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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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Measure blood pressure (systolic and diastolic) and pulse rate.

The Electronic Sphygmomanometer uses an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START/STOP" button, the cuff is inflated automatically by an internal pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. The device will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and stored in the device memory. The cuff is also deflated automatically to 0 mmHg at the same time.

Below is the information regarding the acceptance criteria and the study that proves the device meets those criteria, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines an "Accuracy" acceptance criterion for the device, which is consistent with the predicate device. The clinical study results are stated to have met this criterion.

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

• Sample Size: 120 subjects
• Data Provenance: Not explicitly stated, but the study was conducted to meet ISO 81060-2 standards, which are international. It's implied to be prospective as it describes a clinical validation study.

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. For blood pressure monitors validated according to ISO 81060-2, the "ground truth" (reference blood pressure) is typically established by trained observers (usually clinicians) using a mercury sphygmomanometer or an equivalent reference device, but the specific number and qualifications of these observers are not detailed here.

4. Adjudication method for the test set:

The adjudication method is not explicitly described. However, the ISO 81060-2 standard, which the study adhered to, typically involves simultaneous auscultatory measurements by two trained observers, often with a third observer for adjudication in cases of discrepancies.

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 for automated blood pressure measurement, not an AI-assisted diagnostic tool requiring human reader interpretation. No MRMC study was conducted or is relevant.

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

Yes, a standalone clinical validation study was performed for the device. The study evaluated the accuracy of the automated non-invasive sphygmomanometer (Electronic Sphygmomanometer Model: LT-P30) against a reference method as per ISO 81060-2.

7. The type of ground truth used:

The ground truth for the clinical validation was established by a reference method, typically auscultation by trained observers, as specified by the ISO 81060-2 standard for clinical validation of automated non-invasive sphygmomanometers.

8. The sample size for the training set:

Not applicable. This document describes the validation of a medical device (Electronic Sphygmomanometer) which is likely based on an algorithmic approach but not an "AI" device in the sense of requiring a "training set" in machine learning. Its accuracy and performance are based on its physical design and established oscillometric principles.

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

Not applicable, as there is no mention of a "training set" in the context of machine learning for this device. The device's operational principles are established, and its accuracy is clinically validated.

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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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The Electronic Sphygmomanometer and Automatic Blood Pressure Monitor are intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.

The proposed devices, ABPM50 Automaitc Blood Pressure Monitor, CONTEC08A and CONTEC08C Electronic Sphygmomanometers are battery driven automatic non-invasive Blood Pressure Monitor. They can automatically complete the inflation and BP measurement, which can measure systolic, and diastolic blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. ABPM50 and CONTEC08A and CONTEC08C can be only used on adult individuals.

The devices have the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure and pulse rate.

ABPM50 and CONTEC08A have physiological over-limit prompt function which can be turned on or off by users. When the measurement results exceed the over-limit prompt limit, the physiological over-limit prompt function will be triggered. The over-limit can be set by users, and the low limit must be lower than the corresponding high limit.

In addition, all of the three proposed devices have technical over-limit prompt function, which will be triggered when the battery voltage is low, and this technical over-limit prompt function can not be cancelled unless being closed or the power replaced.

The provided FDA 510(k) summary (K202757) for the Electronic Sphygmomanometer, Automatic Blood Pressure Monitor CONTEC08A/CONTEC08C/ABPM50 details the non-clinical and clinical tests performed to demonstrate substantial equivalence to a predicate device.

Here's an breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device, being a non-invasive blood pressure measurement system, are primarily based on established international standards for accuracy and safety. The reported device performance is presented as compliance with these standards and specific measurement ranges.

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

• Sample Size: "Total 85 subjects are included in each clinical study." (Page 6)
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that the manufacturer and correspondent are based in China, it is highly probable the clinical study was conducted in China. The study appears to be prospective as it describes a clinical investigation for the purpose of regulatory submission.

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

The document states that the clinical study was conducted "in accordance with ISO 81060-2". ISO 81060-2 (Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type) outlines specific requirements for the observers and the comparison method to establish ground truth.

