(231 days)
The TD-1035 Thermometer device is a thermometer intended for body temperature measurement at the axillary measurement site. The device is intended for measurement in patients 12 years and older in a home use environment.
The TD-1035 Thermometer is a wrist band with sensors, which are used to measure axillary temperature. The sensors are located on the inner edge of the wrist band, so when desired the band is removed from the wrist and held under the user's underarm with the sensors contacting the underarm skin directly.
The main function of TD-1035 Thermometer is to measurement the body temperature range easily and accurately. The TD-1035 Thermometer also has a wireless data transmission function which transmits the readings from the TD-1035 Thermometer to a personnel device, such as a smart phone, tablet PC, etc., via Bluetooth pairing.
The provided document is a 510(k) summary for the TaiDoc Technology Corporation's TD-1035 Thermometer. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study for novel acceptance criteria.
Therefore, much of the requested information (such as sample size for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, and standalone performance) would typically be found in detailed clinical trial reports or validation studies, not usually summarized in this level of detail within a 510(k) submission.
However, based on the information available in the provided text, here's what can be extracted and inferred regarding the acceptance criteria and the methods used to demonstrate them:
1. A table of acceptance criteria and the reported device performance
The primary acceptance criteria for performance relate to accuracy, measurement range, and resolution, as compared to the predicate device and relevant international standards.
| Acceptance Criterion | Predicate Device (Omron MC-246) Performance | Proposed Device (TD-1035 Thermometer) Performance | Comments on Equivalence/Acceptance |
|---|---|---|---|
| Accuracy | 89.6°F to 107.6°F: ±0.2°F | ||
| (32.0℃ to 42.0℃: ±0.1℃) | 68.00°F to 94.99°F: ±0.18°F | ||
| 95.00°F to 100.40°F: ±0.09°F | |||
| 100.41°F to 113.00°F: ±0.18°F | |||
| (20.00°C to 34.99°C: ±0.10°C | |||
| 35.00°C to 38.00°C: ±0.05°C | |||
| 38.01°C to 45.00°C: ±0.10°C) | Similar, claimed accuracy is within the predicate device's tolerance and verified per ISO 80601-2-56:2009 requirements. | ||
| Measurement Range | 89.6°F to 107.6°F | ||
| (32.0°C to 42.0°C) | 68.00°F to 113.00°F | ||
| (20.00°C to 45.00°C) | Similar, claimed measurement range includes predicate's range and is verified per ISO 80601-2-56:2009 requirements. | ||
| Resolution | 0.1°C / 0.1°F | 0.01°C / 0.01°F | Same (or better, as resolution is higher). |
| Safety (Electrical, EMC, Shock) | Conformance to EN 60601-1, IEC 60601-1-2 | Conformance to IEC/EN 60601-1, IEC/EN 60601-1-11, IEC/EN 60601-1-2 | Verified per recognized standards. |
| Biocompatibility | Conformance to ISO10993 | Conformance to ISO 10993 (Parts 5, 10, 12) | Verified. |
| Software Validation | - | Compliant with FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices. | Verified. |
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 states, "The accuracy study was performed to demonstrate the TD-1035 Thermometer meet the criteria of ISO 80601-2-56:2009."
- Sample Size: The document does not specify the sample size for the accuracy study. ISO 80601-2-56:2009 outlines methods for performance evaluation but doesn't prescribe a specific sample size for a 510(k) submission summary.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be a prospective laboratory evaluation as per the standard.
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 not applicable as the study described is a technical performance validation against an international standard (ISO 80601-2-56:2009), not a clinical study requiring expert ground truth in the context of diagnoses or interpretations. The "ground truth" for temperature measurements in this context would be reference thermometers traceable to national standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a technical performance validation study against an international standard.
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. The TD-1035 Thermometer is a direct measurement device (clinical electronic 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 essence, the "accuracy study" and other performance data described are standalone evaluations of the device's inherent capabilities. The device itself performs the temperature measurement and displays it. The wireless data transmission function merely transmits these readings to a personal device; the accuracy and resolution are intrinsic to the thermometer's design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for temperature in the accuracy study would be established by a reference standard thermometer (or suite of thermometers) that has known traceability to national or international measurement standards. ISO 80601-2-56:2009 details the requirements for such reference standards and the testing methodology.
8. The sample size for the training set
Not applicable. The TD-1035 Thermometer is a conventional electronic thermometer based on thermistor technology, not a machine learning or AI-based device that would require "training data."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.