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IMMULITE BR-MA: For in vitro diagnostic use with IMMULITE analyzer – for the quantitative measurement of CA 15-3 antigen in human serum, as an aid in the detection of recurrence in previously treated stage II and stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA 15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in Stage II and Stage III disease and for monitoring response to treatment in patients with metastatic breast cancer.

IMMULITE 2000 BR-MA: For in vitro diagnostic use with IMMULITE 2000 analyzer – for the quantitative measurement of CA 15-3 antigen in human serum, as an aid in the detection of recurrence in previously treated stage II and stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA 15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in Stage II and Stage III disease and for monitoring response to treatment in patients with metastatic breast cancer.

IMMULITE BR-MA and IMMULITE 2000 BR-MA are clinical use devices intended for use with their respective IMMULITE and IMMULITE 2000 Automated Immunoassay Analyzers for the quantitative measurement of CA15-3 antigen in serum.

IMMULITE BR-MA and IMMULITE 2000 BR-MA are two-step sequential chemiluminescent enzyme immunoassays, based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the IMMULITE® BR-MA and IMMULITE® 2000 BR-MA devices:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in terms of specific thresholds for each characteristic. Instead, it presents performance characteristics for the IMMULITE devices and compares them to a predicate device (Immuno 1 CA 15-3) and other commercially available kits (Kit A, Kit B). The implicit acceptance criteria appear to be substantial equivalence to these existing, legally marketed devices.

Here's a table summarizing the reported performance, with the implicit acceptance criteria being "comparable to or better than" the predicate/comparator devices.

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

• Method Comparison Studies (Test Sets):

  • IMMULITE BR-MA vs. Kit A: 1400 specimens (healthy females, pregnant women, and female patients with breast cancer, malignant and nonmalignant diseases).
    • Restricted to working range (1307 specimens): For linear regression.
    • Provenance: Two clinical sites in the northeastern and southern United States. Retrospective (implied, as specimens are "evaluated").
  • IMMULITE BR-MA vs. Kit B: 181 specimens (unknown characteristics beyond being used for comparison).
    • Restricted to working range (157 specimens): For linear regression.
    • Provenance: Clinical study conducted in the southern United States. Retrospective (implied).
  • IMMULITE 2000 BR-MA vs. Kit A: 500 specimens (healthy females, pregnant women, and female patients with breast cancer, malignant and nonmalignant diseases).
    • Restricted to working range (447 specimens): For linear regression.
    • Provenance: One clinical site in the northeastern United States. Retrospective (implied).
  • IMMULITE 2000 BR-MA vs. IMMULITE BR-MA: 466 specimens (subset from the IMMULITE 2000 BR-MA vs. Kit A study, within working range).
    • Provenance: Northeastern United States (same site as IMMULITE 2000 BR-MA vs. Kit A). Retrospective (implied).

• Clinical Performance Studies (Test Sets):

  • IMMULITE BR-MA:
    • Patients for recurrence: 99 breast cancer patients (serial samples). Total of 294 specimens tested for comparison with clinical status.
    • Patients for response to treatment: 80 breast cancer patients (serial samples). Total of 282 specimens tested for comparison with clinical status.
    • Provenance: Two clinical studies in the northeastern and southern United States. Retrospective (implied, as historical clinical status is compared).
  • IMMULITE 2000 BR-MA:
    • Patients for recurrence: 35 breast cancer patients (serial samples). Total of 121 specimens tested for comparison with clinical status.
    • Patients for response to treatment: 15 breast cancer patients (serial samples). Total of 67 specimens tested for comparison with clinical status.
    • Provenance: One clinical study in the northeastern United States. Retrospective (implied).

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

The document does not specify the number of experts or their qualifications for establishing ground truth.

For the method comparison studies, the ground truth for the test set is effectively the measurement obtained from the comparator "Kit A" or "Kit B", which are commercially available and presumably validated immunoassays. No human expert interpretation of the comparator results is explicitly mentioned.

For the clinical performance studies, the ground truth is "clinical status" and "clinical history." The document states that IMMULITE BR-MA/2000 BR-MA results were "compared with the clinical history of these patients." It does not specify the number of clinicians or the process for determining this "clinical status." The "NED (No Evidence of Disease)" and "Active" status would have been determined by treating physicians based on standard clinical assessments (imaging, physical exams, symptoms, etc.).

4. Adjudication Method for the Test Set

Not applicable. The ground truth for the method comparison studies is the result from the comparator assay; there's no mention of adjudication between multiple assay results. For the clinical performance studies, the ground truth is the "clinical status," which would be a physician's assessment based on multiple factors, but no explicit adjudication process involving multiple independent experts for this clinical status is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes the performance of an in vitro diagnostic immunoassay, not an imaging device or AI-assisted diagnostic tool that would typically involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the entire study is essentially a standalone performance evaluation of the IMMULITE BR-MA and IMMULITE 2000 BR-MA devices (which are immunoassays, not algorithms in the typical AI sense). The device measures CA 15-3 antigen levels quantitatively. Its performance is assessed inherently as a "device only" performance against reference methods or clinical outcomes. There is no human interpretation of the assay result that is then improved or augmented by an algorithm. The device provides a quantitative number, and that number is then used in conjunction with other clinical methods by a human clinician.

7. The Type of Ground Truth Used

• Analytical Performance Studies: The ground truth for these characteristics (e.g., precision, sensitivity, linearity) is based on established laboratory testing methodologies and reference materials.
• Method Comparison Studies: The ground truth is primarily the results obtained from legally marketed predicate or comparator immunoassays (Kit A, Kit B).
• Clinical Performance Studies: The ground truth is the "clinical status" and "clinical history" of breast cancer patients, determined by established clinical diagnostic and monitoring procedures. This would include patient outcomes data (e.g., recurrence, response to treatment) as assessed by treating clinicians.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. These devices are immunoassay kits, not AI algorithms that undergo a distinct training phase. Their development involves R&D and validation but not "training data" in the AI sense.

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

Not applicable, as there is no "training set" in the typical AI sense for these immunoassay devices. The ground truth for their development and validation would be established through standard immunoassay development practices, including analytical characterization against known standards and evaluation against clinical samples with confirmed diagnoses.

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