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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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