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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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