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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The submission focuses on demonstrating "substantial equivalence" to the predicate device, not on meeting predefined numerical performance targets.	"moorLDI2-IR has achieved the same performance as the predicate device moorLDI laser Doppler imager" in "flow model, single point measurement and image scan using both devices." Specific metrics or quantitative results are not provided.

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.

Summary

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Moor Instruments Ltd

DEC 1 0 2003

EDICAL AND OPTO-ELECTRONIC INSTRUMENTATION

Millwey, Axminster Devon EX13 5HU England

Image /page/0/Picture/4 description: The image is a black and white drawing of a sun-like figure. The figure has a dark, circular center with many lines radiating outwards from the center. The lines vary in length and thickness, and they are arranged in a radial pattern around the center.

TEL: +44 (0) 1297 35715 FAX: +44 (0) 1297 35716 E-MAIL: mail @moor.co.uk WEBSITE: http://www.moor.co.uk

Image /page/0/Picture/6 description: The image contains a handwritten string of alphanumeric characters. The string reads 'K032841'. The characters are written in a cursive style, with some connections between the numbers.

Premarket Notification 510(k) Summary

Company Name:

Address:

Telephone No:

Fax No:

Contact Name:

Contact Title:

Date:

MOOR INSTRUMENTS LIMITED

MILLWEY AXMINSTER, DEVON U.K. EXI3 SHU

+44 (0)1297 35715

+44 (0)1297 35716

DAVE BOGGETT

Managing Director

02/12/2003

Image /page/0/Picture/22 description: The image shows a circular seal with the text "ASSURED FIRM" around the top half of the circle. Inside the circle is the number 5485. Below the number is a check mark and the letters "SGS".

Image /page/0/Picture/23 description: The image contains two logos. The logo on the left is the ISO 9001 quality standard logo, which is a circular seal with the text "QUALITY ASSURED FIRM" around the perimeter and "ISO 9001" in the center. The logo on the right is the UKAS Quality Management logo, which features a crown above a checkmark and the text "UKAS QUALITY MANAGEMENT" below. The number 605 is at the bottom of the UKAS logo.

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K03284|

510(k) Summary

Classification Name:

Blood Flow, Cardiovascular Product Code: DPT

Common/Usual Name:

Trade/Proprietary Name:

Establishment Registration No:

Classification:

Performance Standard:

CFR Section: 870.2120

Laser Doppler Perfusion Imager

moorLDI2-IR Infrared Laser Doppler Imager

8043564

Regulatory Class II

The equipment conforms to IEC 825:1:1993 + A1:1997 + A2:2001 Class 3R Medical Laser Product as per IEC 825:1:1993 + A1:1997 + A2:2001

The equipment complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50. Dated July 26, 2001

Reason for Submission:

Predicate Devices:

New Device

moorLDI Laser Doppler Perfusion Imager 510(k) Number - K980383

Description of the Device

Intended Use

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

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Technological Characteristics

. moorLDI2-IR Compared with moorLDI Laser Doppler Imager

The operation and design of the moor DI2-IR infrared laser Doppler image is based on the predicate device moorLDI. They both have the same intended use. Both devices rely on the same physical principle, i.e. the laser Doppler principle, to measure the tissue blood perfusion. Both instruments scan a low power laser beam over the tissue surface in a raster pattern to produce a two dimensional colour coded blood perfusion image. The main differences between two devices are the laser sources and inclusion of colour video camera in the moorLDI2-IR.

However, the potential hazards due to use of a near infrared lascr source is not considered to compromise the safety of the instrument since the moorLD12-IR has been designed to comply with all related safety standards and has implemented the extra safety precautions such as beam attenuator, visible aiming beam and infrared emission indicator to reduce the risks to an acceptable level.

Performance Data

In order to evaluate the performance of the moorLD2-IR infrared laser Doppler perfusion imager, and determine its substantial equivalence to the predicate device moorLDI, a set of comparison tests has been carried out. These include flow model, single point measurement and image scan using both devices. The results suggest that moorl DI2-IR has achieved the same performance as the predicate device moorLD1 laser Doppler imager.

Conclusions

From the description of the technological characteristics and the performance data, it can be concluded that the moorLDI2-IR infrared laser Doppler imager is substantial cquivalence to the predicate device moorLDI in terms of effectiveness and safety.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

DEC 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. David Boggett Managing Director Moor Instrument Ltd Millwey Axminster Devon, EX 13 5HU United Kingdom

Re: K032841

Trade/Device Name: moorLD12-IR Infrared Laser Doppler Imager Regulation Number: 21 CFR 870.2120, 21 CFR 878.4810 Regulation Name: Extravascular blood flow probe; Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: DPT, GEX Dated: September 5, 2003 Received: September 11, 2003

Dear Dr. Boggett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Spccial Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencics. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. David Boggett

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K 032841

Device Name: moorLD12-1R Infrared Laser Doppler Imager

Indications For Use:

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

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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