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Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure of adult person and adolescents age 18 through 21 years of age. It can be used at home. It is contraindicated in pregnant women, including those with preeclampsia.

The Electronic Sphygmomanometers, including ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24, is suitable for measurement of systolic blood pressure and diastolic blood pressure of adult person and adolescents 18 to 21 years old with arm circumference ranging from 22 cm to 42 cm by the oscillometric technique. The error is controlled within the range specified in IEC 80601-2-30 Non-invasive automated monitor. User can select the blood pressure unit mmHg or kPa. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated.

The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD screen and cuff. And all models are powered by 4 AAA dry batteries (DC 6V).

The device has a memory function that automatically stores 2*99 sets data of the latest measurements. It can also display the latest measurement result. Additionally, the device also can read the data through voice broadcast function.

The seven models have the same intended use, working principle, measuring range, accuracy, cuff, and conformance standard; only appearance have some difference.

The provided FDA 510(k) clearance letter and synopsis for the Electronic Sphygmomanometers (K250185) primarily focus on demonstrating substantial equivalence to a predicate device, rather than detailing a specific clinical study with granular acceptance criteria for an AI-powered diagnostic device. The application is for a standard medical device (blood pressure monitor), not an AI/ML-driven diagnostic tool. Therefore, many of the requested points for an AI study (e.g., number of experts for ground truth, adjudication methods, MRMC studies, effect size of AI assistance, training set details) are not applicable or provided in this document.

However, I can extract and infer information relevant to the device's accuracy and performance validation using the provided text, particularly concerning the mentioned standards and the comparative clinical study.

Here's an attempt to describe the acceptance criteria and study as best as possible given the provided non-AI-specific document:

Device: Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)

Study Type: Comparative Clinical Study (for substantial equivalence to a predicate device and mercury sphygmomanometer) and Non-Clinical Performance Testing.

Regulation/Standard for Accuracy: IEC 80601-2-30, ISO 81060-2 (including Amendment 1(2020)), and FDA Guidance No-Invasive Blood Pressure (NIBP) Monitor Guidance.

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for non-invasive blood pressure monitors, as per ISO 81060-2 (which is explicitly listed as a standard the device complies with), relies on statistical analysis of difference between the device's readings and a reference standard (usually mercury sphygmomanometer readings or an established method). The key metrics are:

• Mean Difference (Bias): The average difference between the device reading and the reference reading.
• Standard Deviation of the Differences: A measure of the spread of these differences.

The ISO 81060-2 standard (for clinical validation of automated measurement type) typically requires:

• Mean difference between the test device and reference measurement: $\leq \pm 5$ mmHg
• Standard deviation of the differences (SD): $\leq 8$ mmHg

Note: The reported accuracy of $\pm 3$ mmHg or 2% of the reading for pressure is a general accuracy specification, not necessarily the mean difference and standard deviation from the clinical validation as per ISO 81060-2. However, achieving $\pm 3$ mmHg as a general accuracy implies that the device is likely to meet or exceed the ISO 81060-2 criteria. The document states compliance with ISO 81060-2, meaning it passed these criteria.

2. Sample Size and Data Provenance

• Test Set (Clinical Study): The document states, "We conducted a comparative clinical study to verify the performance of the proposed device and predicate device as well as a mercury sphygmomanometer according to ISO 81060-2."
  • Sample Size: ISO 81060-2 typically requires a minimum of 85 subjects for clinical validation. The document does not explicitly state the exact sample size used in their study, but implies it met the requirements of the standard it followed.
  • Data Provenance: Not specified (e.g., country of origin). The study is described as a "comparative clinical study," which generally implies a prospective data collection for the purpose of the validation.

3. Number/Qualifications of Experts for Ground Truth

• Not Applicable / Not Specified: For a blood pressure monitor, the "ground truth" for blood pressure measurements is typically established using a reference standard like a mercury sphygmomanometer or an auscultatory method performed by trained observers, as outlined in ISO 81060-2. This is a measurement comparison, not an expert-based image interpretation or diagnosis that would require multiple reading experts in the AI sense.

4. Adjudication Method

• Not Applicable / Not Specified: Since this is a direct physiological measurement comparison, adjudication methods commonly seen in AI/image interpretation studies (e.g., 2+1, 3+1 consensus) are not relevant here. The ISO 81060-2 standard defines precise measurement protocols by trained observers for comparison.