While the exact number and qualifications of experts (e.g., clinicians, trained observers) are not explicitly stated in this FDA submission summary, ISO 81060-2 typically requires:

• At least two trained observers to measure blood pressure using a reference sphygmomanometer simultaneously with the device under test.
• These observers must be trained and certified to perform auscultatory blood pressure measurements (e.g., using a mercury column or validated alternative) with high accuracy and reproducibility. The standard often specifies requirements for their training and regular performance validation to ensure inter-observer agreement.

4. Adjudication Method for the Test Set

The document does not explicitly describe an "adjudication" method in the context of expert consensus, as this is typically seen in studies where multiple readers interpret images or data and discrepancies need resolving. For blood pressure measurement, ISO 81060-2 mandates a specific comparison method where the device's measurements are compared against simultaneous auscultatory measurements obtained by trained observers. The standard defines how these measurements are to be collected and statistically analyzed (e.g., mean difference and standard deviation between the device and the reference measurements) to determine accuracy, rather than an "adjudication" of differing expert opinions on a specific diagnosis.

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

This device (Electronic Sphygmomanometer/Automatic Blood Pressure Monitor) is a medical measurement device, not an AI-based diagnostic tool that assists human readers in interpreting complex data like medical images. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which is common for AI tools in radiology or pathology, was not performed or applicable here. The study focused on demonstrating the device's accuracy and safety against established standards and a predicate device through direct measurement comparison.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary evaluation of this device is a standalone performance assessment. The device is designed to automatically measure and display blood pressure and pulse rate without continuous human intervention during the measurement process. The clinical study evaluated the device's direct measurement performance against a gold standard (auscultatory measurements) as per ISO 81060-2.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was expert consensus/reference measurement through a standardized protocol. Specifically, it involved:

• Simultaneous blood pressure measurements taken by trained observers using a reference method (typically auscultation with a mercury sphygmomanometer or validated equivalent) alongside the device under test.
• This is the standard approach defined in ISO 81060-2 for validating automated non-invasive sphygmomanometers.

8. The Sample Size for the Training Set

The document does not mention a training set because this medical device approval is for a physical measurement device, not a machine learning or AI algorithm that requires a separate training set. The "study" described is a clinical validation study to confirm the accuracy and safety of already developed hardware and software, rather than a development and training phase for a learning algorithm.

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

Since there is no "training set" in the context of an AI/ML algorithm for this type of device, this question is not applicable. The device's underlying measurement algorithms are based on established oscillometric principles and do not "learn" from a dataset in the way a deep learning model would.

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Wrist Electronic Sphygmomanometer is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.

The Wrist Electronic Sphygmomanometer is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the oscillometric technique.

The device uses the oscillometric method to determine blood pressure. This is accomplished by means of a sensitive transducer, which measures cuff pressure and minute pressure oscillations within the cuff. The first determination sequence initially pumps up to a cuff pressure of about 180-230mmHg for adults. After inflating the cuff, the Wrist Electronic Sphygmomanometer begins to deflate it at a rate of 3-6 mmHq/sec, and measures systolic, mean, and diastolic pressure. The Wrist Electronic Sphygmomanometer deflates the cuff one step each time it detects two pulsations of relatively equal amplitude ("peak matching"). The time between deflation steps depends on the frequency of these matched pulses (pulse rate of the patient). However, if the Wrist Electronic Sphygmomanometer is unable to find any pulse within several seconds, it will deflate to the process of finding two matched pulses at each step provides artifact rejection due to patient movement and greatly enhances accuracy.

The device will obtain the pressure point, which is before the maximum peak and whose amplitude of peak is 0.45 times the reference amplitude, is determined to be the systolic pressure; and the pressure point, which is after the maximum peak and whose amplitude of peak is 0.75 times the reference amplitude, is determine to be the diastolic. When the diastolic pressure has been determined, the NIBP Meter finishes deflating the cuff and updates the screen.

