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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.

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

Not applicable. No clinical test set was used, as clinical testing was not required for this 510(k) submission.

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. No clinical test set was used, and therefore no ground truth established by experts.

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

Not applicable. No clinical test set or adjudication was performed.

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. The device is a thermal imaging system, not an AI-assisted diagnostic tool, and no clinical comparative effectiveness study was done.

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

Not applicable. The device itself is the "standalone" component here, but its performance is assessed against technical specifications, not a diagnostic algorithm's performance. The clinical use is described as "adjunctive use only" and "determined by the healthcare professional."

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

Not applicable. For this 510(k), the "ground truth" for demonstrating substantial equivalence was effectively the technical specifications and indications for use of the predicate device, not clinical outcomes or expert consensus. Non-clinical testing focused on electrical safety and EMC standards.

8. The sample size for the training set

Not applicable. As this is a thermal imaging device and not an AI/machine learning system trained on a dataset for diagnostic purposes, there is no "training set."

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

Not applicable, as there is no training set for an AI/machine learning model.

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence of the IRIS-XP to a predicate device (MEDITHERM MED2000) based on comparable technical specifications and indications for use, without requiring clinical performance testing against specific clinical acceptance criteria.

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