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The ABPM 7100 is an automated, microprocessor controlled ambulatory blood pressure monitor (ABPM) which records, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual patient (in the patient's environment) for a session which may last 24 hours. Ambulatory monitoring is not supported for the 14-20 cm cuff size.

It is used with a standard upper-arm cuff for blood pressure measurement.

The ABPM 7100 in combination with the Hypertension Management Software (HMS) provides a derived ascending aortic blood pressure wave form and a range of central indices. It is used in those adult patients, where information related to the ascending aortic blood pressure is desired, but in the physician, the risk of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The ABPM 7100 applies the oscillometric principle for blood pressure measurements. The ABPM 7100 consists of the following hardware:

• the ABPM 7100 recorder -
• the brachial blood pressure cuff -

The ABPM 7100 is available with five different cuff sizes to adapt to the patient's arm size.

Initially, the device is prepared for a new patient and measurements are started. Measurement data is recorded and stored in the device's memory. The data can then be transmitted to a computer in the physician's office via Bluetooth or cable for storage, presentation and analysis.

Central Blood Pressure (CBP) calculation is realized through Pulse Wave Analysis, conducted by the Hypertension Management Software with CBP Upgrade.

Here's an analysis of the acceptance criteria and study details for the ABPM 7100, Hypertension Management Software version 5.0, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the accuracy requirements of ISO 81060-2.

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

The document does not explicitly state the specific number of subjects or measurements used for the test sets (both same arm sequential and ambulatory monitoring). It mentions the accuracy testing covered adults and children (age group 3-12 years) and included the new cuff size (14-20 cm) in the same-arm sequential measurements. The source or country of origin of this clinical data is not specified, but the device manufacturer is based in Germany. The study appears to be prospective as it's a clinical validation performed for regulatory submission.

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

This information is not provided in the document. For blood pressure measurement device validation, the ground truth is typically established by trained technicians or clinicians using validated reference devices.

4. Adjudication Method for the Test Set

The document mentions "averaged paired determination per subject" but does not detail an adjudication method involving multiple experts for discrepant readings. For blood pressure studies according to ISO 81060-2, typically multiple measurements are taken by trained operators, and statistical methods are applied to assess accuracy, rather than an "adjudication" by experts in the context of diagnostic interpretation.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a non-invasive blood pressure monitor with software for pulse wave analysis, not an AI-powered diagnostic imaging tool that would typically involve human readers. The primary evaluation is focused on the accuracy of its measurements compared to reference standards.

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

Yes, a standalone performance evaluation was done. The accuracy tests (ISO 81060-2) assess the device's (ABPM 7100 hardware and embedded software) ability to accurately measure blood pressure independently. The "software testing" for the Hypertension Management Software (HMS) also falls under standalone validation according to FDA Guidance "General Principles of Software Validation," ensuring the software's functionality and calculations are correct.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the blood pressure measurements was established by reference to a validated reference blood pressure measurement method, as specified by ISO 81060-2. This standard typically requires simultaneous or sequential measurements using a trained observer with a auscultatory method or another validated reference device.

8. The Sample Size for the Training Set

The document does not mention a training set. This type of medical device (blood pressure monitor) is typically validated against a known standard and its accuracy demonstrated, rather than employing machine learning algorithms that require separate training and test sets. The software verification and validation would be based on functional requirements and technical specifications.

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

Since there is no mention of a "training set" in the context of machine learning, this question is not applicable. The device's underlying algorithms for blood pressure measurement are based on established oscillometric principles and are not described as being "trained" in a conventional machine learning sense from a dataset with established ground truth labels.

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The ABPM 7100 is an automated microprocessor controlled ambulatory blood pressure monitor (ABPM) which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's environment) for a session which may last 24 hours.

The ABPM 7100 in combination with Hypertension Management Software Client Server (HMS-CS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. Use of the Augmentation Index AIx only is restricted to patients of age 40 and above.

It is used with a standard cuff blood pressure measurement.

It is used in those patients where information related to the ascending aortic blood pressure is desired but in the opinion of the physician, the risk of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The ABPM 7100 consist of the following hardware:

• the ABPM 7100 monitor
• the brachial blood pressure cuff -

The ABPM 7100 is available with three different cuff sizes (S, M, L, XL) to adapt to the patient's arm size.

