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The Flir devices are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of differences in skin surface temperature changes. It can visualize, document temperature patterns and changes. Environment of use: hospital, sub-acute, public areas, i.e., airports

Flir manufactures a number of IR camera's, they all include the same basis temperature measurement and sensing technology. They are non-contacting and employ passive infrared emissions for sensing temperature variations.

The captured energy is processed by software to produce digital output values of the thermal energy captured by the camera's thermal sensors.

The provided document is a 510(k) summary for a telethermographic camera (Series A, E, S, and P - IR cameras). It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the general technical characteristics and intended use.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the telethermographic camera specifies the following performance characteristic:

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

The provided 510(k) summary does not contain information regarding a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The document focuses on demonstrating substantial equivalence based on general technical characteristics and comparison to predicate devices, rather than a clinical performance study with a distinct test dataset.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided in the document. As no clinical performance study with a test set is detailed, there's no mention of experts for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided in the document. Since there's no mention of a test set, there's no adjudication method described.

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

No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The submission relies on a comparison of technical specifications and intended use to predicate devices, not on studies involving human readers and AI assistance.

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

The document does not explicitly describe a standalone performance study of the algorithm without human-in-the-loop. The device itself is a "telethermographic system" that captures thermal images, and its use is as an "adjunct to other clinical diagnostic procedures." The submission's focus is on the device's technical specifications (like accuracy) rather than a complex algorithm that would typically undergo standalone performance testing.

7. The Type of Ground Truth Used

The document does not specify a type of ground truth used, as it doesn't describe a validation study requiring ground truth. The "ground truth" for the device's performance, as implied by the accuracy specification ($±2 °C$ or $±2%$ of reading), would likely be established through calibration against known temperature standards.

8. The Sample Size for the Training Set

The provided 510(k) summary does not contain information regarding a training set or its sample size. This type of detail is typically associated with machine learning or AI-driven devices, which is not explicitly indicated for this "Telethermographic Camera."

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

Since there is no mention of a training set, the document does not provide information on how its ground truth would be established.

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