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Bunkerhill AAQ is a radiological image processing system software indicated for use in the analysis of CT exams with or without contrast, that include the L1 – L5 region of the abdominal aorta, in adults aged 22 and older.

The device is intended to assist appropriately trained medical specialists by providing the user with the maximum axial abdominal aortic diameter measurement of cases that include the abdominal aorta. Bunkerhill AAQ is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate post-operative aortas.

The Bunkerhill AAQ results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a qualified interpreting physician. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.

Bunkerhill AAQ is a software-only medical device that employs deep learning algorithms to provide automatic maximal abdominal aortic diameter measurements from axial CT scans of the abdomen/pelvis, with or without IV contrast.

Bunkerhill AAQ receives DICOM instances and processes them chronologically by running the algorithm on relevant series to measure the maximum abdominal aortic diameter. Following the AI processing, the output of the algorithm analysis is transferred to standard radiology image review and reporting software.

Bunkerhill AAQ produces a preview image annotated with the maximum axial diameter measurement. The diameter marking is not intended to be a final output, but serves the purpose of visualization and measurement. The original, unmarked series remains available in the PACS as well.

The preview image presents an unofficial and not final measurement, and the user is instructed to review the full image and any other clinical information before making a clinical decision. The image includes a disclaimer: "Not for diagnostic use. The measurement is unofficial, not final, and must be reviewed by a qualified interpreting physician".

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) clearance letter for Bunkerhill Abdominal Aortic Quantification (AAQ):

1. Table of Acceptance Criteria and Reported Device Performance

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The Bunkerhill BMD Algorithm is a post-processing AI-powered software intended for adults 30 years and above to assess estimated DXA-measured average areal bone mineral density of spinal bones from existing CT scans and outputs a flag for low bone density below a pre-specified threshold. It is not intended to replace DXA or any other tests dedicated to BMD measurement.

Bunkerhill BMD is an opportunistic AI-powered tool that enables:(1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure

The Bunkerhill BMD application is a software only medical device (SaMD) that includes deep- learning-based computer vision and post-processing algorithms that estimates the bone mineral density from previously obtained computed tomography (CT) images.

The results from Bunkerhill BMD are not intended to be used as the primary input for clinical decision making, but rather are intended to provide information that may assist the clinician to identify 'findings of interest' within existing imaging studies.

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

Acceptance Criteria and Device Performance Study for BunkerHill BMD

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Test Set Sample Size: 371 CT studies
• Data Provenance: The studies were collected from four (4) geographically diverse sites. The retrospective nature of the study is explicitly stated ("stand-alone retrospective study").

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported in the provided text. The study described is a standalone performance evaluation of the algorithm.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The document states: "Bunkerhill BMD performance was validated in a stand-alone retrospective study for overall agreement of the device output compared to the established ground truth."

7. Type of Ground Truth Used

The type of ground truth used is implied to be based on DXA-measured average areal bone mineral density of spinal bones, as the device is intended to "assess estimated DXA-measured average areal bone mineral density." The text refers to "established ground truth" in relation to this assessment.

8. Sample Size for the Training Set

The document does not provide the sample size for the training set. It only describes the test set.

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

The document does not provide information on how the ground truth for the training set was established. It only refers to "established ground truth" for the test set evaluation.

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Bunkerhill AVC is a software device intended for use in detecting presence and estimating quantity of aortic valve calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-contrast 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, non-contrast 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 AVC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems. Bunkerhill AVC detects, localizes, and quantifies aortic valve calcification in non-gated, non-contrast chest CT studies. The core features of the product are:

• Detection of aortic valve calcification at an Agatston-equivalent score threshold of 0 AU. •
• . Estimation of the overall aortic valve calcification burden in the form of an estimated Agatston-equivalent Score.
• Localization of estimated calcium burden in the form of AVC region of interest applied . to a copy of the original CT scan.

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

1. A table of acceptance criteria and the reported device performance

The provided text describes specific performance metrics that were evaluated, although it doesn't explicitly present a formal "acceptance criteria table" with target values. Instead, it describes how the device's observed performance met the acceptance criteria.

