(10 days)
Indicated use- Measure of individual temperature
Measurements- Oral, Axillary -under arm, Rectal
Range of measurement- 90.0° - 108.0° F (32.0° - 42.0° C)
Accuracy- +/-0.2° F
Targeted population- Individuals requiring temperature measurements
Environment of use- Hospital and home
Disposable / reusable- Reusable, clean with alcohol
The intended product is an electronic digital thermometer for measuring patient temperature.
The provided document is a 510(k) premarket notification for the Global Treasure Industries GT980201 Electronic Thermometer. It details the device's characteristics and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GT980201 are primarily established by its claim of substantial equivalence to the predicate device (Wiltec Industries Ltd - K961879) and its compliance with the ASTM E1112 standard.
| Acceptance Criteria / Performance Metric | Reported Device Performance (GT980201) | Predicate Device Performance (Wiltec: K961879) |
|---|---|---|
| Indicated Use | ||
| Measures patient temperature | Yes | Yes |
| Types of Temperature Measurement | ||
| Oral | Yes | Yes |
| Underarm (Axillary) | Yes | Yes |
| Rectal | Yes | Yes |
| Design Characteristics (Examples) | ||
| Digital/Electronic Thermometer | Yes | Yes |
| LCD display | Yes | Yes |
| Temperature increments of 0.1°F | Yes | Yes |
| Sensor type - Thermistor | Yes | Yes |
| Performance Testing | ||
| Temperature Range (Fahrenheit) | 90.0 - 108.0°F | 89.6 - 109.4°F |
| Ambient Temperature (Fahrenheit) | 60.8 - 104°F | 60.8 - 104°F |
| Beeps alarm | Yes | Yes |
| Response time | About 1 minute | About 1 minute |
| Automatic shut off | Yes | Yes |
| Accuracy Standard | ||
| Meets ASTM E1112 | Yes | Yes |
| Stated Clinical Accuracy (from Indications for Use) | +/-0.2°F | Not explicitly stated in the comparison table, but implicitly covered by meeting ASTM E1112. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for a specific test set or the data provenance (country of origin, retrospective/prospective). The primary evidence for meeting acceptance criteria is through comparison to a predicate device and compliance with ASTM E1112. This implies that the testing to meet these standards would have been performed, but the specifics of that testing (sample size, data origin) are not described in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not mention the use of experts to establish ground truth for a test set in the context of device performance. The device is a clinical electronic thermometer, and its performance is typically assessed against established metrology standards (like ASTM E1112) or by comparison to reference thermometers, rather than expert consensus on a test set in the way one might evaluate diagnostic imaging.
4. Adjudication Method for the Test Set
As explained above, the document does not describe a test set with human assessment of ground truth, and therefore, an adjudication method is not applicable or mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices where human interpretation is crucial. For a digital thermometer, the performance is objective (e.g., accuracy of temperature reading).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
For the GT980201 Electronic Thermometer, the device itself is a "standalone" system in its function. Its performance, such as temperature range, accuracy, and response time, would have been evaluated without human intervention during the measurement process, aside from operating the device. However, the term "standalone" in this context usually refers to AI algorithms. Since this is not an AI-powered device, this question is not directly applicable in the way it's usually posed for AI. The performance metrics listed (e.g., accuracy, response time) are intrinsic to the device's function.
7. The Type of Ground Truth Used
The ground truth for this device's performance would primarily be established by:
- Reference Standards: Measurements would be compared against highly accurate, calibrated reference thermometers in controlled environments.
- Compliance with Industry Standards: The device's ability to meet the requirements of ASTM E1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) serves as a primary form of ground truth for its performance characteristics, especially accuracy.
8. The Sample Size for the Training Set
This document does not describe a "training set" in the context of machine learning or AI. The GT980201 is a traditional electronic thermometer, not an AI-driven device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned for an AI/ML algorithm, this question is not applicable.
§ 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.