(204 days)
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 |
§ 884.2980 Telethermographic system.
(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.