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The moorVMS-PRES pressure cuff controller is a device for cuff inflation and deflation control and pressure measurement. It is intended to allow non-invasive measurement of skin perfusion pressure, pulse volume, systolic blood pressure and ankle/toe brachial pressure index when used with a laser Doppler monitor either manually by the operator or automatically by separate dedicated PC software.

The moorVMS-PRES vascular assessment pressure cuff controller is a device for cuff inflation and deflation control and pressure measurement. It allows connection of a range of standard pressure cuffs, ranging in size from small digit cuffs. It incorporates an air pump for cuff inflation and a proportional valve for controlled deflation. The moorVMS-PRES provides measurement of cuff gauge pressure which can be displayed on the front panel, and also the AC component of the cuff pressure (referred to as pulse volume) which can be outputted as analogue signals via a BNC connector or as digital data via the USB port.

The moorVMS-PRES is capable of performing timed inflation/deflation sequences when used alone and also be capable of remote control when connected to a PC via USB.

The moorVMS-PRES is intended to form part of a modular vascular monitoring system when used in conjunction with the moorVMS-LDF laser Doppler perfusion and temperature monitors. When used in this way the instruments will be controlled and monitored via USB using PC software to perform vascular assessment such as Skin Perfusion Pressure (SPP), Limb Blood Pressure or Toe Blood Pressure (LBP/TBP), Pulse Volume (PV), and Post Occlusive Reactive Hyperemia (PORH) analyses.

The moorVMS-PRES Pressure Cuff Controller, a device for cuff inflation, deflation control, and pressure measurement, addresses its acceptance criteria and supporting study within the provided document through a comparison to a predicate device and compliance with established performance standards.

The document primarily focuses on establishing substantial equivalence to a predicate device, the Perimed PF 5050 Pressure Unit (K011899), rather than presenting a de novo clinical study with specific performance metrics and dedicated test sets.

Here's a breakdown based on the provided text:

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

The document does not provide a table of acceptance criteria with specific numerical targets and corresponding device performance values. Instead, it relies on a qualitative comparison to the predicate device and compliance with general safety and performance standards.

The key acceptance criteria and reported performance are implicitly stated through the comparison to the predicate device:

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

The document does not explicitly mention a sample size for a dedicated test set for evaluating the moorVMS-PRES's performance. The basis for proving acceptance criteria is primarily through:

• Comparison to a predicate device: This implies that the predicate device's established performance serves as the benchmark.
• Compliance with international standards: This typically involves laboratory testing against specified requirements, but the document does not detail the specific tests conducted, the number of units tested, or the data provenance for these compliance tests.

Therefore, no specific sample size, country of origin, or information on whether the data was retrospective or prospective is provided for a test set in the context of a clinical performance 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 as there is no mention of a clinical test set requiring expert ground truth establishment.

4. Adjudication method for the test set

This information is not provided in the document, as no clinical test set requiring adjudication is described.

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 involving human readers and AI assistance was not done or described in this document. The device is a "Pressure Cuff Controller" and is not an AI-assisted diagnostic tool in the sense of image interpretation where MRMC studies are common.

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

The device itself is a piece of hardware that performs physical actions (cuff inflation/deflation) and measurements. Its performance is inherent to its design and calibration, not a standalone algorithm in the typical sense of AI/image processing. The document focuses on its inherent performance characteristics and its capability to integrate with PC software for analyses. Therefore, this question doesn't directly apply, but the "standalone" performance is implicitly covered by the accuracy and safety standards listed.

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

For the direct comparison and performance claims, the "ground truth" is established by:

• Predicate device performance: The established and accepted performance of the Perimed PF 5050 Pressure Unit serves as the benchmark.
• International standards: Compliance with standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and ISO 10993-1 means the device has met predefined technical and safety specifications, which act as the "ground truth" for those specific aspects.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for a clinical validation or performance study.

8. The sample size for the training set

This information is not applicable/provided. The moorVMS-PRES is a physical medical device, not a machine learning model that requires a "training set" in the context of AI.

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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