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The ThermPix Thermovisual Camera is intended to view, measure, and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by professional investigation. This device is intended for use by qualified technical personnel. Clinical judgement and experience are required to review and interpret the information transmitted.

The ThermPix Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition.

The system is not intended to be used as a thermometry device.

The ThermPix Thermovisual Camera is a Telethermographic system which consists of an infrared camera embedded in a Tablet case and a Commercial Off the Shelf Tablet (WIFF only). It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. These images along with other patient-specific data are uploaded via WIFI to the ThermPix Cloud, a secure repository where clinicians can access and augment data from a 3rd party device or computer.

It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image. It is suitable for imaging adult human targets and can be used in hospitals, acute and sub-acute healthcare settings, clinics, and any environment where healthcare is provided by a healthcare professional.

Here's a breakdown of the acceptance criteria and study information for the ThermPix Thermovisual Camera, based on the provided document:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document mentions that for the Performance Validation Testing, image data was collected from 2 cameras.
The temperatures ranged from 20°C to 40°C in increments of 2°C.
The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated in the provided text.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document states: "Results indicate that with 99% confidence temperature differences in 1 °C or more are discernible by a trained user."
The number of such "trained users" and their specific qualifications (e.g., radiologist with X years of experience) are not specified.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for the test set.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The study focuses on the device's ability to discern temperature differences by a "trained user" rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The device is described as a "Thermovisual Camera" intended to "view, measure, and record heat patterns." The performance validation assesses its ability to allow users to distinguish temperature differences. This indicates a device-only performance test, where the device itself is producing the thermal images, and a human user then interprets them. The study focuses on how well the device enables a trained user, implying a standalone performance in terms of image quality and accuracy for interpretation. However, there isn't a direct "algorithm-only" performance metric separate from human observation.

7. Type of Ground Truth Used

The ground truth for the "Temperature Difference Accuracy" appears to be based on known temperature differences created using a "traceable certified reference black body calibrator and thermocouples." This represents a highly controlled and objective physical measurement.

8. Sample Size for the Training Set

The document does not provide information about a specific training set or its sample size. The performance validation describes testing the device's ability to allow users to distinguish temperature differences, not the training of an AI algorithm from a specific dataset.

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

Since there is no mention of a training set for an AI algorithm, there is no information on how its ground truth was established. The focus of the provided document is on the device's physical and functional performance, rather than an AI/ML component that requires a training set.

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The ThermPix Thermovisual Camera is intended to view, measure, and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for themally significant indications stemming from heat emitted from the human body. The significance of these thermal pariations is determined by professional investigation. This device is intended for use by qualified technical personnel. Clinical judgement and experience are required to review and interpret the information transmitted.

The ThermPix Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition. The system is not intended to be used as a thermometry device.

The ThermPix Thermovisual Camera is a Telethermographic system which consists of infrared and visual cameras and a touch-screen display. It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. These images along with other patient-specific data are uploaded via Wifi to the ThermPix Cloud, a secure repository where clinicians can access and augment data from a 3rd party device or computer.

It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image. It is suitable for imaging adult human targets and can be used in hospitals, acute and sub-acute healthcare settings, clinics, and any environment where is provided by a healthcare professional.

The provided text focuses on the 510(k) summary for the "ThermPix Thermovisual Camera" and its comparison to a predicate device. It details technical specifications and non-clinical testing performed to establish substantial equivalence. However, it explicitly states that clinical testing was not required and therefore does not contain information about a study proving the device meets acceptance criteria related to human performance, ground truth, expert adjudication, or MRMC studies.

I will extract the available information and highlight what is not present based on your request.

Here's the breakdown of the acceptance criteria and the study that was provided (non-clinical):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct "acceptance criteria" but are implied through the comparison with the predicate device and the non-clinical performance testing. The "reported device performance" is the result of these non-clinical tests.

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SMILE-100 System is intended to review, measure and record skin temperature patterns and variations emitted from the human body. It is intended for use as adjunctive diagnostic imaging for themally significant indications in the breast region. The significance of the value of these thermal patterns is determined by profession. This device is intended for use by qualified healthcare personnel trained in its use. The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

The SMILE-100 System is a breast thermography device with a visualization tool that helps a healthcare personnel to review, measure and analyze thermally significant indications in the breast region. It is intended to be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel.

