(137 days)
The wireless temperature monitor, model ST323C, ST323F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for armpit temperature measurement of the person of all age.
The ST323C and ST323F are the wireless temperature monitor intended to be worn at left arm to monitor the armpit temperature continuously. ST323C and ST323F is composed of two operational parts, the receiver and transmitter. The receiver is the main operation unit on which, the LCD display control circuit and the main operation keys are included. And the transmitter was constructed with the thermo sensor, measuring circuit, and the signal communication unit and is to be worn at left arm for the continuous armpit temperature monitor. For the monitoring operation, both receiver and transmitter shall be switched on. Sooner after these two parts are switched on, the wireless signal communication will be set up between receiver and transmitter. The temperature monitoring signal measured at armpit will be continuously indicated on the LCD of receiver every 15 sec. 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. Regarding the performance of ST323C and ST323F, it was designed and verified according to the US standard ASTM E1112-00.
The provided 510(k) summary describes a wireless temperature monitor (ST323C and ST323F). This device is a thermometer, not an AI/ML device, and therefore the majority of the requested information (related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, etc.) is not applicable.
However, I can extract and present the information that is relevant to the device's accuracy and the study conducted.
Here's the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission refers to compliance with ASTM E1112: 2000 for performance verification. This standard is for electronic thermometers for intermittent determination of patient temperature. Specific acceptance criteria in terms of accuracy (e.g., ±0.1°C) and the device's reported performance against these numerical criteria are not explicitly stated in this 510(k) summary. However, the summary states: "Regarding the performance of ST323C and ST323F, it was designed and verified according to the US standard ASTM E1112-00."
2. Sample Size Used for the Test Set and Data Provenance
A clinical report for measurement accuracy was conducted.
- Sample Size: Not explicitly stated in the document.
- Data Provenance: The measurement was taken from "children less than eight years old." The location of the study (country) is not specified, but the applicant company is based in Taiwan. The study appears to be prospective as it involves taking new measurements for comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device measures a physical parameter (temperature). The "ground truth" is established by a reference thermometer, not by human expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" for temperature measurement is established by a reference thermometer.
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 physical measurement device, not an AI/ML diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The device's performance is inherently "standalone" in that it directly measures and displays temperature.
7. The Type of Ground Truth Used
The "ground truth" for the accuracy study was established by comparison with a "Mesure digital thermometer ST8A3C" which served as a reference. The method followed ASTM-E1965, which specifies standards for clinical thermometers.
8. The Sample Size for the Training Set
Not applicable. This is a non-AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a non-AI device.
Summary of Relevant Information from the provided text:
| Criteria/Study Aspect | Details from 510(k) Summary |
|---|---|
| Acceptance Criteria | Compliance with ASTM E1112: 2000 for performance. (Specific numerical accuracy criteria from the standard are not detailed in the summary). |
| Reported Device Performance | The clinical report indicates that "ST323C is suitable for the indication of intended use" based on comparison with a predicate digital thermometer. Specific numerical performance data (e.g., mean difference, standard deviation, or percentage within a certain error margin) are not provided in this summary. |
| Test Set Sample Size | Not explicitly stated. |
| Test Set Data Provenance | Measurements taken from "children less than eight years old." Prospective study. Country of origin not specified for the clinical study itself, though the manufacturer is Taiwanese. |
| Number of Experts for Ground Truth | Not applicable (physical measurement). |
| Qualifications of Experts | Not applicable (physical measurement). |
| Adjudication Method | Not applicable (physical measurement). |
| MRMC Comparative Effectiveness Study | Not applicable (non-AI device). |
| Standalone Performance Study | The device's direct measurement is its standalone performance. The clinical study evaluated its accuracy against a predicate. |
| Type of Ground Truth Used | Comparison with a "Mesure digital thermometer ST8A3C" which served as a reference, following the method recommended in ASTM-E1965. |
| Training Set Sample Size | Not applicable (non-AI device). |
| How Training Set Ground Truth Established | Not applicable (non-AI 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.