The provided document describes the Wrist Electronic Sphygmomanometer (models CK-101, CK-101S, CK-102S, CK-W118, CK-W132, CK-W133, CK-W135, CK-W175, CK-W176, CK-W355, CK-W356, CK-W358) and its substantial equivalence to a predicate device, the Med-link Wrist Digital Blood Pressure Monitor (Model: ESM101). The primary study proving the device meets acceptance criteria appears to be a performance evaluation according to the AAMI / ANSI / ISO 81060-2 standard, which is a standard for non-invasive blood pressure monitors.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document largely details equivalence to a predicate device rather than precise acceptance criteria and specific performance numbers for the subject device beyond the general range and accuracy claims. However, the performance specifications listed for the subject device can be inferred as its reported performance, and by extension, the acceptance criteria as meeting these specifications (and demonstrating equivalence to the predicate which also meets these).

The document notes that the device "meets the requirements as safety and performance standards required," implying that its performance aligns with what is expected by relevant standards like AAMI / ANSI / ISO 81060-2.

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

The document states that "Performance according to AAMI / ANSI / ISO 81060-2 standard" was conducted. This standard typically specifies requirements for clinical validation, often involving a certain number of subjects. However, the exact sample size used for the test set (clinical validation cohort) is not explicitly stated in the provided text. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

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

The document does not provide this information. For a blood pressure monitor, ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a reference device, not necessarily "experts" in the context of image interpretation. The ISO 81060-2 standard outlines procedures for obtaining reference blood pressure measurements.

4. Adjudication Method for the Test Set

The document does not provide this information. For blood pressure device validation, adjudication usually refers to how discrepancies between multiple reference measurements are handled, which is part of the ISO 81060-2 methodology but not detailed here.

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 (N/A). This device is a non-invasive blood pressure measurement system and not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

The performance evaluation according to AAMI / ANSI / ISO 81060-2 is inherently a standalone performance study of the device, as it evaluates the algorithm's accuracy in measuring blood pressure compared to a reference standard without human intervention in the measurement process (though humans apply the device and record results).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For blood pressure monitoring devices, the ground truth is established through simultaneous measurements using a validated reference method (e.g., auscultation by trained observers with a mercury sphygmomanometer as per AAMI/ISO standards). The document states "Performance according to AAMI / ANSI / ISO 81060-2 standard," which defines how this ground truth is established.

8. The Sample Size for the Training Set

The document does not provide this information. Blood pressure monitors typically do not have a "training set" in the machine learning sense. The device's algorithm is developed based on physiological principles and validated against clinical data.

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

The document does not provide this information. As mentioned above, the concept of a "training set" with established ground truth is not typically relevant for this type of medical device in the same way it would be for an AI/ML algorithm. The underlying oscillometric algorithm is based on established scientific principles and previously collected physiological data, but not usually in a "training set" context as defined for AI.

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Arm Electronic Sphygmomanometer is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm~32 cm. It is intended to be used in hospital environment or at home.

The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.

The proposed devices are intended to be used in medical facilities or at home and provided non-sterile.

The provided document is a 510(k) Premarket Notification for an "Arm Electronic Sphygmomanometer" and demonstrates its substantial equivalence to a predicate device. This type of submission relies on showing equivalency to an already cleared device, rather than proving novel effectiveness through significant clinical studies.

Therefore, the document explicitly does not include the detailed clinical study information requested for an AI/ML powered medical device, such as:

• A complex table of acceptance criteria and reported device performance derived from a clinical trial.
• Sample sizes for test sets in a clinical trial context.
• Details about expert adjudication or multi-reader multi-case (MRMC) studies.
• Information on training set sizes or ground truth establishment relevant to AI/ML.

The device in question is a standard non-invasive blood pressure measurement system, not an AI-powered device. Its performance is evaluated against established electrical, electromagnetic, biocompatibility, and performance standards for such devices.

