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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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