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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 device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1, HS-201Q3/ Aneroid sphygmomanometer with stethoscope, Model HS-50C,HS-50B, HS-50D are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model HS-50C,HS-50D,HS-50B also include a stethoscope. It is conjunction with stethoscope when use.

The provided document is a 510(k) premarket notification for an Aneroid Sphygmomanometer. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results of the device meeting specific acceptance criteria in the same way, for example, a novel AI algorithm might. Therefore, some of the requested information, particularly around clinical studies, ground truth establishment, and expert consensus, is not directly applicable or available in this document.

However, I can extract information related to the device's technical specifications and the standards it aims to meet for substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are primarily defined by the performance requirements of the ISO 81060-1 standard for non-invasive sphygmomanometers, and the "reported device performance" indicates compliance with these standards.

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

The document does not explicitly state a "sample size" for a test set in the context of a clinical study or a dataset for an algorithm. This submission references "Non-clinical testing included biocompatibility and bench testing." It does not provide details on the number of units tested or the specific methodology for these bench tests, beyond stating that they were included in the ISO 10993 and ISO 81060-1 standards.

The data provenance is from non-clinical testing conducted to demonstrate compliance with standards like ISO 10993 and ISO 81060-1. The document does not specify country of origin for this testing data, but the manufacturer is HONSUN (NANTONG) Co., Ltd in China. The testing would be considered bench testing rather than retrospective or prospective clinical data.

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

Not applicable. For this type of device (a mechanical aneroid sphygmomanometer), ground truth for performance claims is established through a calibrated reference standard (e.g., a manometer calibrated to a known pressure standard) during bench testing, as specified by standards like ISO 81060-1. There would be no "experts" establishing a ground truth in the context of subjective interpretation like with medical imaging.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in studies involving human interpretation of data, often in clinical trials or studies for AI algorithms. For a mechanical device's performance testing (like pressure accuracy), the measurement is objective against a standard, not subject to adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

No. This device is an aneroid sphygmomanometer, which is a manual non-invasive blood pressure measurement device. It does not incorporate artificial intelligence, nor does it involve "readers" in the context of image interpretation or diagnostic decision-making. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant or applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a mechanical instrument and does not contain an algorithm. "Standalone performance" in this context would refer to the device's accuracy and performance specifications as outlined in the table above, which are assessed through bench testing against established standards.

7. The Type of Ground Truth Used

For this device, the "ground truth" for pressure accuracy is a calibrated pressure standard as mandated by the ISO 81060-1 standard for non-invasive sphygmomanometers. This standard defines the methods for verifying the accuracy of the device against a known, precise pressure.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical medical instrument. It does not utilize an algorithm, machine learning, or artificial intelligence; therefore, there is no "training set" of data.

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

Not applicable, as there is no training set for this mechanical device.

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The Scian Automatic Digital Blood Pressure Monitor LD-576, LD-579 are devices 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 upper arm.

Scian Automatic Digital Blood Pressure Monitor, Model LD-575, LD-576 and LD-579

This FDA 510(k) clearance letter for the Scian Automatic Digital Blood Pressure Monitor (Models LD-575, LD-576, and LD-579) indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, the provided documents do not contain a detailed study report or specific acceptance criteria and performance data for the device itself.

The letter confirms the device's regulatory classification, product code, and indications for use, but it does not include the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

To answer your prompt, a separate study report or detailed validation document would be required, which is not present in the provided text. The FDA 510(k) process primarily assesses substantial equivalence, and while performance data is part of that assessment, the specific details you're asking for are usually in separate submissions that aren't typically summarized directly in this type of clearance letter.

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The Scian Automatic Digital Blood Pressure Monitor, Models LD-518 & LD-537, are devices 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 upper arm. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Scian Automatic Blood Pressure Monitor, Models LD-518 & LD-537. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study results, acceptance criteria, or the specific data requested in your prompt.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of human readers with AI assistance.
6. Information on a standalone algorithm-only performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory approval letter, not a clinical study report. To obtain the information you're looking for, you would typically need to refer to the 510(k) submission summary or associated clinical validation studies that would have been part of the manufacturer's submission to the FDA.

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The Scian Automatic Digital Blood Pressure Monitor, Models LD-562U, LD-588U & LD-533U, are devices 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 upper arm. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.

Not Found

The provided text is a 510(k) summary for a blood pressure monitor. It includes information about the device's intended use and FDA clearance, but it does not contain the detailed study information needed to answer your request about acceptance criteria and study proving device performance.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Information about the sample size, data provenance, number of experts, adjudication method, or ground truth used for performance studies.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• Details regarding the training set size or how its ground truth was established.

This document primarily serves as an FDA clearance letter and an "Indications for Use" statement, not a scientific study report. To get the information you asked for, you would need to consult a different document, such as the actual clinical or performance study report submitted to the FDA, which is not provided here.

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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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