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The Sentinel BreastScan II System is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion or reperfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.

The Sentinel BreastScan II System consists of a portable device that captures and records thermal infrared energy (heat) emitting from a person's body. There is no compression of the breast or patient contact with the device and the test emits no radiation to the patient. The device consists of a thermal camera, a metal enclosure to secure and protect components, a motor and electronics to raise and lower the tester to adjust the camera for various sized patients, a chair with attached armrests, adjustable special heat reflecting mirrors, a computer with a touchscreen monitor, data storage, software, and Wi-Fi communication. The tester includes an air cooling unit that blows cool air during part of the test cycle.

The provided text describes the Sentinel BreastScan II System, which is a telethermographic system for adjunctive diagnostic screening for breast cancer. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device (Infrared Sciences Corp., BreastScan IR) based on technological characteristics and adherence to safety standards.

Crucially, the provided text DOES NOT contain information regarding a study that proves the device meets specific performance-based acceptance criteria for its diagnostic claims (e.g., sensitivity, specificity, accuracy for breast cancer detection).

The "Performance Data" section only mentions compliance with electrical safety standards (ANSI/AAMI ES60601-1, IEC 60601-1-2) and claims that the device "meets all Sentinel BreastScan II requirements and specifications as provided in the verification and validation testing results reports." It does not provide any specific quantitative performance metrics related to diagnostic accuracy, nor does it detail any clinical studies (such as MRMC or standalone performance studies) that would typically be used to demonstrate such performance.

Therefore, I cannot fulfill the request to provide:

• A table of acceptance criteria and reported device performance specific to diagnostic accuracy, as this data is not present.
• Sample size and data provenance for a diagnostic test set.
• Number of experts and their qualifications for establishing ground truth, adjudication methods, MRMC study details, or standalone performance study details, as these studies are not described.
• Type of ground truth used for diagnostic claims.
• Sample size for the training set or how ground truth was established for it.

The document indicates that the device's 510(k) clearance was based on demonstrating "substantial equivalence" to a predicate device, which often relies on demonstrating similar technological characteristics and adherence to general safety standards rather than new clinical performance studies for diagnostic accuracy, especially for Class I or II devices where a predicate exists with established performance.

In summary, the provided document does not contain the information requested about a study proving the device meets performance-based acceptance criteria for its diagnostic function.

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The FIRSTSense Breast Exam® device is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities, or in an environment where patient care is provided by qualified healthcare personnel. It is intended for use in adult patient populations. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.

The FirstSense Breast Exam® system consists of a portable device (FSBE Tester) that captures and records thermal infrared energy (heat) emitting from a person's body. There is no compression of the breast or patient contact during a screening test. The device emits no radiation to the patient. The device consists of a thermal camera, a 3D camera, a tester main body consisting of metal and plastic to safely and securely house the electronic and mechanical components and motors (to adjust cameras for various sized patients), a computer, software components and two color monitors, as well as an air cooling unit that blows cool air during part of the screening test cycle. The FSBE system also contains a cloud server for safe storage of test data. During a screening test, the FSBE Tester's thermal camera acquires thermal images, and the 3D camera acquires depth data and visible light images of the patient breasts. When a test is completed, the acquired data is uploaded to the FSBE system's cloud server, the FSM Central Server. The uploaded data becomes available to a physician when the FirstSense Data Viewer (FSDV) application downloads the data from the server to a local computer. The FSDV application allows the physician to view the thermal images, the 3D depth image and visible RGB images of the patient breasts. The depth and visible images are provided to the physician as additional information about the breasts with no quantitative data. When the FSDV application provides the thermal images, it allows the application user to select breast regions (nipple, areola, whole breast quadrants) and regions of interest on the thermal views. The FSDV application provides temperature differential data between the left and right breast regions, and temperature differential data for the regions of interest before and after blowing cool air to the breasts in Test Summary report. The FSDV allows the application user to enter threshold values to be compared to the calculated temperature differential data. The FSDV provides comments in the Test Summary Report to indicate that the temperature differential data is within or above the entered threshold value. The FSDV does not include default threshold values and does not provide comments in the Test Summary report should the user choose not to enter threshold values.

The provided document is a 510(k) summary for the FIRSTSense Breast Exam® device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, ground truth details, and training set information) is not explicitly present in the provided text. The document details performance validation tests for the device's components and software, but not a study proving its diagnostic efficacy against specific clinical acceptance criteria.

Missing Information:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy.
• Sample sizes used for a "test set" in the context of diagnostic performance.
• Data provenance (country of origin, retrospective/prospective) for a diagnostic performance study.
• Number and qualifications of experts for establishing ground truth.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or details on the effect size of AI assistance.
• Details on a standalone (algorithm only) performance study.
• The type of ground truth used for diagnostic performance (e.g., pathology, outcomes data).
• Sample size for a training set (as this is a 510(k) for a thermal imaging system, not an AI software where a training set size would be explicitly discussed here).
• How ground truth for a training set was established.

Information that can be extracted from the document:

1. A table of acceptance criteria and the reported device performance:
The document does not provide acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity for breast cancer detection). Instead, it lists various engineering and functional validation tests for the device's components. Since there are no specific diagnostic acceptance criteria stated, there is no corresponding reported performance in that context. The document broadly states that "In all instances, the FIRSTSense Breast Exam® functioned as intended and the results observed and reported were as expected," for the technical performance tests.

Below is a summary of the technical performance validations mentioned:

2. Sample sized used for the test set and the data provenance: Not mentioned as the document describes technical validation tests, not a clinical diagnostic performance study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. Technical validation tests do not typically use expert ground truth in this manner.

4. Adjudication method for the test set: Not applicable/not mentioned.

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: Not mentioned. The device is a "Telethermographic System," and the document describes its hardware and software functionality, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study with AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed diagnostic performance studies with such ground truth are not presented. The "ground truth" for the technical tests would be the expected functional output or measured physical parameters.

8. The sample size for the training set: Not mentioned. This type of submission is for a medical device that captures images and provides temperature differentials, not an AI/ML diagnostic algorithm that would have a distinct training set.

9. How the ground truth for the training set was established: Not mentioned. (See point 8).

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