Here's an analysis of what is provided, framed in the context of device acceptance, while acknowledging that it's for a traditional medical device, not an AI one:

Acceptance Criteria and Device Performance (Based on Standards Compliance, not AI-specific metrics):

• Pressure: ±3mmHg
• Pulse: ±5% |
  | Biocompatibility (ISO 10993-5, ISO 10993-10) | Complies with ISO 10993-5 and ISO 10993-10 for biocompatibility. |
  | Usability (IEC 62366) | Complies with IEC 62366 for usability. |
  | Software Verification & Validation (FDA Guidance) | Complies with FDA guidance for software V&V. |
  | Lithium Battery Safety (IEC 62133) | Complies with IEC 62133 (if applicable model). |
  | Intended Use / Indications for Use | Substantially Equivalent to predicate device. Measures diastolic/systolic BP and pulse rate in adults via oscillometric technique. Cuff circumference 22-32cm. Use in hospital or home. |
  | Measuring Range (Pressure) | 0mmHg299 mmHg |
  | Measuring Range (Pulse) | 40 bpm199 bpm |
  | Pressure Resolution | 1 mmHg or 0.1kPa |
  | Cuff Circumference | 22~32cm |
  | Operation Condition | Temperature: +5 to +40 °C, Humidity: 15 to 90%, Atmospheric Pressure: 80-106 kPa |
  | Transport/Storage Environment | Temperature: -25°C to +70°C, Humidity: ≤93%R.H., Atmospheric Pressure: 70-106 kPa |

Study Details (as per the provided document):

1. Sample Size and Data Provenance:

   • The document mentions "lab bench testing" and compliance with international standards (e.g., ISO 81060-2 for blood pressure performance, IEC 60601 series for safety/EMC).
   • For blood pressure measurement devices, ISO 81060-2 typically requires a specific number of subjects for clinical validation (often at least 85 subjects with specific demographic and blood pressure range distributions). However, the document does not explicitly state the sample size or provenance (country/retrospective/prospective) of the data used for the ISO 81060-2 performance evaluation. It only states compliance.
   • This is a 510(k) submission, so the primary "study" is a comparison to a predicate device, not a de novo clinical trial. The performance data would have been generated to show compliance with the standards referenced in the submission.

2. Number of Experts and Qualifications for Ground Truth:

   • Not applicable in the context of this traditional medical device submission. Ground truth for blood pressure measurement performance is typically established by simultaneous readings from a calibrated mercury sphygmomanometer (or an equivalent reference device) by trained observers, as specified in standards like ISO 81060-2. There isn't an "expert consensus" process like for imaging AI.

3. Adjudication Method:

   • Not applicable as this is not an AI/ML device requiring human expert adjudication.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No MRMC study was done, as this is a standalone blood pressure measurement device, not an AI assistance tool for human readers.

5. Standalone Performance:

   • Yes, the performance tests (e.g., per AAMI / ANSI / ISO 81060-2) evaluate the standalone performance of the algorithm/device in measuring blood pressure and pulse rate. The accuracy criteria (±3mmHg for pressure, ±5% for pulse) are direct measurements of the device's capability.

6. Type of Ground Truth Used:

   • For blood pressure accuracy, the ground truth is typically established by simultaneous measurements from a reference standard method (e.g., auscultation with a calibrated mercury sphygmomanometer) conducted by trained observers, as described in blood pressure measurement standards like ISO 81060-2. This is direct physiological measurement, not expert consensus or pathology in the sense of diagnostic imaging.

7. Sample Size for Training Set:

   • Not applicable. This is not an AI/ML device that requires a "training set." The device is based on established oscillometric principles and hardware.

8. How Ground Truth for Training Set was Established:

   • Not applicable for the same reason as above.

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The device is intended to measure diastolic, systolic blood pressure and the pulse rate of an adult patient via non-invasive technique in which an inflatable cuff is wrapped around the upper arm. It is intended to be used at home. The intended arm circumference is 17cm22cm, 22cm32cm, 32cm~42cm.

The subject device is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and the pulse rate of adult at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa. All the models included in this submission follow the same software, same measurement principle and same specifications. The WBP100 does not have LCD display but has Bluetooth; WBP201 does not have Bluetooth but has LCD display, and WBP202 has LCD display and Bluetooth. The difference will not affect the safety and effectiveness of the subject device.

This document describes a 510(k) submission for an Electronic Sphygmomanometer (Model: WBP100, WBP201, WBP202) by Guangdong Biolight Meditech Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K131558).