SMILE-100 System consists of the following:

• An off-the-shelf FDA cleared thermal camera with its associated camera control software (i) provided by the thermal camera vendor for capturing and viewing thermal images
• An off the shelf laptop/desktop computer system with display, keyboard and mouse. (ii)
• SMILE-100 Software for viewing thermal patterns in thermal images (iii)

The SMILE-100 Software takes thermal images captured using off-the-shelf FDA-cleared thermal camera and provides various visualization options in multiple customizable views/palettes and also generates a report with quantitative thermal parameters and annotated images. The Software supports two user roles (i) a thermographer or imaging technician role and (ii) Expert thermologist role. The imaging technician captures thermal images and uploads them to the cloud-hosted SMILE-100 Software which performs image quality checks and submits to Expert. The Expert can select a temperature threshold for the SMILE-100 Software to highlight areas with thermal activity above the threshold in thermal images. The software makes no estimation of the thermal threshold. The software makes no determination regarding what the thermal patterns or relative temperature values mean. Expert thermologist needs to infer the meaning of high thermal activity and other areas of interest based on his/her visual interpretation of those patterns and thermal values.

Here's a breakdown of the acceptance criteria and study information for the SMILE-100 System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in a quantitative manner for the SMILE-100 software's diagnostic performance or a clinical study proving its effectiveness in identifying thermally significant indications. The performance testing section primarily focuses on technical verification and comparison with a predicate device's technological characteristics.

However, based on the provided comparison tables, we can infer some technical performance characteristics that are critical for equivalence with the predicate device.

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The IRIS XP is a thermal based imaging device intended for measuring relative skin temperature generated by the human body in the clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. (for adjunctive use only)

The IRIS XP provides for use with both laptop and desktop computer provides the user interface, image storage and display. Use of this device is determined by the healthcare professional and is based upon his or her of the patient's medical condition and requirements. The patient populations include all assessment age groups from adult to pediatric and neonatal. The device is for providing thermal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use.

The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

IRIS-XP shows an image analysis on the display to measure the amount of infrared rays radiated from the patient. The appropriate color image according to the temperature difference is shown on the screen. The IRIS XP is intended for relative skin temperature measurements (temperature mapping) for adjunctive use only.

The provided text is a 510(k) summary for the IRIS-XP device, which is a thermal based imaging device. It primarily focuses on demonstrating substantial equivalence to a predicate device (MEDITHERM MED2000) rather than presenting a detailed study proving the device meets specific acceptance criteria in the format requested.

Therefore, many of the requested categories cannot be directly extracted from the provided document. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the IRIS-XP to its predicate device." This means that a clinical study designed to prove the device meets acceptance criteria as typically understood for performance metrics (like sensitivity, specificity, accuracy against a ground truth) was not performed.

Here's a breakdown of what can be inferred and what cannot:

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

The document does not present specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, or image quality against a predefined benchmark for a diagnostic task). Instead, it relies on demonstrating that its technical characteristics (specifications) are substantially equivalent to a predicate device.

The closest to "acceptance criteria" and "reported performance" are the technical specifications compared in Table 1 (page 6-7). The implicit acceptance criterion for this submission is that its technical specifications and indications for use are similar enough to the predicate device to not raise new questions of safety or effectiveness.

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The Thermidas IR System is for adjunctive use in addition to other clinical diagnostic procedures for diagnostic imaging for thermally significant indications of all skin regions of the human body. The system is for reviewing and reporting of temperature patterns and changes. The significance of the value of these thermal patterns is determined by professional investigation. The system is not intended for absolute temperature measurements. The Thermidas IR system is intended for use by trained technical personnel.

The Thermidas IR System consists of an off-the-shelf thermal imaging camera, a mount for the camera and a Windows workstation running the Thermidas Imager software. The Thermidas IR System is a non-invasive medical device which uses infrared radiation naturally emitted by the patient, which senses variations in temperature. The captured data is processed by software producing a quantitative image on the computer screen. The medical professional can use the image to review, analyze, investigate, and quantify the temperature of the objects that are imaged.

The Thermidas IR System (ThIR-A615) is a Class I, reserved telethermographic system. Since it is a Class I device, clinical studies were not required and were not performed. Therefore, information regarding acceptance criteria based on clinical performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, adjudication methods, or multi-reader multi-case studies is not available in the provided text.

The substantial equivalence determination was based on non-clinical performance testing against several international and national standards.

