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This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia).

Electronic blood pressure monitor is a Noninvasive Blood Pressure Measurement System that is intended to measure blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record may be revisited. It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The electronic blood pressure monitor is small, portable and used in home or medical facilities environment. It consists of two parts: main unit and cuffs. The electronic blood pressure monitor is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm32cm and cuff of size 22cm42cm.

The provided text describes the acceptance criteria and the study that proves the device (Electronic Blood Pressure Monitor models D6606US, D6607US) meets these criteria, primarily by demonstrating substantial equivalence to a predicate device (HTD6602US, K223170).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international standards and are met by the device. The reported device performance is that it meets these standards.

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

The document states that a clinical study was performed on the predicate device (HTD6602US, K223170). The results of this study were transferred to the subject device (D6606US, D6607US) because the subject device has the same specifications, intended use, method of measurement, measurement type, critical components (e.g., air pump, sensor, cuff), and algorithm as the predicate device.

• Sample Size for Clinical Accuracy Testing: The document does not explicitly state the sample size. It only refers to "all the relevant activities were performed by designate individual(s)" as per ISO 81060-2. ISO 81060-2 specifies requirements for clinical investigation of automated non-invasive sphygmomanometers, which includes specific sample size requirements (e.g., typically at least 85 subjects with a distribution across blood pressure ranges). However, the exact number is not provided in this submission summary.
• Data Provenance: The clinical study data originates from the testing done for the predicate device K223170. The country of origin and whether it was retrospective or prospective are not specified in this document, but "clinical investigation" usually implies a prospective study.

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

The document mentions that for the clinical accuracy testing (performed on the predicate device), "all the relevant activities were performed by designate individual(s)". It does not specify the number of experts or their qualifications for establishing ground truth, but implicitly, highly qualified medical professionals/technicians are required to perform and verify measurements according to ISO 81060-2.

4. Adjudication method for the test set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). For blood pressure measurement studies following ISO 81060-2, ground truth is typically established by trained observers (often two) using a reference sphygmomanometer, with specific protocols for resolving discrepancies, although these details are not provided 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

• No MRMC Study: This device is an Electronic Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done as it is irrelevant for this type of device.

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

• Yes, a standalone performance assessment was done (implicitly). The primary study cited is the clinical accuracy testing of the predicate device against ISO 81060-2. This standard evaluates the accuracy of the automated device (algorithm only) compared to a reference measurement performed by trained observers, effectively assessing its standalone performance. The results of this standalone performance were deemed acceptable for the predicate and transferred to the subject device.

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

The ground truth for the clinical accuracy testing (following ISO 81060-2) is established by simultaneous or sequential measurements using a standardized reference method (e.g., mercury sphygmomanometer with trained observers) against which the automated device's readings are compared. This is a form of expert measurement/consensus in a controlled clinical setting.

8. The sample size for the training set

This information is not applicable/provided. The device is an Electronic Blood Pressure Monitor based on oscillometric measurement, not a machine learning or AI device that typically requires a "training set" in the conventional sense. The development of its algorithm would involve engineering and calibration, not statistical training on a dataset of labeled cases in the AI context.

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

This information is not applicable/provided for the same reasons as point 8.

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The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm.
The intended arm circumference includes 22 cm~32 cm.

The proposed device, Electronic Blood Pressure Monitor, is a battery driven non-invasive blood pressure monitor. It can complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHq or KPa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. The proposed electronic blood pressure monitor has 13 models, including PG-800B30, PG-800B39, PG-800B45, PG-800B46, PG-800B48, PG-800B48, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
The product is provided non-sterile, and not to be sterilized by the user prior to use.

The provided document is a 510(k) summary for an Electronic Blood Pressure Monitor (Model: PG-800B30, etc.) from Shenzhen Pango Medical Electronics Co., Ltd. This document does not contain information about software algorithms for intelligent analysis or AI assistance. Therefore, it does not provide the details requested for acceptance criteria and study proving device performance for such AI-based systems.

The document discusses the substantial equivalence of the new device to a predicate device (K170151), focusing on non-clinical tests (electrical safety, EMC, software verification/validation, human factors/usability) and stating that no clinical measurement performance test was needed because the blood pressure measurement function, principle, and NIBP algorithm are identical to the legally marketed predicate device.

