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Bunkerhill MAC is a software device intended for use in detecting presence and estimating quantity of mitral annulus 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 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 MAC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems. Bunkerhill MAC detects, localizes, and quantifies mitral annulus calcification in non-gated, non-contrast chest CT studies. The core features of the product are:

• Detection of mitral annulus calcification at an Agatston-equivalent score threshold of 0 AU.
• Quantification of the overall mitral annulus calcification burden in the form of an estimated Agatston Score up to 5000 Agatston-equivalent units
• Localization of estimated calcium burden in the form of circular region of interest applied to a copy of the original CT scan.

Here's a detailed breakdown of the acceptance criteria and the study proving the Bunkerhill MAC device meets them, 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 the data provenance:

   • Test Set Sample Size: Not explicitly stated as a number of cases, but referred to as "the pivotal dataset."
   • Data Provenance: "curated from multiple sites across three geographical regions in the United States." (Retrospective study).

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

   • The document states "agreement of the device output compared to the established reference standard." It does not explicitly state the number of experts used or their qualifications for establishing this "established reference standard." It only refers to "clinical literature in high impact journals that investigate the inter-reader agreement of manual segmentation" as informing the acceptance criteria.

3. Adjudication method for the test set:

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

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance was not conducted or reported in this document. The study was a "stand-alone retrospective study for detection, localization and agreement of the device output compared to the established reference standard."

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

   • Yes, a standalone study was performed. The document explicitly states: "The Bunkerhill MAC performance was validated in a stand-alone retrospective study for detection, localization and agreement of the device output compared to the established reference standard."

6. The type of ground truth used:

   • The ground truth was an "established reference standard" which was used for comparison against the device's output. The document implies this reference standard is based on non-gated CT reference measurements and potentially "manual segmentation" informed by clinical literature. It does not explicitly state pathology confirmation or direct outcomes data as the primary ground truth.

7. The sample size for the training set:

   • The sample size for the training set is not provided in the document.

8. 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 the performance validation on a "pivotal dataset" (test set).

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Bunkerhill ECG-EF is software intended to aid in screening for Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% in adults at risk for, but not already diagnosed with low LVEF.

Bunkerhill ECG-EF is not intended to be a stand-alone diagnostic device for cardiac conditions, should not be used for monitoring of patients, and should not be used on ECGs with a paced rhythm. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%.

Additionally, if the patient is at high risk for the cardiac condition, a negative result should not rule out further non-invasive evaluation.

Bunkerhill ECG-EF is adjunctive and must be interpreted in conjunction with the clinician's judgment, the patient's medical history, symptoms, and additional diagnostic tests. For a final clinical diagnosis, further confirmatory testing, such as echocardiography, is required.

ECG-EF is a software-only medical device that employs deep learning algorithms to analyze 12-lead ECG data for the detection of low left ventricular ejection fraction (LVEF < 40%). The algorithm processes 10-second ECG waveform snippets, providing predictions to assist healthcare professionals in the early identification of patients at risk for heart failure.

ECG-EF algorithm receives digital 12-lead ECG data and processes it through its machine learning model. The output of the analysis is transmitted to integrated third-party software systems, such as Electronic Medical Records (EMR) or ECG Management Systems (EMS). The results are displayed by the third-party software on a device such as a smartphone, tablet, or PC.

ECG-EF algorithm produces a result indicating "Low EF Screen Positive - High probability of low ejection fraction based on the ECG", " Low EF Screen Negative - Low probability of low ejection fraction based on the ECG" or "Error – device input criteria not met " for cases that do not meet data input requirements. These results are not intended to be definitive diagnostic outputs but rather serve as adjunctive information to support clinical decision-making. A disclaimer accompanies the output, stating: "Not for diagnostic use. The results are not final and must be reviewed alongside clinical judgment and other diagnostic methods."

The Low Ejection Fraction AI-ECG Algorithm device is intended to address the unmet need for a point-of-care screen for LVEF less than or equal to 40% and is expected to be used by cardiologists, front-line clinicians at primary care, urgent care, and emergency care settings, where cardiac imaging may not be available or may be difficult or unreliable for clinicians to operate. Clinicians will use the Low Ejection Fraction AI-ECG Algorithm to aid in screening for LVEF less than or equal to 40% and making a decision for further cardiac evaluation.

Here's a breakdown of the acceptance criteria and the study details for the Bunkerhill ECG-EF device, based on the provided FDA 510(k) Clearance Letter:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: 15,994 patient records.
• Data Provenance:
  • Country of Origin: United States.
  • Source: Two health systems.
  • Type: Retrospective study.
  • Diversity: Representative of the U.S. population (65.5% White, 18.8% Hispanic, 5.7% American Indian or Alaska Native, 3.9% Asian, 3.0% Black/African American, 2.8% Other; 53% Male, 47% Female).
  • Geographical Distribution: Curated from 5 geographically distributed sites throughout the United States.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth. It only mentions that the ground truth was established from echocardiograms.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. The ground truth was derived directly from echocardiogram measurements.

5. MRMC Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The study focuses solely on the standalone performance of the AI algorithm.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone study evaluating the algorithm's performance without human-in-the-loop was conducted. The performance metrics (Sensitivity, Specificity, PPV, NPV) and the confusion matrix presented are for the algorithm's direct output.

7. Type of Ground Truth Used

The ground truth used was Transthoracic Echocardiogram (TTE) with disease, specifically using the Simpson's Biplane measurement method to determine Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. The echocardiogram was taken less than 15 days apart from the ECG scan.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set. It only mentions the retrospective study for validation involved 15,994 patient records.

9. How Ground Truth for the Training Set Was Established

The document states that the "Ground Truth for Model Training" was Transthoracic echocardiogram (TTE) with disease. It can be inferred that this same method (TTE, likely Simpson's Biplane) was used to establish ground truth for the training data, similar to the test set, but specific details on the process for the training set are not provided.

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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

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

• Test Set Sample Size: 258 patients
• Data Provenance: Retrospective study. Data sourced from North Carolina, Alabama, the greater Washington D.C. area (all in the USA), and Sao Paulo, Brazil. This indicates a diverse geographical origin for the data.

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

• Number of Experts: 3
• Qualifications of Experts: U.S. Board Certified Radiologists. Specific experience level (e.g., 10 years) is not provided, but Board Certification implies a high level of expertise.

4. Adjudication Method for the Test Set

• The text states "a ground truth established by 3 U.S. Board Certified Radiologists." This implies a consensus-based approach among the three experts to establish the definitive ground truth reference. The specific adjudication method (e.g., majority vote, discussion to reach consensus) is not detailed, but the use of three experts suggests a robust process beyond a single reader.

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

• No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not reported. The study described is a standalone performance study of the algorithm against a defined ground truth.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance study was done. The text explicitly states, "The AAQ algorithm performance was validated in a stand-alone retrospective study for overall agreement of the device output compared to a ground truth established by 3 U.S. Board Certified Radiologists." The results (MAE, ΔICC, Bland-Altman limits) are all reflective of the algorithm's performance in isolation.

7. The Type of Ground Truth Used

• Expert Consensus. The ground truth was "established by 3 U.S. Board Certified Radiologists," indicating that their consensus measurements were considered the true values for comparison.

8. The Sample Size for the Training Set

• Not provided. The document only references the test set of 258 patients. Information regarding the training set size is not included in this excerpt.

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

• Not provided. Since the training set size itself is not mentioned, the method for establishing its ground truth is also absent from this document. It's common practice for similar methods (e.g., expert annotations) to be used for training data, but this specific excerpt doesn't confirm it.

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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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