The Artemis Light Engine is a primary LED light source when used in conjunction with laparoscopes or surgical cameras to illuminated surgical sites that allow observation or manipulation of body cavities, hollow organs, and canals.

Device Description

The Light Engine is a family of light engines that are designed for laboratory and clinical use in applications. The Light Engine provides a light source of which the intensity can be controlled via a PC. The output power of the Light Engine is calibrated as to provide a linear response over the full range of intensity and life-time. The Light Engine can be controlled by an external software device, or directly with the serial port provided by the USB interface (RS232-via-USB).

AI/ML Overview

This 510(k) premarket notification for the Artemis Light Engine primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and adherence to voluntary standards, rather than extensive clinical performance studies with specific statistical acceptance criteria for a diagnostic algorithm.

Therefore, many of the requested categories regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies validating diagnostic AI, are not explicitly provided or are not applicable in the context of this submission. The device is an LED light source, not a diagnostic algorithm.

Here's a breakdown of the information available and what is not applicable based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an LED light source and not a diagnostic AI, the acceptance criteria are not in terms of diagnostic metrics like sensitivity, specificity, or AUC, but rather functional performance.

Acceptance Criteria (Implied)	Reported Device Performance (Implied from "Performance Testing")
Light output intensity control and linearity	"The output power of the Light Engine is calibrated as to provide a linear response over the full range of intensity and life-time."
Functionality as intended (safety & effectiveness)	"Design Test and Verification demonstrates that the device functions as it is intended and its performance does not raise any issues of safety and effectiveness."
Software functionality	"Software verification testing was successfully performed and completed."
Electromagnetic Compatibility (EMC)	Compliance with "IEC 60601-1-2 Edition 3: 2007-03 Medical Electrical Equipment Part1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests."
Risk Management	Compliance with "ISO 14971 Second edition 2007-03-01, Medical Devices - Application of Risk Management to Medical Devices."

The "study that proves the device meets the acceptance criteria" is referred to as "Performance Testing", specifically "Bench Testing protocol attached." While the summary mentions this, the details of the protocol are not provided in the excerpt.

2. Sample size used for the test set and the data provenance

Not Applicable. As a medical device (LED light source), the testing mentioned refers to bench testing of the device's physical and software performance, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth, in the context of diagnostic algorithms, involves expert labeling of patient data. This is an LED light source, so such a "test set" and "ground truth" are not relevant. The testing would have involved engineering and quality control personnel validating the device's technical specifications.

4. Adjudication method for the test set

Not Applicable. There is no "test set" of patient data requiring adjudication in this submission.

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. The Artemis Light Engine is an LED light source for illuminating surgical sites, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with or without AI assistance is irrelevant to this device.

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

Not Applicable. The Artemis Light Engine is a hardware device (LED light source with software control), not a standalone diagnostic algorithm.

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

Not Applicable. For a light source, "ground truth" would be related to objective physical measurements of light output, color temperature, intensity, control accuracy, and adherence to safety standards, verified through calibrated instruments and engineering specifications. It's not clinical "ground truth" as understood for diagnostic systems.

8. The sample size for the training set

Not Applicable. The device is not an AI algorithm that requires a "training set."

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

Not Applicable. No training set exists for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 16. 2015

Ouest Medical Imaging Mr. Martin Heuvelmans Quality Assurance Manager Industrieweg 41 1775 PW Middenmeer Netherlands

Re: K141164

Trade/Device Name: Artemis Light Engine Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NTN Dated: February 13, 2015 Received: February 13, 2015

Dear Mr. Heuvelmans:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141164

Device Name

Artemis Light Engine

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑Prescription Use (Part 21 CFR 801 Subpart D)
☐Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Quest Medical Imaging. The logo features a stylized letter "Q" in gray and blue, with the word "Quest" in bold black letters next to it. To the right of "Quest" is a vertical blue line, followed by the words "medical imaging" in a smaller, italicized font.

510(k) Summary (21 CFR 807.92(c))

Administrative information

Manufacturer Name:	Quest Medical ImagingIndustrieweg 411775 PW MiddenmeerNetherlands
Contact Person:	Martin Heuvelmans, QA ManagerTel: +31 227 604046Fax: +31 227 604053E-mail: martin.heuvelmans@quest-innovations.com
Official Correspondent:	Quest Medical ImagingMartin Heuvelmans, QA ManagerE-mail: martin.heuvelmans@quest-innovations.com

FDA Establishment Registration Number: 3010590422

Date prepared:	March 3, 2014
Name of Device:
Trade Name:	Artemis Light Engine
Common Name:	LED light source
Classification Name:	21 CFR 876.1500

Identification of Predicate Device(s):

Product Code:

510(k)Number	Device	Manufacturer
K130819	CLLV1, LED Light Source	Olympus Winter & IbeGmbH
K123956	Power LED 175	Karl Storz GmbH & Co. KG

NTN

Intended Use Statement

Device description

The Light Engine is a family of light engines that are designed for laboratory and clinical use in applications. The Light Engine provides a light source of which the

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intensity can be controlled via a PC. The output power of the Light Engine is calibrated as to provide a linear response over the full range of intensity and life-time. The Light Engine can be controlled by an external software device, or directly with the serial port provided by the USB interface (RS232-via-USB).

Performance Testing

The performance testing to verify light output of the Artemis Light Engine was done as per the Bench Testing protocol attached. Design Test and Verification demonstrates that the device functions as it is intended and its performance does not raise any issues of safety and effectiveness. Software verification testing was successfully performed and completed. The manufacturer complies with the following voluntary standards:

IEC 60601-1-2 Edition 3: 2007-03 Medical Electrical Equipment Part1-2: ● General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
. ISO 14971 Second edition 2007-03-01, Medical Devices - Application of Risk Management to Medical Devices.

Predicate Device Comparison

The Artemis Light Engine is substantially equivalent to the above listed 510(k) cleared devices on the market. Wording differences between indications for use of the Artemis Light Engine and those of the above-listed predicate devices do not constitute a new intended use. The characteristics and technology used are comparable with the predicate devices.

Conclusions

The Artemis Light Engine has similar intended use and technical features as the predicate devices listed above. Therefore, the Artemis Light Engine is substantially equivalent to the predicate devices listed above.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.