The Quantel Optimis II Q-Switched Nd:YAG Photodisruptor in a Nd:YAG laser which operates at a nano-second pulse rate. The laser energy is delivered to the treatment site using a provided Optimis II slit lamp.

AI/ML Overview

The provided document is a 510(k) summary for the Quantel Optimis II Q-Switched Nd:YAG Photodisruptor, which is an ophthalmic laser.

Crucially, the document states "Performance Data: None required - comparison of indications and specifications/characteristics established the substantial equivalence of the Optimis II laser to predicates." This means that the device was not required to undergo a specific performance study to establish acceptance criteria or to prove that it meets such criteria in the context of this 510(k) submission. Instead, its substantial equivalence to previously marketed predicate devices was established through a comparison of their intended uses and technical specifications.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth cannot be extracted from this document, as a performance study as typically understood was not conducted.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified	Not specified
(No performance data was required or submitted for this 510(k) based on the "substantially equivalent" determination)	(The device was deemed substantially equivalent to predicate devices based on indications and specifications. No specific efficacy or safety performance metrics, such as sensitivity, specificity, accuracy, or other clinical outcomes, are provided or were assessed in a dedicated study for this submission.)

2. Sample size used for the test set and the data provenance: Not applicable, as no dedicated performance study using a test set was required or conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no dedicated performance study requiring expert ground truth was conducted.

4. Adjudication method for the test set: Not applicable, as no dedicated performance study requiring adjudication was conducted.

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. This device is an ophthalmic laser, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned or required.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a laser, not a standalone algorithm.

7. The type of ground truth used: Not applicable, as no dedicated performance study requiring ground truth was conducted. The "ground truth" for this submission was established by comparing the device's indications and specifications to those of legally marketed predicate devices.

8. The sample size for the training set: Not applicable, as no algorithm training was involved.

9. How the ground truth for the training set was established: Not applicable, as no algorithm training was involved.

Summary

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K043613, p. 1 of 2

510(k) SUMMARY

This 510(k) summary of safety and effectiveness for the modification in the Indications for Use for the Quantel Optimis II Q-Switched Nd: Y AG Photodisruptor is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant:	Quantel Medical	MAR 2 4 2005
Address:	QUANTEL MEDICAL89, Boulevard EtienneCLEMENTEL63100 Clermont-FerrandFRANCE
Contact Person:	Mr. Jean AbascalRegulatory Affairs Manager(+33) 169 29 17 25(+33) 169 29 17 00
Preparation Date:(of the Summary)	December 2004
Device Name:	Quantel Optimis II Q-Switched Nd:YAG Photodisruptor
Common Name:	Ophthalmic Laser PhotodisruptorLaser Surgical Instrument
Classification:	Ophthalmic laser (21 CFR 886.4390)
Product Code:	HQF; Panel: 86
Predicate devices:	AURA™ (Coherent), LQP4106 ERA (Laserex), 3000 LE (Alcon), LQ2106 (Laserex), LQP3106 (Laserex) and 3000LX (Laserex) - see K992824.
Device description:	The Quantel Optimis II Q-Switched Nd:YAG Photodisruptor in a Nd:YAG laser which operates at a nano-second pulse rate. The laser energy is delivered to the treatment site using a provided Optimis II slit lamp.
Indications:	The Quantel Optimis II Q-Switched Nd:YAG Photodisruptor is indicated for posterior capsulotomy.
Performance Data:	None required - comparison of indications and specifications/characteristics established the substantial equivalence of the Optimis II laser to predicates.

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K043613, p. 2 of 2

CONCLUSION: Based on the information in this notification Quantel Medical concludes that the Optimis II Q-Switched Nd:YAG Photodisruptor is substantially equivalent to the cited legally marketed predicates (K992824).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2005

Quantel Medical c/o Mr. Roger Barnes Regulatory Consultant 342 Sunset Bay Road Hot Springs, Arkansas 71913

Re: K043613

Trade/Device Name: Quantel Optimis II Q-Switched Nd: YAG Photodisruptor Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: December 30, 2004 Received: December 30, 2004

Dear Mr. Barnes:

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 (IPMA). 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 fisting (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Mr. Roger Barnes

This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier wifi and w you to organ inding of substantial equivalence of your device to a legally premaired 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 IT you ucare specific acrite in 1 2 - 1 1 5. Also, please note the regulation entitled, Colliaci the Office of Comphalise at (21 notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Miriam C. Provost, Ph.D. Acting 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Quantel Optimis II Q-Switched Nd: YAG Photodisruptor_____________________________________________________________________________________________________________

Indications for Use Statement:

The Optimis II Q-Switched Nd:YAG Photodisruptor is intended for posterior capsulotomy.

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Concurrence of CDRH, Office of Device Evaluation Over-The Counter Use __ OR Prescription Use L (Per 21 CFR 801.109) Conorative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . র ব

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.