The VisioLite® Ophthalmic Er: Y AG Laser System creates a laser beam with a wavelength of 2940nm, which is highly absorbed by water, collagen and hydroxy apatite and therefore causes rapid vaporization, or ablation, in both hard and soft biological tissues. Because the absorption is highly efficient, tissue removal is very precise with virtually no collateral thermal damage.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy compared to a ground truth.

Instead, the document is a 510(k) summary for the VisioLite® Ophthalmic Er:YAG Laser System, focusing on its substantial equivalence to predicate devices and outlining technical characteristics.

Here's a breakdown of what is mentioned regarding safety and effectiveness, which are the closest equivalents to "acceptance criteria" in this context:

Acceptance Criteria (implicit for GEX product code and Class II device): The device is substantially equivalent to legally marketed predicate devices. This implies that the device must meet the safety and effectiveness standards of its predicates.
- Predicate Devices: Oculase MD from Biolase Technology Inc (K052354) and Laserscope Vela Erbium: YAG laser system (K971843).
- Specific Criteria Met:
  - Electrical safety testing
  - Laser safety testing
  - Electromagnetic compatibility testing
  - Compliance with applicable requirements of CFR 1040 (likely related to laser product performance standards).
  - Compliance with general controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).
Study Proving Acceptance Criteria: The document states:
- "There are no substantial differences between the VisioLite® Ophthalmic Er: Y AG Laser System defined in this 510(k) submission and the predicate devices."
- "The VisioLite® Ophthalmic Er:YAG Laser System included electrical safety testing, laser safety testing and electromagnetic compatibility testing."
- "The VisioLite® Ophthalmic Er:YAG Laser System meets the applicable requirements of CFR 1040."

Therefore, I cannot provide the detailed information requested in your bullet points because the provided text describes a regulatory submission for substantial equivalence rather than a performance study with detailed acceptance criteria for metrics like sensitivity or specificity.

The document does not include:

A table of acceptance criteria and reported device performance beyond general safety and regulatory compliance.
Sample size for a test set or data provenance regarding clinical performance.
Number of experts or their qualifications for establishing ground truth.
Adjudication method for a test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of human readers with/without AI assistance.
Standalone performance details (as it's a laser system, not an AI diagnostic tool).
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical performance study.
Sample size for a training set (as this is not an AI/ML device that requires a training set in the typical sense).
How ground truth for a training set was established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for ACE VISION. The logo consists of an eye-like shape with a six-pointed star in the center. Below the eye is the text "ACEVISION" in a bold, sans-serif font. The logo is simple and modern, and the use of the eye shape suggests that the company is involved in vision care or a related field.

OCT 3 ี 2007

510(k) Summary (per 21 CFR 807.92)

K070296

Applicant I. ACE VISION GROUP 247 N. Westmonte Road Altamonte Springs, FL 32714

Tim Elliott, VP Operations Contact Person: Tel: (216) 632-1988 Fax: (440) 815-2262 Email: telliott@acevisiongroup.com

Date Prepared: August 17, 2007

II. Device Name

Proprietary Name:	VisioLite® Ophthalmic Er:YAG Laser System
Common/ Usual Name:	Laser instrument, surgical, powered
Classification Name:	Laser surgical instrument for use in general andplastic surgery and in dermatology
Regulation Number:	878.4810
Product Codes:	GEX
Classification:	2
Classification Panel:	General & Plastic Surgery

III. Predicate Device

The VisioLite® Ophthalmic Er: YAG Laser System is substantially equivalent to the Oculase MD from Biolase Technology Inc and the Laserscope Vela Erbium: YAG laser system. The Oculase MD was cleared by the FDA under 510(k) K052354 and the Vela Erbium:YAG laser system was cleared by the FDA under 510(k) K971843

IV. Intended Use of the Device

The VisioLite® is indicated for the ophthalmic soft tissue surrounding the eye and orbit.

V. Description of the Device

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Image /page/1/Picture/0 description: The image shows the logo for ACE VISION. The logo consists of an eye-shaped symbol with a six-pointed star in the center. Below the symbol is the text "ACE VISION" in a bold, sans-serif font. Underneath "ACE VISION" are the words "REAL COMPANY. REAL PEOPLE."

The VisioLite® Ophthalmic Er:YAG Laser System is equivalent in design to the Delight laser System from Hoya ConBio.

VI. Summary of the Technical Characteristics

Type of Laser	Er:YAG
Laser Beam Wavelength	2940 nm (invisible, mid-infrared)
Energy Output	Up to 350 mJ
Type of Operation	Pulsed Only, Pulse Width < 300 $\mu$ sec
Angle of Laser Beam Divergence at Tip	230 mrad
Class of Laser Products	Class IV

VII. Safety & Effectiveness

There are no substantial differences between the VisioLite® Ophthalmic Er: Y AG Laser System defined in this 510(k) submission and the predicate devices.

The VisioLite® Ophthalmic Er:YAG Laser System included electrical safety testing , laser safety testing and electromagnetic compatibility testing.

The VisioLite® Ophthalmic Er:YAG Laser System meets the applicable requirements of CFR 1040.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ace Vision Group % Emergo Group Inc. Mr. Ian P. Gordon Senior Vice President 1705 South Capital of Texas Highway Suite 500 Austin, Texas 78746

OCT 3 2007

Re: K070296

Trade/Device Name: VisioLite® Ophthalmic Dr: YAG 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: II Product Code: GEX Dated: September 18, 2007 Received: September 19, 2007

Dear Mr. 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.

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

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Page 2 - Mr. Ian P. Gordon

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 obtains 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 20tm1

Sincerely yours,

for

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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Image /page/4/Picture/0 description: The image shows the logo for ACEVISION. The logo consists of an eye-shaped symbol with a six-pointed star in the center. Below the eye symbol, the word "ACEVISION" is written in a bold, sans-serif font. Underneath the company name is the text "ONE COMPANY ONE VISION" in a smaller font.

4. Indication for Use Statement

510(k) Number (if known): K070296

Device Name: VisioLite® Ophthalmic Er:YAG Laser System

Indications for Use:

The VisioLite® is indicated for the ophthalmic soft tissue surrounding the eye and orbit.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K070296

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.