(218 days)
The infrared thermometer, Model XW-60 is intermittent measurement and monitoring of forehead temperature of human body. The device is indicated for use by people of one month old and above age in the home.
The device is intended for the intermittent measurement and monitoring of forehead temperature of human body. The device is indicated for use by people of all ages in the home. It has the following features:
- . Three button operation;
- Optional mode for Fahrenheit and Celsius; .
- Short measurement response time;
- . There are 20 measurement data can be memorized and stored;
- . Two color backlight display;
- Low and high temperature warning beeps;
- Automatic shutdown feature to save energy; ●
- . Low battery indication;
The provided text describes the acceptance criteria and the study conducted for the Infrared Thermometer, Model XW-60.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
The document states that the device's clinical data, represented by clinical bias and clinical repeatability, met the acceptance criteria of the clinical study protocol. However, the specific numerical acceptance criteria for clinical bias and clinical repeatability are not explicitly provided in the document. The general acceptance is that it meets the requirements of ASTM E1965-98 (Reapproved 2016) and ISO 80601-2-56:2017+AMD2018.
| Acceptance Criteria (from standards referenced) | Reported Device Performance (as stated in document) |
|---|---|
| Clinical Bias (meeting ASTM E1965-98 and ISO 80601-2-56 requirements) | Met the acceptance criteria of the clinical study protocol. |
| Clinical Repeatability (meeting ASTM E1965-98 and ISO 80601-2-56 requirements) | Met the acceptance criteria of the clinical study protocol. |
| Measurement Accuracy (Specific ranges per ASTM E1965-98 and ISO 80601-2-56) | $±0.2°C :35.0°C ~42.0°C$, $± 0.3°C: 32.0°C |
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 the test set: 150 subjects.
- 50 subjects: one month to one year old
- 50 subjects: one year to five years old
- 50 subjects: over 5 years old
- Data Provenance: The document does not explicitly state the country of origin of the data. It mentions the manufacturer is in Shenzhen, China, but this doesn't confirm the location of the clinical study. The study is described as a "clinical investigation," which typically implies prospective data collection.
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 specify the number or qualifications of experts used to establish the ground truth for the test set. It only mentions a "clinical study" was conducted, and the ground truth would typically be established by a reference thermometer or standard clinical measurement methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method 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
This device is an infrared thermometer, not an AI-assisted diagnostic tool typically assessed with MRMC studies involving human readers. Therefore, no MRMC comparative effectiveness study was done and this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone study (clinical study of the device itself) was done. The entire Section 8, "Clinical Study," describes this. The device performance (clinical bias and clinical repeatability) was measured directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical study would have been established by a reference thermometer or standard clinical measurement methods as per the requirements of ASTM E1965-98 (Reapproved 2016). The document does not explicitly state the type of reference standard used, but for thermometer accuracy studies, it typically involves comparing readings against highly accurate clinical reference thermometers.
8. The sample size for the training set
The document does not provide information regarding a separate training set or its sample size. The description of the study focuses solely on the clinical validation (test set).
9. How the ground truth for the training set was established
As no training set is mentioned, information on how its ground truth was established is not available in the document.
§ 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.