Test Set:

  • Sample Size: 668 patients.
  • Data Provenance: Prospective clinical trial conducted at 23 sites. The country of origin is not explicitly stated but implied to be the US given the submission to the FDA.

• Non-Clinical Test Set (Reproducibility by Laboratory Technicians):

  • Sample Size: 150 individual reads per panel level (3 readers x 10 devices per panel x 5 days) for 4 NMP22 levels (0, 5, 15, 25 U/mL). Total 600 reads per lot. Experiment conducted on three separate lots, so 1800 total unique device reads.
  • Data Provenance: Not specified, but likely internal lab studies.

• Non-Clinical Test Set (Reproducibility by Lay Users Compared to Professional Readers):

  • Sample Size: 5 lay readers (10 results per level) and 2 professional readers (10 results per level) for a three-level precision panel (2, 10, 15 U/mL). In total, 50 lay user results and 20 professional reader results.
  • Data Provenance: Not specified, but likely internal lab studies.

• Non-Clinical Test Set (Performance of Lay Users Compared to Professionals – Field Studies):

  • Sample Size: 137 volunteers (aged 50+), across 3 sites.
  • Data Provenance: Field studies at three unspecified locations.

• Non-Clinical Test Set (Concordance of NMP22 BladderChek and NMP22 Test Kit (microplate)):

  • Sample Size: 217 voided urine samples.
  • Data Provenance: Urology clinics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Clinical Test Set:

  • Number of Experts: Not explicitly stated, but the ground truth for bladder cancer status was determined by physicians conducting cystoscopies and subsequent pathological examination of resected lesions. These are highly qualified medical professionals (e.g., urologists and pathologists).
  • Qualifications: "Physicians conducting the cystoscopies" and "pathologically determined to be malignant."

• Non-Clinical Test Set (Reproducibility):

  • Laboratory Technicians: 3 laboratory technicians. Qualifications not specified, but implied to be trained in laboratory procedures.
  • Professional Readers (Lay User Reproducibility): 2 professional readers. Qualifications not specified.

4. Adjudication Method for the Test Set:

• Clinical Test Set: The primary ground truth was established by cystoscopy findings, confirmed by pathology for resected lesions. Physicians were blinded to the device results, suggesting an independent assessment of ground truth. There is no mention of a specific adjudication method (like 2+1 or 3+1) among multiple experts for establishing the cancer status itself, rather it relies on standard medical diagnostic procedures.

• Non-Clinical Test Set (Reproducibility):

  • For the lab technician reproducibility, the ground truth was based on the known NMP22 concentration of the prepared specimen panels (0, 5, 15, 25 U/mL).
  • For lay user vs. professional reproducibility, the ground truth was based on the known NMP22 concentration of the prepared samples (2, 10, 15 U/mL). Concordance was measured between readers rather than against an external adjudicator.

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

• No specific MRMC comparative effectiveness study was mentioned comparing human readers with and without AI assistance (as the device is a diagnostic kit, not an AI).
• However, the study did involve a comparison of lay users vs. professional readers using the device, which is a form of multi-reader evaluation. There was 100% concordance between lay and professional readers on precision panels and high concordance (95.6% - 96.4%) in field studies for real urine samples, indicating that the device design allows for consistent interpretation across different user types.

6. Standalone Performance:

• Yes, a standalone performance study was done. The entire clinical study assessed the performance of the NMP22 BladderChek™ Test alone (algorithm/device only, without human-in-the-loop assistance influencing the result) against the cystoscopy/pathology ground truth. The reported sensitivity, specificity, PPV, and NPV are all measures of this standalone performance.

7. Type of Ground Truth Used:

• Clinical Test Set: The ground truth was based on cystoscopy findings, with confirmation by pathology for malignant lesions. "Patients were considered negative if no tumor was seen endoscopically, or, if a lesion was seen, was pathologically determined to be nonmalignant. Patients were considered positive for bladder cancer if a tumor was seen during cystoscopy, and, if removed was pathologically determined to be malignant." This is a combination of observational medical findings and definitive pathological diagnosis.

• Non-Clinical Test Set (Reproducibility): The ground truth was based on known concentrations of NMP22 in prepared urine specimens.

8. Sample Size for the Training Set:

• Not explicitly stated. The submission describes validation studies but does not detail a separate training set size for the development of the device itself (e.g., for antibody selection or cut-off determination). This is typical for a diagnostic kit where the "training" (e.g., cut-off determination) often happens during product development and optimization, rather than a distinct "training set" in the context of an AI algorithm.

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

• Not explicitly detailed as a distinct training set is not explicitly mentioned. For the development and optimization of such a diagnostic device (e.g., determining the NMP22 threshold for a positive result like 10 U/mL mentioned in the microplate comparison), ground truth would typically be established similarly to the clinical test set: using urine samples from known bladder cancer patients and healthy controls, confirmed by established diagnostic methods like cystoscopy and pathology. The 10 U/mL cutoff for the NMP22 microplate test is stated, implying that this was an established threshold for a positive result.

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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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