(259 days)
JXB182 Non-contact Infrared Thermometer is an infrared thermometer intended to measure forehead temperature of infants and adults without contacting human body. It can be used by consumers in household environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The intensity of this energy depends on the temperature of the object. The JXB-182 infrared thermometer is therefore able to measure the temperature of a person by the energy the person emits. This measurement can be taken thanks to an external temperature probe on the device which permanently analyses and registers the ambient temperature. Therefore, as soon as the operator holds the thermometer near the forehead and activates the radiation sensor, the measurement is taken instantly by detection of the infrared heat generated by the arterial blood flow. Body heat can therefore be measured without any interference from the heat of the surrounding environment. The JXB-182 thermometer without contact has been developed using latest infrared technology . This technology allows temporal artery (TA) temperature to be taken at a distance of about 5cm away from the forehead. Then the result will be displayed on LCD. Besides, it owns Led backlight which can show three different colors in different temperature ranges and three-language prompt function.
The provided text describes the JXB-182 Non-contact Infrared Thermometer and its substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Item / Criteria | Acceptance Criteria (Predicate) | Reported Device Performance (JXB-182) |
|---|---|---|
| Measurement Method | Infrared Radiation Detection | Infrared Radiation Detection |
| Range (Body Mode) | 32-42.9° C | 32-42.9° C |
| Accuracy | ± 0.3°C | ± 0.3°C |
| Precision | ± 0.3°C (34-35.9° C), ±0.2°C (36-39°C), ±0.3°C (39-42.5°C) | ± 0.3°C (34-35.9° C), ±0.2°C (36-39°C), ±0.3°C (39-42.5°C) |
| Power Supply | DC 3V (2AA Batteries) | DC 3V (2AA Batteries) |
| Material | ABS | ABS |
| Operating Condition (Temperature) | 10° C to 40° C | 10° C to 40° C |
| Display | LCD | LCD |
| Display Resolution | 0.1° C | 0.1° C |
| Measurement Distance | 5cm-8cm | 3cm~5cm |
| Operating Condition (Humidity rate) | ≤ 85% | ≤ 95% |
2. Sample Size for the Test Set and Data Provenance
The document states: "Subject device JXB 182 is compliant to the ASTM E 1965-98(Reapproved 2009), Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."
However, it does not specify the sample size used for the clinical tests nor the data provenance (e.g., country of origin, retrospective or prospective nature of the study).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical tests. It only mentions that activities were performed by "designate individual(s)."
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a standalone infrared thermometer, not an AI-assisted diagnostic tool that would involve human readers. Therefore, there's no information on humans improving with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was conducted. The clinical tests were performed to ensure the device itself met the performance criteria outlined in ASTM E 1965-98. The device's performance characteristics (accuracy, precision, range) are reported for the device operating independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used for the clinical tests is implied to be reference temperature measurements, as per the industry standard ASTM E 1965-98, which sets specifications for infrared thermometers. This standard typically involves comparing the device's measurements to a highly accurate reference thermometer.
8. The sample size for the training set
The document does not provide information on a training set size. As this is a medical device, and not explicitly an AI/ML product developed with distinct training and test sets in the typical AI sense, the concept of a "training set" for the device's core functionality (temperature measurement) is not outlined. Performance is validated against established standards.
9. How the ground truth for the training set was established
Since no specific "training set" is mentioned in the context of AI/ML development, how its ground truth would be established is not applicable or described in this document. The device's design and engineering would have been developed against known thermodynamic principles and calibrated using established standards.
§ 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.