(378 days)
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:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tissue Oxygen Measurement (SO2, oxy-Hb, deoxy-Hb) | Substantial equivalence to predicate device (T-Stat 303) | "The moorVMS-OXY has been subjected to both in vitro and in vivo testing to determine its substantial equivalence to the predicate device, Spectros T-Stat 303 for tissue oxygen measurement." "Based on the design, technological characteristics, performance and functional testing and intended use, it can be concluded that the moorVMS-OXY tissue oxygen monitor is substantially equivalent to the predicate device." |
| Simultaneous Tissue Oxygen and Blood Flow Measurement (with moorVMS-LDF monitor) | No interference between measurements and effective simultaneous measurement. | "The tissue oxygen and laser Doppler blood flow combined probes have been tested for simultaneous tissue oxygen and blood flow measurement. The results show that there is no interference between the tissue oxygen and blood flow measurements, and the moorVMS-OXY combined probes can provide simultaneous tissue oxygen and blood flow measurement when they are used in conjunction with a moorVMS-LDF laser Doppler blood flow monitor." |
| Electrical Safety, EMC, Biocompatibility | Compliance with relevant requirements | "The moorVMS-OXY is designed to comply with the requirements of electrical safety, electromagnetic compatibility and biocompatibility." |
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.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).