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The MYTECH / HAPPY LIFE / MAXIAIDS Arm Blood Pressure Monitor,, Model HPL-301, HPL-302, HPL-310, 180310 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.

The cuff circumference is limited to be 7"-15".

Basically, the subject device and the predicated device are the same in intended use, technological characteristics, power supply, LCD display, range, accuracy, and operating environments, dimensions, weight, and storage environments. The minor differences are the memory and display layout. That means the predicate device has 60 memory capacities and the new devices have 60 memory capacities. Besides, the new devices add 3 colors LED warming lights for the visional appearance.

The main differences of the new devices are:

• HPL-301 is the representative model of the new devices;
• HPL-302 is same as the HPL-301, add USB port for PC-LINK function; ●
• HPL-310 is same as the HPL-301, add voice prompt function for arm; ●
• 180310 is all the same as HPL-310, just using another model name. ●

Acceptance Criteria and Device Performance for MYTECH / HAPPY LIFE / MAXIAIDS Arm Blood Pressure Monitor

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the MYTECH / HAPPY LIFE / MAXIAIDS Arm Blood Pressure Monitor (models HPL-301, HPL-302, HPL-310, 180310) references adherence to specific standards for its performance. The primary standard mentioned for clinical performance is AAMI/ANSI SP10.

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the clinical performance test (AAMI/ANSI SP10). It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number and Qualifications of Experts for Ground Truth

The provided document does not detail the number or qualifications of experts used to establish ground truth for the clinical performance testing. AAMI/ANSI SP10 typically requires trained observers for reference blood pressure measurements.

4. Adjudication Method

The document does not describe the adjudication method used for the clinical performance test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers.

6. Standalone Performance

Yes, a standalone performance assessment was done. The device's clinical accuracy was evaluated against the AAMI/ANSI SP10 standard, which assesses the accuracy of the automated blood pressure monitor in measuring blood pressure and pulse rate without human-in-the-loop assistance.

7. Type of Ground Truth Used

For the AAMI/ANSI SP10 standard, the ground truth for blood pressure measurements is typically established through simultaneous or closely timed measurements taken by trained observers using a auscultatory method (e.g., stethoscope and manometer) or other reference methods as defined by the standard. The document itself does not explicitly state the ground truth method but refers to the standard, which dictates it.

8. Sample Size for the Training Set

This device does not appear to utilize machine learning or AI that would require a separate "training set" in the conventional sense of AI models. It relies on established oscillometric algorithms for blood pressure measurement. Therefore, no information on a training set sample size is provided.

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

As noted in point 8, there is no mention of a "training set" in the context of AI/ML for this device. The underlying algorithms are based on established physiological principles and engineering, not typically on a "training set" with established ground truth in the way a deep learning model would be trained. The fundamental accuracy is verified through clinical validation against the AAMI/ANSI SP10 standard, which serves as the "testing" of its inherent design and algorithm.

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The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" – 7.75".

Basically, the subject device and the predicated device are the same in intended use, technological characteristics, power supply, LCD display, range, accuracy, and operating environments, memory, dimensions, weight, and storage environments. The only difference is the display layout.

The provided text describes a 510(k) summary for the MYTECH WRIST BLOOD PRESSURE MONITOR, HPL-200. This document primarily focuses on demonstrating substantial equivalence to a predicate device (MYTECH WRIST BLOOD PRESSURE MONITOR, HPL-100) and does not contain a detailed study proving the device meets specific acceptance criteria related to its performance beyond general safety and EMC.

The key points of the submission are:

• Substantial Equivalence: The manufacturer asserts that the HPL-200 is substantially equivalent to the HPL-100.
• Minimal Differences: The only stated difference between the two devices is the "display layout."
• Testing for Equivalence: Electric safety and EMC testing was performed for the HPL-200 to ensure safety and effectiveness aspects were not compromised by the display change. The testing standards cited are EN 60601-1 and EN 60601-1-2.
• Performance & Clinical Test: A "Performance & Clinical Test" to AAMI/ANSI SP10 is mentioned, but no detailed results or acceptance criteria for this test are provided in the summary.
• Indications for Use: The device is intended to measure systolic and diastolic blood pressures and pulse rate of adults over 18 years old at home, using a non-invasive technique with a wrist cuff (5.25" – 7.75" circumference).

Given this information, it is not possible to fully answer the request as no specific acceptance criteria for blood pressure measurement accuracy are explicitly stated, nor are detailed study results provided to demonstrate meeting such criteria. The document focuses on demonstrating equivalence based on minimal changes and general safety/EMC standards, rather than a clinical performance study with predefined acceptance metrics.

However, based on the limited information, here's an attempt to structure the answer, highlighting what is available and what is missing:

Acceptance Criteria and Device Performance (Based on Available Information)

The provided document does not explicitly state quantitative acceptance criteria for blood pressure measurement accuracy (e.g., mean difference and standard deviation compared to a reference method) nor does it provide a detailed study report with results demonstrating compliance against such criteria. The submission relies on establishing substantial equivalence to a predicate device (MYTECH WRIST BLOOD PRESSURE MONITOR, HPL-100) based on minimal design changes and general safety/EMC testing.

The only "acceptance criteria" implied or directly mentioned are related to:

1. Electrical Safety: Compliance with EN 60601-1:1990+A1+A2+A11+A12+A13.
2. Electromagnetic Compatibility (EMC): Conformity with EN 60601-1-2: 1993.
3. Performance & Clinical Test: Compliance with AAMI / ANSI SP10. However, the specific criteria within AAMI/ANSI SP10 that were met, and the actual performance results, are not detailed in this summary.

