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The Quantra™ software application is intended for use with mammographic images acquired using digital breast x-ray systems. The Quantra software segregates breast density into categories, which may be useful in the reporting of consistent BI-RADS® breast composition categories as mandated by certain state regulations. The Quantra software reports a result for each subject, which is intended to aid radiologists in the assessment of breast tissue composition. The Quantra software produces adjunctive information; it is not a diagnostic aid.

Quantra is a software application used to produce assessments of breast composition and categorize them. A breast consists of fat and fibroglandular tissue. Fibroglandular tissue, also referred to as dense tissue, contains a mixture of fibrous connective tissue (stroma) and glandular tissue (epithelial cells), and usually appears brighter than surrounding tissue on a digital mammographic image. Abnormal lesions also appear bright on a mammogram and can be obscured or masked by fibroglandular tissue.

The Quantra software is designed to estimate breast composition categories by analyzing distribution and texture of parenchymal tissue patterns which can be responsible for the masking effect during mammographic reading.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal acceptance criteria with specific thresholds for performance metrics. Instead, it presents performance results from a study, effectively demonstrating the device's capabilities. The "Acceptance Criteria" here are inferred from the demonstrated performance in categorizing breast density.

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

• Sample Size: 230 studies.
• Data Provenance: Retrospectively collected images of 4-view screening negative cases. The country of origin is not specified in the provided text.

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

• Number of Experts: 5 radiologists.
• Qualifications of Experts: Not explicitly stated, beyond being "radiologists". It's implied they are qualified to assess BI-RADS® 5th Edition categories.

4. Adjudication Method for the Test Set

• Adjudication Method: "5 radiologists' consensus assessment of BI-RADS 5th Edition categories" was used to establish the ground truth. This implies a consensus method, but the specific rule (e.g., simple majority, all 5 agree) is not detailed.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study assessing human readers with and without AI assistance was not explicitly mentioned or performed. The study described focuses on the standalone performance of the Quantra software against a consensus ground truth.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Standalone Performance Study: Yes, a standalone performance study of the algorithm without human-in-the-loop was performed. The tables clearly show the Quantra 2.2 software's performance (Quantra 2.2- QDC 2D and Quantra2.2 – QDC Tomo) against the BI-RADS 5th Ed. ground truth.

7. The Type of Ground Truth Used

• Ground Truth Type: Expert consensus. Specifically, it was the "5 radiologists' consensus assessment of BI-RADS 5th Edition categories."

8. The Sample Size for the Training Set

• The provided document does not specify the sample size for the training set. It only discusses the testing against an independent dataset.

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

• The provided document does not specify how the ground truth for the training set was established, as details about the training set itself are absent.

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