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The moorLDI2 Laser Doppler Imager is intended for blood flow measurements in the microcirculation. It is intended to be used for clinical research applications and pre-clinical research applications.

The moorLDI2 is a device to perform non-invasive blood flow measurements in the microcirculation, for example skin, using the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. The system scans a very low power laser beam across the tissue. Moving blood in the microvasculature causes a Doppler frequency shift of the laser light, which is photo detected and processed to generate a colour coded blood flow map, line by line. An in built CCD camera records a colour photograph to aid visualisation of the scan site.

The Moor Instruments Ltd moorLDI2 Laser Doppler Imager is a device intended for blood flow measurements in the microcirculation for clinical and pre-clinical research applications. The 510(k) summary provides information regarding its performance and comparison to a predicate device (moorLDI2-IR laser Doppler imager, K032841).

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a pass/fail sense for a clinical study comparing the new device against specific benchmarks. Instead, it focuses on demonstrating substantial equivalence to the predicate device. The performance characteristics of the device itself are given.

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

The document states: "The moorLDI2 laser Doppler imager was tested in direct comparison to the predicate device using laboratory models and skin blood flow measurements on volunteers."

• Sample Size: Not explicitly provided. The number of laboratory models or volunteers used is not specified.
• Data Provenance: The study involved "laboratory models" and "skin blood flow measurements on volunteers." The country of origin for the data is implicitly the United Kingdom, where Moor Instruments Ltd is based. The data would be considered prospective as it involves new testing for the purpose of this submission.

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. The type of testing performed (laboratory models, skin blood flow measurements) suggests objective measurements rather than subjective expert consensus for ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable as the document describes direct comparison testing using objective measurements of performance characteristics rather than an expert-adjudicated test set in the traditional sense.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not conducted or described. The device is a measurement instrument, and the study focused on technical performance comparison rather than human reader interpretation with and without AI assistance.

6. Standalone Performance:

Yes, a standalone performance evaluation was done. The document provides detailed specifications and performance parameters like "Accuracy" for Flux, Concentration, and DC (Intensity), stating these accuracies relative to a standard. The study also concludes that the device performs "as well as or better than the predicate device," which implies standalone performance evaluation of the new device and its comparison to the predicate.

7. Type of Ground Truth Used:

The ground truth appears to be based on objective physical measurements from "laboratory models" and "skin blood flow measurements on volunteers." For parameters like Flux, Conc, and DC, accuracy is given relative to "Moor Instruments 'standard' moorLDI" and a "temperature controlled (22 ±1°C) motility standard." This suggests a reliance on established measurement standards and controlled experimental conditions to define the true values.

8. Sample Size for the Training Set:

This information is not provided and is likely not applicable. The device is not described as an AI/ML algorithm that requires a training set in the conventional sense. It's a measurement instrument, and its development would involve engineering design and calibration rather than AI model training.

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

This information is not provided and is not applicable, as there is no mention of an AI/ML component requiring a training set with established ground truth.

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The moorLDLS-BI laser Doppler burns imager assesses the blood flow in burn wounds of the skin, when cleaned of surface debris, to aid in the clinician's assessment of burn wound healing potential. It is intended to be used as an aid to burn wound management for patients with Total Body Surface Area burn of up to 30%.

The device is intended to be used as an aid to burn wound assessment, and not as a stand-alone prediction device.

The moor DLS-BI laser Doppler burns imager is an imaging device to aid the clinician to judge the healing potential of bums and the need for surgery.

It uses the laser Doppler imaging technique to quantify the blood flow in an area of skin damaged by a burn. The device uses a line of laser light projected onto the tissue and a linear detector arrav that sample from the line as it is swept across the tissue to rapidly build up a colour coded image of blood flow in the burn area and the surrounding normal skin for healing potential prediction. In addition, a CCD camera is integrated into the scanner unit for recording a colour photograph at the time of scanning, corresponding closely with the blood flow image in size and aspect.

The moorLDLS-BI laser Doppler burns imager is a substantial equivalent to the predicate device moorLDI2-B1 and assesses burn wound healing potential.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the clinical investigation's objectives and the comparative analysis against the predicate device. The primary performance metrics are accuracy in predicting healing potential and agreement with the predicate device.

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

• Sample Size for Test Set: 596 burn cases for 204 burn patients.
• Data Provenance: Multi-center clinical investigation conducted in five burns centers across various countries: 2 in the UK, 1 in the USA, 1 in Belgium, and 1 in Australia. The study was prospective in nature, as it was a "Clinical Investigation" designed to assess the performance of a new device.

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

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with X years of experience).

