(178 days)
This device is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.
This device is an electronic infrared digital forehead thermometer. It scans the forehead area for temperature of the arterial blood supply under the skin. The thermometer displays the results digitally as well as by talking, between 35℃ (95ºF) and 42.2ºC (108ºF). This device includes also display of current date and time. Range of date display falls within Gregorian calendar year 1901~2099, time display includes 12 hours shift or 24 hours shift. HV-T36 stores up to 30 sets of measurement records. Each set has a maximum storage time of 30 days. Temperature is stored together with measuring date and time of measurement.
Please note that the provided text is a 510(k) summary for a forehead thermometer, focusing on demonstrating substantial equivalence to a predicate device. It does not contain an independent clinical study with a detailed acceptance criterion table, performance metrics, sample sizes, expert involvement, or MRMC studies as typically found for more complex AI/ML-based medical devices.
Therefore, many of the requested sections below will indicate "Not Applicable" or "Not Provided in the Document" as the 510(k) summary (at least the provided snippets) does not detail such information.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not include an explicit table of acceptance criteria with reported numerical performance values for the IR Forehead Thermometer (HV-T36). Instead, it relies on demonstrating substantial equivalence to a predicate device (FT101 Forehead Infrared Digital Thermometer, K020433) across various technological characteristics.
The "Comparison result" column in the table indicates "Similar" or "Identical" for most characteristics which implies that the device performs equivalently to the predicate, but specific performance metrics are not quantified in this document.
| Acceptance Criteria Category | Reported Device Performance (Summary from Document) |
|---|---|
| Indications for Use | Identical to predicate device |
| Target Population | Identical to predicate device |
| Design | Similar to predicate device |
| Materials | Similar to predicate device |
| Performance | Similar to predicate device |
| Sterility | Similar to predicate device |
| Biocompatibility | Similar to predicate device |
| Mechanical Safety | Similar to predicate device |
| Chemical Safety | Not Applicable (Implies no chemical components requiring assessment) |
| Anatomical Sites | Identical to predicate device |
| Human Factors | Similar to predicate device |
| Energy Used/Delivered | Similar to predicate device |
| Compatibility | Similar to predicate device |
| Where Used | Identical to predicate device |
| Standards Met | Similar to predicate device |
| Electrical Safety | Similar to predicate device |
| Thermal Safety | Similar to predicate device |
| Radiation Safety | Similar to predicate device |
Study that proves the device meets the acceptance criteria:
The document states: "This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)". The "study" here is essentially the analysis detailed in Paragraph 14, which is a comparative analysis of technological characteristics against the predicate device. It does not describe a new clinical performance study the manufacturer conducted, but rather a justification of equivalence based on design and intended use alignment.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable / Not provided. The provided 510(k) summary does not detail a separate test set, sample size, or data provenance as it relies on demonstrating equivalence through comparison of technical specifications, not independent performance testing against a specific dataset.
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)
Not applicable / Not provided. Since no independent test set or ground truth establishment is described in the provided text, information about experts is not relevant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Not provided.
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 device is a standalone electronic thermometer, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this is a standalone device. The device itself (HV-T36 IR Forehead Thermometer) performs its function autonomously to measure and display temperature. The 510(k) process here focuses on ensuring its performance is similar to previously cleared devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable / Not provided directly for the new device. For a thermometer, "ground truth" during development or validation typically refers to a reference temperature measured by a highly accurate, calibrated device. The 510(k) summary, however, relies on the assumption that the predicate device's performance aligns with established accuracy standards, and the new device is "similar" in performance.
8. The sample size for the training set
Not applicable / Not provided. This type of thermometer does not typically involve a "training set" in the context of machine learning or complex algorithms. Its design and calibration are based on established physics and engineering principles for infrared thermometry.
9. How the ground truth for the training set was established
Not applicable / Not provided.
§ 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.