(307 days)
The Wireless Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons over two years old.
The wireless thermometer, WT701, which is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously. For the monitoring operation, switch the thermometer on and stick the thermometer in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measures the body temperature by means of testing the NTC resistance value and calculates the body temperature every 4 seconds continuously and sends the temperature data to the receiver through Bluetooth connection. The wireless thermometer uses a CR2032 battery for operation. When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.
Here's the analysis of the provided text, focusing on acceptance criteria and supporting study details:
Acceptance Criteria and Device Performance Study for Wireless Thermometer (K132761)
The provided document describes the 510(k) submission for the Raiing Medical Company Wireless Thermometer, Model WT701. The core of the information regarding acceptance criteria and device performance is found in the "Comparison of Technology Characteristics" table and the "Non-Clinical Test Conclusion" section.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Wireless Thermometer WT701 are primarily outlined by its specifications, which are compared to a predicate device. The performance is reported as meeting these specifications and complying with relevant standards.
| Acceptance Criteria (Specification / Standard) | Reported Device Performance |
|---|---|
| Measurement Range | 25 °C ~ 45 °C |
| Accuracy | ±0.05℃ (35℃-38.5℃) |
| ±0.1℃ (25℃-34.99℃ and 38.51°C-45°C) | |
| Operating Temperature | 5℃~40℃ |
| Operating Humidity | 15-85% |
| Signal Transmission (Valid distance) | Up to 5 meters |
| IEC60601-1:2005 (Basic safety & essential performance) | Complies |
| IEC 60601-1-2:2007 (EMC) | Complies |
| FCC Part 15 Subpart C & 15.247 (Wireless) | Complies |
| ASTM E1112-00: 2006 (Intermittent Temp) | Complies |
| EN 12470-4: 2000+A1:2009 (Continuous Temp) | Complies |
| Performance Test (Dimension, Weight, Accuracy transmission) | Conducted and met specifications |
2. Sample Size and Data Provenance
The document does not specify the sample size used for any of the tests, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature). The tests are categorized as "non-clinical tests" and "performance tests," suggesting laboratory-based assessments rather than patient-based clinical trials for establishing accuracy.
3. Number and Qualifications of Experts for Ground Truth
The document does not mention the involvement of experts to establish ground truth for testing. Given the type of device (thermometer) and the standards cited (e.g., ASTM E1112, EN 12470-4), the "ground truth" for temperature measurements would typically be established by calibrated reference thermometers or environmental chambers, not human experts.
4. Adjudication Method
The document does not mention any adjudication method, as it does not describe a study involving human interpretation or subjective measurements that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study involving human readers. This device is a measurement tool, not an interpretive diagnostic aid, so such a study would not be applicable.
6. Standalone Performance Study
Yes, a standalone performance assessment was conducted. The "Non-Clinical Test Conclusion" section states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and complied with various standards (IEC, FCC, ASTM, EN). These tests assess the algorithm's and hardware's ability to accurately measure temperature independently. Specific performance tests mentioned include:
- Dimension Test
- Weight Test
- Accuracy transmission test under a complex electromagnetic environment
- Compliance with accuracy specifications: ±0.05℃ (35℃-38.5℃) and ±0.1℃ (25℃-34.99℃ and 38.51°C-45°C).
7. Type of Ground Truth Used for Standalone Performance
The type of ground truth used for the standalone performance testing would have been calibrated reference standards and physical measurements. For temperature accuracy, this implies using highly accurate, traceable reference thermometers and controlled environments (e.g., temperature-controlled baths or chambers) to simulate body temperatures across the specified range. For other tests like dimension, weight, and signal transmission, physical measurement tools and electromagnetic compatibility testing equipment would serve as the ground truth.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This is expected as the device appears to be a hardware-based electronic thermometer, not a device employing machine learning or AI that typically requires training data.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set or machine learning/AI components, this information is not applicable and is not provided in the document. The device's functionality is based on direct physical measurement of NTC resistance and conversion to temperature.
§ 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.