However, given the nature of "healing records" being the ground truth and the device's intended use as an aid to "clinician's assessment of burn wound healing potential" by "burn surgeons," it is highly probable that the ground truth was established by burn care clinicians/surgeons responsible for patient management and outcome tracking.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for establishing the ground truth from "healing records."

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

• No, a MRMC comparative effectiveness study was not explicitly done for human readers. The study focused on comparing the performance of the device (moorLDLS-BI) against the predicate device (moorLDI2-BI) and against healing records, not on comparing human reader performance with and without AI assistance.
• Effect size of human reader improvement: Not applicable, as this type of study was not conducted as described. The device is intended as an "aid to burn wound management," implying human oversight, but the study directly compares device performance, not human-AI synergy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance assessment was done. The "overall accuracy of 94.2% was found for moorLDLS-Bl when compared with healing records" represents the device's standalone performance in predicting healing potential.
• It's important to note that while the device has standalone accuracy, its intended use statement explicitly says, "It is intended to be used as an aid to burn wound assessment, and not as a stand-alone prediction device," indicating that clinical interpretation by a human is still required.

7. The Type of Ground Truth Used

• Outcomes Data (Healing Records): The primary ground truth for the overall accuracy of the moorLDLS-BI was based on "healing records." This refers to the actual observed healing time of the burn wounds, which is a direct patient outcome.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. The description mentions a "clinical investigation" and performance data, but does not distinguish between a training set and a testing set in the context of machine learning model development. This suggests the moorLDLS-BI, while a new device, might not be heavily reliant on a trainable "algorithm" in the modern AI sense, but rather on a refined physical measurement principle and associated processing algorithms for which the mentioned clinical investigation serves as a validation/test set.

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

Since a distinct "training set" is not mentioned or detailed, the method for establishing its ground truth is also not described. If any internal development process involved a training phase, that information is not part of this 510(k) summary.

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The moorFLPI-2 Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.

The moorFLPI-2 is a device to perform non-contact imaging of tissue blood perfusion in the microcirculation, for example skin, using speckle contrast analysis. The tissue surface is illuminated with a diverging infra-red laser beam resulting in a laser speckle pattern. The pattern is imaged by a CCD camera and image processing of the speckle contrast is used to generate colour coded images of the tissue blood perfusion in the microcirculation.

The provided text describes the moorFLPI-2 Full-Field Laser Perfusion Imager, a device intended for non-contact imaging of tissue blood perfusion in the microcirculation for clinical research use. It focuses on demonstrating substantial equivalence to a predicate device (moorFLPI Full-Field Laser Perfusion Imager, K063586).

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on a qualitative comparison to the predicate device.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "test set." It mentions "laboratory models and skin blood flow measurements on volunteers." The number of volunteers or specific lab models used is not provided.
• Data Provenance: The study was conducted by Moor Instruments Ltd, located in the United Kingdom. It appears to be a prospective comparison study as it describes testing the moorFLPI-2 directly against the predicate device.

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. The study focuses on direct device comparison rather than relying on expert-established ground truth for a diagnostic outcome.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a direct device comparison (measuring blood flow), a traditional expert adjudication method for a test set of cases is unlikely to be applicable in the same way as for diagnostic imaging.

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 was not done. This device is a measurement instrument for blood flow, not an AI-powered diagnostic tool that assists human readers.

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

The moorFLPI-2 is a standalone device ("Full-Field Laser Perfusion Imager") that performs measurements. The study described compares its performance to another standalone device (the predicate). Therefore, the study, by its nature of comparing two instruments, can be considered evaluating its standalone performance in relation to the predicate. However, it's not an "algorithm only" in the sense of a software-based AI system; it's a hardware device with integrated signal processing.

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

The concept of "ground truth" in the diagnostic sense (e.g., pathology for a tumor) is not directly applicable here. The study established "ground truth" through direct comparison to the predicate device's measurements on the same laboratory models and volunteers. The predicate device (moorFLPI) itself implicitly serves as the "reference standard" or "ground truth" for the new device's performance, as the goal was to demonstrate equivalence.

8. The Sample Size for the Training Set

This information is not applicable or not provided. The moorFLPI-2 is a measurement device that uses speckle contrast analysis, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its underlying physics and signal processing are based on established principles, rather than learning from a large dataset.

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

This information is not applicable as there is no "training set" for an AI algorithm.