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

Since clinical performance testing was not required or performed, the "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity) is not available. The acceptance criteria were met by demonstrating compliance with the following non-clinical testing standards:

Discussion on Device Features Compared to Predicate (Found in the "Predicate Device Comparison" Table):

While not formal performance metrics, the device's technical specifications and features were compared to the predicate to establish substantial equivalence. These comparisons highlight attributes that contribute to the device's functional performance:

• Resolution: Both the predicate and proposed device support high resolution (e.g., 640x480). The proposed device explicitly states it uses a "640 x 480 pixel microbolometer that detects temperature differences as small as 50 mK, for accuracy at longer distances."
• Image Frequency: Both devices offer high image frequency (e.g., 50-60 Hz) for real-time viewing. The proposed device specifies "Stream full-frame 16-bit images at 50 Hz, or in windowed mode as high as 200 Hz, for high-speed processes."
• Focus: Both offer automatic focus.
• Connectivity: Both use Gigabit Ethernet.
• Calibration: Both are factory calibrated.
• Lens: Both use a 25-degree standard lens.
• Software Features: Both provide software for capturing, displaying, and analyzing thermal patterns (e.g., patient records, image capture, visualization, ROI analysis, reporting).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. Clinical studies were not required or performed for this Class I device. The testing involved compliance with non-clinical engineering and quality standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Clinical studies were not required or performed. There was no clinical ground truth established for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No clinical test set requiring adjudication was used.

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 Applicable. No MRMC study was conducted. The device is a telethermographic system for adjunctive diagnostic imaging, and the provided documentation does not indicate it uses AI for image interpretation or for assisting human readers in a comparative effectiveness study.

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

• Not Applicable. Clinical studies were not performed. The device is a system for reviewing and reporting temperature patterns, with the interpretation by trained technical personnel. The software itself "makes no determination regarding what the thermal patterns or relative temperature values mean" and "The decision making is not based on the software itself."

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

• Not Applicable. No clinical ground truth was established as clinical studies were not performed. For the non-clinical testing, compliance with standards served as the "ground truth" for safety and performance according to those standards.

8. The sample size for the training set

• Not Applicable. As clinical studies were not performed, there was no clinical training set.

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

• Not Applicable. As clinical studies were not performed, there was no clinical training set or associated ground truth establishment.

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The InTouch Thermal Camera is intended to view, measure and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by profession. This device is intended for use by qualified technical personnel trained in its use. Clinical judgment and experience are required to review and interpret the information transmitted.

The InTouch Thermal Camera is only for use in addition to other medical devices (i.e. Thermometer, Ultrasound, Mammography). It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition.

The InTouch Thermal Camera™ is a hardware and software package that enables thermographic imagery and data during a real-time telemedicine consultation. The system includes a 320-pixel-wide thermal camera and a USB cable that allows connection of the camera to a Windows-based computer, which serves as the patientside InTouch Health Telemedicine Device.

The InTouch Thermal Camera software consists of two components. The first is installed on a Windows-based system to serve as the InTouch Health Telemedicine Device. The second component is installed on a Windows or iOS-based system serving as the InTouch Health Provider Access device, enabling a healthcare professional access to the InTouch Health Telemedicine Device. The core software serves as a telecommunications platform that enables real-time videoconferencing and clinical communications, and provides a means of transmitting, receiving, and storing real-time audio and video data.

The InTouch Health Telemedicine System software provides a real-time link between the patient and the healthcare professional(s). The link occurs over a wired or wireless broadband connection, and includes real-time audio and video to facilitate communication between the patient-side healthcare professionals, and remote healthcare professional(s). The InTouch Health software further provides an ability to toggle between an InTouch Health Telemedicine Device's optical camera and the InTouch Thermal Camera, or to view both simultaneously.

When utilizing the InTouch Thermal Camera, the clinician is provided with interface controls to allow a variety of options in the visualization of the thermal imagery.

The basic purpose of the InTouch Thermal Camera is to allow a physician to view the heat pattern of a patient, while engaged in a telemedicine consultation. When the InTouch Thermal Camera is engaged, the InTouch Health software provides the physician with a variety of controls for visualizing temperature patterns and temperature differences.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Med-Hot Thermal Imaging Systems are intended to review, measure and record skin temperature patterns and variations emitted from the human body. They are intended for use as adjunctive diagnostic imaging for thermally significant indications in the regions of the head and neck, breast, chest, abdomen, back and extremities. The value of the value of these thermal patterns is determined by professional investigation. This device is intended for use by qualified technical personnel trained in its use.