Specifically, the document lacks the following:

• Acceptance criteria table and reported device performance for an AI/ML algorithm. The "Accuracy" row in the comparison table refers to the device's accuracy for blood pressure measurement (3mmHg), not an AI algorithm's performance metrics.
• Sample size and data provenance for an AI test set.
• Number of experts and their qualifications used for ground truth establishment for an AI algorithm.
• Adjudication method for an AI test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study details.
• Standalone (algorithm-only) performance data.
• Type of ground truth used for an AI algorithm.
• Training set sample size for an AI algorithm.
• Method for establishing ground truth for an AI training set.

The document states that the device's software was considered a "Moderate" level of concern, and software verification and validation testing were conducted as per FDA guidance. However, this is for the device's core functionality (non-invasive blood pressure measurement using an oscillometric technique), not an AI-driven diagnostic or analytical tool.

In summary, this document is for a standard electronic blood pressure monitor, not a device incorporating a novel AI/ML algorithm that would require the detailed performance study and acceptance criteria you've asked for.

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Electronic Blood Pressure Monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm.

Electronic Blood Pressure Monitor mainly consist of the main body (include screen display, air tube connector, memory button and start/stop button), cuff, USB cable, air tube, and AA batteries. Electronic Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body. Electronic Blood Pressure Monitor can be divided into three models (YJ320, YJ321E, YJ326E) according to their appearance and functions.

The provided text is for an FDA 510(k) clearance for an Electronic Blood Pressure Monitor. It details non-clinical and clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document provides a comprehensive table of non-clinical performance and safety acceptance criteria, along with the reported "Conclusion" (Pass/Fail). For the clinical validation, it states the acceptance criteria are met based on deviations from a reference standard.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Clinical Validation Acceptance Criteria (Simplified, based on ISO 81060-2:2018):

For the clinical study, the acceptance criteria are implicit in the statement: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018."

• Reported Device Performance: The device (YJ320) met these limits, indicating it performed within the required accuracy for blood pressure measurement against a reference standard.

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

• Test Set Sample Size:
  • Clinical Data: 86 adult subjects (49 females, 37 males).
  • Non-Clinical Data: Not explicitly stated as a "test set" in terms of subject count, but performance was evaluated based on the device itself and its components against established standards.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study participants or if it was retrospective or prospective. Given it's a 510(k) submission from a Chinese company, common practice would be for the clinical study to be prospective and likely conducted in China or a region where the standard is recognized.

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

• Clinical Ground Truth: The clinical validation was conducted according to ISO 81060-2:2018, which is "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard outlines specific methods for clinical validation, typically involving simultaneous measurements by trained observers (auscultation) against the automated device being tested. The number of experts (observers) involved in establishing the reference measurement (ground truth) is usually prescribed by this standard, but not explicitly stated in this summary. The standard generally requires at least two trained observers. Their qualifications would typically involve being trained and validated to perform accurate auscultatory blood pressure measurements.
• Non-Clinical Ground Truth: For the non-clinical tests, the "ground truth" is defined by the technical specifications and performance limits set by the referenced international standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993, IEC 80601-2-30). Test equipment and calibrated reference standards are used by technical personnel to verify compliance.

4. Adjudication method for the test set

• Clinical Data: The "Same Arm Sequential Method" was used as per ISO 81060-2:2018. This method involves taking sequential measurements from the same patient's arm using both the test device and a reference method (typically auscultation by trained observers). The standard itself dictates how discrepancies are handled and how the mean error and standard deviation of differences are calculated, which serves as the "adjudication" against the standard's limits. No explicit "expert adjudication" process like 2+1 or 3+1 is mentioned, as the standard relies on the statistical agreement of measurements.
• Non-Clinical Data: Not applicable in the context of expert adjudication for defining a "ground truth" in the same way as clinical or image-based studies. Tests are performed against objective criteria and measured by calibrated equipment.

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-powered diagnostic or assistive devices where human interpretation is involved. This device is an automated blood pressure monitor, not an AI diagnostic tool.

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

• Yes, the clinical validation study (ISO 81060-2:2018) is essentially a standalone performance assessment of the automated blood pressure monitor against a reference standard. The device's algorithm performs the measurement autonomously, and its output (systolic and diastolic pressure) is compared directly to the ground truth.

