(212 days)
Infrared Thermometer (model: CK-T1501, CK-T1503) is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
Infrared Thermometer (model: CK-T1501,CK-T1502,CK-T1503) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when meas ure from 3-5 cm of the subiect's forehead with no contact.
lt uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.
It composed by a measuring sensor, PCB, 4 buttons, a LCD and an enclosure. The functions of the three models are similar. The functions of "Temperature Alarm Point", "Temperature Offset", and "Warning Tone Switch" can be set. When measuring body temperature, users need to measure in body mode from 3-5 cm from their forehead. Press the measuring key, after 0.5 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 15 sec. The No. and stored value of the stored data are displayed at the bottom of the LCD screen. Press "+" / " -" to view the previous or next stored data, it can store 32 sets of measurements.
User contact components are the enclosure and keys. The materials of the components are ABS plastic.
The provided text describes the 510(k) premarket notification for an Infrared Thermometer (Models: CK-T1501, CK-T1502, CK-T1503). Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document primarily references compliance with established standards rather than specific acceptance criteria values in a table. However, based on the Comparison to predicate device and conclusion section (page 5), and the Summary of Non-Clinical Testing and Discussion of Clinical Tests Performed sections (pages 7-8), we can infer the acceptance criteria and reported performance:
| Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|
| Accuracy (ISO 80601-2-56 / ASTM E1965-98): | |
| - 32°C | 32°C |
| - 35°C | 35°C |
| - 42.1°C | 42.1°C |
| Measuring Range: Consistent with medical thermometer standards | 32°C |
| Display Resolution: 0.1°C/0.1°F | 0.1°C/0.1°F |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 | Devices tested in compliance with IEC 60601-1-2. |
| Electrical Safety: Compliance with ANSI/AAMIES60601-1 | Devices tested in compliance with ANSI/AAMIES60601-1. |
| Home Healthcare Environment Safety: Compliance with IEC 60601-1-11 | Devices tested in compliance with IEC 60601-1-11. |
| Biocompatibility: Compliance with ISO 10993-1, including cytotoxicity, sensitization, irritation | Patient contacting components (ABS plastic) subjected to biocompatibility testing in compliance with ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10). (Results implicitly positive as substantial equivalence was claimed). |
| Software Verification: Compliance with FDA guidance for software in medical devices | Software documentation provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005. (Implicitly met, as substantial equivalence was claimed). |
| Clinical Performance: Compliance with ISO 80601-2-56 and ASTM E1965-98 (clinical accuracy requirements) | The clinical performance test protocol and data analysis showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016) and ISO 80601-2-56. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 240 subjects.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the test was a "clinical performance test" conducted in accordance with ASTM E1965-98 (2009/2016) and ISO 80601-2-56. These standards typically involve prospective clinical studies where actual body temperatures are measured. The document refers to "clinical tests evaluated 240 of subjects," strongly implying a prospective study.
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)
The document does not provide details on the number or qualifications of experts used to establish ground truth. For clinical thermometers, ground truth for body temperature is typically established by simultaneously measuring temperature with a highly accurate reference thermometer (e.g., a rectal thermometer or other core body temperature measuring device) as specified by the testing standards (ASTM E1965-98 and ISO 80601-2-56). The text only states that "the clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2009)."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe an adjudication method. For clinical thermometer studies, adjudication of ground truth measurements by multiple human experts is not typically applicable in the same way it would be for image-based diagnostic AI. The gold standard for temperature measurement is usually a precise physical sensor.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools that involve human interpretation of medical images or data. This device is a standalone infrared thermometer, which does not involve human "readers" or AI assistance in a diagnostic capacity, but rather directly provides a measurement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, a standalone performance assessment was done. The entire clinical and non-clinical testing described assesses the performance of the device itself (algorithm and hardware combined) in measuring temperature, without human interpretation of its output being part of the primary performance evaluation. The device provides a direct temperature reading.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical performance study would be simultaneous, direct body temperature measurements using a highly accurate reference thermometer (e.g., rectal, oral, or axillary measurements with a calibrated clinical electronic thermometer) as prescribed by the testing standards (ISO 80601-2-56 and ASTM E1965-98). While not explicitly stated, this is the standard method for validating thermometer accuracy.
8. The sample size for the training set
- Not applicable. This device is a traditional medical device (infrared thermometer), not an AI/ML-based diagnostic system that typically requires a large training set of data to "learn" patterns. Its internal firmware/algorithm would have been developed and validated through engineering principles and testing against specifications, not through machine learning on a "training set" of patient data in the typical sense.
9. How the ground truth for the training set was established
- Not applicable. As stated above, this device does not involve a training set for machine learning. The "ground truth" for its development would be the fundamental laws of physics related to infrared radiation and temperature, and established metrological standards for temperature measurement, used to design and calibrate the hardware and firmware.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.