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TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region. The device is intended for population age of six months and above, which is designed for home use.

TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region, and transmit data to personnel device via Bluetooth pairing. The design concept is equivalent to the predicate device, K152680. There are two modifications made to the subject device: (1) indication for use (2) an elastic band was added. The elastic band is designed for more suitable and comfortable wearing. Moreover, the detected sensor contacts user skin directly, which is located on the silicone belt. The parts that contact the user are: (1) elastic band (2) sensor head (3) silicone belt.

The device in question is the TaiDoc TD-1035 Thermometer, intended for measuring body temperature in the axillary region for individuals aged six months and above, designed for home use.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Laboratory Accuracy Test (A1.8): A sample size of 80 measurements was used.
• Clinical Test (A1.16): The document mentions "non-febrile and febrile group of subjects, infants (6 months and above), children, adults and elderly," but does not specify the exact sample size for the clinical test set.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that TaiDoc Technology Corporation is based in Taiwan, it is likely the studies were conducted there. The nature of the performance tests (laboratory, mechanical, storage, operating environment) suggests prospective testing. The clinical trial would also typically be prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not provide information on the number of experts or their qualifications for establishing ground truth, particularly for the clinical study. For temperature measurement, ground truth for clinical accuracy studies typically involves highly accurate reference thermometers or direct measurement of core body temperature by qualified medical professionals.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method.

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 medical device (thermometer), not an AI-assisted diagnostic tool that involves human "readers" interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is a physical thermometer. The performance tests (A1.1 - A1.16) evaluate the device's inherent capabilities, which can be considered "standalone" as they assess the device's readings against established standards or reference measurements. There isn't an "algorithm only" in the sense of software interpreting medical images, but rather the device's internal processing of temperature signals.

7. The Type of Ground Truth Used

• Laboratory Accuracy Tests (A1.5, A1.6, A1.8, A1.9, A1.11): The acceptance criteria refer to "calculated error δ" against a known or reference temperature. This implies comparison against calibrated reference standards/devices in controlled laboratory environments.
• Clinical Test (A1.16): The clinical accuracy is verified "by comparing its output with that of a reference device, which has a specified uncertainty for measuring true temperature." This strongly suggests the use of a highly accurate reference thermometer or method to establish the "true" body temperature for comparison.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" as this is not an AI/machine learning device that typically involves distinct training data. The device's performance is based on its engineering design and calibration, not a learned model from a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an AI/machine learning model.

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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.

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.

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