7. The type of ground truth used

• Clinical Ground Truth: The ground truth for blood pressure measurements in the clinical study was established by comparison with a reference method as defined by ISO 81060-2:2018. This standard typically refers to invasive measurements or, more commonly for non-invasive validation, simultaneous auscultatory measurements performed by trained observers. The document also states, "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018," which confirms adherence to this specific standard for ground truth establishment.
• Non-Clinical Ground Truth: The "ground truth" for non-clinical tests (e.g., accuracy, range, safety features) is based on the objective technical specifications and performance requirements outlined in referenced international standards, tested using appropriate calibrated measuring equipment.

8. The sample size for the training set

• This device is an Electronic Blood Pressure Monitor, which likely uses traditional signal processing and algorithms (oscillometric principle) rather than deep learning or AI that requires a "training set" in the modern machine learning sense. Therefore, a distinct "training set" of data for algorithm development, as seen in AI/ML medical devices, is not referenced or applicable here. The algorithms are based on established physiological principles and engineering.

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

• As explained in point 8, the concept of a "training set" as it applies to establishing ground truth for machine learning models is not relevant to this traditional medical device. The underlying algorithms are based on established physical and biological principles, and their accuracy is demonstrated through the clinical and non-clinical validation studies described.

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This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia)

Electronic blood pressure monitor, model: HTD6602US is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited. It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The HTD6602US is small, portable and used in home or medical facilities environment. The Electronic blood pressure monitor consists of two parts: main unit and cuffs. The HTD6602US is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm32cm and cuff of size 22cm42cm.

Here's a breakdown of the acceptance criteria and the study details for the Electronic Blood Pressure Monitor, model: HTD6602US, based on the provided document:

Acceptance Criteria and Device Performance

Note: The primary acceptance criteria for accuracy are based on compliance with ISO 81060-2 Third Edition 2018-11, as indicated in the "Performance" row of the comparison table and the discussion of clinical accuracy testing. The specific numerical accuracy values are explicitly stated in the comparison table.

Study Details

The study that proves the device meets the acceptance criteria is a clinical accuracy test.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 85 subjects
• Data Provenance: Not explicitly stated, but since the submission is by Hetaida Technology Co., Ltd. from China and it's a 510(k) submission to the US FDA, it likely refers to a prospective clinical trial conducted to meet ISO standards. The document doesn't specify if the subjects were from a particular country.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated. The document refers to "reference equipment" (Sphygmomanometer - Stethoscope health box) and "Measuring Method: Auscultatory," which implies measurements were taken by trained personnel (e.g., medical professionals, technicians) using a standard, validated auscultatory method simultaneously with the device being tested.
• Qualifications of Experts: Not explicitly stated. However, for auscultatory measurements to establish ground truth in blood pressure studies, the personnel typically need to be trained clinicians or technicians adhering to standardized measurement protocols.

4. Adjudication Method for Test Set

• Adjudication Method: Not explicitly stated, but the method used for "ground truth" is "Auscultatory" measurements. In clinical blood pressure validation studies following ISO 81060-2, this usually involves at least two trained observers taking simultaneous readings (often blinded to each other's readings) and resolving discrepancies. The document mentions "Reference equipment used for measurements," implying a direct comparison to established, validated manual methods.

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

• Was an MRMC study done? No, this type of study is not applicable to a non-invasive blood pressure monitor that directly measures physiological parameters. MRMC studies are typically used for diagnostic imaging devices where human readers interpret images.

6. Standalone Performance Study

• Was a standalone (algorithm only without human-in-the-loop performance) study done? Yes, the entire clinical accuracy study evaluates the device's (algorithm's) performance in measuring blood pressure and pulse rate autonomously against a gold standard (auscultatory measurements). The device operates without human interpretation of its internal measurements; it directly provides readings.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus via Auscultatory Measurement Method using a reference Sphygmomanometer - Stethoscope health box. This is the gold standard for clinical validation of automated blood pressure devices.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable or not provided. This device is a hardware-based measurement system with an embedded algorithm, not a machine learning model that typically has a distinct training phase with labeled data in the same way. The algorithm's development (training) phase would occur during the device's engineering and calibration, not necessarily with a separate "training set" as understood in modern AI/ML contexts.

