(197 days)
The Infrared Digital No-Touch Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
The iHealth PT2L Infrared Digital No-Touch Thermometer is hand-held, reusable, battery operated device, which can measure human body forehead skin temperature without touching patient's skin. Its operation is based on measuring the natural thermal radiation from the central forehead. Put the probe of the thermometer at a measurement distance less than or equal to 1.18 inch (3cm) without touching the skin at the center of the patient's forehead. It uses a thermopile sensor to measure the patient's forehead temperature and convert it to the oral equivalent. Pressing the activation button to start the measurement of proposed infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display.
The document is a 510(k) summary for the iHealth PT2L Infrared Digital No-Touch Thermometer. It details the device's characteristics, indications for use, comparison to a predicate device, and the non-clinical and clinical tests performed to support its substantial equivalence.
Here's a breakdown of the requested information regarding acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The primary acceptance criterion mentioned, specifically for clinical accuracy, is conformance to ASTM E1965-98 (2016). This standard outlines requirements for "Standard Test Method for Infrared Thermometers for Intermittent Determination of Patient Temperature." The document states that the device complies with this requirement.
| Acceptance Criteria (Standard) | Performance Met Acknowledged |
|---|---|
| ASTM E1965-98 (2016) | Complies |
Note: While not explicitly presented as a table in the document, the "Accuracy" row in the comparison table on page 5 provides specific numerical criteria that the device's performance is intended to meet. The clinical accuracy study confirms that the device meets the ASTM standard, which encompasses these accuracy specifications.
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 (Clinical Accuracy): 130 subjects
- Infants (0-1 year): 40 subjects
- Children (1-5 years): 40 subjects
- Adults (>5 years): 50 subjects
- Data Provenance: The document does not specify the country of origin of the data. It implies a prospective clinical investigation ("Clinical investigation and data analysis have performed according to ASTM F1965-98").
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)
This is not applicable as the device is a thermometer measuring body temperature, not an AI diagnostic device requiring expert interpretation of images or other data for ground truth. The ground truth for temperature measurement would be established by a reference standard thermometer as per the ASTM F1965-98 protocol. The document does not specify details of the reference thermometer or its calibration.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The clinical accuracy study for a thermometer involves direct comparison of the device's readings against a reference standard, not a subjective interpretation requiring adjudication among multiple experts.
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
Not applicable. This is a standalone medical device (thermometer), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the clinical accuracy validation test described is a standalone performance test of the device. The device itself (the thermometer) performs the measurement, and its accuracy is assessed against a reference standard. There is no human interaction for 'interpretation' of results in the way an AI diagnostic algorithm might have.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical accuracy study would be the temperature measurements obtained from a reference standard thermometer (e.g., a highly accurate rectus or oral thermometer) as described in ASTM F1965-98. The document does not specify the type of reference standard used.
8. The sample size for the training set
Not applicable. This is a traditional medical device (thermometer) that does not use machine learning, and therefore does not have a "training set" in the context of AI/ML models.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.