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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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The moorVMS-LDF1 and moorVMSLDF2 laser Doppler perfusion and temperature monitors are intended for simultaneous measurement of tissue temperature and blood flow in the microcirculation. The devices are intended for clinical research use.

moorVMS-LDF1 Laser Doppler perfusion and temperature monitor
moorVMS-LDF2 Laser Doppler perfusion and temperature monitor

The provided text is a 510(k) summary for the moorVMS-LDF1 and moorVMS-LDF2 Laser Doppler perfusion and temperature monitors. It outlines the device, its classification, and the substantial equivalence determination by the FDA. However, it does not contain information regarding detailed acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical study report.

The document states that the FDA has determined the device is substantially equivalent to a legally marketed predicate device (DRT4 Laser Doppler perfusion and temperature monitor, K011070). This means the FDA believes the new device is as safe and effective as the predicate, but it does not detail specific performance metrics and their validation studies.

Therefore, I cannot provide the requested information in the structured format you asked for.

Here's why each point cannot be addressed with the provided text:

1. Table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory approval based on substantial equivalence, not detailed performance criteria.
2. Sample size used for the test set and the data provenance: No test set information is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No test set or adjudication method is mentioned.
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 a Laser Doppler perfusion and temperature monitor, not an AI-based diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a monitor, not an algorithm, so this is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no specific performance study with ground truth is detailed.
8. The sample size for the training set: Not applicable as this is not an AI-based device that would require a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as point 8.

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The moorLDI2-BI laser Doppler burns imager assesses the blood flow in debrided burn wounds of the skin. It is intended to be used as an aid to burn wound management for patients with Total Body Surface Area burn of up to 30%.

The moorLDI2-BI laser Doppler imager is a measurement device to aid the clinician judge the healing potential of burns and the need for surgery. It uses the laser Doppler technique to quantify the blood flow in an area of skin damaged by a burn. The device has the means to scan a low power visible red laser beam or low power near infrared laser beam combined with a visible red target beam, across the skin surface enabling a colour coded image of the blood flow in the burn area and the surrounding normal skin to be recorded, together with a monochrome photo image. In addition, a colour video image of the scanned area is recorded using a CCD camera which is an integral part of the device. Regions of interest (e.g. a burn area) can be selected and the statistics of the blood flow values, within the region, calculated and displayed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the moorLDI2-BI Laser Doppler Burns Imager:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a number of cases or patients. The study was conducted "over a 3 year period, from 2001 to 2004."
• Data Provenance: The study was conducted by a group of experienced burns surgeons working in 5 hospital burns centers. The country of origin is not explicitly stated, but the company is based in the UK and the initial predicate device was cleared by the FDA, suggesting international relevance. The study appears to be prospective in nature, as it investigated the use of the devices over a 3-year period to identify and quantify blood flow ranges for prediction.

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

• Number of Experts: A "group of experienced burns surgeons" from 5 hospital burns centers. The exact number is not specified, but it implies multiple experts.
• Qualifications of Experts: "Experienced burns surgeons." No further details on years of experience are provided.

4. Adjudication Method for the Test Set

The text mentions that the experts "identified and quantified three laser Doppler blood flow ranges (high, medium and low) which allow an experienced burns surgeon to predict the healing potential." This suggests a consensus-based approach among the group of surgeons, but a specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not explicitly mentioned. The study described focused on the device's ability to aid surgeons in prediction, not on comparing surgeon performance with and without AI assistance or the device.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not explicitly mentioned. The device is described as an "aid to burn wound management" and for use "by a trained operator (a burns surgeon or under the direction of a burns surgeon)," indicating a human-in-the-loop system rather than a fully autonomous algorithm. The "PC software uses a colour palette for blood flow images based on the results of this clinical investigate which can be used by a trained operator... as an aid to predicting healing potential."

7. Type of Ground Truth Used

The ground truth was based on the healing potential of the burn, categorized as "healing in 21 days." This is a form of outcomes data or clinical endpoint as assessed by experienced burns surgeons.

8. Sample Size for the Training Set

The document does not explicitly mention a separate training set or its sample size. The description of the performance study sounds more like a validation of pre-established "laser Doppler blood flow ranges (high, medium and low)" rather than a development or training study for a new algorithm within the moorLDI2-BI. The "PC software for the moorLDI2-BI is designed specifically for the recording and measurement of blood flow in skin burns... uses a colour palette for blood flow images based on the results of this clinical investigate." This implies the "clinical investigate" informed the color palette and predictive ranges used in the software, rather than explicitly training a machine learning model.

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

As no separate training set is explicitly described in the context of a machine learning algorithm, the establishment of ground truth for a training set is not applicable in the conventional sense of AI/ML development. Instead, the "laser Doppler blood flow ranges (high, medium and low)" (which could be considered analogous to predictive categories) were "identified and quantified" by the "group of experienced burns surgeons" over the 3-year study period based on observed healing outcomes.