Patient data is stored in the device's memory. The data can then be transmitted to a computer in the physician's office via Bluetooth and Cable. The recordings are displayed for the evaluation by the health professional by the application of the Hypertension Management Software Client Server ("HMS CS").

The ABPM 7100 is used together with the application software the Hypertension Management Software Client Server (HMS-CS 4.7-US) as a system.

The provided document, a 510(k) premarket notification for the ABPM 7100 PWA with Hypertension Management Software Client Server 4.7, indicates that no dedicated clinical performance study was conducted to prove the device meets acceptance criteria. Instead, the submission relies on the device being substantially equivalent to a legally marketed predicate device (K110603 Mobil-O-Graph 24h PWA and HMS CS Version 4.3 by I.E.M. GmbH).

Here's a breakdown of the requested information based on the provided text, with "N/A" (Not Applicable) where the information is explicitly stated as not being required or not performed:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific clinical performance study was conducted for the ABPM 7100 to establish new acceptance criteria and demonstrate performance against them, this table is not explicitly available in the provided document. The primary "acceptance criteria" here is substantial equivalence to the predicate device, which implies meeting its performance characteristics. The document focuses on non-clinical performance data and compliance with standards.

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

• Sample Size for Test Set: N/A (No clinical test set was used for the ABPM 7100 as part of this submission). The non-clinical performance tests mentioned relate to hardware and software validation, not clinical performance on human subjects for efficacy.
• Data Provenance: N/A (No clinical data was generated for the ABPM 7100). The document mentions that the predicate device has been "on the market for many years" with "proven safety and efficacy," implying historical clinical use, but not specific data relevant to a new test set for this submission.

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)

• N/A (No clinical test set was required or used). The "ground truth" for non-clinical tests is based on engineering standards and specifications.

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

• N/A (No clinical test set was required or used).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• N/A (This device is an ambulatory blood pressure monitor; it does not involve "readers" or "cases" in the context of an MRMC study typically seen for imaging AI. There is no AI assistance aspect described for human interpretation).

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

• The device performs automated measurements and provides derived values such as ascending aortic blood pressure waveform and central indices. Its performance described relates to the accuracy and reliability of these automated measurements and derivations. While not explicitly called "standalone performance" in the AI sense, the non-clinical tests validate the algorithm and hardware operating independently to produce these measurements.
• However, the document states: "The ABPM 7100 in combination with Hypertension Management Software (HMS-CS) provides a derived ascending aortic blood pressure waveform and a range of central indices. Use of the Augmentation Index AIx only is restricted to patients of age 40 and above. It is used with a standard cuff blood pressure measurement." This indicates it's a system (device + software) that produces outputs, intended to be evaluated by a healthcare professional ("in the opinion of the physician"). The software's performance was tested according to validation procedures, implying its algorithms operate in a "standalone" fashion to process data and generate outputs.

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

• For the non-clinical hardware tests, the "ground truth" would be established by the specifications and acceptance limits defined in the relevant international standards (e.g., IEC 60601-1 for electrical safety, IEC 80601-2-30 for non-invasive sphygmomanometers, ISO 10993-1 for biocompatibility, IEC 60601-1-2 for EMC).
• For the software, the "ground truth" for its verification and validation would be established by functional and performance requirements derived from its design inputs and intended use, verified against those requirements according to internal procedures and FDA guidance.
• No clinical ground truth (like expert consensus on actual patient conditions or pathology) was used for this submission for the ABPM 7100, as no clinical testing was performed.

8. The sample size for the training set

• N/A (No de novo clinical training set for algorithms was mentioned or implied for this device). The device relies on established principles of blood pressure measurement and arterial waveform analysis, likely incorporating algorithms developed through previous research or calibration data, but the submission does not detail a new "training set" for the ABPM 7100 itself.

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

• N/A (No de novo clinical training set was mentioned).

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The Mobil-O-Graph 24h PWA system featuring PWA is an automated microprocessor controlled ambulatory blood pressure monitor (ABPM) which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient's environment) for a session which may last 24 hours.

The Mobil-O-Graph 24h PWA in combination with Hypertension Management Software Client Server (HMS-CS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. Use of the Augmentation Index Alx only is restricted to patients of age 40 and above.

It is used with a standard cuff blood pressure measurement.