9. How Ground Truth for Training Set was Established

• How Ground Truth for Training Set was Established: Not applicable. As noted above, this isn't a typical AI/ML model where a training set with established ground truth is used for iterative learning. The accuracy of the device's algorithm would be refined through engineering and calibration processes based on physiological principles and potentially internal testing, not a "training set" of patient data in the same sense. The ISO 81060-2 clinical trial serves as the validation of the finalized algorithm's performance against clinical ground truth.

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The Electronic Blood Pressure Monitor is 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 intended wrist circumference is 13.5-21.5 cm.

The Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor, comprised of the host machine and the wrist cuff. It can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device can store 199 groups of measurement data for two users.

This document describes the regulatory approval of an Electronic Blood Pressure Monitor (Models HWA11, HWA10) by Shenzhen Jumper Medical Equipment Co., Ltd. The approval is based on demonstrating substantial equivalence to a predicate device (Omron Model BP6100, K182127).

The provided text does not contain detailed acceptance criteria or a comprehensive study plan with the specific information requested in the prompt (e.g., specific thresholds for accuracy, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC study details, etc.).

However, based on the information provided, here's what can be extracted and inferred regarding acceptance criteria and the supporting study:

Implied Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily implied by conformance to international standards for blood pressure monitors and demonstration of statistical equivalence to a recognized measurement method.

Table of Acceptance Criteria and Reported Device Performance (Inferred from Text):

Study Information (Extracted and Inferred):

1. Sample size used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated. The text mentions a "clinical investigation" but does not specify the number of subjects. However, for validation to ANSI/AAMI/ISO 81060-2:2013, a specific number of subjects (usually 85 for the initial phase, and more for specific populations) from a defined demographic (e.g., age and blood pressure ranges) are typically required.
   • Data Provenance: Not explicitly stated, but clinical studies for such devices are typically prospective. The text does not mention the country of origin where the clinical study was conducted.

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

   • Number of Experts: Not explicitly stated.
   • Qualifications of Experts: "Trained medical staff" were used for the auscultation method. ANSI/AAMI/ISO 81060-2:2013 guidelines require specific training and certification for these observers.

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

   • No adjudication method is mentioned. The ground truth was established by "trained medical staff" using the auscultation method, implying a direct comparison rather than a multi-reader consensus process for image interpretation.

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, an MRMC study was NOT done. This device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging device. The "study" here refers to the clinical validation of its measurement accuracy compared to a standard reference method (auscultation), not a human-in-the-loop diagnostic improvement study.

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

   • Yes, in essence, this was a standalone performance study for the device. The study validated the "accuracy of blood pressure measurements by HWA11 based on an oscillometric method as compared to an auscultation method." This is the device's inherent performance.

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

   • Expert Reference Method (Auscultation): The ground truth for blood pressure measurements was established using the "auscultation method using a calibrated sphygmomanometer by trained medical staff." This is considered the gold standard for clinical blood pressure measurement in such validation studies.

7. The sample size for the training set:

   • This is not applicable for this type of device and study. The device is a non-AI, oscillometric blood pressure monitor. It uses a defined algorithm, not a machine learning model that requires a "training set" in the common AI sense.

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

   • Not applicable (see point 7).

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The Electronic Blood Pressure Monitor 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 upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32 cm.

Not Found

The provided text is an FDA 510(k) clearance letter for an Electronic Blood Pressure Monitor. It confirms the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed information required to answer your questions about acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document does not include any performance data, clinical trial results, or technical specifications that would outline acceptance criteria or how the device's performance was validated.

Therefore, I cannot extract the information requested for the following points:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The provided text only states that the device is an "Electronic Blood Pressure Monitor" intended for "non-invasive blood measurement of arterial blood pressure values in adults" and that it measures "diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the upper arm." The cuff circumference is limited to 22-32 cm.

To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical specification submitted with the 510(k) application, which typically contains the performance data and validation methodology.

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The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm.

The patient population does not include adolescents aged 12 to <18 years of age. The patient population includes transition adolescent B (18 to < 22 years of age but treated like adult) and adults (at least 22 years of age).

