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The Digital Clinical thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030's intended use are medical devices, supplied by internal power and intended to precisely measure human body temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.

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This document is a 510(k) clearance letter from the FDA for a digital clinical thermometer, not a study report or clinical trial. Therefore, it does not contain the detailed information about acceptance criteria or a study proving device performance as typically described for software or AI-based medical devices.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined that the device is as safe and effective as a device already on the market, but it does not detail the specific performance metrics or studies used to demonstrate this equivalence.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. This document does not specify acceptance criteria for performance (e.g., accuracy, precision) or report specific device performance data. It is a clearance letter, not a performance report.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not mention any sample sizes for test sets or data provenance.

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)

• Cannot be provided. This information is not relevant to a thermometer's performance evaluation and is not present in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. This detail is not included in the document.

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

• Cannot be provided. This type of study is not applicable to a digital clinical thermometer, which is a standalone measurement device, and is not mentioned.

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

• Cannot be directly answered in the context of "algorithm" performance as understood for AI. The device itself is a standalone clinical thermometer. Its performance would be evaluated in a standalone manner (e.g., accuracy tests against a reference standard). However, the document does not detail these tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. While a thermometer's ground truth would typically be a highly accurate reference thermometer, the specific method used for this device's testing is not mentioned.

8. The sample size for the training set

• Cannot be provided. This device is a digital clinical thermometer, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

• Cannot be provided. As above, there is no training set for this type of device.

Summary based on the provided document:

The provided document is an FDA 510(k) clearance letter for a "Digital Clinical Thermometer." The FDA determined the device to be substantially equivalent to legally marketed predicate devices (K010238). This decision is based on an assessment that the device is as safe and effective as existing devices; however, the letter itself does not contain the detailed performance data, acceptance criteria, or study designs that would typically be provided in a clinical study report for an AI-enabled device. The information requested regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, training sets, and how ground truth was established is not available in this document because it outlines a regulatory clearance, not a scientific study report for an AI/ML product.

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The Digital Clinical Thermometer, model BABY TEMP / WL-3305 and BABY TEMP(+) WL-3306 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be measurement of oral, axially and rectal temperature.

The Digital Clinical Thermometers, model BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, are the electronic thermometers by using a the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) -- controlled circuit, which is considered the hard-wire control instead of programmable control. Basically WL-3305 and WL-3306 have the same intended use and operation function except for the different measuring range caused by some small different design in IC circuit.

From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.

This system uses a 1.5V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, it was designed and verified according to the US standard ASTM E1112-98.

Acceptance Criteria and Study Details for Innovatech Digital Clinical Thermometer

The Innovatech Digital Clinical Thermometer, model BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, was designed and verified according to the US standard ASTM E1112-98. The submission also states compliance with EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirements. The primary basis of clearance is substantial equivalence to the predicate device, Actherm model ACT 2020 and ACT 2020+.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a specific test set. The evaluation is primarily based on compliance with existing standards (ASTM E1112-98, EN 60601 series) and substantiating substantial equivalence to a predicate device.

The data provenance is not explicitly stated as retrospective or prospective clinical data. The document refers to "verification tests" and compliance with standards. Given the nature of a 510(k) for a clinical thermometer, these tests would typically involve laboratory validation, potentially including in-vitro or in-vivo performance testing against a reference standard in a controlled environment. No information on the country of origin of testing data is provided beyond the manufacturer's location in Taiwan.

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

This information is not provided in the document. The evaluation is based on compliance with established performance standards for clinical thermometers, which prescribe methods for determining accuracy and other performance characteristics. It does not appear to involve expert consensus for ground truth as would be common in diagnostic imaging or clinical decision support AI devices.

4. Adjudication Method for the Test Set

An adjudication method is not applicable and therefore not described in this document. The assessment relies on objective measurements against established technical standards for thermometer performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed as this is a standalone device (clinical thermometer) and not an AI-assisted diagnostic tool requiring human interpretation comparison.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, a standalone performance evaluation was done in the sense that the device's accuracy was verified against the requirements of ASTM E1112-98. This standard dictates the methods for determining the accuracy of electronic thermometers, and the device's performance was measured independently of human interpretation of the readings. The "verification tests" demonstrating "the same safety and effectiveness" as the predicate device are indicative of standalone performance assessment.

7. Type of Ground Truth Used

The ground truth for performance evaluation would be established by reference temperature standards as defined by ASTM E1112-98, which specifies the requirements for electronic thermometers for intermittent determination of patient temperature. This standard outlines procedures for testing accuracy against known, highly precise temperature sources.

8. Sample Size for the Training Set

This question is not applicable as the device is a hardware-based electronic clinical thermometer controlled by an ASIC (Application Specific IC) and does not involve AI or machine learning algorithms that require a training set. The "ASIC-controlled circuit" is described as "hard-wire control instead of programmable control."

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

This question is not applicable as the device does not employ machine learning or AI and therefore does not have a "training set."

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