(25 days)
The Digital temperature monitor, model GT-202, GT-204, and GT-205 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for the measurement of oral, armpit and rectal temperature of all ages.
The Digital temperature monitor, model GT-202/GT-204/GT-205, are the electronic thermometers by using a 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 1.5V 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 GT-202/GT-204/GT-205, it was designed and verified according to the US standard ASTM E1112-98.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Digital Temperature Monitor, models GT-202, GT-204, GT-205:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary explicitly states that the device was designed and verified according to the US standard ASTM E1112-98. As the document does not provide specific numerical acceptance criteria from ASTM E1112-98 or detailed performance results, the table below reflects what is stated in the document.
| Acceptance Criterion (Based on ASTM E1112-98) | Reported Device Performance |
|---|---|
| Compliance with ASTM E1112-98 | "designed and verified according to the US standard ASTM E1112-98" |
| Not explicitly stated in the document | Not explicitly stated in the document |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the device was "designed and verified according to the US standard ASTM E1112-98" and that "verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be related to engineering verification against a standard rather than clinical expert evaluation for ground truth.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for a test set. The validation appears to be against a technical standard (ASTM E1112-98) rather than an expert-adjudicated clinical dataset.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is a standalone temperature monitor, and the evaluation focuses on its technical performance against a standard, not on assisting human interpretation.
6. Standalone Performance Study
Yes, a standalone performance evaluation was done. The document states: "Regarding the performance of GT-202/GT-204/GT-205, it was designed and verified according to the US standard ASTM E1112-98." This indicates that the device's accuracy and performance were evaluated according to this standard.
7. Type of Ground Truth Used
The ground truth used for the standalone performance study was based on the standards and specifications outlined in ASTM E1112-98. This standard would define the acceptable accuracy limits and test methodologies for digital clinical thermometers. It's an engineering and performance standard rather than a clinical ground truth like pathology or expert consensus on a medical image.
8. Sample Size for the Training Set
The document does not mention any training set size. This device (a digital thermometer) is a hard-wired control system (ASIC-controlled circuit) rather than a software-based AI system that would typically require a training set. The performance is determined by its hardware design and implementation to meet specific accuracy standards.
9. How Ground Truth for the Training Set Was Established
Since there is no mention of a training set, there is no information on how its ground truth was established. This type of device does not involve machine learning or AI that would typically use a training set with established ground truth.
§ 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.