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The moorFLPI Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.

The moorFLPI is a device to perform non-contact imaging of tissue blood perfusion in the microcirculation, for example skin, using speckle contrast analysis. The tissue surface is illuminated with a diverging infra-red laser beam resulting in a laser speckle pattern. The pattern is imaged by a CCD camera and image processing of the speckle contrast is used to generate colour code images of the tissue blood perfusion in the microcirculation.

This 510(k) summary does not contain sufficient information to fully address all the requested points about acceptance criteria and a definitive study to prove the device meets them. The document describes the device, its intended use, and technological characteristics, and makes a general claim of substantial equivalence to a predicate device. However, it lacks specific details on formal acceptance criteria and the comprehensive study methodology typically found in detailed performance studies.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or a direct comparison table are provided in this 510(k) summary. The document states that the moorFLPI has "substantially the same performance as the predicate device for measurements of superficial blood flow." This suggests that the acceptance criterion was likely general equivalence to the predicate, moorLDI2-IR, rather than specific numerical targets for metrics like accuracy, precision, sensitivity, or specificity.

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

The document states: "a set of comparison tests has been carried out. These include measurements from a simple flow model and single point and image scans from blood flow in skin, using both devices."

• Sample Size: Not specified. The exact number of measurements, flow models, or human/animal subjects (if any for skin blood flow) is not provided.
• Data Provenance: The tests were conducted internally by Moor Instruments Ltd. (UK-based company). It's a retrospective analysis of test data conducted for the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document does not describe the involvement of human experts for establishing ground truth, as the performance evaluation primarily focuses on the device's ability to measure physiological parameters and demonstrate equivalence to a physical gold standard (simple flow model) and another device (predicate).

4. Adjudication Method for the Test Set

Not applicable. No mention of expert adjudication as the study is not based on diagnostic interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed. The device is a measurement tool, and the comparison was made against a predicate device and a physical flow model, not human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done. The described "comparison tests" of the moorFLPI's measurements against a simple flow model and against the predicate device represent the standalone performance of the device itself.

7. Type of Ground Truth Used

• Physical Model Data: "measurements from a simple flow model." This serves as a controlled, known ground truth for flow.
• Comparative Device Measurements: "single point and image scans from blood flow in skin, using both devices." The predicate device (moorLDI2-IR) essentially served as a reference or a comparative 'ground truth' for real-world superficial blood flow measurements. The statement implies that the moorFLPI's measurements were expected to align with those of the predicate.

8. Sample Size for the Training Set

Not applicable. This device is a measurement instrument, not an AI/machine learning algorithm requiring a "training set" in the typical sense. The "image processing software" uses established physics and signal processing principles (speckle contrast analysis) rather than being trained on a dataset.

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

Not applicable. As implied above, there is no training set in the AI/ML context. The device relies on physical principles for its operation.

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The moorLDLS Laser Doppler Line Scanner is intended for blood flow measurements in the microcirculation.

The moorLDLS laser Doppler line scanner is a device for imaging blood flow in the microcirculation. It uses the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. Unlike the predicate device moorLDI2-IR laser Doppler imager, which use a single low power infrared laser beam, the moorLDLS line scanner sweeps a line of laser light across the tissue to build up a colour coded image of blood flow rapidly.

The document provided is a 510(k) summary for the moorLDLS Laser Doppler Line Scanner, which is a regulatory submission to the FDA. It does not contain a detailed study report with acceptance criteria and specific device performance metrics in the format requested.

However, based on the provided text, I can infer some aspects relevant to your request. The core of this submission is to demonstrate "substantial equivalence" to a predicate device, which inherently means meeting similar performance characteristics.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

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

Study Details:

The document describes a comparison test to evaluate the performance of the moorLDLS line scanner and determine its substantial equivalence to the predicate device moorLDI2-IR.

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: Not specified in the provided text. The text only mentions "a set of comparison tests" including "flow model and image scan using both devices." The number of flow models, images, or subjects/instances used is not detailed.
• Data Provenance: Not explicitly stated as "country of origin of data." The submitter is Moor Instruments Ltd, located in the UK. It is highly probable that the data was generated in the UK. The study appears to be prospective in nature, as it describes tests carried out to evaluate a new device.

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)

• Not applicable/Not specified. This type of study (comparing a new device against a predicate for substantial equivalence) typically focuses on objective performance measurements (e.g., accuracy, reproducibility, correlation with the predicate) rather than expert-established ground truth for diagnostic interpretation. The "ground truth" would likely be the known output of the flow models or the established measurements from the predicate device.

