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The IRIS-IV Infrared Imaging System is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging device intended for viewing heat patterns generated by the relative surface temperature of human heart tissue and vessels during coronary bypass surgery. Images of the exposed heart may be captured as black and white video images using a digital frame grabber and computer hard-drive. Digitally stored images may then be transferred from the hard-drive to a CD-ROM for portability.

The IRIS-IV Infrared Imaging System may be used to perform the viewing and documenting of temperature differences prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting.

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Here's an analysis based on the provided document. It's important to note that this document is a 510(k) clearance letter, which focuses on substantial equivalence to a predicate device, rather than a detailed study report proving specific acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, study design, and performance metrics is not available in this type of FDA communication.

Here's what can be extracted and what cannot:

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

This document (a 510(k) clearance letter) does not provide explicit acceptance criteria or detailed reported device performance data. The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on proving specific performance metrics against pre-defined acceptance criteria in the same way a PMA (Premarket Approval) process would. The "performance" here is implied to be similar to the predicate device because of the substantial equivalence determination.

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

This information is not available in the provided document. A 510(k) clearance letter typically summarizes the FDA's finding and does not include details on the specific studies, sample sizes, or data provenance used in the substantial equivalence determination.

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)

This information is not available in the provided document.

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

This information is not available in the provided document.

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

This information is not applicable/not available in the provided document. The IRIS-IV Infrared Imaging System is described as a "viewing and documenting" device for heat patterns, primarily for use during coronary bypass surgery by the surgical team. There is no mention of "human readers" or "AI assistance" in the context of diagnostic interpretation, which is typically where MRMC studies and AI effect sizes are relevant. This device appears to be for direct visualization and documentation by the surgeon.

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

This information is not applicable/not available in the provided document. As noted above, this device is for direct visualization and documentation by a human operator, not an autonomous algorithm.

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

This information is not available in the provided document. Given the device's function (viewing heat patterns for surgeons), the "ground truth" during its development would likely relate to the accuracy of temperature measurement and spatial representation, verified against established thermal imaging principles or perhaps clinical observation during surgery, but the document does not specify this.

8. The sample size for the training set

This information is not available in the provided document. This device does not appear to be an AI/machine learning device that would typically involve a "training set."

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

This information is not available in the provided document. Again, this device does not appear to be an AI/machine learning device.

Summary of what can be gleaned from the document:

The document is an FDA 510(k) clearance letter for the IRIS-IV Infrared Imaging System. It states that the device is "substantially equivalent" to legally marketed predicate devices.

• Indications for Use:
  • Non-contact, non-invasive, non-radiating, thermal (infrared) imaging device.
  • Intended for viewing heat patterns generated by the relative surface temperature of human heart tissue and vessels during coronary bypass surgery.
  • Images of the exposed heart may be captured as black and white video images using a digital frame grabber and computer hard-drive.
  • Digitally stored images may then be transferred from the hard-drive to a CD-ROM for portability.
  • May be used to perform the viewing and documenting of temperature differences prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting.

The "study that proves the device meets the acceptance criteria" in the context of this 510(k) is the submission and review of information by the manufacturer to the FDA demonstrating substantial equivalence to a predicate device. This process does not typically involve the detailed performance data and acceptance criteria as outlined in your request for new, novel device approvals (like PMAs). The FDA's substantial equivalence determination implies that the device performs as safely and effectively as a legally marketed predicate device for its intended use.

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The IRIS-3 Infrared Imaging System is a thermal camera based imaging device intended for use during coronary bypass surgery. Thermal imaging of the exposed heart, using the IRIS-3, permits the viewing and recording of changes in tissue temperature prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting. Recording of the temperature difference may be obtained using the videocassette recorder.

The IRIS-3 Infrared Imaging System is a thermal camera based imaging device.

I am sorry, but the provided text is a 510(k) clearance letter and an "Indications For Use" statement from the FDA for a device called the "Thermatrek Iris-3 Infrared Imaging System."

This document does not contain any information regarding:

• Acceptance criteria for the device's performance.
• Details of any study that proves the device meets acceptance criteria.
• Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for any studies.

The document primarily states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and outlines its intended use during coronary bypass surgery for thermal imaging.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device