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Bunkerhill Contrast CAC is a software device intended for use in detecting presence and estimating quantity of coronary artery calcification for adult patients aged 30 years and above. The device automatically analyzes non-gated, contrast-enhanced chest computed tomography (CT) images collected during clinical care and outputs the region of interest (intended for informational purposes only) and quantification of detected calcium.

The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device-generated quantification can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium region of interest in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original non-gated, contrast-enhanced CT scan; both are still available to be viewed and used at the discretion of the physician.

The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient's results.

Bunkerhill Contrast CAC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems. Bunkerhill Contrast CAC detects, localizes, and quantifies coronary artery calcification volume in non-gated, contrast-enhanced chest CT studies. The core features of the product are:

• Detection of coronary artery calcification volume at a threshold of 0 mm³.
• Quantification of the overall coronary artery calcification burden in the form of an estimated volume score.
• Localization of estimated calcium burden in the form of a CAC region of interest applied to a copy of the original CT scan.

Here's a breakdown of the acceptance criteria and study details for the Bunkerhill Contrast CAC device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: The exact number of cases in the "pivotal dataset" is not explicitly stated. It mentions the dataset was "curated from multiple sites across three geographical regions in the United States."
   • Data Provenance: Retrospective, from "multiple sites across three geographical regions in the United States."

2. Number of Experts Used for Ground Truth and Qualifications:

   • The document states that acceptance criteria were "derived from the performance of the predicate device and clinical literature in high impact journals that investigate the inter-reader agreement of manual segmentation." It does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set.

3. Adjudication Method for the Test Set:

   • The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It refers to the "established ground truth."

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

   • Not explicitly stated. The document describes a "stand-alone retrospective study for detection, localization and agreement of the device output compared to the established ground truth," and mentions that results "are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician." This implies a focus on standalone performance against ground truth rather than a comparative effectiveness study with human readers.

5. Standalone Performance:

   • Yes, a standalone study was done. The document states, "The Contrast CAC performance was validated in a stand-alone retrospective study for detection, localization and agreement of the device output compared to the established ground truth."

6. Type of Ground Truth Used:

   • The type of ground truth is not explicitly specified as "expert consensus," "pathology," or "outcomes data." However, the statement that acceptance criteria were "derived from... clinical literature in high impact journals that investigate the inter-reader agreement of manual segmentation" strongly suggests that the ground truth was established through expert manual segmentation or review, potentially leading to an expert consensus, on the coronary artery calcification volume.

7. Sample Size for the Training Set:

   • The document does not state the sample size for the training set.

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

   • The document does not explicitly describe how the ground truth for the training set was established. It only mentions that the device uses "deep-learning algorithms," which implies a training phase with labeled data.

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