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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.

Note: The document explicitly states: "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." This indicates that the device's technical performance is about accurate capture and display of thermal data, and the diagnostic interpretation remains with the human expert. Therefore, a clinical performance study with sensitivity/specificity metrics for disease detection is not presented for the software itself.

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

The provided document does not detail a specific test set sample size or data provenance (country of origin, retrospective/prospective) for a clinical performance study of the SMILE-100 software's diagnostic capabilities.

The "Performance Testing" section mentions:

• "Verification during Product Development"
• "Verification of SMILE-100 System Output Parameters"
• "Interoperability Testing with different Thermal Camera Models"
• "Comparison of the equivalence of temperature values between thermal camera and SMILE-100 Software"

These are technical verification activities, not a clinical performance study involving patient data for diagnostic accuracy.

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

Not applicable. As there is no clinical performance study on a test set mentioned in the document, there is no information about experts used for establishing ground truth. The device relies on the interpretation of an "Expert thermologist."

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is described.

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

No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The SMILE-100 software provides visualization and quantitative parameters, but the "Expert thermologist" is still responsible for interpretation.

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

No. The document explicitly states: "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." This confirms that the device is not intended for standalone diagnostic performance. It is an "adjunctive diagnostic imaging" tool.

7. The Type of Ground Truth Used

Not applicable. Since no clinical performance study evaluating diagnostic accuracy is presented, there is no ground truth type (pathology, outcomes data, expert consensus, etc.) mentioned in relation to the SMILE-100 software's performance as a diagnostic aid.

8. The Sample Size for the Training Set

Not mentioned. The document does not provide details on a training set size, as it focuses on technical verification and equivalence rather than a machine learning model's diagnostic performance for which training data would be required.

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

Not applicable/Not mentioned. Similar to point 8, with no training set data or a clinical performance study described, the method for establishing ground truth for a training set is not provided.

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