(568 days)
The wireless temperature monitor, model ST313C/F, ST314C/F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for wrist and abdomen temperature measurement of the baby less than eight years old, and the baby of eight years old.
The Wireless temperature monitor, model ST-314C/F, are the electronic thermometers by using a thermistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 3.0V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Reqarding the performance of ST-314C/F, it was designed and verified according to the US standard ASTM E1112-98.
The provided text describes the 510(k) summary for a Wireless temperature monitor, models ST-313C/F and ST-314C/F. The information related to acceptance criteria and the study proving device performance is extracted below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ASTM E1112:1998 for electronic thermometers. | Device was designed and verified according to ASTM E1112-98. "The result of clinical report indicates that ST313C is suitable for the indication of intended use." |
| Compliance with EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirements (Electrical safety and EMC standards). | Device met these standards. |
| Measurement accuracy (relative to a predicate device, Funai RT-9101, for wrist and abdomen temperature measurements in children less than eight years old). | "The result of clinical report indicates that ST313C is suitable for the indication of intended use." (Specific numerical accuracy metrics are not provided in this summary, but a clinical test was performed to compare accuracy with the predicate device). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of subjects. The text mentions "clinical report for measurement accuracy" and "The measurement was taken by both ST313C and RT-9101 at wrist and abdomen location for the children less than eight years old."
- Data Provenance: The study was a "clinical report," suggesting prospective data collection. The location is not specified, but the submitter is based in Taiwan, R.O.C.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. For a temperature monitor, the "ground truth" would likely be established by a reference thermometer or highly accurate direct measurement, rather than human experts.
4. Adjudication Method for the Test Set
This information is not provided in the given text. It is unlikely to be relevant for a device measuring a physical parameter directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.
- MRMC Study: No, this was not an MRMC study. It was a comparison of device performance against a predicate device and standards, not a study evaluating human readers' effectiveness with or without AI assistance.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the primary evaluation appears to be a standalone performance assessment of the device. The "clinical report for measurement accuracy" compared the new device (ST313C) directly against a predicate device (Funai RT-9101). The device itself is an electronic thermometer, and its accuracy is assessed independently of human interpretation.
7. The Type of Ground Truth Used
The ground truth for accuracy was established by:
- Compliance with ASTM E1112:1998 standard for electronic thermometers.
- Comparison of measurements against a predicate device (Funai model RT-9101). The predicate device's measurements would serve as the "ground truth" for comparative accuracy.
8. The Sample Size for the Training Set
The provided text does not mention a training set as this device is a hardware electronic thermometer and not an AI/machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no 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.