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

• Not Applicable: This type of study is relevant for AI-assisted diagnostic aids where human readers' performance (e.g., accuracy, efficiency) is evaluated with and without AI. This device is a standalone measurement tool, not an AI diagnostic aid for human readers.

6. Standalone (Algorithm Only) Performance

• Implicitly Done: The "Performance Data" section explicitly states compliance with "IEC 80601-2-30" and "ISO 81060-2." These standards define the requirements for the automated (standalone) measurement of non-invasive blood pressure, requiring the device algorithm (oscillometric technique) to provide accurate pressure readings independently. The clinical study compares the device's automated readings against a reference standard.

7. Type of Ground Truth Used

• Reference Standard Measurement: The ground truth for blood pressure measurements was established using a mercury sphygmomanometer (or an equivalent valid reference method) during the comparative clinical study, as per the ISO 81060-2 standard. This is a direct, objective physiological measurement.

8. Sample Size for the Training Set

• Not Applicable: This is a traditional medical device (blood pressure monitor) that utilizes a deterministic oscillometric algorithm, not a machine learning or AI model that requires a "training set" in the context of deep learning. Its algorithm is based on established engineering principles for detecting pressure oscillations.

9. How Ground Truth for Training Set Was Established

• Not Applicable: As there is no "training set" for a machine learning model, this point is not relevant for this device.

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Electronic Sphygmomanometer (Model JN-163EW) is a home use digital monitor intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm.
The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Electronic Sphygmomanometer is designed to measure the systolic and diastolic blood pressure of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This is a home use device.
Measurement method to define systolic and diastolic pressure is similar to the Oscillometric method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. With a sensor, the microprocessor converts tiny alterations in cuff pressure to electrical signals and analyzes those signals to define the systolic and diastolic blood pressure and calculates heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".
The electronic sphygmomanometer achieves its function by a software. As the hardware includes an LCD, it can show the results of the blood pressure measurements and store 99 groups of data which can be checked and deleted.
The device is composed of a main unit and a cuff unit. The cuff unit, which is applicable to wrist circumference approximately between 13.5 and 19.5 cm, includes the inflatable bladder and shell. The main unit consists of the microprocessor, pressure sensor, pump, the electromagnetic deflation control valve and the battery. The subject device is powered by 2X AAA Lithium battery.

The provided document describes the 510(k) submission for the Electronic Sphygmomanometer (Model JN-163EW). This submission demonstrates the device's substantial equivalence to a predicate device and includes information about performance testing, including clinical trials.

However, the document does not provide the detailed acceptance criteria and a study that proves the device meets those criteria in the format requested. Specifically, it lacks:

• A table of specific quantitative acceptance criteria for blood pressure measurement accuracy (e.g., mean absolute difference, standard deviation) and the corresponding reported performance values for the subject device.
• Detailed information about the sample size, data provenance, ground truth establishment, expert qualifications, and adjudication methods for the clinical study.
• Information about MRMC studies or independent standalone algorithm performance.

The document states that clinical trials were performed according to ISO 81060-2:2019+A1:2020, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type. This standard defines the methodology for clinically validating automated sphygmomanometers, including acceptance criteria. While the submission states that "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement," it does not present the results of this clinical trial against the acceptance criteria outlined in the standard.

Therefore, I cannot fully answer the request based on the provided text, as the specific performance data against defined acceptance criteria is missing. I can, however, extract what information is present regarding the clinical study and identify what is missing.

Based on the provided text, here is what can be inferred and what is explicitly missing regarding the acceptance criteria and study:

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

• Acceptance Criteria: Not explicitly stated in a table. However, the document mentions that "The clinical trials for the Electronic Sphygmomanometers were performed according to the standard ISO 81060-2:2019+A1:2020." This ISO standard defines specific accuracy requirements for automated sphygmomanometers. For example, ISO 81060-2 typically requires:
  • Mean difference between the device and reference method to be within ±5 mmHg.
  • Standard deviation of the difference to be within 8 mmHg.
  • Specific percentages of measurements falling within ±5 mmHg, ±10 mmHg, and ±15 mmHg.
  • These apply to both systolic and diastolic blood pressure.
• Reported Device Performance: NOT PROVIDED IN THE DOCUMENT. The document states that performance testing was carried out and that the device meets "performance specifications for its intended use" and that "clinical tests" demonstrate effectiveness, but it does not provide the numerical results (e.g., mean difference, standard deviation) from the clinical study that would demonstrate it met the ISO 81060-2 criteria.

