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The moorVMS-OXY monitor is a non-invasive monitoring system that measures tissue oxygen saturation and tissue temperature in microcirculation. It is intended to noninvasively and continuously measure approximated value of hemoglobin oxygen saturation in superficial tissues for clinical research applications. The clinical value of measurements in disease states has not been demonstrated. The moorVMS-OXY monitor should not be used as the sole basis for diagnosis or therapy.

The moorVMS-OXY monitor can also be used for the simultaneous measurement of tissue oxygen saturation and blood flow in microcirculation using a combined probe in conjunction with a moorVMS-LDF laser Doppler blood flow monitor.

The moorVMS-OXY is a device for taking non-invasive measurements of tissue hemoglobin (oxy-Hb and deoxy-Hb) and oxygen saturation (SO2), together with tissue temperature. It is based on the theory of while-light reflectance spectroscopy and its measurement relies on spectrophotometric principles that relate light absorption to chromophore concentrations.

Measurements are taken using probes which are placed with the tissue at the measurement site. Optical fibres are used to deliver illumination light to the tissue and collect reflectance light to the instrument for processing. The moorVMS-OXY™ analyses the back scattered reflected light in the wavelength range of 500 to 650nm and calculates tissue oxygenation by matching the collected spectra to the absorption curves from known concentrations of oxygenated / deoxygenated hemoglobin. This is to allow a rapid and accurate measurement of oxygenation saturation SO2(%), total hemoglobin and oxygenated hemoglobin levels in the sample volume.

When used in conjunction with a moorVMS-LDF laser Doppler blood flow monitor, the moorVMS-OXY can also be used for the simultaneous measurement of tissue oxygen saturation and blood flow in microcirculation using a combined probe.

The moorVMS-OXY Tissue Oxygen and Temperature Monitor is a non-invasive device designed to measure tissue hemoglobin (oxy-Hb and deoxy-Hb) and oxygen saturation (SO2), along with tissue temperature, in microcirculation. It utilizes white-light reflectance spectroscopy and spectrophotometric principles to analyze light absorption and chromophore concentrations.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes performance testing but does not explicitly list quantitative acceptance criteria with corresponding reported device performance values in a table. Instead, it states that "extensive functionality and performance testing have been conducted for the moorVMS-OXY to verify its adherence to the requirements."

However, the key performance claim for substantial equivalence is based on:

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

The document mentions "both in vitro and in vivo testing" but does not specify the sample size for these tests for either the test set or the training set. It also does not explicitly state the country of origin or whether the data was retrospective or prospective. However, Moor Instruments Ltd is based in the United Kingdom, suggesting the studies likely occurred there or in collaboration with institutions in other developed countries. Given the nature of a 510(k) submission and the reference to "clinical research applications," the in vivo testing would typically be prospective, though this is not explicitly stated.

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

The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used 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:

This device is an oximeter, a measurement device, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.

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

The moorVMS-OXY is a standalone measurement device. The performance testing described (in vitro and in vivo testing to determine substantial equivalence) inherently represents the standalone performance of the algorithm and hardware in measuring tissue oxygenation and temperature.

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

The document does not explicitly state the type of ground truth used. Given that the device measures physiological parameters (hemoglobin, oxygen saturation, temperature), the ground truth for "substantial equivalence" would typically involve comparison against:

• Reference standard instruments: Highly accurate, established oximetry or spectrophotometry systems that are considered gold standards for measuring these parameters.
• Physiological challenges: Inducing controlled changes in tissue oxygenation (e.g., occlusion, hyperoxia, hypoxia) and comparing the device's readings against expected physiological responses.

8. The Sample Size for the Training Set:

The document does not specify the sample size for the training set.

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

The document does not provide information on how the ground truth for any training set might have been established. Given the device's nature as a direct physiological measurement tool, it's more likely to be calibrated and validated against known standards rather than trained on a dataset with expert-labeled ground truth in the way a diagnostic AI model would be. Calibration would typically involve known concentrations of oxygenated/deoxygenated hemoglobin in a controlled environment.

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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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