(279 days)
DT100 Digital thermometer is intended for the measurement of human body temperature by doctor or consumers in the hospital or home. It can be used for axillary, oral and rectal measurement. The product is reusable and provided non-sterile. The device is for people of all ages.
DT100 digital thermometer is a fast, highly accurate, and easy to use clinical instrument for measuring patient temperatures by oral, axillary or rectal means. The digital thermometer is a hand-held, reusable, multi-user, battery operated device. It has one model DT100.
The provided text is an FDA 510(k) summary for a digital thermometer (DT100). It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results for novel AI-powered diagnostic devices. Therefore, a direct answer to the request regarding AI acceptance criteria, specific test set details, expert ground truth, MRMC studies, or standalone algorithm performance, as typically seen in AI/ML device submissions, cannot be fully provided from this document.
However, I can extract the relevant information from the document that pertains to the device's performance and the non-clinical testing performed to demonstrate its safety and effectiveness.
Here's a breakdown of the information that can and cannot be extracted:
Information that can be extracted related to acceptance criteria and performance:
- Acceptance Criteria (Accuracy) and Reported Device Performance: This is explicitly stated in the substantial equivalence table.
- Non-Clinical Performance Data: The document lists the standards the device was tested against (Biocompatibility, Electrical Safety/EMC, Performance Testing, Software V&V). While it doesn't give specific results for each test (e.g., exact current leakage values), it states the device was evaluated according to these standards, implying it met their requirements.
- Ground Truth Type for Non-Clinical Testing: For performance, it relies on established standards (e.g., ASTM E1112 for accuracy).
Information that cannot be extracted (as it's beyond the scope of this 510(k) for a conventional thermometer):
- Sample sizes for a test set (as no clinical test set in the AI/ML sense was used for performance evaluation).
- Data provenance (not applicable for a simple thermometer's non-clinical testing).
- Number of experts, qualifications, or adjudication methods (not applicable as no expert-review based ground truth was established for "cases").
- MRMC comparative effectiveness study (not applicable).
- Standalone algorithm performance (not applicable, as it's a hardware device, not an algorithm).
- Sample size for training set (not applicable, as it's not an AI/ML device).
- How ground truth for training set was established (not applicable).
Based on the provided document for the DT100 Digital Thermometer:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (DT100 Digital Thermometer) |
|---|---|
| Accuracy | 32°C (89.6°F) - 42.9°C (109.2°F): +/- 0.1 °C (+/- 0.2°F) |
Notes on Acceptance Criteria and Performance:
The document states that the DT100 Digital Thermometer's accuracy is the same as the predicate device (Fudakang Digital thermometer; Model: BTA41-CN). The non-clinical testing performed (against standards like ASTM E1112) would have implicitly confirmed that the device met this accuracy requirement.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. For this type of conventional electronic thermometer, performance is demonstrated through non-clinical laboratory testing against recognized standards (e.g., ASTM E1112), not a "test set" in the context of an AI/ML algorithm requiring patient data.
- Data Provenance: Not applicable. The testing is laboratory-based and performed to international and national standards.
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)
- Not applicable. Ground truth for a digital thermometer's accuracy is established by highly accurate reference temperature measurements in a controlled laboratory environment, not by expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 is a standalone digital thermometer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The device's performance (accuracy, electrical safety, biocompatibility, etc.) was evaluated as a standalone product through non-clinical laboratory testing according to relevant standards. The "algorithm" here essentially refers to the device's internal temperature measurement and display mechanism, which operates without human intervention beyond taking the measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For performance (accuracy): The ground truth is established by highly precise and calibrated reference thermometers and temperature baths/devices, as per the requirements of standards like ASTM E1112. This is an objective, physical measurement standard rather than a subjective human interpretation.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 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.