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

• Sample Size: The document only states "relevant volunteers were collected." The specific number required by ISO 81060-2 is typically at least 85 subjects with sufficient blood pressure distribution across different ranges (hypertensive, normotensive, hypotensive). The document does not specify the actual number of subjects used in this study.
• Data Provenance: Not explicitly stated. Likely collected prospectively as it refers to "actual clinical trial." The country of origin of the data is not specified, but given the manufacturer is in China, it's plausible the study was conducted there.

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

• Ground Truth Establishment: The ISO 81060-2 standard requires ground truth for blood pressure measurements to be established by two or more trained observers using a reference sphygmomanometer (e.g., mercury or an accepted equivalent).
• Number and Qualifications of Experts: The document does not specify the number of experts or their qualifications (e.g., trained clinicians, physicians) used for establishing the ground truth in this particular study.

4. Adjudication method for the test set:

• Adjudication Method: ISO 81060-2 typically involves multiple observers taking simultaneous measurements on the same subject. The standard specifies how the readings from these observers are to be handled (e.g., averaging of simultaneous readings from two independent observers, with a third observer if there's a significant discrepancy). The document does not explicitly state the adjudication method used, beyond the general reference to adherence to ISO 81060-2.

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 device is an Electronic Sphygmomanometer, which directly measures blood pressure. It is not an AI-based diagnostic imaging device that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

• This device is a standalone automated device. Its "algorithm" is the oscillometric method embedded in the device to calculate blood pressure. The clinical validation per ISO 81060-2 is effectively a standalone performance test, comparing the device's readings to standard reference measurements performed by human observers.

7. The type of ground truth used:

• The ground truth for blood pressure measurement, as per ISO 81060-2, is typically established through simultaneous auscultatory measurements performed by trained human observers using a reference sphygmomanometer (e.g., mercury or appropriately calibrated aneroid/electronic device). This is a highly controlled clinical measurement.

8. The sample size for the training set:

• Not Applicable/Not Provided. Electronic sphygmomanometers using the oscillometric method are based on established biophysical principles and do not typically involve a "training set" in the machine learning sense. Their internal algorithms are generally fixed based on these principles and extensive engineering validation, rather than being "trained" on a large dataset of patient measurements to learn patterns. If any internal parameters were optimized, the document does not mention it or the size of such a dataset.

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

• Not Applicable/Not Provided, for the same reasons as point 8.

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Electronic Sphygmomanometers is intended to measure the systolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.

The Electronic Sphygmomanometers, including X1, X2, X5, X6, X7, X8, X11, is suitable for measurement of systolic blood pressure, diastolic blood pressure and the pulse rate of adult person and adolescents 18 to 21 years old with arm circumference ranging from 22 cm to 42 cm by the oscillometric technique. The error is controlled within the range specified in IEC 80601-2-30 Non-invasive automated monitor. User can select the blood pressure unit mmHg or kPa. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated.

The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD screen and cuff. And all models are powered by 4 AAA dry batteries (DC 6V).

The device has a memory function that automatically stores 2*99 sets data of the latest measurements. It can also display the latest measurement result. Additionally, the device also can read the data through voice broadcast function.

The seven models have the same intended use, working principle, measuring range, accuracy, cuff, and conformance standard; only appearance have some difference.

The document provided is a 510(k) Premarket Notification for Electronic Sphygmomanometers. It describes the device, its intended use, and comparative studies to demonstrate substantial equivalence to a predicate device, focusing on electrical, EMC safety, performance, software verification, biocompatibility, and clinical studies. However, it does not describe an AI/ML-driven medical device, nor does it detail acceptance criteria and a study proving an AI/ML device meets those criteria.

Therefore, I cannot extract the requested information regarding an AI/ML device's acceptance criteria, performance, sample sizes, expert involvement, or ground truth establishment based on the provided text. The document pertains to a traditional medical device (blood pressure monitors).

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