(389 days)
DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
DT008 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
The basic principle of Digital Thermometer is that a change in thermistor resistance is caused by a change in temperature. The device measure body temperature by using a direct mode. The resistance is measured by a microcontroller unit, so that changes in temperature will correspond to changes in resistance. And the temperature value is displayed on the LCD screen. The device can be used for axillary, oral in the home, and used for axillary, oral and rectal temperature measurement in the hospital. The device is reusable and provided non-sterile. The device is intended for use on people of all ages. The probe cover is required when measuring the oral or rectal temperature, but not when measuring the axillary temperature.
The Digital Thermometer includes two models: DT007 and DT008. The differences of these two models are in appearance, PCB layout, external dimension and weight. All of them have the same function and they have the following basic functions:
- Data displayed on LCD
- Automatic stop (energy saver)
- Small, convenient, easy to use
The provided text describes the acceptance criteria and a study for a Digital Thermometer (Models DT007, DT008). Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally implied by conformity to specific standards and the stated "Measuring Accuracy". The reported device performance is presented in the comparison table with the predicate device and the non-clinical test summary.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (Subject Device) |
|---|---|
| Measuring Accuracy: To meet requirements of ASTM E1112 and ISO 80601-2-56. | * $32.0^\circ C \sim 35.9^\circ C \pm 0.2^\circ C$ |
| * $36.0^\circ C \sim 39.0^\circ C \pm 0.1^\circ C$ | |
| * $39.1^\circ C \sim 42.9^\circ C \pm 0.2^\circ C$ | |
| Electromagnetic Compatibility & Electrical Safety: Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11. | Tested in compliance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, and IEC 60601-1-11:2015. |
| Biocompatibility: Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 for human body contacting material. | Same human body contacting material as cleared device K163603; safety demonstrated in K163603 submission, complying with ISO 10993-1, ISO 10993-5 and ISO 10993-10. |
| General Performance: Compliance with ISO 80601-2-56 and ASTM E1112 for body temperature measurement. | Tested in compliance with ISO 80601-2-56:2017+A1:2018 and ASTM E1112-00 (Reapproved 2011). |
| Software Verification: Compliance with FDA guidance "Guidance for the Content of Premarket Submissions for Software in Medical Devices" (May 11, 2005). | Software documentation provided in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued May 11, 2005. |
| Operating Environment Condition: Ambient temperature, relative humidity, pressure altitude. | Ambient temperature: $5^\circ C \sim 40^\circ C$ ($41^\circ F \sim 104^\circ F$); Relative humidity: $\le 85%$; Pressure altitude: 700hPa to 1060hPa. (Passed performance tests; no adverse impact on safety/effectiveness) |
| Storage Condition: Storage temperature, storage humidity, pressure altitude. | Storage temperature: $-20^\circ C \sim 55^\circ C$ ($-4^\circ F \sim 131^\circ F$); Storage humidity: $\le 95%$; Pressure altitude: 700hPa $\sim$ 1060hPa. (Passed performance tests; no adverse impact on safety/effectiveness) |
| Response Time: Sufficient response time for temperature measurement. | 30s. (Passed performance tests; no adverse impact on safety/effectiveness) |
| Auto-off Time: Sufficient for intended use. | 10 mins. (Sufficient for intended user to obtain temperature data; no adverse impact on safety/effectiveness) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance test" against standards like ASTM E1112 and ISO 80601-2-56. These typically involve rigorous testing of multiple units under controlled conditions. However, the specific sample size of devices tested and the number of measurements taken for these performance tests are not explicitly stated in the provided text. The document also does not provide details on data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a digital thermometer, and the "ground truth" for temperature measurements is established against traceable reference standards and methods as defined by the performance standards (e.g., ASTM E1112, ISO 80601-2-56), not by human expert consensus or interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for a digital thermometer as its performance is objectively measured against physical standards, not through expert adjudication of subjective interpretations.
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
This information is not applicable as the device is a digital thermometer and does not involve AI assistance or human reader interpretation for its primary function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a digital thermometer in the context of diagnostic AI algorithms. The device itself is solely responsible for measuring temperature, and its performance is evaluated in a "standalone" manner (i.e., the device itself without human intervention affecting the measurement accuracy).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of the digital thermometer is based on established metrological standards and reference temperatures as outlined in the technical standards ASTM E1112 and ISO 80601-2-56. These standards define the acceptable deviation from a true reference temperature.
8. The sample size for the training set
This information is not applicable as the digital thermometer is a hardware device with embedded firmware for measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as #8.
§ 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.