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

Device Description

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.

AI/ML Overview

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.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantially equivalent performance to predicate device (moorLDI2-IR) for superficial blood flow measurements.	The results show that the moorFLPI, "within its specified range for flow measurements and area of tissue that can be imaged, has substantially the same performance as the predicate device for measurements of superficial blood flow."
Compliance with electrical safety standards.	"The moorFLPI Full-Field Laser Perfusion Imager has been designed and tested for compliance with the standards for electrical safety..."
Compliance with laser radiation safety standards.	"...laser radiation safety..."
Compliance with electromagnetic compatibility (EMC) standards.	"...electromagnetic compatibility..."
Compliance with programmable medical device standards.	"...and programmable medical device."

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.

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 words "moor instruments" in a sans-serif font. Below the company name is the tagline "laser Doppler blood flow assessment" in a smaller, lighter font.

K063586

7 510(k) Summary

Submitter:	Moor Instruments Ltd
Address:	MillweyAxminster, DevonEX13 5HU, United Kingdom
	JAN 2 5 2007
Telephone:	(+44) 1297 35715
Fax:	(+44) 1297 35716
Contact:	Xiabing Huang
Contact title:	Technical Manager
E-mail:	xhuang@moor.co.uk
Date:	November 27, 2006
Model Name:	moorFLPI Full-Field Laser Perfusion Imager
Model Number:	moorFLPI
Common Name:	Full-Field Laser Perfusion 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 L.td Millwey Axminster Devon EX13 5HU UK 1el +44 (0)1297 35715 fax +44 (0)1297 35716 emall sales@moor.co.uk website www.moor.co.uk Company Registered in England No. 2205367 VAT Registration No. GB490867906

Image /page/0/Picture/5 description: The image contains two certification logos. The logo on the left has a check mark inside a circle with the text "ISO 9001:2015 SGS". The logo on the right has a check mark with a crown above it and the text "UKAS QUALITY MANAGEMENT 005" below it.

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Description of the Device 7.1

7.2 Intended Use

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

7.3 Technological Characteristics

Tissue is illuminated by floodlighting with a diverging infra-red laser beam. The tissue is imaged with a CCD camera and video data is acquired by a PC. Image processing software on the PC is used to generate colour-coded maps of tissue perfusion. The image processing software uses the fact that high perfusion produces rapid variation in the laser speckle pattern, which is integrated by the CCD to produce an area of low contrast (seen as blurring of the speckle pattern in the video image). Conversely, low perfusion causes little variation in the speckle pattern and as a result a high contrast area of well-defined speckle is produced in the video image. Contrast is quantified and the resulting flux is colour-coded to produce a perfusion image.

The moorFLPI uses a large diameter diverging laser beam to illuminate an area of tissue and measures tissue perfusion at all points in the image simultaneously, hence the "Full-Field" designation in the device name. The predicate device uses a collimated laser beam to sequentially illuminate very small areas of tissue and generates images by scanning the beam in a raster pattern. These differences in the means to capture a single frame image mean that the moorFLPI is able to generate images more rapidly than the predicate device. The moorFLPI records images at video rates (25 frames/second) and the moorLDI2-IR takes approximately 2 minutes to record a single 'frame' 100x150 pixel blood flow image. The effect of possible temporal variations in tissue perfusion recorded with the moorFLPI are therefore greatly reduced.

The moorFLPI uses a diverging infrared laser beam and is classified as a Class 1 laser product (IEC 60825-1:2001). Class 1 laser products are generally regarded as nonhazardous to the eye and skin and protective eyewear is not required to be worn by the operator or patient. The predicate device uses a collimated laser beam of the same wavelength and is classified as a Class 3R laser product (IEC60825-1:2001) and as such is potentially harmful to the eye. The lower laser classification of the moorFLPI provides an increased level of safety compared with the predicate device.

The moorFLPI and the moorLDI2-IR both measure tissue perfusion by making use of the Doppler frequency shifts that result from coherent laser light being scattered

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from moving red blood cells. The moorFLPI measurement of blood perfusion depends on analysing the speckle pattern contrast that results from interference between the Doppler shifted laser light and the laser light scattered from the tissue in which the blood is moving, whereas the moorLDI2-IR measurement of blood perfusion depends on direct measurements of the Doppler frequency shifts. The speckle pattern contrast is generated mainly by laser light scattered from the superficial layers of tissue. Detected light coming from deeper regions e.g. from underlying veins, is of low intensity and contributes little to the recorded light intensity. Flow in veins that are more than a mm or so below the surface are not imaged by the moorFLPI; however because the moorLDI2-IR is measuring the Doppler frequency shifts and calculates blood flow from the first moment of the integrated power spectral density of the detected photocurrent, (i.e. the frequency weighted power spectral density), it records not only the blood flow in the superficial tissue layers but also the faster flow in underlying veins.

Both the moorFLPI and the moorLDI2-IR can be used to image flow in small blood vessels exposed during open surgery.

7.4 Performance Data

In order to evaluate the performance of the moorFLPI Full-Field Laser Perfusion Imager, and determine its substantial equivalence to the predicate device (moorLDI2-IR), 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. The results show that the moorFLPI, within its specified range for flow measurements and area of tissue that can be imaged, has substantially the same performance as the predicate device for measurements of superficial blood flow.

The moorFLPI Full-Field Laser Perfusion Imager has been designed and tested for compliance with the standards for electrical safety, laser radiation safety, electromagnetic compatibility and programmable medical device.

7.5 Conclusions

From the description of the technological characteristics and the performance data, it can be concluded that the moorFLPI Full-Field Laser Perfusion Imager is substantial equivalence to the predicate device moorLDI2-IR laser Doppler imager in terms of effectiveness and safety.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design.

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 2 5 2007

Re: K063586

Trade/Device Name: moorFLPI Full-Field Laser Perfusion Imager Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular blood flow probe Regulatory Class: II Product Code: DPT, GEX Dated: November 27, 2006 Received: December 1, 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

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Page 2 -- Xiabing Huang

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.

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

Sincerely yours,

Mark N. Melkerson

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: K063586

Device name: moorFLP1 Full-Field Laser Perfusion Imager

Indications for use:

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

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

K063586

510(k) Number

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).