It is used in those patients where information related to the ascending aortic blood pressure is desired but in the opinion of the physician, the risk of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The Mobil-O-Graph 24h PWA is a modified version of the Mobil-O-Graph New Generation (K072446). Hardware, general design and housing are very similar, being different in minor items such as artwork /labeling, etc. Full blood pressure measurement technology, hardware including electrical components, sensors, safety circuits and the cuff are identical to the cleared device. The internal device software (=firmware) algorithms for blood pressure measurement are identical. Minor additions have been made to allow for execution of PWA-measurements. Internal memory has been extended to collect the additional data generated during PWA measurement.

Like the predicate Mobil-O-Graph New Generation (K072446), the new device Mobil-O-Graph 24h PWA is used together with the Hypertension Management Software Client-Server (HMS-CS). Full functionality and technology for read-out, storage, evaluation and display of data related to ambulatory blood pressure monitoring (ABPM) is therefore substantially equivalent.

Like the predicate device SphygmoCor CvMS (K070795), consisting of data acquisition hardware and associated computer software, the Mobil-O-Graph 24h PWA together with its analysis software Hypertension Management Software Client-Server (HMS-CS) is a computerized tool for the assessment of a range of central indices. The Mobil-O-Graph 24h PWA system featuring PWA measures peripheral (brachial) blood pressure and records the peripheral pulse wave. The software HMS-CS utilizes a general transfer function (GTF) to derive an ascending aortic pulse wave from the readings. Measurements and the pulse wave are used to calculate a range of central arterial indices.

The Mobil-O-Graph 24h PWA is used with a standard brachial blood pressure cuff measurement, like the predicate Mobil-O-Graph New Generation. The Mobil-O-Graph 24h PWA is intended for use on those patients where information related to ascending aortic blood pressure is desired. In addition, the Mobil-O-Graph 24h PWA incorporates an option to enable users to carry out and store Pulse Wave Analysis (PWA) over 24 hours, in parallel to regular 24h ambulatory blood pressure measurement.

The Mobil-O-Graph 24h PWA is made up of two primary system components: 1) a modified reqular ABPM Mobil-O-Graph New Generation (K072446); 2) proprietary software HMS-CS, current version V4.3.

Full data acquisition and storage of measurements for both ABPM and PWA is realized by the Mobil-O-Graph 24h PWA device itself, without any use of the HMS-CS software. Analysis of raw data and calculation of PWA-related parameters is realized through the HMS-CS software. To calculate and display the PWA results, the Mobil-O-Graph 24h PWA must be coupled via Bluetooth to a physician's computer that is currently running HMS-CS Software.

For PWA measurements, there are two modes, 1 and 2. Mode 1 is called "practice monitoring". where the patient is at the physician's office and has both blood pressure and PWA measurements started manually. Data transfer is directly after completion of the measurement, via Bluetooth wireless technology. PWA parameters are calculated right away, so the physician can evaluate the result while seeing the patient.

Mode 2 is called "24h PWA", where the patient leaves the office and the device takes both measurements in automated mode, over a period of 24 hours. Upon return of the patient (and the device) to the physician, data is transferred completely to the physician's PC for later evaluation.

The Mobil-O-Graph 24h PWA system is available with three different cuff sizes (M, L, XL) based on patient's arm size.

All measurements may be stored and viewed on a computer which is connected to the Mobil-O-Graph 24h PWA via a standard Bluetooth connection. Patient data can be printed using a reqular installed office printer, preferably with color capability.

The device does not generate any real-time alarms. It does not provide diagnosis. Clinical judgment and experience are required to evaluate and interpret the information provided.

The provided text describes the Mobil-O-Graph 24h PWA, a device that monitors blood pressure and performs pulse wave analysis (PWA). The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a dedicated study report for the device's performance against specific metrics.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the Mobil-O-Graph 24h PWA in a tabular format as would typically be found in a comprehensive validation study. Instead, it relies on demonstrating substantial equivalence to predicate devices, particularly the SphygmoCor CvMS for the PWA features.

The key statement regarding performance is:
"In addition, a clinical study comparing the Mobil-O-Graph 24h PWA with HMS-CS and the SphygmoCor CvMS has been conducted and it has demonstrated that the devices performed substantially equivalently with regard to their ability to provide a derived ascending aortic blood pressure waveform and a range of central arterial indices."

