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510(k) Data Aggregation
(30 days)
Lunit INSIGHT DBT is a computer-assisted detection and diagnosis (CADe/x) software intended to be used concurrently by interpreting physicians to aid in the detection and characterization of suspected lesions for breast cancer in digital breast tomosynthesis (DBT) exams from compatible DBT systems. Through the analysis. the regions of soft tissue lesions and calcifications are marked with an abnormality score indicating the likelihood of the presence of malignancy for each lesion. Lunit INSIGHT DBT uses screening mammograms of the female population.
Lunit INSIGHT DBT is not intended as a replacement for a complete interpreting physician's review or their clinical judgment that takes into account other relevant information from the image or patient history.
Lunit INSIGHT DBT is a computer-assisted detection/diagnosis (CADe/x) software as a medical device that provides information about the presence, location and characteristics of lesions suspicious for breast cancer to assist interpreting physicians in making diagnostic decisions when reading digital breast tomosynthesis (DBT) images. The software automatically analyzes digital breast tomosynthesis slices via artificial intelligence technology that has been trained via deep learning.
For each DBT case, Lunit INSIGHT DBT generates an artificial intelligence analysis results that include the lesion type, location, lesion-level/case-level score, and outline of the regions suspected of breast cancer. This peripheral information intends to augment the physician's workflow to better aid in detection and diagnosis of breast cancer.
The provided text describes the 510(k) submission for Lunit INSIGHT DBT v1.1, a computer-assisted detection and diagnosis (CADe/x) software for breast cancer in digital breast tomosynthesis (DBT) exams. The document primarily focuses on demonstrating substantial equivalence to its predicate device, Lunit INSIGHT DBT v1.0.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The core acceptance criterion explicitly mentioned for the standalone performance testing is an AUROC (Area Under the Receiver Operating Characteristic curve) greater than 0.903. This is directly compared to the predicate device's performance.
| Acceptance Criterion (Primary Endpoint) | Reported Device Performance (Lunit INSIGHT DBT v1.1) |
|---|---|
| AUROC in standalone performance > 0.903 | AUROC = 0.931 (95% CI: 0.920 - 0.941) |
| Statistical Significance | p 0.903)**, which was the same criterion used for its predicate device. However, it lacks detailed information regarding the specifics of the data used (sample sizes, provenance), the ground truth establishment process (experts, adjudication), and the absence of an MRMC study is notable for a CADe/x device, though not explicitly required for this specific 510(k) submission that highlights substantial equivalence based on standalone performance to a predicate. |
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