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The infrared forehead thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except the age under the 1 year.

The HONSUN infrared forehead thermometer is designed for measuring the body's temperature, is a handheld non-contact infrared thermometer, battery powered, detecting the infrared energy emitted in the forehead area within 0-3 cm (exclude 0 cm) that converts to a body temperature. The measurement site is center of the forehead, while reference body site is the oral. It is intended to measure the temperature of human body in home and hospital. lt consists of thermopile sensor, printed circuit board, enclosure, button and liquid crystal display. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then displayed on the LCD screen in digital form. It will be automatically power off if left idle for 20 seconds.

The document describes the acceptance criteria and study proving the device meets them for the HONSUN infrared forehead thermometer LD-FT-100B.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Infrared Forehead Thermometer LD-FT-100B are primarily based on the international standard ISO 80601-2-56 for clinical thermometers and ASTM E 1965. The device's performance is demonstrated through testing against these standards.

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

• Sample Size:
  • Clinical Accuracy Test Set: 105 subjects in total.
    • 40 people were older than 1 year and younger than 5 years (17 with fever).
    • 65 people were older than 5 years (28 with fever).
• Data Provenance: The details of the country of origin are not explicitly stated for the clinical accuracy test. However, given that HONSUN (Nantong) Co., Ltd is located in China, it is reasonable to infer the study was conducted there. The clinical accuracy test was conducted in September 2020, implying a prospective study design for this specific test.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical accuracy test. It states that the YUWELL infrared thermometer YT-1 (the predicate device) was used as the reference device to establish the "ground truth" for temperature measurements in the clinical accuracy study. It implies comparison with a calibrated, legally marketed device rather than human experts interpreting results.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the traditional sense (e.g., 2+1, 3+1). For the clinical accuracy test, the comparison was made against a reference thermometer (YUWELL infrared thermometer YT-1) by taking three measurements at the same site (forehead) alternately with the reference thermometer and the subject device. The ground truth was essentially the measurement reported by the reference device, as per the standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a thermometer, not an AI diagnostic tool that requires human interpretation. Therefore, a study comparing human readers with and without AI assistance is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary performance evaluation for the thermometer is its standalone accuracy and compliance with relevant standards (ISO 80601-2-56, ASTM E 1965) without human interpretation being part of the measurement process itself. The clinical accuracy test directly measured the device's performance against a reference.

7. The Type of Ground Truth Used

The ground truth used for the clinical accuracy study was established by comparison against a reference thermometer (YUWELL infrared thermometer YT-1), in accordance with the requirements of ISO 80601-2-56. This is a form of device-based ground truth, where a well-characterized and established medical device serves as the standard for comparison.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" as this device is a physical medical device, not a machine learning model that undergoes a training phase with data. The tests described are for validation and verification of the device's hardware and software performance.

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

As there is no mention of a training set for a machine learning model, this question is not applicable to the information provided. The device's design and operating principle are based on known physics of infrared detection and conversion, rather than learned patterns from a training dataset.

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The Fully Automatic Blood Pressure Monitor LD-535 & LD-539 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.

Fully Automatic Blood Pressure Monitor Model: LD-535 & LD-539

The provided text is an FDA 510(k) clearance letter for an automatic digital blood pressure monitor. It does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications. This document primarily confirms that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested table and information based on the given input.

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The Wrist Automatic Blood Pressure Monitor LD-737 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

Wrist Automatic Blood Pressure Monitor Model: LD-737

The provided text is a 510(k) summary for a Wrist Automatic Blood Pressure Monitor and primarily focuses on regulatory approval. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for any test set.
• Information about multi-reader multi-case studies or standalone algorithm performance.
• Details on the type of ground truth used or how it was established.
• Sample size for a training set.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is expected to be similar to existing approved devices. However, it does not provide the actual performance data or the specific studies conducted to establish this equivalence, beyond simply stating it was reviewed.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the 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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document is purely a regulatory approval letter.

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The Aneroid Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users over age 18 at hospitals or at home. The device is for use in OTC.

The Aneroid Sphygmomanometer with Stethoscope is a non-invasive blood pressure monitor that uses an occluding cuff, an aneroid Sphygmomanometer to measure pressure and a stethoscope for detecting Korotkoff sounds. The Aneroid Sphygmomanometer with Stethoscope contains: 1. Adjustable D-ring Cuff (Adult Size) 2. Stethoscope (Attaches to the cuff) 3. Non-stop rotary pin, 300 mmHg gauge 4. Instruction booklet and record 5. Carrying case.

The provided text describes a 510(k) summary for an Aneroid Sphygmomanometer with Stethoscope, Model LD-100. This document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized standards for non-automated sphygmomanometers.

Based on the provided text, the following information can be extracted:

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

   Acceptance Criteria	Reported Device Performance
   Conformance to AAMI/ANSI SP10:2002/A2:2006 Standard for Non-automated Sphygmomanometers	AAMI/ANSI SP10:2002/A2:2006 "Standard for Manual, Automated, and Semi-automated Sphygmomanometers" was used. The conclusion states "conformance to AAMI/ANSI SP10:2002/A2:2006".
   Non-clinical mechanical testing	Non-clinical mechanical testing was performed.

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

   • The document does not specify sample sizes for any test sets.
   • The document does not specify data provenance (e.g., country of origin, retrospective or prospective) for clinical data. The studies mentioned are referred to simply as "studies" and "non-clinical mechanical testing." It's possible the AAMI/ANSI standard itself outlines testing methodologies that were followed, but the specific details of participants/data provenance are not in this summary.

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

   • This information is not provided in the document. The studies mentioned are non-clinical and based on a standard for manual/automated sphygmomanometers, which typically involves technical performance metrics rather than expert interpretation of results.

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

   • This information is not provided in the document. Given the nature of a non-automated sphygmomanometer and the focus on technical standards, an adjudication method for a test set is unlikely to be relevant in the same way it would be for an AI diagnostic device.

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, an MRMC comparative effectiveness study was not conducted. This device is a mechanical blood pressure monitor, not an AI diagnostic device that assists human readers.

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

   • This device is a "non-automated, mechanical blood pressure monitor." It is not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done. The device's performance is inherently "standalone" in the sense that its measurements are direct, although it requires a human operator for proper use and interpretation of Korotkoff sounds via the stethoscope.

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

   • The document implies the ground truth for performance is established by the AAMI/ANSI SP10:2002/A2:2006 standard. This standard outlines performance requirements and test methods for accuracy and other characteristics of sphygmomanometers. The ground truth would therefore be derived from reference devices or established measurement protocols defined in the standard.

8. The sample size for the training set:

   • The device is a mechanical blood pressure monitor, not an AI/machine learning algorithm. Therefore, there is no training set in the context of machine learning.

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

   • As there is no training set (the device is mechanical), this question is not applicable.

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