This implies that the acceptance criteria for the PWA features were met if the Mobil-O-Graph 24h PWA's performance was "substantially equivalent" to that of the SphygmoCor CvMS for "derived ascending aortic blood pressure waveform and a range of central arterial indices." However, no specific numerical thresholds for this equivalence (e.g., mean difference, standard deviation of difference) are provided.

For the basic blood pressure measurement, the device meets relevant standards:

• SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003 (Manual, electronic or automated sphygmomanometers)
• IEC 80601-2-30:2009 (Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers)
• ISO 81060-2:2009 (Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type)

Meeting these standards implicitly defines acceptance criteria for blood pressure accuracy, but the document does not list the specific performance reported against these standards for this particular device (it refers to the original 510(k) for the Mobil-O-Graph New Generation for this evidence).

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

• Sample Size: Not explicitly stated. The document mentions "a clinical study comparing the Mobil-O-Graph 24h PWA with HMS-CS and the SphygmoCor CvMS has been conducted." However, the number of participants or cases in this clinical study is not provided in the summary.
• Data Provenance: Not explicitly stated. The submitter is based in Germany, and clinical studies for medical devices often involve subjects from the country of origin or regions where the device is intended for sale, but this is not confirmed in the summary. It's also not specified whether the study was retrospective or prospective.

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

Not applicable/Not specified. The study described is a comparison study against a predicate device (SphygmoCor CvMS), not a study where human experts establish ground truth for a diagnostic task. The SphygmoCor CvMS itself serves as the "reference" or "gold standard" for comparison in this context.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Since the study is a comparison against a predicate device and not an evaluation of diagnostic performance against expert consensus, an adjudication method in the traditional sense (e.g., for discrepancy resolution among experts) is not relevant to the described study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

Not applicable. The Mobil-O-Graph 24h PWA is a device for measuring physiological parameters (blood pressure, pulse wave analysis) and calculating derived indices. It is not an AI-assisted diagnostic tool designed to improve human reader performance in interpreting images or other complex data. Therefore, an MRMC study and the concept of "improving human readers with AI assistance" do not apply to this device.

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

Yes, in essence. The Mobil-O-Graph 24h PWA, particularly its PWA feature with the HMS-CS software, operates as an algorithm-only system to derive central arterial indices. The clinical study mentioned compares the output of this standalone system (Mobil-O-Graph 24h PWA + HMS-CS) directly against the output of the predicate standalone system (SphygmoCor CvMS). The device's output is then interpreted by a physician, but the generation of the PWA parameters themselves is an automated process without real-time human intervention in the calculation pipeline.

7. The Type of Ground Truth Used

The "ground truth" for the PWA features in the comparison study was the measurements and derived indices from the predicate device, SphygmoCor CvMS. This is a comparative study where the predicate device acts as the reference for establishing "substantial equivalence," not an independent gold standard like pathology or long-term outcomes data. For the basic blood pressure measurements, ground truth would typically be established by a reference standard like intra-arterial pressure measurement for clinical validation (as per ISO 81060-2:2009), but the document refers to previous 510(k) submissions for this.

8. The Sample Size for the Training Set

Not applicable/Not specified. The document does not describe the development or training of a machine learning model. The PWA functionality appears to be based on "a general transfer function (GTF)" and "algorithms (called ARCSolver)," which are likely deterministic or model-based, rather than learned from a training set in the machine learning sense. If there was any parameter tuning or development data used for these algorithms, it is not mentioned.

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

Not applicable. As no training set is described for a machine learning model, this question is not relevant.

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The Mobil-O-Graph ABPM system is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's environment) for a session which may last 24 to 48 hours.

The Mobil-O-Graph NG ABPM (24 hour Automatic Blood Pressure Monitor) is a fully automatic table model device that measures blood pressure by means of an inflatable cuff on the upper arm. It employs the Oscillometric Principle.

This 510(k) summary states that the Mobil-O-Graph NG ABPM is substantially equivalent to a predicate device (ABPM Mobil-O-Graph Blood Pressure Monitor, K964235) manufactured by the same company. The basis for this equivalency is stated to be similar intended use, general design, materials, components, and performance characteristics.