Table of Acceptance Criteria and Reported Device Performance

Since the provided document is a 510(k) summary demonstrating substantial equivalence for a non-AI medical device (blood pressure monitor), many of the requested points related to AI/algorithm studies, expert ground truth, and training data are not applicable or detailed.

Here's an analysis of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance:

   • See table above. Specific performance metrics for blood pressure accuracy (mean difference, standard deviation) against AAMI/ANSI SP10 are not reported in this summary, only that "Performance & Clinical Test" was done.

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

   • This information is not provided in the summary. The summary mentions a "Performance & Clinical Test" to AAMI/ANSI SP10, which would involve a clinical study with human subjects, but details on sample size, study design (prospective/retrospective), or data provenance are absent.

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):

   • This information is not applicable as the device is a blood pressure monitor, not an imaging or diagnostic AI device requiring expert interpretation for ground truth. AAMI/ANSI SP10 studies typically use a highly accurate reference blood pressure measurement device (e.g., mercury sphygmomanometer) carefully operated by trained technicians for ground truth comparison. No details on this are provided.

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

   • This information is not applicable (see point 3).

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 done. This type of study is relevant for AI-assisted diagnostic tools and is not applicable to an automated blood pressure monitor.

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

   • The device is a standalone blood pressure monitor (an algorithm automatically measures BP). The "Performance & Clinical Test" to AAMI/ANSI SP10 can be considered a standalone performance evaluation against a reference standard. However, no specific results of this performance are detailed in the summary.

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

   • As inferred from AAMI/ANSI SP10, the ground truth would be from a validated reference blood pressure measurement method (e.g., auscultatory method with a mercury sphygmomanometer) performed by trained observers. The summary does not explicitly state this, but it is the standard for such tests.

8. The sample size for the training set:

   • This information is not applicable. The HPL-200 is not an AI/machine learning device that requires a "training set" in the conventional sense. Its measurement algorithm is based on established oscillometric principles.

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

   • This information is not applicable (see point 8).

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The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to be 7"-15".

noninvasive blood pressure measurement system

This is a 510(k) premarket notification for a blood pressure monitor, not a study report for a medical device that uses AI or image analysis. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance in the context of AI or expert evaluation is not present in the provided text.

The document describes the FDA's clearance of the Mytech Happy Life Blood Pressure Monitor (Models HPL-300 and HPL-300A) as substantially equivalent to a legally marketed predicate device. The core of this clearance is based on the device meeting the requirements for a noninvasive blood pressure measurement system as defined in 21 CFR 870.1130.

Here's what can be extracted and inferred, with explanations for what is not present:

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

Explanation: The document does not provide specific numerical acceptance criteria (e.g., accuracy +/- X mmHg) or a detailed summary of device performance (e.g., mean difference, standard deviation compared to a reference method). These would typically be found in a detailed test report submitted as part of the 510(k) application, but are not included in the FDA's clearance letter itself. The "reported device performance" in this context is the FDA's determination of substantial equivalence based on the provided data in the 510(k) submission.

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

• Sample size: Not specified in the provided text.
• Data provenance: Not specified in the provided text. It is common for these devices to undergo clinical validation studies (e.g., according to ISO 81060-2 or similar standards), which would involve prospective data collection from human subjects. However, the document does not detail this.

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

• Not applicable / Not specified. This type of information is relevant for devices involving subjective interpretation, such as image analysis. For a blood pressure monitor, ground truth is typically established by using a highly accurate reference method (e.g., invasive arterial blood pressure measurement or auscultation by trained observers using a mercury sphygmomanometer) performed by trained technicians or medical professionals, not necessarily "experts" in the context of interpretation. The document does not detail the specific methodology for ground truth establishment.

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

• Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used when there's subjective interpretation by multiple readers (e.g., radiologists) and a disagreement resolution process is needed. For a blood pressure monitor, the measurements are objective, and while there might be multiple measurements or different observers for the reference method, "adjudication" in this sense is not typically used.

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 is not relevant for a blood pressure monitor. MRMC studies are specific to diagnostic devices where human readers interpret medical images or data, and AI assistance might augment their performance. This device is a standalone measurement system.

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

• Yes, effectively. A blood pressure monitor operates as a standalone device. While a human initiates the measurement and reads the display, the core function (blood pressure measurement) is performed algorithmically by the device itself without human interpretation influencing the measurement outcome. The performance assessment would focus on the accuracy of the device's measurements against a reference.

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

• Most likely a reference blood pressure measurement method. For blood pressure monitors, the ground truth is typically established using a highly accurate, often invasive or a validated auscultatory method (e.g., mercury sphygmomanometer with trained observers), against which the device's readings are compared. The document does not specify which method was used.

8. The sample size for the training set

• Not applicable / Not specified. The provided document does not mention a training set, as modern AI/machine learning models are not typically involved in the fundamental operation of this type of traditional blood pressure monitor. If the device uses adaptive algorithms, those might be "trained" or calibrated, but the document does not provide details.

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

• Not applicable / Not specified. As there's no mention of a traditional "training set" in the context of AI/ML, this information is not available.

In summary, the provided FDA clearance letter focuses on regulatory compliance and substantial equivalence for a non-AI medical device. It does not contain the detailed study design, performance results, or expert evaluation specifics that would be present in a study report for an AI-powered diagnostic device.

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The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" - 7.75".

Not Found

This document is a 510(k) clearance letter from the FDA for the Mytech/Happy Life Blood Pressure Monitor. It does not contain the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed, but it does not detail the technical performance criteria or the studies conducted to establish that equivalence.

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