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It is an electronic thermometer used for clinical temperature measurement. It is intended for use at home and hospital environment for both children and adult.

The Rapid Digital Thermometer is an electronic thermometer by using a thermistor as the temperature sensor. The thermometer uses a 1.5V button battery for operation.

The provided text describes the 510(k) summary for the Rapid Digital Thermometer, Model RDT-18-XY. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific performance metric against acceptance criteria in the way a clinical trial for an AI diagnostic device would.

Therefore, many of the requested categories for AI device studies (e.g., sample size for test set/training set, number of experts, adjudication methods, MRMC studies, standalone performance with AI assistance, type of ground truth) are not applicable to this submission as it's for a simple electronic thermometer.

However, I can extract the acceptance criteria and performance information that is relevant.

Acceptance Criteria and Device Performance

Study Information (Relevant to this device type)

1. Sample size used for the test set and the data provenance: Not explicitly stated as a clinical study with a specific test set. Performance testing was conducted according to ASTM E1112 standards, which typically involve a specified number of measurements or devices for testing, but the exact sample size for these non-clinical tests is not detailed in the provided summary. The data provenance would be from internal lab testing based on the standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a digital thermometer, "ground truth" would be established by reference temperature standards and measurement protocols, not expert consensus.
3. Adjudication method for the test set: Not applicable. Performance testing for a thermometer involves direct measurement against known standards.
4. 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 not an AI diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a standalone electronic device, not an AI algorithm. Its performance is inherent to its design and calibration.
6. The type of ground truth used: For accuracy and other performance metrics, the ground truth would be established by reference temperature standards and calibrated measurement equipment as per ASTM E1112.
7. The sample size for the training set: Not applicable. This device does not use machine learning or require a training set.
8. How the ground truth for the training set was established: Not applicable.

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It is an electronic thermometer used for clinical temperature measurement. It is intended for use at home and hospital environment for both children and adult.

The Rapid Digital Thermometer is an electronic thermometer by using a thermistor as the temperature sensor. The thermometer uses a 1.5V button battery for operation.

It's important to clarify that the provided document does not describe a study that proves the device meets acceptance criteria in the way a clinical trial or a performance study for an AI-powered diagnostic device would.

This document is a 510(k) Summary for a Rapid Digital Thermometer, which is a Class II medical device. For such devices, regulatory clearance often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical studies proving novel diagnostic performance.

Therefore, many of the typical questions regarding AI device studies (like expert consensus, MRMC studies, training set details) are not applicable to this type of device and submission.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance for Rapid Digital Thermometer (Model RDT-18-XY)

The "acceptance criteria" for this device are largely defined by compliance with established performance standards for clinical electronic thermometers and by demonstrating substantial equivalence to a predicate device. The "study" referenced is primarily a series of non-clinical tests performed according to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. For performance tests like temperature range, accuracy, and resolution conducted according to ASTM E1112, there would be specific sample sizes (e.g., number of readings, number of devices tested). However, this detail is not included in the summary.
• Data Provenance: The tests were "conducted according to ASTM E1112 standards," "IEC 60601-1, IEC 60601-1-2 requirements," and "ISO 10993-1:2003 biocompatibility testing." The location where these tests were performed is not explicitly stated but is likely within a lab setting. The data is non-clinical/bench testing, not data collected from patients. It's retrospective in the sense that these are lab tests designed to demonstrate performance characteristics.

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

• Not Applicable. For a basic electronic thermometer, "ground truth" is typically established by reference standards or calibrated equipment (e.g., a highly accurate reference thermometer in a temperature-controlled bath) for the performance tests, not by human experts interpreting clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "adjudication" in the sense of resolving discrepancies between human readers or between an algorithm and human readers, as this is a non-AI, non-diagnostic device. The tests involve comparing device readings against a known reference or standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI-powered diagnostic device, and no MRMC study was conducted.

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

• Not Applicable. This is an electronic thermometer, not an algorithm. Its performance is inherent in its design and manufacturing. The "standalone" performance refers to the device's ability to measure temperature accurately on its own.

7. The Type of Ground Truth Used

• Reference Standards/Calibrated Equipment: For performance tests like accuracy, the ground truth would be established by highly accurate, calibrated reference instruments (e.g., a standard thermometer or a temperature bath maintained at precise temperatures) as prescribed by standards like ASTM E1112. For electrical safety and biocompatibility, the "ground truth" is compliance with documented international standards.

8. The Sample Size for the Training Set

• Not Applicable. As this is not an AI/machine learning device, there is no "training set."

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

• Not Applicable. As there is no training set, this question is irrelevant.

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