Here's an analysis of the provided text to answer your questions regarding acceptance criteria and the study proving the device meets them:

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

The document explicitly states that the clinical study was conducted to evaluate if the device meets the accuracy requirements of ISO 81060-2:2013, "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."

While the document references this standard as the acceptance criterion, it does not provide a table of the specific numerical acceptance criteria (e.g., mean difference, standard deviation) from ISO 81060-2:2013, nor does it present the reported device performance with those specific numbers. It only states that the device "meets the accuracy requirements."

To fully answer this question, one would need to refer to ISO 81060-2:2013 to determine its specific accuracy criteria and then examine the full clinical study report (which is not provided in this excerpt) for the device's measured performance against those criteria.

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

• Sample Size for Test Set: The document mentions a "clinical study" but does not explicitly state the sample size used for the test set (i.e., the number of subjects enrolled in the clinical validation). ISO 81060-2:2013 typically specifies minimum sample sizes for clinical validation (e.g., usually 85 subjects for Phase 1 and Phase 2 combined, or similar, depending on the specific method).
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Clinical validation studies for medical devices are typically prospective in nature.

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

For non-invasive blood pressure monitors, the "ground truth" for blood pressure measurements in a clinical validation study typically involves simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer, often with a "double stethoscope" setup to ensure independent readings.

The document does not specify the number of experts (observers) used or their qualifications (e.g., "trained observers" or "physicians with X years of experience"). ISO 81060-2:2013 outlines detailed requirements for the training and procedures for these observers to ensure accurate reference measurements.

4. Adjudication method for the test set:

In the context of blood pressure validation studies, "adjudication" usually refers to managing discrepancies between simultaneous reference measurements (e.g., if two observers get slightly different readings). ISO 81060-2:2013 specifies procedures for this, often involving taking the average of the two observer readings if they are within a certain range, or a third observer if they are too disparate.

The document does not explicitly state the adjudication method used for the test set, but it would have followed the methodology defined in ISO 81060-2:2013.

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:

This device is an Electronic Sphygmomanometer, a direct measurement device, not an AI-powered diagnostic imaging tool that would typically involve human readers. Therefore, an MRMC comparative effectiveness study is not applicable to this type of device, and the concept of "human readers improving with AI assistance" does not apply.

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

The device itself is an automated non-invasive sphygmomanometer. Its operation is inherently "standalone" in the sense that the device's algorithm performs the measurement and calculation of blood pressure without human intervention during the measurement process. The clinical validation outlined by ISO 81060-2:2013 evaluates this automated performance against reference measurements. So, the clinical study is effectively a standalone performance assessment of the automated device.

7. The type of ground truth used:

The ground truth for non-invasive blood pressure measurement devices validated against ISO 81060-2:2013 is typically established by simultaneous, direct auscultatory measurements performed by trained human observers using a calibrated reference device (e.g., mercury sphygmomanometer). This is considered the "gold standard" for clinical validation of these devices. It is not pathology or outcomes data.

8. The sample size for the training set:

This device is a hardware product with a measurement algorithm, not a machine learning model that requires a "training set" in the conventional sense of AI development. The "algorithm" here refers to the oscillometric method's logic and the device's internal programming for calculating BP. Therefore, the concept of a separate "training set" for an AI model does not apply to this medical device submission as described.

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

As mentioned above, the concept of a "training set" and establishing ground truth for it does not apply in the context of this traditional medical device validation. The "ground truth" is relevant for the clinical validation (test set) to ensure the accuracy of the device's measurements against accepted reference methods.

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ABPM50 Automatic Blood Pressure Monitor is intended to monitor the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.

The proposed device, ABPM50 Automatic Blood Pressure Monitor, is battery driven automatic non-invasive Blood Pressure Monitor. It can automatically complete the inflation and BP measurement, which can measure systolic, diastolic and mean blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. ABPM50 can be used on adult, pediatric, and neonatal individuals.

The device has the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate. These records can be uploaded to PC via USB and processed with the PC software.

