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510(k) Data Aggregation
(204 days)
TEXAS INFRARED
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
| Acceptance Criteria Category | Specific Metric (ICI P and S Series IR Cameras) | Reported Device Performance (ICI P and S Series IR Cameras) | Predicate Device (A20M) Performance |
|---|---|---|---|
| Intended Use | Adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature. | Meets stated intended use. | Matches predicate device. |
| Environment of Use | Hospitals, sub-acute healthcare settings, public areas (e.g., airport). | Meets stated environment of use. | Matches predicate device. |
| Technology | FPA uncooled Microbolometer | FPA uncooled Microbolometer | FPA uncooled Microbolometer |
| Material | Vanadium Oxide | Vanadium Oxide | Amorphous Silica (Difference noted) |
| Spectral Response | 8 - 14 um | 8 - 14 um | 7.5 - 13 um (Difference noted) |
| Contrast/Brightness | Software Controlled | Software Controlled | Manual or Software Controlled (Difference noted) |
| Spatial Resolution IFOV | 1.13 mrad | 1.13 mrad | 2.7 mrad (Superior performance) |
| Data Output | Digital USB 2.0 | Digital USB 2.0 | RS170 EIA/NTSC or CCIR/PAL composite (Difference noted) |
| Thermal Time Constant | 14 ms | 14 ms | Unknown |
| Thermal Sensitivity | 0.038C @ 25C | 0.038C @ 25C | 0.120C @ 30C (Superior performance) |
| Accuracy | +2C or 2% | +2C or 2% | +2C or 2% |
| Emissivity Correction | Computer Controlled | Computer Controlled | Variable from 0.1 to 1.0 (Difference noted) |
| Performance (NETD) | 38 mK NETD | 38 mK NETD | Under |
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