When a device is determined to be substantially equivalent to a predicate device, it typically means that specific new clinical studies to prove effectiveness are often not required if the new device does not raise new questions of safety or effectiveness. Instead, the focus is on demonstrating that the new device performs as well as, or better than, the predicate device through comparative data.

However, the provided text does not contain any specific acceptance criteria or details of a study with performance data that directly measure device accuracy (e.g., against a reference standard like intra-arterial blood pressure measurements) or clinical effectiveness. The document primarily focuses on establishing substantial equivalence based on technological characteristics and intended use.

Here's an analysis based on the provided text, while noting the absence of detailed study information:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the document. For blood pressure monitors, acceptance criteria typically involve accuracy standards (e.g., ISO 81060-2 or AAMI/ANSI SP10) for mean difference and standard deviation between the device and a reference method for systolic and diastolic blood pressure.
• Reported Device Performance: Not reported in the document. The document states that the new device "has the same general design and performance characteristics as the predicate device," implying similar performance to the already cleared predicate. However, no specific performance metrics are provided for the Mobil-O-Graph NG.

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified, as no specific performance study is detailed in the summary.

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

• Not applicable, as no specific performance study with expert ground truth establishment is described.

4. Adjudication Method for the Test Set

• Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this 510(k) summary, as it's not relevant for a blood pressure monitor.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

• The document implies that performance is expected to be similar to the predicate device due to shared technological characteristics. However, a specific standalone performance study for the Mobil-O-Graph NG is not described in this summary. Blood pressure monitors are inherently "standalone" in their measurement function, but validation typically involves comparison to a gold standard.

7. The Type of Ground Truth Used

• Not applicable, as no specific performance study with ground truth is described. For blood pressure devices, the "ground truth" for accuracy studies is typically intra-arterial blood pressure measurement or auscultation by trained observers using a mercury sphygmomanometer, according to recognized standards.

8. The Sample Size for the Training Set

• Not applicable, as this device's clearance appears to be based on substantial equivalence to a predicate device, rather than a de novo algorithm development that would involve a training set.

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

• Not applicable.

In conclusion, the document emphasizes that the Mobil-O-Graph NG ABPM is substantially equivalent to a previously cleared predicate device due to shared fundamental characteristics. While this is sufficient for 510(k) clearance in many cases, this specific summary does not provide details about a performance study with acceptance criteria, reported performance, sample sizes, or ground truth establishment for the Mobil-O-Graph NG itself. The assumption is that the predicate device met the necessary performance standards, and thus, the substantially equivalent new device will also perform adequately.

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The Stabil-O-Graph Blood Pressure Monitor is intended to be used by adults at home to measure blood pressure (systolic and diastolic) and pulse rate from the upper arm.

The I.E.M. Stabil-O-Graph is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).

The Stabil-O-Graph Blood Pressure Monitor is a fully automatic table model device that measures blood pressure in a human being by means of an inflatable cuff on the upper arm. It employs the method of the "Oscillometric Principle".

This 510(k) summary for the Stabil-O-Graph Blood Pressure Monitor (K041313) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested format.

The document primarily focuses on establishing substantial equivalence to a predicate device (OMRON, Model HEM-711 (773AC), K021862) based on similar intended use, design, technological characteristics, materials, and components.

Here's why the requested information cannot be extracted from the provided text:

• No specific acceptance criteria are listed. The document states the device has "the same general design and performance characteristics as the predicate devices" but doesn't quantify what those performance characteristics are or what statistical thresholds constitute "acceptance."
• No study details are provided. There is no mention of a clinical trial or performance study conducted for the Stabil-O-Graph. The submission relies on the substantial equivalence to the predicate, implying that the predicate's performance data is sufficient without new testing.

Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided document.

Summary of what can be inferred from the document:

• Device Type: Noninvasive Blood Pressure Measurement System.
• Intended Use: For adults at home to measure blood pressure (systolic and diastolic) and pulse rate from the upper arm.
• Method: Oscillometric Principle.
• Comparison: Substantially equivalent to OMRON, Model HEM-711 (773AC) (K021862).

To fulfill the request, a document that describes the actual performance testing and the specific criteria used to evaluate the Stabil-O-Graph Blood Pressure Monitor would be required. This typically involves comparison to a reference standard (e.g., auscultatory measurements) and predefined accuracy standards (like those from ISO, AAMI, or BHS).

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