(599 days)
Infrared Thermometer is intended temperature measurement at home or hospital for people of all ages without contact to human body.
Not Found
Here's an analysis of the provided text regarding the acceptance criteria and study for the JKH Health Co., Ltd. Infrared Thermometer:
Based on the provided FDA 510(k) clearance letter and Indications for Use, the document does not contain detailed information about the specific acceptance criteria for performance, the study design, sample sizes, expert qualifications, or ground truth establishment that would typically be found in a clinical study report or detailed submission summary.
The document primarily focuses on the regulatory clearance process, confirming that the device (Infrared Thermometer, Models: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304) is substantially equivalent to legally marketed predicate devices. It states its intended use for non-contact temperature measurement for people of all ages at home or in a hospital setting.
Therefore, many of the requested details cannot be extracted from this particular document. I will highlight what can be inferred or is directly stated, and mark what is not present.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
| (Typically would include accuracy, precision, bias, measurement range, e.g., "Accuracy +/- 0.2°C at 37.0°C") | (e.g., "Accuracy was measured as +/- 0.15°C for 95% of readings") |
2. Sample sized used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set
- Adjudication method: Not specified.
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
- MRMC study: Not applicable. This device is a standalone thermometer, not an AI-assisted diagnostic tool that would typically involve human readers interpreting results.
- Effect size of human improvement with AI: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Yes, this is an inference given the device's nature as an infrared thermometer. Its performance would be evaluated as a standalone device without human interpretation of its core function (temperature measurement). However, the specific details of this testing (e.g., how accuracy was validated against a reference standard) are not provided in this document.
7. The type of ground truth used
- Type of ground truth: Not explicitly stated. For a thermometer, the ground truth would typically be a highly accurate reference thermometer measurement (e.g., a laboratory-grade precision thermometer, or an invasive core body temperature measurement in a clinical setting for calibration/validation).
8. The sample size for the training set
- Sample size for training set: Not applicable and not specified. Infrared thermometers typically do not involve "training sets" in the machine learning sense. Their calibration and performance are based on physical principles and manufacturing processes, demonstrated through verification and validation testing.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable and not specified. See point 8.
Summary of what's provided for the JKH Health Co., Ltd. Infrared Thermometer:
- Device Name: Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
- Regulation Number/Name: 21 CFR 880.2910, Clinical Electronic Thermometer
- Regulatory Class: Class II
- Product Code: FLL
- Intended Use: Temperature measurement at home or hospital for people of all ages without contact to the human body.
- Type of Use: Over-The-Counter Use
- Regulatory Status: Cleared via 510(k) (K211050) as substantially equivalent to predicate devices.
What is NOT provided in this FDA 510(k) clearance letter (and would typically be found in a detailed test report or submission summary):
- Specific numerical acceptance criteria for accuracy, precision, or other performance characteristics.
- Detailed results of the device's performance against these criteria.
- Information about the clinical or laboratory studies conducted (e.g., number of subjects, age groups, measurement sites, comparison methods, statistical analysis).
- Any information regarding training data, ground truth establishment, or expert involvement, as these are more pertinent to AI/ML-driven devices.
§ 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.