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The ICI Series P and S IR Cameras, which provides capture of skin surface temperature of any part of the body, and the IR Flash Software version 1.0, which provides visualization and reporting functionalities, are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature. Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e., airports.

The ICI Series P and S IR Cameras, which provides capture of skin surface temperature of any part of the body, and the IR Flash Software version 1.0, which provides visualization and reporting functionalities, are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature. Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e., airport. Components of the system include: ICI P or S Series IR Camera, USB Cable, Tripp-Lite model IS250HG isolation transformer.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the ICI P and S Series IR Camera(s) and IR Flash Software version 1.0:

It's important to note that this document is a 510(k) summary for a Telethermographic System (Adjunctive Use), not a typical diagnostic AI device that would undergo rigorous clinical trials for sensitivity and specificity. The acceptance criteria here primarily focus on demonstrating substantial equivalence to a predicate device and adherence to electrical safety and software validation standards, rather than clinical performance metrics like accuracy, sensitivity, or specificity against a ground truth.

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Test Set Sample Size: Not applicable/Not provided. The submission focuses on substantial equivalence based on technical specifications and non-clinical testing (electrical safety, software validation), rather than clinical performance against a specific test set of cases.
   • Data Provenance: Not applicable, as there was no clinical study involving a test set of patient data described.

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

   • Not applicable. No ground truth establishment by experts for a clinical test set is described in this 510(k) summary.

3. Adjudication Method for the Test Set:

   • Not applicable. No clinical test set or adjudication process is described.

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

   • No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Discussion of Clinical Tests Performed: Not applicable." This indicates no clinical performance study involving human readers with or without AI assistance was conducted or submitted.

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

   • No, a standalone clinical performance study was not done. The device (ICI P and S Series IR Cameras and IR Flash Software) is a telethermographic system intended for adjunctive use. This means it provides data (skin surface temperature) to be interpreted in conjunction with other clinical diagnostic procedures by a human clinician. It is not an algorithm that autonomously diagnoses or provides a primary screening outcome. The software validation mentioned is likely for functional correctness and safety, not for diagnostic accuracy.

6. The Type of Ground Truth Used:

   • Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used in the context of this 510(k) submission, as it did not involve clinical performance testing against a disease state. The "ground truth" implicitly referred to would be instrument calibration standards for thermal accuracy and engineering specifications for other technical parameters.

7. The Sample Size for the Training Set:

   • Not applicable. This device is a thermal imaging system with visualization and reporting software, not an AI/ML diagnostic algorithm that requires a training set of labeled data in the conventional sense for clinical performance. The software validation would rely on test cases to ensure functionality, not a "training set" for an AI model.

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

   • Not applicable, as there was no training set for an AI model. The validation of the device would involve testing against known physical standards (e.g., blackbody radiators for temperature accuracy) and software functional requirements.

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