(286 days)
Infrared Thermometer (FT-F11) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.
Infrared Thermometer, (FT-F21, FT-F31, FT-F41) is intended for intermittent measurement of human body temperature in people of all ages.
This infrared Ear Thermometer measure the temperature. It's from the ear canal which can be got more quickly and accurate the human body temperature.
This product has the following advantages:
1). Easy to Clean& Probe cover Free.
2). High speed & Accuracy scan the reading of temperature.
3). Conveniency, Only one key operation.
4). Automatic display last memorized measuring temperature. When do you turn on the power.
The provided text describes the substantial equivalence of the "Infrared Thermometer (FT-F11, FT-F21, FT-F31, FT-F41)". The acceptance criteria, study details, and related information are extracted below:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for performance metrics like accuracy, but rather uses a comparison table to predicate devices. The implied acceptance criteria are that the new device's specifications are comparable to or within acceptable ranges of the predicate devices, and that testing confirms its safety and effectiveness.
| Feature | Predicate Device (K081788) (InnoTherm ICT-100, ICT-200) | Predicate Device (K101912) (THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301) | Subject Device (FT-F11, FT-F21, FT-F31, FT-F41) | Reported Device Performance (Implied) |
|---|---|---|---|---|
| Intended Use | Electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in neonatal, pediatric, and adult populations. | Intermittent measurement of human body temperature in people of all ages. | FT-F11: Electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in neonatal, pediatric, and adult populations. FT-F21, F31, F41: Intermittent measurement of human body temperature in people of all ages. | Matches intended use of predicate devices, with specialization for FT-F11. |
| Measurement temp range | 32.0 ~ 43.0 °C (89.6 ~ 109.4°F) | 34 ~ 42.5°C | 34°C - 43°C | Within or comparable to predicate ranges. |
| Ambient range | 16.0 ~ 40.0°C (93.2 ~ 108°F) | 15 ~ 40°C | 10.0°C-40.0°C | Within or comparable to predicate ranges. |
| Storage range | -10 ~ 41°C (14 ~ 105.8°F) | -20 ~ 50°C | -25.0°C-55.0°C | Within or comparable to predicate ranges. |
| Display type | LCD | LCD | LCD | Matches predicate device. |
| Activation | Scan button | Scan button | Scan button | Matches predicate device. |
| Battery type | CR2032 * 1 pcs | Two 1.5V AAA type batteries | Two 1.5V AAA type batteries | Comparable to predicate devices. |
| Classification | thermometer, electronic, clinical (Class II), 21 CFR 880.2910 | thermometer, electronic, clinical (Class II), 21 CFR 880.2910 | thermometer, electronic, clinical (Class II), 21 CFR 880.2910 | Matches predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size for the test set used in the clinical or bench tests. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.
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 information is not provided in the document. For a clinical thermometer, ground truth typically comes from highly accurate reference thermometers or other established temperature measurement methods, rather than expert interpretation of images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method for establishing ground truth 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 for which MRMC studies involving human readers would typically be conducted. Therefore, no MRMC study or effect size related to human reader improvement with AI is mentioned or relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone electronic clinical thermometer. The clinical and bench tests assess the performance of the device on its own. The document states, "The clinical and bench tests demonstrated its accuracy and effectiveness." This implies standalone performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a clinical thermometer, the ground truth for temperature measurement would typically be established using a highly accurate reference thermometer or other validated temperature measurement standard. This would be part of the "clinical and bench tests" conducted, specifically adhering to standards like ASTM E 1965. The document does not explicitly state the specific method used to establish ground truth beyond referencing standards.
8. The sample size for the training set:
This information is not applicable and not provided. As an infrared thermometer, this device is likely a hardware-based measurement system and does not typically involve "training sets" in the context of machine learning or AI algorithms. Its functionality is based on established physical principles of infrared detection.
9. How the ground truth for the training set was established:
This information is not applicable and not provided, as there is no mention of a "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.