The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, vellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments including:

. Retinal photocoagulation, panretinal photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and nonproliferative diabetic retinopathy .
- Choroidal neovascularization .
- Branch retinal vein occlusion .
- . Retinal tears and detachments
- Retinopathy of prematurity .
Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and . open angle glaucoma

Device Description

The Vision One Laser System is classified as a Class IV laser by the Center for Devices and Radiological Health of the Food and Drug Administration. The Vision One Laser System is intended for use in the treatment of ocular pathology. The system's green, yellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments. The Vision One Laser System will incorporate the newest laser technology - Optically Pumped Semiconductor Laser (OPSL) in additions to Nd:YAG which are both subsets of DPSS (Diode Pumped Solid State Laser).
The system shall be configurable so that any combination of up to three (3) treatment lasers can be installed and used.
The Vision One Laser System is comprised of the laser console, control and display panel, remote control, an external door interlock plug, & footswitch.

AI/ML Overview

The provided document is a 510(k) summary for the Lumenis Vision One Laser System, an ophthalmic surgical laser. It establishes substantial equivalence to a predicate device and details the device's intended use and technical specifications. However, it does not contain the specific information required to answer your request regarding acceptance criteria for a study proving device performance.

Specifically, the document states under "VII. Performance Data:" that "The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted." However, it does not provide the detailed results of these tests, acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

Cannot be answered from the provided text. The document states that performance testing was conducted but does not provide specific acceptance criteria or detailed reported performance metrics.

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

Cannot be answered from the provided text. The document does not describe a clinical study or a test set, nor does it provide details on sample size or data provenance for any performance testing.

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):

Cannot be answered from the provided text. There is no mention of a test set, ground truth establishment, or experts involved in performance evaluation.

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

Cannot be answered from the provided text. There is no information about a test set or adjudication methods.

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:

Cannot be answered from the provided text. This device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers improving with AI assistance is not applicable and not mentioned.

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

Cannot be answered from the provided text. This device is a surgical laser, not an algorithm. Standalone algorithm performance is not applicable.

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

Cannot be answered from the provided text. There is no information on ground truth establishment for any performance testing.

8. The sample size for the training set:

Cannot be answered from the provided text. This device is a surgical laser; the concept of a "training set" in the context of machine learning or AI is not applicable here.

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

Cannot be answered from the provided text. Not applicable for this type of device.

In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device based on intended use, fundamental scientific technology, patient population, principles of operation, and method of energy delivery. It does not provide the detailed performance study information with acceptance criteria, sample sizes, or ground truth establishment that you are requesting.

Summary

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K11/215 Page ① of ③

5. 510(k) SUMMARY

510(k) Summary

JUL 25 2011

Submitter General Information: .

Device Owner Name:	Lumenis, Inc.
Address:	3959 West 1820 SouthSalt Lake City, UT 84104
Contact:	Jace R. McLane
Phone:	801-656-2328
Fax:	801-656-2627
Date of Preparation:	April 29, 2011

II. Device Name:

Trade Name:	Vision One Laser System
Common/Usual Name(s):	Surgical Laser, Ophthalmic Laser
Class:	Class II
Classification Name(s):	79 GEX, Laser Powered Surgical Instrument
	86 HQF, Laser, Ophthalmic
CFR Reference:	21 CFR § 878.4810, Laser surgical instrument for use ingeneral and plastic surgery and in dermatology
	21 CFR § 886.4390, Ophthalmic Laser

III. Predicate Device Name(s):

Novus Varia Laser System (K022181) Trade Name(s):

IV. Device Description:

The system shall be configurable so that any combination of up to three (3) treatment lasers can be installed and used.

The Vision One Laser System is comprised of the laser console, control and display panel, remote control, an external door interlock plug, & footswitch.

Lumenis, Inc. 3959 West 1820 South Salt Lake City, UT 84104, USA

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Image /page/1/Picture/0 description: The image shows the logo for Lumenis. The logo consists of a stylized "L" inside of a circle, followed by the word "LUMENIS" in all caps. Below the word "LUMENIS" is the tagline "Enhancing Life. Advancing Technology."

K11/2/3 Page (2) of (3)

The following accessories & delivery devices are compatible and available for the Vision One Laser System: ·

Lumenis 1000 Integrated Slit Lamp, Lumenis InSight Integrated Slit Lamp, LaserLinks: SL130 Zeiss Slit Lamp, 30SL Zeiss Slit Lamp, 20SL Zeiss Slit Lamp, 125SL Zeiss Slit Lamp, Haag Streit Slit Lamp, Lumenis LaserLink S, Eye Safety Filter for all LaserLinks listed, Single and Dual Endo Kits for Zeiss and Leica / Wild microscopes, Endo Kit for Leica M840, Keeler LIO (Laser Indirect Ophthalmoscope), & Heine LIO (Laser Indirect Ophthalmoscope).

The Vision One Laser System uses the same types of delivery devices and accessories as the predicate device.

V. Intended Use:

The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, yellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments including:

Retinal photocoagulation, panretinal photocoagulation, and intravitreal . endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and nonproliferative diabetic retinopathy .
- Choroidal neovascularization .
- Branch retinal vein occlusion .
- Retinal tears and detachments .
- . Retinopathy of prematurity
Iridotomy, iridectomy, and trabeculoplasty in angle closure . glaucoma and open angle glaucoma

VI. Substantial Equivalence Summary:

The Vision One Laser System has the same intended use as the predicate device -Novus Varia Ophthalmic Laser (K022181). It uses the same fundamental scientific technology as the predicate device. In addition, Vision One Laser System and the predicate device have the same patient population, principles of operation, method of energy delivery, critical materials, and basal design.

VII. Performance Data:

The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted.

Lumenis, Inc. 3959 West 1820 South Salt Lake City, UT 84104, USA

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Image /page/2/Picture/0 description: The image shows the logo for Lumenis. The logo consists of a stylized "L" inside of a circle, followed by the word "LUMENIS" in all caps. Below the word "LUMENIS" is the tagline "Enhancing Life. Advancing Technology."

K11/13 page 3 of (3)

VIII. Conclusion:

The subject device, the Vision One Laser System, has the same intended use, general design, and fundamental scientific technology as the predicate device (K022181).

The Vision One Laser System uses technology substantially equivalent to the Novus Varia Ophthalmic Laser (K022181). There are no new hazards introduced by the Vision One Laser System as compared with the predicate device.

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Lumenis, Inc. 3959 West 1820 South Salt Lake City, UT 84104, USA

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

Lumenis, Inc. % Ms. Jace R. McLane 3959 West 1820 South Regulatory Affairs Specialist Salt Lake City, Utah 84104

JUL 2 5 2011

Re: K111213

Trade/Device Name: Vision One 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: GEX Dated: July 15, 2011 Received: July 18, 2011

Dear Ms. McLane:

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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Page 2 - Ms. Jace R. McLane

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

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

Sincerely yours,

Eunel Keith

for Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT

Indications for Use

KILLE 510(k) Number (if known):

Device Name: Vision One Laser System

Indications for Use:

. Retinal photocoagulation, panretinal photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and nonproliferative diabetic retinopathy .
- Choroidal neovascularization .
- Branch retinal vein occlusion .
- . Retinal tears and detachments
- Retinopathy of prematurity .
Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and . open angle glaucoma

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page U of O

Neil R.P. Oden for man
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111213

Page 8 of 25

Lumenis, Inc. 3959 West 1820 South .Salt Lake City, UT 84104, USA

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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.