The Med-Hot Thermal Imaging Systems are non-contact infrared imaging devices, with all functions controlled at the computer screen. TotalVision is a patented, clinical personnel friendly software application, validated in the field. The system is delivered with a computer including installed and tested software. The Med-Hot Thermal Imaging camera is suitable for high quality imaging of the human body. The TotalVision Capture Software allows for incoming image data from the camera head and configures that data in a form that can be displayed on the computer screen. This display will include an image of the scene within the camera's field of view allowing the user to visualize thermal patterns or analyze the image in terms relative temperature values. The software makes no determination regarding what the thermal patterns or relative temperature values mean. It will be left to the user to infer areas of interest based on his/her visual interpretation of those patterns or values. The new device consists of: 1. Infrared Camera (MAX 076 320 x 240 array detector or MAX 307 640 x 480 array detector), 2. TotalVision Software, 3. Laptop or desktop computer.

Here's an analysis of the provided information regarding the Med-Hot Thermal Imaging Systems:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria or reported device performance in the traditional sense of a clinical or performance study. The submission is a 510(k) premarket notification for a Class I device (Telethermographic System, Product Code LHO).

For Class I devices with a predicate, the primary focus is often on demonstrating substantial equivalence to a legally marketed predicate device, rather than meeting specific performance metrics from a de novo clinical study. The "performance" described here relates to the technical specifications of the imaging system and software capabilities, and how they compare to the predicate.

Here's an attempt to structure the information, recognizing it's not a typical performance table found in a clinical study report:

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

• Sample Size for Test Set: Not applicable. No clinical or performance test set (in terms of patient data) was used or described in this submission for defining "acceptance criteria" or "device performance" in a quantitative sense related to clinical outcomes.
• Data Provenance: Not applicable, as no human data (retrospective or prospective) was used for performance evaluation in this 510(k) submission.

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

• Not applicable. No ground truth was established by experts for a test set in this context. The device's function is to display thermal patterns, with the interpretation left to the user.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method was used, as there was no test set requiring expert review.

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

• No. A MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were conducted."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This device is not an AI/algorithm-only device with a standalone performance claim. It is an imaging system (camera + software) that captures and displays thermal data for human interpretation. The software's role is to capture and display the image data, not to make diagnostic determinations. The document states: "The software makes no determination regarding what the thermal patterns or relative temperature values mean. It will be left to the user to infer areas of interest based on his/her visual interpretation of those patterns or values."

7. The Type of Ground Truth Used

• Not applicable. No ground truth based on expert consensus, pathology, or outcomes data was used for performance evaluation in this 510(k) submission, as it explicitly states that no clinical studies were conducted. The "ground truth" for the device's technical specifications would be its manufacturing and calibration standards.

8. The Sample Size for the Training Set

• Not applicable. This device is a telethermographic imaging system, not an AI/machine learning algorithm that requires a training set of patient data. The "TotalVision Capture software" is described as an "evolution of the original Med-Hot software program" with "Improvements and new features added were based on user-driven needs and requests over the years." This suggests an iterative development process driven by user feedback rather than a formal machine learning training paradigm.

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

• Not applicable, as there was no formal training set requiring ground truth establishment in the context of machine learning. The software's functionality improvement was "based on user-driven needs and requests."

Summary of Device Nature and Regulatory Context:

It's crucial to understand that this 510(k) submission is for a Class I medical device which primarily relies on demonstrating substantial equivalence to an existing predicate device. The device is a diagnostic imaging tool that measures and records skin temperature patterns; it is explicitly stated to be for "adjunctive diagnostic imaging" and the "value of these thermal patterns is determined by professional investigation." The software's role is to present data, not interpret it.

Therefore, the submission focuses on:

• Technical specifications of the hardware (camera resolution, frequency, interface, calibration).
• Functional description of the software (capture, display, basic analysis of regions of interest).
• Comparison of these features to the predicate device.
• Compliance with relevant electrical and environmental safety standards (ISO, IEC, EN, CFR).

The absence of clinical studies, ground truth establishment, or AI-specific performance metrics is typical for this type of device and regulatory pathway.

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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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The AlfaSight 9000 is intended for the adjunct diagnosis of the female breast; 2) peripheral vascular disease; 3) musculoskeletal disorders; 4) extracranial cerebral and facial vascular disease; 5) abnormalities of the thyroid gland; and 6) various neoplastic and inflammatory conditions.

The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure.

