(167 days)
Digital Thermometer is intended to measure the body temperature either oral or axillaries (under arms) and to be used by consumers in a household environment. The device is intended for repeatable use by one patient. It is intended for use on people of all ages.
The Digital Thermometer utilizes measured thermistor resistance and a microcontroller unit to determine and display human body temperature. Changes in the probe temperature due to oral or auxiliary contact correspond to changes in resistance. The probe Temperature values are digitally displayed on an LCD screen in 0.2 degrees Fahrenheit increments. The measurements do not account for a probe cover. The user contacting materials are Stainless steel and Acrylonitrile Butadiene Styrene (ABS).
The Digital Thermometer includes 3 models: DT001, DT007 and DT008. The differences of these models are in appearance and specifications. All of them have the same basic functions:
- Precision of 0.1℃ for measurements between 35℃ and 39℃ for measurement
- Data displayed in Celsius -
- Automatic stop (energy saver) -
The provided document is a 510(k) premarket notification for a Digital Thermometer. It describes the device, its intended use, and a comparison to a predicate device. It also mentions non-clinical tests performed to demonstrate substantial equivalence.
However, the document does not contain the specific acceptance criteria for performance metrics of the digital thermometer (e.g., specific accuracy limits for different temperature ranges as defined by the manufacturer for acceptance) and does not explicitly detail a study report showing the device meets predefined acceptance criteria for these specific metrics. It lists the regulated accuracy standard, but not the manufacturer's internal acceptance criteria.
Therefore, many of the requested items cannot be fully answered from this document. I will extract what is available and indicate when information is not present.
1. A table of acceptance criteria and the reported device performance
The document lists performance standards and typical accuracy ranges for clinical electronic thermometers. It does not provide a table of acceptance criteria set by the manufacturer for the specific device and then report the device performance against those criteria in a tabular format. Instead, it states that the device complies with the standards.
| Metric (Criterion Type) | Acceptance Criteria (from Standard) | Reported Device Performance (Compliance Statement) |
|---|---|---|
| Measuring Accuracy | ±0.1°C between 36.0°C to 39.0°C; The rest: ±0.2°C (from ASTM E1112, ISO 80601-2-56) | Complies with ASTM E1112 and ISO 80601-2-56 |
| Response Time | Shorter than predicate device (60s) | 30s |
| Biocompatibility | Comply with ISO 10993-5:2009, ISO 10993-10:2010 | Complies with ISO 10993-5:2009, ISO 10993-10:2010 |
| Electrical Safety & EMC | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11:2010 | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11:2010 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "nonclinical testing performed in accordance with applicable standards and FDA guidance documents," but does not detail the specific sample size of devices tested or the data provenance for these tests.
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 is a physical medical device (digital thermometer) and the "ground truth" for its accuracy would typically be established by comparison to a traceable temperature standard or reference thermometer in laboratory conditions, not by expert interpretation. Therefore, this question is not applicable in the context of this device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
As per the answer to point 3, this is not applicable for a physical device like a digital thermometer. Adjudication methods are typically relevant for studies involving human interpretation (e.g., image analysis by radiologists).
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 is a physical medical device (digital thermometer) and its performance is evaluated in terms of accuracy and technical specifications, not human interpretive tasks. Therefore, an MRMC study is not applicable to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a digital thermometer. Its "standalone" performance refers to its ability to accurately measure temperature on its own. The document states "Performance tests protocols were performed in accordance with applicable standards... The results of the tests demonstrate the compliance to applicable thermometer standards." This implicitly indicates that the device's standalone performance was evaluated against these standards. The response time of 30s is also a standalone performance characteristic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a digital thermometer, the "ground truth" would be the actual temperature measured by a highly accurate, calibrated reference thermometer or established through a traceable temperature standard in a controlled laboratory environment. The document implies this type of ground truth was used by stating compliance with standards like ASTM E1112 and ISO 80601-2-56, which outline methods for calibrating and testing thermometer accuracy.
8. The sample size for the training set
This information is not provided in the document. Digital thermometers typically do not involve "training sets" in the sense of machine learning algorithms. The development involves engineering and calibration, not algorithm training on data.
9. How the ground truth for the training set was established
As per the answer to point 8, the concept of a "training set" with ground truth as typically understood in AI/ML contexts is not applicable to a digital thermometer. Ground truth for calibration and testing would be established by reference to traceable temperature standards.
§ 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.