(190 days)
Wireless Smart Thermometer is intended to be used at home for the intermittent measurement and monitoring of human body temperature orally, rectally, and under the arm. The devices are reusable for the adult and pediatic patient population (not suitable for neonates).
Wireless Smart Thermometer (Model: FDTH3400, FDTH3401, FDTH3402, FDTH3403, FDTH3404, FDTH3405, FDTH3406, FDTH3407, FDTH3408, FDTH3409, FDTH3410, FDTH3411, FDTH-V0-13, FDTH-V0-4) utilizes a modular design method and consists of six main modules:
- Buzzer module: Control the product buzzer to produce audible notifications;
- Display module: Display driver content through notifications, and combine to produce various display interfaces;
- Battery voltage management module: Detect the battery power of the product and output the battery power level;
- Temperature measurement module: After collecting the electrical signal of the external temperature sensor through AD, it is restored to the temperature value through various algorithms
- Button module: This module is used to identify whether the product button is active;
- Wireless function module: Transfer the measurement data to the mobile device.
The provided text describes the Wireless Smart Thermometer (models FDTH3400, FDTH3401, FDTH3402, FDTH3403, FDTH3404, FDTH3405, FDTH3406, FDTH3407, FDTH3408, FDTH3409, FDTH3410, FDTH3411, FDTH-V0-13, FDTH-V0-4) and its substantial equivalence to a predicate device. While it mentions performance criteria and clinical testing, it does not detail specific acceptance criteria values or the results of a statistically powered clinical study to "prove" the device meets them in the way typically expected for a full clinical study report. Most of the information provided refers to compliance with standards.
Here's an attempt to extract the requested information based on the provided text, with significant limitations due to the nature of the document (a 510(k) summary, not a detailed study report):
1. A table of acceptance criteria and the reported device performance
The document primarily references compliance with standards rather than specific acceptance criteria values and reported performance figures. It lists the measuring accuracy as:
- For FDTH3400~FDTH3405 and FDTH-V0-13: ±0.10°C between 35.00°C
42.00°C (±0.18°F between 95.00°F107.60°F), and ±0.20°C (or ±0.36°F) outside this range. - For FDTH3406~FDTH3411 and FDTH-V0-4: ±0.3°C between 34.0°C
42.0°C (±0.6°F between 93.2°F107.6°F), and ±0.4°C (or ±0.8°F) outside this range.
The document states: "The results showed the accuracy of the subject device is within acceptable scope specified in ISO 80601-2-56." This implies that the device's measured accuracy performance meets the acceptance criteria defined by the ISO 80601-2-56 standard for clinical thermometers, which generally defines the maximum permissible error for different temperature ranges. However, the specific measured performance values from the clinical study are not provided in this summary.
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 Study): 105 patients.
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be prospective, as it states "105 patients participated in the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any adverse events."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The text refers to "clinical validation data" and states results were "within acceptable scope specified in ISO 80601-2-56," but does not mention experts establishing ground truth or their qualifications. For thermometer accuracy validation, ground truth is typically established by high-precision reference thermometers rather than expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of medical images or other subjective interpretations to establish ground truth. For a clinical thermometer, the accuracy is validated against a reference standard, not through expert adjudication of results.
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 information is not applicable/not provided. The device is a "Wireless Smart Thermometer" and not an AI-powered diagnostic imaging tool that would typically involve human readers or an MRMC study. It measures body temperature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was conducted. The clinical testing evaluates the device's accuracy in measuring body temperature, which is a standalone function of the thermometer. The "Wireless function module" transfers data to a mobile device, but the core temperature measurement capability is inherent to the device itself, making it a standalone functional assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical study would be established by high-precision reference thermometers or validated methods of core body temperature measurement, implicitly adhering to the requirements of ISO 80601-2-56. The document mentions "water bath" in relation to measurement time, but for clinical accuracy, more direct human body temperature references are used.
8. The sample size for the training set
This information is not applicable/not provided. The device is a clinical electronic thermometer, not a machine learning or AI algorithm in the context that would typically require a "training set" of data to develop its core functionality. While there might be internal calibration data or algorithm fine-tuning, the concept of a "training set" as in AI/ML development does not apply here in the way it would for image analysis algorithms.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as #8.
§ 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.