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

• Not applicable/Not specified. Adjudication methods are typically used in clinical studies where expert consensus is needed to resolve discrepancies in interpretation. This specific submission focuses on objective technical comparison.

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

• Not applicable. This is not an AI-assisted diagnostic device, nor is it a multi-reader, multi-case study in the context of human reader performance. It's a device for measuring blood flow, and the comparison is between two instruments.

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

• Yes, implicitly. The performance data described ("flow model and image scan using both devices") implies a standalone evaluation of the device's ability to measure blood flow, independent of human interpretation or assistance beyond operating the device.

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

• Based on the description "flow model and image scan," the ground truth would likely be physical measurements from controlled flow models and/or measurements produced by the predicate device itself, which is considered a legally marketed and established standard for blood flow measurement.

8. The sample size for the training set

• Not applicable/Not specified. This is not a machine learning or AI device that requires a training set in the conventional sense. The "training" for such a device would be its engineering design and calibration based on known physical principles.

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

• Not applicable (as per point 8). The device's design and calibration would be based on fundamental physics and engineering principles, with validation against established standards and methods in laboratory settings.

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The moorLDI2-IR infrared laser Doppler Imager is intended for blood flow measurements in the microcirculation.

The moorLD12-IR infrared laser Doppler imager is a device for imaging blood flow in the microcirculation. It uses the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. Unlike the existing MK1 moorLDI laser Doppler imager, which use a low power visible red HeNe laser, the moorLDI2-IR has a low power infrared laser beam combined with a visible target beam to scan in a raster pattern over the skin surface to build up a colour coded image of blood flow.

Here's an analysis of the provided text regarding the Moor Instruments Ltd. moorLDI2-IR Infrared Laser Doppler Imager:

No specific acceptance criteria or a dedicated study proving device meets acceptance criteria are explicitly provided in the furnished text. The document describes a 510(k) premarket notification for a new device, the moorLDI2-IR, asserting its substantial equivalence to a predicate device, the moorLDI.

The "Performance Data" section briefly mentions "a set of comparison tests has been carried out," but it does not detail specific acceptance criteria (e.g., a target accuracy, precision, or sensitivity/specificity value) that the device must meet, nor does it provide the results in a structured format against such criteria. Instead, it concludes broadly that the new device "has achieved the same performance as the predicate device moorLDI laser Doppler imager."

Therefore, I cannot populate the table with specific acceptance criteria and reported device performance from the provided text. I will provide the other requested information based on what is available.

Acceptance Criteria and Study Details for moorLDI2-IR Infrared Laser Doppler Imager

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified. The document mentions "a set of comparison tests" including "flow model, single point measurement and image scan." It does not provide the number of measurements, cases, or subjects used in these tests.
• Data Provenance: Not explicitly stated whether the data obtained from the comparison tests (flow model, single point, image scan) was collected retrospectively or prospectively. The tests were presumably performed at the manufacturer's location in the UK ("Millwey, Axminster Devon," "United Kingdom").

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

• Not applicable. The document describes technical comparison tests using "flow model, single point measurement and image scan" rather than clinical studies requiring expert interpretation and ground truth establishment from patient data.

4. Adjudication Method for the Test Set

• Not applicable. This type of adjudication method (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation of medical images or data where a consensus ground truth needs to be established. The described tests are technical comparisons of device performance.

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 MRMC comparative effectiveness study was done. This device is a medical instrument for measuring blood flow, not an AI-assisted diagnostic tool that aids human readers.

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

• The document implies that standalone performance testing was done, as it mentions "flow model, single point measurement and image scan using both devices" (the moorLDI2-IR and the predicate moorLDI) for comparison. The tests seem to evaluate the device's inherent capability to measure blood flow rather than its performance in conjunction with human interpretation.

7. The Type of Ground Truth Used

• For the "flow model" tests, the ground truth would likely be established by the known flow characteristics of the model itself.
• For "single point measurement and image scan," the comparison is made against the predicate device (moorLDI), which served as the reference for equivalent performance. Therefore, the "ground truth" implicitly refers to the established performance characteristics and measurements of the predicate device, assuming the predicate device's measurements are considered accurate and reliable.

8. The Sample Size for the Training Set

• Not applicable. This device is a measurement instrument, and the provided document does not mention any machine learning or AI components that would require a "training set" in the conventional sense. The "training" for such devices typically involves calibration in the manufacturing process rather than data-driven model training.

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

• Not applicable, as there is no mention of a training set for an AI/ML model for this device.

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