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The Electronic Thermometers are intended to measure the human body temperature under arm, and the devices are nonsterile, reusable for clinical or home use on people of all ages.

Electronic Thermometer, Model: AET-F331, AET-F332, AET-F334, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383

I'm sorry, but this document does not contain the information required to answer your request. The provided text is an FDA 510(k) clearance letter for an electronic thermometer. It details regulatory information, product codes, indications for use, and compliance requirements. However, it does not include any details about:

• Acceptance criteria and reported device performance related to a study. The document lists the device models and their intended use (measuring human body temperature under the arm), but no specific performance metrics or thresholds are mentioned.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance data.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of information, particularly regarding studies, performance data, and ground truth establishment, is typically found in the 510(k) submission itself (which often includes a "Truth in Labeling" section or performance testing reports), but it is not presented in the FDA's clearance letter.

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The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.

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I cannot fulfill this request. The provided text is an FDA 510(k) clearance letter for an Arm Blood Pressure Monitor. It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory requirements. However, this document does not contain any information about acceptance criteria, device performance details, or a study proving that the device meets acceptance criteria.

Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, data provenance, or details about ground truth establishment.
• Information on expert involvement, adjudication methods, or MRMC studies.
• Any data related to standalone algorithm performance.

Therefore, I cannot extract the requested information from the provided input.

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The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.

Arm Blood Pressure Monitor, Model: AES-U112, AES-U122, AES-U132, AES-U312, AES-U322, and AES-U332.

Based on the provided FDA 510(k) clearance letter for the Alicn Medical Shenzhen, Inc. Arm Blood Pressure Monitor, I cannot extract the specific details requested regarding acceptance criteria and study data because this document does not contain that information.

The FDA 510(k) clearance letter is a regulatory document that confirms substantial equivalence to a predicate device. It indicates that the device has met the FDA's requirements for marketing, but it typically does not include the granular details of the performance study results, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications. These details are usually found in the manufacturer's 510(k) submission, which is not publicly available in this letter.

Therefore, many of your questions, particularly those related to the study design and results (points 1-9), cannot be answered from the provided text.

Here's what I can tell you based on the document:

• Device: Arm Blood Pressure Monitor, Model: AES-U112, AES-U122, AES-U132, AES-U312, AES-U322, and AES-U332.
• Intended Use: To measure systolic blood pressure and pulse rate via non-invasive oscillometric technique using an inflatable cuff on the upper arm. Can be used at medical facilities or at home. Suitable for adults and adolescents over 12, with an upper arm circumference of 22-42cm.
• Regulatory Class: Class II
• Product Code: DXN (Noninvasive Blood Pressure Measurement System)

Regarding your specific questions, and why I cannot answer them from this document:

1. A table of acceptance criteria and the reported device performance: This information is not in the FDA clearance letter. It would be in the manufacturer's internal test reports and the 510(k) submission.
2. Sample sized used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
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 is a blood pressure monitor, not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an AI algorithm; this is a direct measurement device. Its performance is its "standalone" performance. The specific study details are not here.
7. The type of ground truth used: Not specified in this document, but for blood pressure monitors, ground truth is typically established against a reference method, such as invasive arterial pressure measurement or a highly accurate auscultatory method performed by trained observers.
8. The sample size for the training set: Not applicable and not mentioned. This device likely relies on a fixed algorithm based on oscillometric principles, not machine learning (training sets).
9. How the ground truth for the training set was established: Not applicable for this type of device.

To obtain the detailed study information, one would typically need to refer to the full 510(k) submission (which is proprietary and not released publicly with the clearance letter) or a published clinical validation study by the manufacturer, if available.

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The Infrared Thermometer (model of AET-R612W.AET-R612G.AET-R612A.AET-R612B.AET-R612C) is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from ear canal or non-contact (about 1.5-5.0cm distances) with the forehead in the home or hospital environment.

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The provided document is an FDA 510(k) clearance letter for an infrared thermometer. It outlines the regulatory approval for marketing the device. However, it does not contain the detailed technical study information typically found in a clinical study report or a 510(k) summary submission that would include acceptance criteria and a description of the study proving the device meets those criteria.

Therefore,Based on the provided text, I cannot provide the information requested regarding:

1. A table of acceptance criteria and the reported device performance: This document only states the device is "substantially equivalent" to predicate devices, but does not present specific performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and generally not applicable for a thermometer.
6. If a standalone performance was done: Not explicitly detailed, but implied by the device's function. No specific performance data is provided.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not applicable as this is a physical device, not an AI/ML algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

The document is a regulatory communication, not a technical report detailing the performance validation study. For such information, one would typically look for a 510(k) Summary, which is often available through the FDA's public database after a device is cleared, or a detailed technical file submitted to the FDA by the manufacturer.

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The Electronic Thermometers (AET-F101, AET-F221, AET-F241) are intended to measure human body temperature orally or under the arm. The devices are reusable for clinical or home use on people of all ages.

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

I am sorry, but the provided text is an FDA 510(k) clearance letter for an Electronic Thermometer. It does not contain information about the acceptance criteria, device performance, or any studies using AI or human readers. The document is a regulatory approval and does not detail the technical performance evaluation in the way requested in your prompt.

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The Electronic Thermometers(AET-E201, AET-E21, AET-E231, AET-E241, AET-E241, AET-E251, AET-E301, AET-E311) are intended to measure the human body temperature orally, or axillary, and the devices are non-sterile, reusable for clinical or home use on people of all ages.

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This is an FDA clearance letter for a medical device (Electronic Thermometer), not a study report. Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and safety and effectiveness. The FDA clearance process for a 510(k) often involves demonstrating compliance with recognized standards or conducting comparison testing against a predicate device, but the details of such testing (like specific acceptance criteria, sample sizes, ground truth, etc.) are typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested table and information based on the provided text.

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The Infrared Thermometer (model of AET-R811,AET-R832,AET-R842,AET-R852,AET-R862) is intended for measuring human body temperature of people aged 3 months and above by detecting infract contact with the forehead and ear canal in the home or hospital environment.

The Infrared Thermometer (model of AET-R101, AET-R151, AET-R1A3, AET-R1A6, AET-R1C1) is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from the ear canal in the home or hospital environment.

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The provided text is a 510(k) premarket notification clearance letter for an Infrared Thermometer. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the requested format.

The document states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices. However, this letter itself does not include the detailed test results, performance data, or study designs that would typically be found in the actual 510(k) submission or an associated test report.

Therefore, I cannot provide the requested information based on the given text. To answer your questions, I would need access to the full 510(k) submission, including the performance testing and clinical data sections.

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