ABPM50 has physiological alarm function which can be turned on or off by users. When the measurement results exceed the alarm limit, the physiological alarm function will be triggered. The alarm limit can be set by users, and the low limit must be lower than the corresponding high limit. In addition, it has technical alarm function which will be triggered when the battery voltage is lower than 2.3V , and this alarm can not be cancelled unless being closed or the power replaced.

Here's a breakdown of the acceptance criteria and the study details for the ABPM50 Automatic Blood Pressure Monitor, based on the provided text:

Acceptance Criteria and Device Performance

The provided document states that the clinical tests were conducted following the ANSI/AAMI SP10:2002+A1:2003+A2:2006 standard for manual, electronic, or automated sphygmomanometers. While the specific numerical acceptance criteria are not explicitly detailed in the provided text, this standard generally outlines requirements for accuracy of blood pressure measurements. The document does state that the device "complies with the standard requirements and the accuracy the manufacture declared." Without the explicit declared accuracy from the manufacturer, we can infer that the device meets the general accuracy requirements of the ANSI/AAMI SP10 standard.

General Acceptance Criteria (Inferred from ANSI/AAMI SP10):
The ANSI/AAMI SP10 standard typically requires that:

• The mean difference between the device measurement and reference measurement (mercury sphygmomanometer) should be ± 5 mmHg or less.
• The standard deviation of the differences should be ± 8 mmHg or less.
• A minimum number of subjects (e.g., 85 adult subjects) should be tested.

Study Details

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

   • Sample Size: Not explicitly stated. The document refers to "clinical tests following ANSI/AAMI SP10:2002+A1:2003+A2:2006". This standard specifies a minimum number of subjects (e.g., 85 for adults, with specific requirements for pediatric and neonatal populations, including a minimum of 15 subjects for each age group within those populations). Given it covers "adult, pediatric, and neonatal individuals," it would involve multiple age cohorts.
   • Data Provenance: The study was conducted in Qinhuangdao Maternal and Child Health Hospital. This indicates a prospective study conducted in China.

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

   • Not specified in the provided text. The ANSI/AAMI SP10 standard typically requires simultaneous auscultation by two trained observers for ground truth, often using a Y-tube and a third supervisor, but the exact number and qualifications are not detailed here.

3. Adjudication method for the test set:

   • Not specified. Assuming adherence to ANSI/AAMI SP10, the ground truth would typically be established by trained observers taking manual readings, often with a method to resolve discrepancies between observers, such as averaging or a third adjudicator.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, a MRMC comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI systems where human reader performance is a key metric. This study focused on the standalone accuracy of the blood pressure monitor against a reference method.

   • Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was performed.

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

   • Yes, the study described is effectively a standalone performance study of the ABPM50 device. It tested the device's accuracy in measuring blood pressure and pulse rate (algorithm only) compared to a reference standard (human-measured manual blood pressure, implied by ANSI/AAMI SP10).

6. The type of ground truth used:

   • Expert concensus / Manual auscultatory readings from trained observers. The ANSI/AAMI SP10 standard dictates that the reference blood pressure measurements are taken by trained observers using a mercury sphygmomanometer (or an equivalent validated reference device) simultaneously with the device under test.

7. The sample size for the training set:

   • Not applicable. The provided document describes a clinical validation study for a device, not a machine learning model that requires a distinct training set. The device operates based on oscillometric principles, not a deep learning algorithm trained on a large dataset in the typical sense.

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

   • Not applicable, as a training set for a machine learning model is not explicitly mentioned or implied for this device's function. The "training" for such a device would instead relate to the engineering and calibration processes during development, which aren't typically described with ground truth in the same way as AI models.

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CONTEC08C Electronic Sphygmomanometer is intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult individuals.

The proposed device, CONTEC08C Electronic Sphygmomanometer is battery driven automatic non-invasive Blood Pressure Monitor. The device can automatically complete the inflation, deflation and BP measurement, which can measure systolic, diastolic and mean blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. It can be only used on adult individuals.

The device has the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate. These records can be uploaded to PC via USB and processed with the PC software.