The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the person at wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or Kpa.

The proposed electronic blood pressure monitor has eight models, including PG-800A18, PG-800A19, PG-800A28, PG-800A51, PG-800A52, PG-800A11-1, PG-800A36-1 and PG-800A37-1. All models follow the same software, measurement principle, algorithm and data storage. The main differences are product appearance.

The proposed device is intended to be used in medical facilities or at home.

The provided document is a 510(k) Summary for an Electronic Blood Pressure Monitor (K223291), seeking substantial equivalence to a predicate device (K161845). It includes information about non-clinical and clinical testing performed to demonstrate device performance and safety.

Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the Electronic Blood Pressure Monitor are related to its accuracy in measuring blood pressure and pulse rate, and its compliance with relevant medical device standards.

Table 1: Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The document describes both non-clinical and clinical testing.

Clinical Testing (Performance Study)

The clinical test was conducted to verify that the proposed device met the requirements of the ISO 81060-2:2018 standard.

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

   • Sample Size: Not explicitly stated in the provided text. The ISO 81060-2 standard typically requires a minimum of 85 subjects with specific demographic balance (e.g., age, sex, arm circumference, and blood pressure distribution) for a full validation.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it is a clinical test for device validation, it is generally assumed to be prospective.

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

   • Not applicable for blood pressure monitor validation studies. Ground truth in such studies is typically established by simultaneous measurements using a validated reference method (e.g., auscultatory method by trained observers with a mercury sphygmomanometer) as per the ISO 81060-2 standard, not by expert consensus on images or data interpretation.

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

   • Not applicable as the ground truth is established by simultaneous reference measurements, not by expert interpretation requiring adjudication. ISO 81060-2 involves multiple trained observers for reference measurements.

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:

   • This is not an AI-assisted device for diagnostic interpretation; it is a direct measurement device. Therefore, an MRMC study is not relevant or applicable.

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

   • The "clinical test" is essentially the "standalone" performance of the device (algorithm and hardware combined) against a reference standard. The device operates automatically once initiated.

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

   • The ground truth for blood pressure monitor validation (as per ISO 81060-2) is established by simultaneous auscultatory measurements performed by trained observers using a validated reference method (e.g., mercury sphygmomanometer with a stethoscope). This is generally considered a highly reliable and direct physiological measurement.

7. The sample size for the training set:

   • This device is an Electronic Blood Pressure Monitor using an oscillometric technique, not a machine learning/AI model that typically requires a separate "training set" in the conventional sense. The "algorithm" for blood pressure calculation from oscillometric pulses is built into the device. Therefore, a distinct "training set" like those used for AI models is not applicable or specified.

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

   • Not applicable for the reason stated above. The underlying oscillometric principle and algorithms are well-established.

Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. These tests covered various aspects of safety and performance.

• Testing Standards:
  • ISO 10993-1:2018 (Biological evaluation - risk management)
  • ISO 10993-5:2009 (Cytotoxicity)
  • ISO 10993-10:2010 (Irritation and delayed-type hypersensitivity)
  • IEC 60601-1:2005 + A1:2012 (Medical electrical equipment - general requirements for basic safety and essential performance)
  • IEC 60601-1-11:2015 (Home healthcare environment)
  • IEC 60601-1-2:2014 (EMC)
  • IEC 80601-2-30:2018 (Automated non-invasive sphygmomanometers)

The document concludes that the non-clinical tests and the clinical test demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device.

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The Electronic Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic 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.

Electronic Blood Pressure Monitor

The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria for the Electronic Blood Pressure Monitor. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not detail performance study results.

Therefore, I cannot provide the requested information.

Ask a specific question about this device

The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm32 cm and 32 cm42 cm.

The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.

The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the World Health Organization (WHO) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.

The proposed electronic blood pressure monitor has six models, including PG-800B18, PG-800B19, PG-800B19L. PG-800B28. PG-800B29. PG-800B51. All models follow the same software, measurement principle and NIBP algorithm.

The proposed device is intended to be used in medical facilities or at home.

The product is provided non-sterile, and not to be sterilized by the user prior to use.

The provided document describes the FDA 510(k) premarket notification for an Electronic Blood Pressure Monitor (K200716).

