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.

AI/ML Overview

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

Acceptance Criteria (Inferred from Substantial Equivalence to Predicate)	Reported Device Performance
Intended Use: For blood flow measurements in the microcirculation.	Meets intended use.
Technological Principle: Relies on the laser Doppler principle to measure tissue blood perfusion.	Relies on the same physical principle.
Safety: Compliance with standards for electrical safety, laser radiation safety, electromagnetic compatibility, and programmable medical devices.	Designed and tested for compliance with relevant safety standards.
Effectiveness: Achieve the same performance as the predicate device (moorLDI2-IR) in terms of blood flow imaging.	"Achieved the same performance as the predicate device moorLDI2-IR laser Doppler imager" in comparison tests involving flow models and image scans.

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Moor Instruments. The logo consists of a stylized sunburst graphic on the left, followed by the text "moor instruments" in a bold, sans-serif font. Below this, the text "laser Doppler blood flow assessment" is written in a smaller, lighter font.

Image /page/0/Picture/1 description: The image contains a handwritten sequence of characters. It starts with a capital letter 'K', followed by 'of', and then the numbers '3561'. The characters are written in a cursive style, with the numbers being slightly more spaced out than the letters.

7 510(k) Summary

Submitter:	Moor Instruments Ltd
Address:	MillweyAxminster, DevonEX13 5HU, United Kingdom
Telephone:	(+44) 1297 35715
Fax:	(+44) 1297 35716
Contact:	Xiabing Huang
Contact title:	Technical Manager
E-mail:	xhuang@moor.co.uk
Date:	November 17, 2006
Model Name:	moorLDLS Laser Doppler Line Scanner
Model Number:	moorLDLS
Common Name:	Laser Doppler Imager
Classification Name:	Extravascular blood flow probe, DPT, 21 CFR 870.2120Laser surgical instrument for use in general and plasticsurgery and in dermatology, GEX, 21 CFR 878.4810
Regulatory Status:	Class II
Establishment Reg No:	8043564
Type of 510(k):	Traditional
Reason for submission:	New device
Predicate Device:	moorLDI2-IR Infrared Laser Doppler Imager510(k) Number K032841

Moor Instruments Ltd Millwey Axminster Devon EX13 5HU UK tel +44 (0)1297 35715 fax +44 (0)1297 35716 email sales@moor.co.uk website www.moor.co.uk Company Registered in England No. 2209367 VAT Registration No. GB490667906

Image /page/0/Picture/5 description: The image contains two certification logos. The logo on the left is the SGS certification logo, with a checkmark inside a circle and the text "ISO 13485:2003 SGS" around the circle. The logo on the right is the UKAS Quality Management logo, with a crown above a checkmark and the text "UKAS QUALITY MANAGEMENT 005" below the checkmark.

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Description of the Device 7.1

7.2 Intended Use

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

Technological Characteristics 7.3

The operation and design of the moorLDLS line scanner and moorLDI2-IR laser Doppler image are very similar. 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.

The main difference between two devices is the scanning method. The moorLDI2-IR device scans a low power laser beam over the tissue surface in a raster pattern to produce a two dimensional colour coded blood perfusion image. while the moorLDLS line scanner uses a low power laser line to sweep across the tissue for rapid scanning.

7.4 Performance Data

In order to evaluate the performance of the moorLDLS laser Doppler line scanner. and determine its substantial equivalence to the predicate device moorLDI2-IR, a set of comparison tests has been carried out. These include flow model and image scan using both devices. The results suggest that moorLDLS line scanner has achieved the same performance as the predicate device moorLDI2-IR laser Doppler imager.

The moorLDLS line scanner has been designed and tested for compliance with the standards for electrical safety, laser radiation safety, electromagnetic compatibility and programmable medical device.

Conclusions 7.5

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Moor Instruments Ltd % Xiabing Huang Technical Manager Millwey Axminster, Devon EX13 5HU United Kingdom

JAN 1 9 2007

Re: K063561

Trade/Device Name: moorLDLS Laser Doppler Line Scanner Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular blood flow probe Regulatory Class: Class II Product Code: DPT Dated: November 17, 2006 Received: November 27, 2006

Dear Xiabing Huang:

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 (Special 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 complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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.

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three horizontal lines extending from its body.

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Page 2 -- Xiabing Huang

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 (240) 276-0115 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for
Mark N. Melkerson
Director

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 Statement 5

510(k) Number: K 063561

Device name: moorLDLS Laser Doppler Line Scanner

Indications for use:

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

Prescription Use. Yes (Part 21 CFR 801 SubpartD)

AND/OR

Over-The-Counter Use: No (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number 1063561

Regulation Number and Section

§ 870.2120 Extravascular blood flow probe.

(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).