The device has technical alarm function which will be triggered when the battery voltage is lower than 3.7V, and this alarm can not be cancelled unless being closed or the power replaced.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CONTEC08C Electronic Sphygmomanometer:

The provided document describes the clearance of a non-invasive blood pressure monitor (sphygmomanometer) through the 510(k) pathway, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This type of submission generally relies on performance testing against recognized standards rather than extensive clinical efficacy studies typically seen for novel devices.

Acceptance Criteria and Reported Device Performance

The device's performance is primarily assessed against the recognized standard ANSI/AAMI SP10: 2002 & A1: 2003 & A2: 2006. This standard outlines requirements for automatic sphygmomanometers, including accuracy specifications.

Note: The provided text states that "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ... ANSI/AAMI SP10: 2002 & A1: 2003 & A2: 2006." While it confirms compliance, specific numerical performance results (e.g., the exact mean difference and standard deviation achieved) are not detailed in this summary. However, meeting ANSI/AAMI SP10 implicitly means meeting its accuracy requirements for blood pressure (mean difference ≤ ±5 mmHg and standard deviation ≤ 8 mmHg).

Study Details

Given the nature of a 510(k) for a sphygmomanometer tested against ANSI/AAMI SP10, the "study" referred to is a specific blood pressure accuracy validation protocol as defined by that standard.

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

   • Sample Size: The document does not explicitly state the number of subjects (the sample size) used for the blood pressure accuracy testing according to ANSI/AAMI SP10. The standard itself specifies minimum subject requirements for various test phases (e.g., 85 subjects for the clinical validation of accuracy).
   • Data Provenance: The document states that "Bench tests were conducted." The sponsor and submission correspondent are based in China (CONTEC MEDICAL SYSTEMS CO., LTD and Mid-Link Consulting Co., Ltd.), which suggests the testing was likely conducted in China. The data is prospective, meaning it was collected specifically for the purpose of validating the device.

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

   • For blood pressure validation, the "ground truth" is typically established by trained observers (auscultators) using a mercury sphygmomanometer or validated reference device according to a standardized protocol. ANSI/AAMI SP10 requires at least two trained observers to simultaneously obtain reference blood pressure measurements.
   • Qualifications of experts: These observers must be specifically trained and certified as competent in auscultatory blood pressure measurement. While the document doesn't detail their specific qualifications, compliance with ANSI/AAMI SP10 implies that appropriately qualified personnel were used.

3. Adjudication method for the test set:

   • ANSI/AAMI SP10 specifies an adjudication method for observer differences. Typically, if the two observers' readings differ by more than a predefined amount (e.g., 4 mmHg), a third observer or a re-measurement may be required, or the data point may be discarded. The exact protocol would follow the standard.

4. 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 device is an automatic electronic sphygmomanometer and does not involve "human readers" interpreting images or data with or without AI assistance in the way an MRMC study would apply. Its function is to provide direct measurements. Therefore, an MRMC comparative effectiveness study was not performed and is not applicable here.

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

   • Yes, the primary testing described is a standalone performance test of the device. The device's algorithm (oscillometric technique) measures blood pressure automatically without human input during the measurement phase. The "bench tests" and compliance with ANSI/AAMI SP10 are evaluations of this standalone performance.

6. The type of ground truth used:

   • For blood pressure devices, the ground truth is expert auscultatory measurements (or another validated reference method) conducted concurrently with the device measurements on human subjects, as dictated by the ANSI/AAMI SP10 standard.

7. The sample size for the training set:

   • The document does not refer to a distinct "training set" for an algorithm to be learned or optimized in the sense of machine learning. The device utilizes an oscillometric algorithm which is a well-established technique for blood pressure measurement. Any internal calibration or algorithm refinement by the manufacturer would have been part of the device's design and development, not typically described as a "training set" in a 510(k) summary for such a device. The testing described is validation of the final device.

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

   • As there is no "training set" explicitly mentioned or applicable in the context of an AI/machine learning model as typically discussed, this question is not relevant to the provided information. The device's underlying algorithm is based on established oscillometric principles rather than a data-driven "training" process from a ground truth dataset in the AI sense.

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