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The document doesn't explicitly state "acceptance criteria" in a separate section, but it does list specifications the device claims to meet, which serve as acceptance criteria. The device's reported performance is directly stated as meeting these specifications or being identical to the predicate device.

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

The document explicitly states: "No Clinical study is included in this submission" for the proposed device (K200716). Therefore, there is no sample size for a test set, nor data provenance information for a clinical study of this specific device.

The basis for proving substantial equivalence to the predicate device (K170151) is that the blood pressure measurement function, including the measurement principle and NIBP algorithm, and cuff size are identical. The predicate device did conduct a clinical study according to ISO 81060-2 (as noted in the comparison table), but the details of that study (sample size, provenance) are not provided in this document.

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)

Since no clinical study was conducted for the proposed device (K200716), there were no experts used to establish ground truth for a test set for this submission.

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

Not applicable, as no clinical study was conducted for the proposed device.

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. The device is an automated blood pressure monitor and does not involve AI assistance for human readers/operators in its primary function of blood pressure measurement.

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

For the proposed device (K200716), a standalone performance evaluation in a clinical setting was not done. Its performance is asserted as identical to the predicate device (K170151) due to shared measurement principles and algorithms.

Non-clinical tests were conducted to verify design specifications and compliance with standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30, IEC 60601-1-11, IEC 62133), which can be considered "standalone" technical evaluations.

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

For the proposed device (K200716) submission, no new clinical ground truth was established. The submission relies on the ground truth established by the predicate device's clinical study (which was "conducted according to ISO 81060-2"). ISO 81060-2 defines the clinical investigation of non-invasive sphygmomanometers, which typically involves comparing the device's readings against a reference measurement (e.g., auscultatory method performed by trained observers).

8. The sample size for the training set

Not applicable. There is no mention of a training set for a machine learning model, as this is an automated blood pressure monitor based on an established oscillometric algorithm, not an AI/ML-based diagnostic device in the context of typical training sets. The comparison focuses on the measurement algorithm being identical to the predicate.

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

Not applicable, as there is no training set mentioned or implied for this device.

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Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia)

The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The subject devices will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; the time, date, blood pressure value and pulse value are included. The record maybe revisited.

Here's a breakdown of the acceptance criteria and study information for the Electronic Blood Pressure Monitor (models YE620B, YE620D, YE660E, YE660F, and YE680B), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Clinical Validation (Test Set): 85 participants.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. It is a prospective study as participants were "involved in the study" and "three valid blood pressure values are taken for each participant."

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

• Number of Experts: The document states that "nurses" took the blood pressure values for the participants. The exact number of nurses is not specified, nor are their specific qualifications (e.g., years of experience in blood pressure measurement), beyond being "nurses."
• Ground Truth Establishment: The ground truth was established by these nurses using a reference device, a mercury sphygmomanometer.

4. Adjudication Method for the Test Set

• The document implies that the ground truth for each participant consisted of "three valid blood pressure values" taken by nurses. An explicit adjudication method (e.g., 2+1, 3+1 consensus) for these three values is not specified. It suggests these three values were directly used, perhaps averaged, or that "valid" implies some internal consistency checking.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The study described is a clinical validation against a reference standard (mercury sphygmomanometer), not a comparison of human readers with and without AI assistance.

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

• Yes, a standalone performance study was done. The clinical validation detailed is focused on the device's (algorithm's) accuracy in measuring blood pressure compared to a reference standard (mercury sphygmomanometer), without human intervention in the device's measurement process itself.

7. The Type of Ground Truth Used

• Expert Consensus / Reference Standard: The ground truth was established by "nurses" using a "mercury sphygmomanometer" as the reference device. This falls under the category of a reference standard established by human experts.

8. The Sample Size for the Training Set

• The document does not specify a training set sample size. This is typical for a 510(k) submission for a non-AI medical device like a blood pressure monitor, where the focus is on clinical validation against a standard, not machine learning model training. The device's underlying oscillometric algorithm would have been developed and validated internally by the manufacturer, but details of that process (including training sets for the algorithm itself) are not usually part of a 510(k) summary focused on clinical performance for regulatory clearance.

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

• As no training set is explicitly mentioned or detailed in the document, how its ground truth was established is not provided.

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