SOLUTIS is a Q-switched, frequency doubled Nd:YAG laser providing a wavelength of 532 nm for use in Sclective Laser Trabeculoplasty. The treatment beam delivers a 4ns, 0.2-2 mJ adjustable single pulse of energy. The aiming beam and treatment beams are coaxial with each other and focused by the slit lamp objective to a 400um spot at the focal point of the lens. The SOLUTIS is compatible with Haag Streit 900 BM and Haag Streit 900 BQ slit lamps only.

AI/ML Overview

The provided text is a 510(k) Summary for the Quantel Medical SOLUTIS, an ophthalmic laser system. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving acceptance criteria for device performance in a clinical or diagnostic context, especially not one that would involve AI, human readers, ground truth establishment, or sample sizes as typically inquired about for AI/ML-based medical devices.

Instead, the performance data section states:
"Laboratory testing was conducted to validate and verify that the SOLUTIS Laser met all design specifications and was substantially equivalent to the predicate device."

This indicates that the "acceptance criteria" were related to engineering design specifications and technical parameters to show equivalence to existing devices in a laboratory setting, rather than clinical efficacy or diagnostic accuracy.

Therefore, most of the requested information regarding acceptance criteria and a study proving device meets them (especially those pertaining to AI, human reader performance, ground truth, and sample sizes of a test or training set) cannot be extracted from this document as it does not contain details about such a study.

Here's what can be gathered, with caveats:

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

The document states: "Laboratory testing was conducted to validate and verify that the SOLUTIS Laser met all design specifications and was substantially equivalent to the predicate device."

It does not provide a specific table of acceptance criteria (e.g., specific energy output ranges, spot size tolerances) nor the numerical reported performance for each criterion. The general acceptance criterion was likely meeting predefined design specifications and demonstrating performance comparable to the predicate devices.

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

Not applicable. The "test set" was laboratory testing, not a clinical study with patient data.

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 applicable. Ground truth as typically understood in AI/ML medical devices (e.g., expert consensus on images, pathology results) is not relevant for this type of laboratory performance testing. "Ground truth" would likely refer to calibrated measurement equipment in the lab.

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

Not applicable. This concept applies to expert review of clinical cases.

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

No. This device is an ophthalmic laser for treatment (Selective Laser Trabeculoplasty), not a diagnostic device involving AI assistance for human readers.

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

No. This is a physical laser device, not an algorithm.

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

Not specified, but for laboratory testing, ground truth would be established by calibrated measurement tools and engineering standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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510(k) Summary for the Quantel Medical SOLUTIS

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1. General Information

Submitter:	Quantel Medical11 Rue du Bois Joli - CS 4001563808 Cournon D'Auvergne CedexFRANCE33-473 745 74533-473 745 700 (Fax)
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Contact Person:	Maureen O'ConnellO'Connell Regulatory Consultants, Inc.5 Timber LaneNorth Reading, MA 01864Telephone: 978-207-1245Fax: 978-824-2541
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AUG 0 2 2013Summary Preparation Date: July 18, 2013

1. Names
  Device Trade Name:

Common Namc:

Ophthalmic Laser

SOLUTIS

Laser Instrument, Surgical, Powered and Laser, Classification Names: Ophthalmic Product Code: GEX (21 CFR 878.4810) and HQF (21 CFR 886.4390) Panel: General & Plastic Surgery and Ophthalmology

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3. Predicate Devices

Lumenis Selecta Duct (K021550) -
Lumenis Family of Ophthalmic laser Systems, Model : Selecta SLT (K081704) -

4. Device Description

5. