· In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser), Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Latice Degeneration, Retinal Tears and Detachments (Laser Retinopexy).

· For the imaging (capture, display, storage and manipulation) of the eve, including via color. fluorescein angiography and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye.

· In Laser Trabeculoplasty for Primary Open Angle Glaucoma, as well as Iridotomy and Iridoplasty for Closed Angle Glaucoma.

Device Description

The NAVILAS Laser System combines imaging technologies (fundus live imaging, infra-red imaging and fluorescein angiography) with established retinal laser photocoagulation treatment methods, providing the doctor with a system for image capture, display, storage and manipulation for treatment planning and documentation.

The primary components of the Navilas Laser System include:

. One of three optional ophthalmic laser sources:
- a frequency doubled ND:YVO4 laser source that operates at 532nm, or -
- an optically-pumped semiconductor laser source that also operates at the same -532nm, or
- an optically-pumped semiconductor laser source that operates at 577nm -
An integrated delivery system that directs the laser beam through ophthalmoscope optics using motorized mirrors,
A digital camera and computer hardware that provides continuous real-time imaging ● using slit illumination that is projected through the ophthalmoscope optics and panned automatically at a rapid rate of 25 Hz across the subject area using the motorized mirrors. Imaging can be in color (using white light illumination) or in monochrome (using infrared illumination or blue light illuminations).

Laser photocoagulation with the NAVILAS can be performed using single shot (Single Spot Mode), repeated shots (Repeat Mode), and scanned patterns (Pattern Mode).

AI/ML Overview

The provided text is a 510(k) summary for the Navilas Laser System. It focuses on demonstrating substantial equivalence to predicate devices and adherence to performance standards, rather than detailing a specific clinical study with acceptance criteria for device performance in terms of diagnostic or therapeutic accuracy.

Therefore, the document does not contain the acceptance criteria and study details as requested in the input prompt, particularly regarding a study that proves the device meets specific performance metrics for an AI/algorithm-driven application.

The sections that would contain such information (4.8 SUMMARY OF PERFORMANCE TEST RESULTS and 4.9 CONCLUSIONS) are very general. They state that "Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the Navilas Laser System" and "All criteria for this testing were met and results demonstrate that the Navilas Laser System meets all performance specifications and requirements." However, they do not provide the specific acceptance criteria or the study details (sample size, ground truth, expert qualifications, etc.) for any performance evaluation in the context of an AI-driven component.

To directly answer your prompt based only on the provided text, the information requested is largely absent.

Here's a breakdown of what is and isn't available based on your requested structure:

1. A table of acceptance criteria and the reported device performance

Not available in the provided text. The document states that performance testing was completed and criteria were met, but it does not list the specific acceptance criteria or the quantitative results of the device's performance against those criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available in the provided text. There is no mention of a test set sample size or data provenance for any performance evaluation.

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 available in the provided text. The document does not describe the establishment of ground truth by experts, as it does not detail a study involving such a process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not available in the provided text. No adjudication method is described.

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 available in the provided text. The document does not describe an MRMC study or the use of AI assistance for human readers. The Navilas Laser System, as described, is a surgical laser system with imaging, planning, and documentation capabilities, not an AI diagnostic assistant.

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

Not available in the provided text. No standalone algorithm performance study is described.

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

Not available in the provided text. As no study requiring ground truth is detailed, the type of ground truth is not mentioned.

8. The sample size for the training set

Not available in the provided text. There is no mention of a training set, indicating that this submission is not about an AI/ML algorithm requiring such data.

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

Not available in the provided text. As no training set is mentioned, the method for establishing its ground truth is not provided.

Conclusion: The provided 510(k) summary (K141851) for the Navilas Laser System is focused on establishing substantial equivalence based on indications for use, technological characteristics, and compliance with general safety and performance standards (like IEC and ISO). It does not present data from a clinical or performance study that would typically include acceptance criteria, sample sizes, ground truth establishment, or expert evaluations as requested for an AI/algorithm-based device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above and below them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

January 2, 2015

OD-OS GMBH c/o Judy F. Gordon ClinReg Consulting Services, Inc. 733 Bolsana Drive Laguna Beach, CA 92651

Re: K141851

Trade/Device Name: Navilas Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: HGF, GEX, HKI, NFF, NFG Dated: November 29, 2014 Received: December 1, 2014

Dear Dr. Gordon:

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.

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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 of medical 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/ResourcesforYou/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.

Deborah L. Falls -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141851

Device Name Navilas Laser System

Indications for Use (Describe)

The Navilas Laser System/Navilas Laser System 532+/ Navilas Laser System 577+ are indicated for use:

· In Laser Trabeculoplasty for Primary Open Angle Glaucoma, as well as Iridotomy and Iridoplasty for Closed Angle Glaucoma.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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4.0 510(K) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).

4.1 SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED

APPLICANT:	OD-OS GmbHWarthestr. 2114513 TeltowGermany
CONTACT PERSON:	Judy Gordon, D.V.M.ClinReg Consulting Services, Inc.733 Bolsana DriveLaguna Beach, CA 92651judy@clinregconsulting.comTel: (949) 715-0609Fax: (949) 715-0610

DATE SUMMARY PREPARED: December 22, 2014

4.2 NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME

COMMON NAME:	Photocoagulator with a Digital Camera
DEVICE CLASSIFICATION:	Laser Instrument, Surgical, Powered(Class II, per 21 CFR §878.4810
	Camera, OphthalmicClass II, per 21 CFR §886.1120
	Device, Storage, Images, OphthalmicClass I per 21 CFR §892.2010
	Device, Communication, Images, OphthalmicClass I per 21 CFR §892.2020
PRODUCT CODES:	GEX; HKI, NFF, NFG
TRADE/PROPRIETARY NAME:	Navilas® Laser System

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K141851

4.3 PREDICATE DEVICES

510(K) #	TRADE NAME	MANUFACTURER
K091064	Navilas Laser System	OD-OS
K123542	PASCAL® Synthesis OphthalmicScanning Laser System	Topcon Medical Systems
K071687	Iridex IQ Family	Iridex

PREDICATE DEVICES FOR NAVILAS LASER SYSTEM

PREDICATE DEVICES FOR NAVILAS LASER SYSTEM 532+

510(K) #	TRADE NAME	MANUFACTURER
K091064	Navilas Laser System	OD-OS
K123542	PASCAL® Synthesis OphthalmicScanning Laser System	Topcon Medical Systems
K071687	Iridex IQ Family	Iridex

PREDICATE DEVICES FOR NAVILAS LASER SYSTEM 577+

510(K) #	TRADE NAME	MANUFACTURER
K091064	Navilas Laser System	OD-OS
K123542	PASCAL® Synthesis OphthalmicScanning Laser System	Topcon Medical Systems
K071687	Iridex IQ Family	Iridex
K091581	Quantel Supra 577	Quantel

4.4 DEVICE DESCRIPTION

The primary components of the Navilas Laser System include:

. One of three optional ophthalmic laser sources:
- a frequency doubled ND:YVO4 laser source that operates at 532nm, or -
- an optically-pumped semiconductor laser source that also operates at the same -532nm, or
- an optically-pumped semiconductor laser source that operates at 577nm -

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An integrated delivery system that directs the laser beam through ophthalmoscope optics using motorized mirrors,
A digital camera and computer hardware that provides continuous real-time imaging ● using slit illumination that is projected through the ophthalmoscope optics and panned automatically at a rapid rate of 25 Hz across the subject area using the motorized mirrors. Imaging can be in color (using white light illumination) or in monochrome (using infrared illumination or blue light illuminations).

Laser photocoagulation with the NAVILAS can be performed using single shot (Single Spot Mode), repeated shots (Repeat Mode), and scanned patterns (Pattern Mode).

4.5 STATEMENT OF INTENDED USE

The Navilas Laser System/Navilas Laser System 532+/ Navilas Laser System 577+ are indicated for use:

In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser), Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Lattice Degeneration, Retinal Tears and Detachments (Laser Retinopexy).
. For the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye.
. In Laser Trabeculoplasty for Primary Open Angle Glaucoma, as well as Iridotomy and Iridoplasty for Closed Angle Glaucoma.

TECHNOLOGICAL CHARACTERISTICS COMPARISON 4.6

The Navilas Laser System has the same indications for use, similar design and functional features and is therefore substantially equivalent to the predicate devices.

4.7 PERFORMANCE STANDARDS

The Navilas is designed, manufactured and tested in accordance with both mandatory and voluntary standards including:

. IEC 60601-1 Medical Electric Equipment, Part 1: General requirements for safety Medical Electrical Equipment - Part 1-2: General requirements ● IEC 60601-1-2 for safety (Collateral standard: electromagnetic compatibility requirements and tests)

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• IEC 60601-2-22	Medical Electrical Equipment, Part 2: Particular requirements forthe safety and diagnostic and therapeutic laser equipment
• IEC 62366	Medical Devices – Application of usability engineering to medicaldevices
• IEC 60825-1	Safety of Laser Products, Part 1: Equipment classification andrequirements
• ISO 15004-2	Ophthalmic Instruments – Fundamental requirements and testmethods – Part 2: Light hazard protection
• ISO 14971	Application of risk management to medical devices

This device also complies with European Medical Device Directive 93/42/EEC and U.S. Federal Performance Standards per 21 CFR Part 1040 for light emitting products.

SUMMARY OF PERFORMANCE TEST RESULTS 4.8

Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the Navilas Laser System. This was accomplished by software and hardware verification & validation testing, along with system level bench testing of the Navilas Laser System. All criteria for this testing were met and results demonstrate that the Navilas Laser System meets all performance specifications and requirements.

4.9 CONCLUSIONS

As described in this 510(k) Summary, all testing deemed necessary was conducted on the Navilas Laser System to ensure that the device is safe and effective for its intended use and is substantially equivalent to legally marketed devices intended for laser treatment and imaging of the eye.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.