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TRUQUANT® BR™ RIA is an in vitro diagnostic device indicated for the quantitative determination of CA 27.29 antigen in serum or EDTA plasma of patients previously treated for stage II or stage III breast cancer. Serial testing for CA 27.29 antigen with TRUQUANT® BR™ RIA in patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of recurrence. In addition, quantitation of CA 27.29 antigen in conjunction with other clinical methods can be used as an aid in monitoring response to therapy in patients with stage IV breast cancer.

Device Description

TRUQUANT® BR™ RIA quantitates CA 27.29 by competitive inhibition RIA. 125(iodine-labelled monoclonal antibody, specific for CA 27.29, is added to antigen-coated polystyrene tubes with the specimen in the form of plasma or serum. Antigen (CA 27.29) in the specimen inhibits the antibody from binding to the CA 27.29 antigen on the tube and after a subsequent wash step, bound radioactivity is determined. A calibration curve, generated from standards containing known quantities of CA 27.29, is used to determine the amount of antigen in the specimen.

AI/ML Overview

The TRUQUANT® BR™ RIA device is indicated for the quantitative determination of CA 27.29 antigen in serum or EDTA plasma for two main purposes:

Monitoring for recurrence in patients previously treated for stage II or stage III breast cancer who are clinically free of disease (used in conjunction with other clinical methods).
Monitoring response to therapy in patients with stage IV breast cancer (used in conjunction with other clinical methods).

The provided text focuses on the clinical studies supporting the device's use in monitoring remission and progression in breast cancer patients with stage IV disease.

Here's the detailed breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TRUQUANT® BR™ RIA in the context of monitoring stage IV breast cancer patients appear to be based on its ability to predict disease progression or remission using a 50% change in CA27.29 values. The presented data reflects the device's performance in these specific scenarios.

Acceptance Criteria (Implicit from Study Findings)	Reported Device Performance (for Stage IV Breast Cancer Monitoring)
Statistically significant prediction of disease progression with a ≥50% increase in CA27.29 from baseline.	Cox regression analysis of prospective study data indicates that a 50% or greater increase in CA27.29 values from baseline, detected at least one examination prior to clinical assessment, is a statistically significant predictor of disease progression. Positive Predictive Value (PPV) for disease progression: 71% (17/24). A marker increase of 50% or more suggests a high probability of treatment failure and likelihood of disease progression.
Statistically significant prediction of disease remission with a ≥50% decrease in CA27.29 from baseline.	Cox regression analysis of prospective study data indicates that a 50% or greater decrease in CA27.29 values from baseline, detected at least one examination prior to clinical assessment, is a statistically significant predictor of disease remission. Negative Predictive Value (NPV) for disease remission: 78% (54/69).
Ability to predict disease remission in patients with progressive or stable disease (mucin-producing subset).	Sensitivity: 25% (5/20)
Specificity: 87% (54/62)
Accuracy: 72% (59/82)
Ability to detect disease progression in patients with complete or partial remission or with stable disease (mucin-producing subset).	Sensitivity: 52% (17/33)
Specificity: 59% (10/17)
Accuracy: 54% (27/50)
A marker decrease of less than 50% is also associated with ineffective therapy and failure to induce remission.
Provide clinically useful information in the management of late-stage breast cancer.	The positive and negative predictive values (71% for progression and 78% for remission) provide clinically useful information. The device can facilitate clinical decisions through surveillance of soluble marker levels in metastatic breast cancer patients whose tumors produce and secrete mucin (CA27.29).

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

The text explicitly mentions a "prospective study data."

Sample Size for predicting disease remission in patients with progressive or stable disease: 82 patients (20 true remissions, 62 true non-remissions based on clinical assessment).
Sample Size for detecting disease progression in patients with complete or partial remission or with stable disease: 50 patients (33 true progressions, 17 true non-progressions based on clinical assessment).
Data Provenance: The study was a prospective study. The geographical origin of the data is not specified in the provided text.

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

The text states that changes in CA27.29 values were compared against "clinical assessment of status change." It does not specify the number of experts, their qualifications (e.g., specific medical specialties, years of experience), or the precise methodology used for the clinical assessment that served as the ground truth.

4. Adjudication Method for the Test Set

The text does not explicitly describe an adjudication method for establishing the clinical assessment (ground truth). It simply refers to "clinical assessment of status change," implying that this was the established clinical determination made by healthcare providers.

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 section is not applicable. The TRUQUANT® BR™ RIA is an in vitro diagnostic (IVD) device that quantitates a molecular marker (CA 27.29) by competitive inhibition RIA. It is not an AI-powered image analysis tool or a device that involves "human readers" in the typical sense of interpreting medical images or complex data where AI assistance would be measured in an MRMC study. The device provides a quantitative measurement, which clinicians then incorporate into their decision-making, along with other clinical methods.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the performance metrics (sensitivity, specificity, accuracy, PVs) presented for the TRUQUANT® BR™ RIA are standalone performance of the assay itself, demonstrating its ability to correlate with clinical outcomes based on its quantitative output. The device generates a numerical value (CA 27.29 concentration) independently of human interpretation of that specific assay output. The interpretation of the clinical significance of that numerical output is then made by a clinician.

7. The Type of Ground Truth Used

The ground truth used in the study was clinical assessment of status change (disease progression or remission). This implies that the ground truth was based on a comprehensive clinical evaluation of the patients, which would typically include imaging, physical examination, and other laboratory tests, not just the CA 27.29 levels.

8. The Sample Size for the Training Set

The provided text does not specify a separate "training set" or its sample size. The analysis described appears to be based on a single prospective study for evaluating the device's performance against clinical outcomes. For an IVD assay like this, "training set" is not typically referenced in the same way as for machine learning algorithms. The development of the assay itself involves internal validation and calibration, but the clinical study described is for performance evaluation.

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

As no "training set" is explicitly mentioned in the context of this clinical study, this question is not applicable based on the provided information.

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