The AlfaSight 9000 system is a non-invasive, handheld and battery-operated adjunctive diagnostic device that measures and records skin surface temperatures. The system is intended for use as an adjunct to other clinical diagnostic procedures to quantify relative skin surface temperatures. It is not intended as a sole diagnostic device and does not replace or substitute any clinical test or device such as X-Ray, CT scans, mammography or other similar equipment. The system is for prescription-only use by licensed medical practitioners for use in hospitals, sub-acute healthcare settings, and private clinics.

The AlfaSight 9000 system consists of: 1) a handheld probe, 2) an off-the-shelf computer 3) a standard USB charging cable and 4) biocompatible sheaths. The single use theath is placed over the handheld probe covering the entire probe, three capacitive pins sense contact of the skin through the sheath to start the temperature measurement. Temperature samples are then sent from the handheld probe to the computer wirelessly using Bluetooth technology and are represented in a graphical display on the computer. Samples are organized into specified regions of the body as they are sampled in a fixed order as directed by the software.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in terms of accuracy, sensitivity, or specificity for its intended diagnostic uses. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Eidam's CRT 2000, K971956) based on technological characteristics and safety.

Here's a breakdown of what information is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific, quantifiable acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) and then reporting the device's performance against those criteria.

The only direct performance metric mentioned for the probe is:

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

• Sample Size: Not applicable as no clinical performance study demonstrating diagnostic accuracy was conducted. The "test set" in this context refers to non-clinical bench testing.
• Data Provenance: Not applicable for diagnostic performance. Bench testing data is implicitly from internal lab settings.

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

• Not applicable as no clinical study with ground truth established by experts was performed for diagnostic performance validation.

4. Adjudication Method for the Test Set:

• Not applicable as no clinical study with adjudication of ground truth was performed.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states that the new device measures skin temperature using infrared technology rather than the thermocouple measurements employed by the predicate device, but it asserts that this difference "does not affect the safety or effectiveness" without providing a comparative clinical trial.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• The device, a "Thermographic System," measures and presents temperature data to a healthcare practitioner. It's not an AI algorithm in the contemporary sense that provides diagnostic outputs. Therefore, the concept of "standalone (algorithm only)" as typically applied to AI/ML devices is not directly applicable. The performance testing conducted was non-clinical bench testing of the hardware and software's ability to measure and process temperature data.

7. The Type of Ground Truth Used:

• For the non-clinical testing, the "ground truth" implicitly refers to physical standards and measurements (e.g., precise temperature references) used to verify the probe's accuracy and internal consistency during bench testing. There is no mention of clinical ground truth (like pathology, expert consensus, or outcomes data) being used to validate the device's diagnostic claims.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML system that requires a "training set" in the context of machine learning model development. The software development focuses on requirements, validation, and verification, typical for traditional medical device software.

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

• Not applicable for the same reason as above.

Summary of what the document does provide regarding "performance testing":

The "PERFORMANCE TESTING" section primarily describes non-clinical bench testing to demonstrate the device's technical specifications and safety profile, asserting that these differences from the predicate do not affect its safety or effectiveness for its intended use.

• Testing Categories:

  • Biocompatibility (conforms to ISO 10993-1)
  • Software Risk Analysis
  • Software Requirements Specification
  • Software Validation Protocol
  • Software Verification Summary and Test Case Report
  • Software Test Results Report and Revision History
  • Software Design Specification
  • Software Development Environment Description Document
  • Electromagnetic Compatibility and Electrical Safety (conforms to IEC 60601-1; IEC 60601-1-2)
  • Corvalent Design Verification Testing
  • Temperature Probe with Sheath Performance Testing (this likely verified the +/- 0.2 degrees C error margin)

• Conclusion: "In sum, the results of non-clinical testing demonstrate that the AlfaSight 9000 System is as safe, as effective and performs as well as the predicate device." This conclusion is based on the technical and safety performance, not on direct clinical diagnostic accuracy comparison.

Key Missing Information:
The document does not include any clinical studies (e.g., prospective, retrospective, expert-read) that quantify the diagnostic accuracy (sensitivity, specificity, AUC) of the AlfaSight 9000 Thermographic System for any of its stated indications for use (e.g., "adjunct diagnosis of the female breast," "peripheral vascular disease"). The FDA clearance is based on substantial equivalence to an existing predicate device (CRT 2000), assuming the new technology (infrared vs. thermocouple) does not alter the fundamental safety or effectiveness for the adjunct diagnostic purpose, as demonstrated by bench testing.

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