Notes on Acceptance Criteria: The document states that "The acceptance criteria were derived from the performance of the predicate device and clinical literature in high impact journals that inter-reader agreement of manual segmentation." This indicates a benchmark against established clinical practice and a comparable device.

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated as a numerical count of patients or cases. However, the data for the pivotal study was "curated from thirty-three (33) sites."
• Data Provenance:
  • Country of Origin: United States ("thirty-three (33) sites across three geographical regions in the United States").
  • Retrospective or Prospective: Retrospective ("standalone retrospective study").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set. It only mentions that the ground truth was "established."

4. Adjudication method for the test set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study assessing human reader improvement with AI assistance was not conducted or reported. The study described is a "standalone retrospective study for localization and agreement of the device output compared to the established ground truth." The device is intended as an "adjunctive information" tool, not a human-in-the-loop performance enhancer for diagnostic accuracy per se, but rather an aid for quantifying calcification.

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

Yes, a standalone study was done. The text explicitly states: "The Bunkerhill AVC performance was validated in a stand-alone retrospective study for localization and agreement of the device output compared to the established ground truth."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth used was "established ground truth." While this term is somewhat generic, given the context of Agatston-equivalent scores and "inter-reader agreement of manual segmentation" mentioned for acceptance criteria, it strongly implies ground truth established by expert (likely radiologist or cardiologist) review and manual measurement/segmentation. It is not stated to be pathology or outcomes data.

8. The sample size for the training set

The document does not provide the sample size for the training set. It only discusses the pivotal test set.

9. How the ground truth for the training set was established

The document does not provide information on how the ground truth for the training set was established.

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CAC (gated) is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above. The device automatically analyzes non-contrast electrocardiogram (ECG) gated cardiac computed tomography (CT) images collected and outputs the segmentation (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 segmentation in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original cardiac 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 CAC (gated) is a software as a medical device (SaMD) product that interfaces with compatible and commercially available CT systems. Bunkerhill CAC (gated) localizes, quantifies, and categorizes coronary artery calcification in non-contrast, electrocardiogram (ECG) gated, chest CT studies. The core features of the product are:

• Categorization of the coronary artery calcium burden in the form of a range of Agatston scores. Calcium score groupings are defined as one of the four following ranges of Agatston units:
  • a. Group 1: 0 Agatston units
  • b. Group 2: 1-99 Agatston units
  • Group 3: 100-399 Agatston units C.
  • d. Group 4: 400+ Agatston units
• Quantification of the overall coronary artery calcium burden in the form of an exact Agatston Score.
• o Quantification of each coronary artery's (left main (LCA), left anterior descending (LAD), left circumflex (LCX), and right coronary artery (RCA)) calcium burden in the form of an exact Agatston score.
• Localization of estimated calcium burden in the form of a CAC segmentation applied to a copy of the original CT scan (intended for informational purposes only).

Acceptance Criteria and Study Details for BunkerHill Health's CAC (gated) Algorithm (K240369)

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: The exact number of cases in the test set is not explicitly stated, but it included "adequate representation from each coronary calcium detection category."
• Data Provenance: Retrospective study involving gated CT studies from six (6) geographically diverse sites. The specific countries of origin are not mentioned.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., years of experience as a radiologist). However, it mentions "established ground truth," implying expert review.

4. Adjudication Method for Test Set

The adjudication method used to establish the ground truth for the test set is not specified in the provided document.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was mentioned in the document. The study focused on the standalone performance of the AI algorithm against a ground truth.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The document states:
"The CAC (gated) Device performance was validated in a stand-alone retrospective study for overall agreement of the device output compared to the established ground truth."

7. Type of Ground Truth Used

The type of ground truth used was "ground truth coronary calcium detection category," which was established for each case in the test set. While not explicitly detailed, this typically implies a consensus among expert readers or a gold standard interpretation.

8. Sample Size for Training Set

The document does not provide information regarding the sample size used for the training set.

9. How Ground Truth for Training Set Was Established

The document does not specify how the ground truth for the training set was established.

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