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This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal or on the forehead in the neonatal, pediatric and adult population used at home.

The easytem duo Forehead/Ear Thermometer is a dual purpose hand held instrument that measures body temperature on the forehead or through the opening of the auditory canal. The forehead operation is based on measuring the temperature on the surface of the forehead while the ear operation measures the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.

The provided text describes the "easytem duo, Dual Thermometer, Forehead/Ear, Model BT-021" and its substantial equivalence to predicate devices, but it does not contain the detailed study information requested. Specifically, it lacks information on acceptance criteria, a performance study, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance. The document is primarily a 510(k) summary and FDA clearance letter, focusing on regulatory equivalence rather than a detailed performance study report.

Therefore, many of your requested fields cannot be filled from the provided text.

Here's what can be extracted related to the device and its regulatory status:

Device: easytem duo, Dual Thermometer, Forehead/Ear, Model BT-021

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating "substantial equivalence" to predicate devices, implying that the performance of the easytem duo should be comparable to the predicates, particularly in terms of accuracy for temperature measurement.
• Reported Device Performance: Not explicitly stated with specific numerical performance metrics. The document mentions: "The easytem duo Forehead/Ear Thermometer has the same general design and performance characteristics as the predicate devices from Braun, and SAAT." It also states, "This submitter concludes that the easytem duo Thermometer is therefore substantially equivalent in the 'ear mode' as to the predicate devices 'Braun Thermoscan RT3520' and to the 'ThermoTek 718F' in the 'forehead mode'." This is a statement of perceived equivalence rather than a direct report of performance data.

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

• Not provided. The document does not describe a performance study with a test set.

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/Not provided. No performance study with expert-established ground truth is described.

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

• Not applicable/Not provided. No performance study with a test set.

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:

• No. This device is a thermometer, not an AI-assisted diagnostic tool for human readers. An MRMC study is not relevant here.

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

• Not provided. While the device itself is a standalone thermometer, the document does not detail a standalone performance study with specific metrics, but rather relies on substantial equivalence.

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

• Not provided. No detailed performance study, and therefore no specific ground truth method, is described. For a thermometer, the "ground truth" would typically come from an accurate reference thermometer or controlled temperature environments, which are not mentioned.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI/machine learning device that would typically have a "training set."

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

• Not applicable/Not provided. This is not an AI/machine learning device.

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This device is an electronic clinical thermometer using a themistor probe sensor to detect oral, rectal or axillary temperatures. It is intended for home use on people of all ages.

The 9 second Digital Thermometer is designed to measure body temperature. The device is measuring oral, rectal or axillary temperatures by change of resistance in a thermistor located in the tip of the device. When the probe, particular the metal tip is in contact with the body, the thermistor in the probe will generate equivalent electrical resistance, which will be processed by a micro computer chip in the circuitry and then displayed.

This document describes a 510(k) submission for the 9 second Digital Thermometer, Model BT-S09 by Media Trade Corporation. The submission declares substantial equivalence to the predicate device, Microlife MT3001 (QTIJA).

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy +/- X degrees, sensitivity, specificity). Instead, the basis for clearance is substantial equivalence to a predicate device.

The document states:

• "The 9 second Digital Thermometer has the same general design and performance characteristics as the predicate device from Microlife."
• "The main difference is the physical size, shape and weight."
• "The 9 second Digital Thermometer has the same intended use, general design and incorporates similar materials and components, hence should therefore raise no new questions of safety and effectiveness."

Therefore, the "acceptance criteria" can be inferred as meeting the performance (accuracy/precision) of the predicate device, although no specific values are given in this document.

2. Sample size used for the test set and the data provenance:

The provided 510(k) summary does not contain details of any clinical or in-vivo testing to demonstrate performance specifically for the 9 second Digital Thermometer. The entire argument rests on technological characteristics and substantial equivalence to the predicate device. Therefore, there is no mention of a "test set" sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

As no specific clinical or performance study details are provided, there is no information on the number or qualifications of experts used to establish ground truth.

4. Adjudication method for the test set:

Since no specific study with a test set is described, no adjudication method is mentioned.

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:

This device is a digital thermometer, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed/described.

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

This is a standalone electronic thermometer. The "study" described is a comparison of the device's technical characteristics to a predicate device for the purpose of demonstrating substantial equivalence. The document states:

• "The 9 second Digital Thermometer has the same Technological Characteristics: general design and performance characteristics as the predicate device from Microlife. The main difference is the physical size, shape and weight."
• "This submitter concludes that the 9 second Digital Thermometer is therefore substantially equivalent to the predicate device 'Microlife MT3001 (QT1JA1)'."

This constitutes the "study" or evidence presented for clearance, focusing on direct comparison of design and intended use rather than specific performance data against a ground truth.

7. The type of ground truth used:

Given the nature of the device and the submission (substantial equivalence based on technological characteristics), no specific "ground truth" in the traditional sense (e.g., pathology, outcomes data, expert consensus on disease presence) is mentioned or used. The ground truth, implicitly, is the established, legally marketed performance of the predicate device.

8. The sample size for the training set:

As this is not an AI/machine learning device, the concept of a "training set" is not applicable and no information is provided.

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

Not applicable, as no training set exists for this device.

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This device is an electronic clinical thermometer using an infrared sensor to detect body temperature via the auditory canal in the neonatal, pediatric and adult population used at home.

The easytem Ear Thermometer is a hand held instrument that measures body temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.

The provided text is a 510(k) summary for the Easytem Ear Thermometer, Model BT-020. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information regarding specific acceptance criteria, a study proving the device meets these criteria, or any details about test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth for training was established.

The document focuses on:

• Administrative details: Submitter information, contact, date of summary, trade name, classification, and predicate devices.
• Device description: How it measures temperature (infrared sensor in the auditory canal).
• Intended use: Intermittent measurement and monitoring of human body temperature in the home for people of all ages.
• Technological characteristics: States that it has the same general design and performance characteristics as predicate devices, with the main difference being physical size, shape, and weight. It claims "no new questions of safety and effectiveness."
• Purpose of submission: New device for the USA, similar to approved predicate devices.
• FDA correspondence: The letter from the FDA confirming the substantial equivalence and allowing the device to be marketed.

Without specific performance data, I cannot complete the requested table or answer most of the questions.

Here's what can be inferred or explicitly stated based only on the provided text, with the understanding that key information is missing:

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

No acceptance criteria or reported device performance data are provided in the document. The 510(k) summary asserts "the same general design and performance characteristics as the predicate devices" but does not quantify these characteristics or provide test results.

2. Sample sized used for the test set and the data provenance

No information provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

No information provided.

4. Adjudication method for the test set

No information provided.

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 device is an ear thermometer, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This device is a direct measurement tool, not an algorithm. Its performance is inherent in its design and operation.

7. The type of ground truth used

No information provided, as no study details are given. For a thermometer, "ground truth" performance typically involves comparison against a highly accurate reference thermometer in a controlled setting, but no such details are mentioned.

8. The sample size for the training set

Not applicable. This device is a hardware measurement device, not an AI model that requires a training set.

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

Not applicable. As above, this device does not involve a training set.

Conclusion: The provided 510(k) summary for the Easytem Ear Thermometer focuses on establishing substantial equivalence to predicate devices based on design and intended use, rather than detailing a specific performance study with acceptance criteria and results. Therefore, most of the requested information regarding study details, sample sizes, and ground truth establishment is not available in the given document.

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