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The devices models ET-100A、ET-100D、ET-100E、ET-100G、ET-1001、ET-100J, are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home . they are intended for use on people of all ages.

Infra-red ear thermometer model: ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J

The provided text describes an FDA 510(k) clearance for an infra-red ear thermometer. It does not contain specific details about acceptance criteria, a comprehensive study report, or the methodology used to establish the device's performance against detailed acceptance criteria.

The document is a clearance letter, indicating that the device is substantially equivalent to legally marketed predicate devices. This implies that the manufacturer would have submitted data demonstrating this equivalence, but the details of that data and the specific acceptance criteria for performance are not explicitly in this letter.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
• Sample sized used for the test set and the data provenance: This information is not present in the provided document.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the provided document.
• Adjudication method for the test set: This information is not present in the provided document.
• 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 is an infra-red ear thermometer, not an AI diagnostic device. Therefore, this type of study is irrelevant and not mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is an infra-red ear thermometer, so "algorithm only" performance in the context of human interpretation is not applicable. Its performance is its direct measurement.
• The type of ground truth used: While the device measures body temperature, the specific "ground truth" methodology (e.g., comparison to rectal temperature, oral temperature, or a traceable reference thermometer) for the equivalence study is not detailed in this document.
• The sample size for the training set: This information is not present in the provided document.
• How the ground truth for the training set was established: This information is not present in the provided document.

The document primarily focuses on the regulatory aspects of the device's clearance and its intended use as an infra-red ear thermometer for intermittent measurement of human body temperature.

To get the detailed information you are looking for (acceptance criteria, study design, sample sizes, ground truth establishment, etc.), you would typically need to review the full 510(k) submission, which is not provided here, or a detailed clinical study report published by the manufacturer.

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The devices models DT-K11E, DT-11H, are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.

electronic clinical thermometer

This is a 510(k) premarket notification for a digital thermometer, not an AI/ML powered device. As such, the document does not contain the information requested in the prompt regarding acceptance criteria and studies for AI/ML validation. The medical device in question is a simple electronic thermometer.

Therefore, I cannot provide the requested information from the provided text.

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The devices models FT-100A FT-100D FT-100E are electronic clinical thermometer intended to measure human body temperature in people of all ages, its operation is based on measuring the natural thermal radiation emanating from the forehead.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for an infra-red forehead thermometer. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the text does not contain any information about:

• Acceptance criteria and reported device performance.
• The study that proves the device meets the acceptance criteria.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

This document is a regulatory approval letter based on equivalence, not a detailed study report. Therefore, I cannot generate the requested information based on the provided text.

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The devices models DT-K11B, DT-K111B, DT-K111D, DT-111D, DT-111G, DT-11G, DT-Y111D are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.

Rapid digital thermometer DT-K11B, Rapid digital flexible thermometer DT-K111B DT-K111D, Digital flexible thermometer DT-111G DT-111D, Digital Thermometer (Water-proof) DT-11G, Predictive Digital Thermometer DT-Y111D

The provided text outlines the FDA's 510(k) clearance for several digital thermometers. While it confirms the clearance and lists the indications for use, it does not include detailed information about the acceptance criteria and the study that proves the device meets those criteria.

Therefore, I cannot provide the requested information from the given text. The document is an FDA clearance letter, not a detailed technical report of the device's validation study.

To answer your request, I would need a different type of document, such as:

• A summary of safety and effectiveness data (SSE) submitted to the FDA.
• A clinical study report.
• A test report detailing performance validation.

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The devices models DT Series (barring model DT-201A and DT-211A) are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.

The device model DT-201A and DT-211A are electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.

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This document is a 510(k) premarket notification from the FDA, determining substantial equivalence for a range of digital thermometers. It does not contain specific information about acceptance criteria for device performance or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance data.

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The model MB-300 Series Upperarm Digital Blood Pressure Monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in addrio, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.

Upperarm Digital Blood Pressure Monitor (Upperarm Digital Sphygmomanometer), Model MB-300 Series

The provided text is a letter from the FDA regarding a 510(k) premarket notification for an Upperarm Digital Blood Pressure Monitor. It does not contain the acceptance criteria, reported device performance, or details of a study (like sample size, ground truth, expert information, or specific study types like MRMC or standalone) to prove the device meets said criteria.

Therefore, I cannot fulfill your request for this information from the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the FDA's regulatory decision, but doesn't detail the performance study data itself.

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The model MW-300 series wrist pressure monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.

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The provided text is a 510(k) premarket notification letter from the FDA for a Wrist Digital Blood Pressure Monitor (Digital Sphygmomanometer), Model MW-300 Series. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding the acceptance criteria, the study that proves the device meets the acceptance criteria, or any of the specific details requested in your prompt (e.g., sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

Therefore, I cannot provide the requested table or answer the specific questions based on the input text. The document is a regulatory approval letter, not a detailed study report.

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The devices models DT-02 and DT-101 are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.

The device model NT-01 is an electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.

Digital Flexible Thermometer Model DT-101
Basal Digital Thermometer Model DT-02
Digital Pacifier Thermometer Model NT-01

The provided text is a 510(k) premarket notification approval letter for several digital thermometers. It does not contain information regarding the acceptance criteria, performance study details (like sample size, provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, ground truth establishment, or training set specifics.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976."

This means the devices were approved based on demonstrating substantial equivalence to existing predicate devices, rather than a new clinical study with specific acceptance criteria and performance metrics described in the kind of detail typically found in a clinical trial report.

Therefore, I cannot populate the requested tables and information based on the provided text. The document is an approval letter, not a study report.

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The model ET-100 series Infrared Ear Thermometer are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home. They are intended for use on people of all ages.

Infrared Ear Thermometer Model ET-100 Series

This document is a 510(k) clearance letter from the FDA for an Infrared Ear Thermometer, Model ET-100 Series. It does not contain the detailed study results, acceptance criteria, or other specific information about device performance and validation that you have requested.

Therefore, I cannot provide the requested information based solely on the provided text. The document confirms that the device has been found substantially equivalent to a predicate device, allowing it to be marketed, but does not detail the technical performance data from studies.

To answer your questions, I would need access to the actual 510(k) submission packet, which would contain the performance testing reports.

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The devices models DT-01Fand DT-11F are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.

Digital Thermometer Model DT-01F & DT-11F

This document is a 510(k) premarket notification letter from the FDA regarding a digital thermometer. It confirms the device's substantial equivalence to legally marketed predicate devices. However, it does not contain the detailed information necessary to complete the acceptance criteria table or descriptions of a study proving the device meets those criteria. The provided text is primarily administrative and regulatory.

Therefore, I cannot fulfill your request for the acceptance criteria table and study details based on the given input. The document does not describe performance specifications, test methods, sample sizes, expert qualifications, or ground truth establishment.

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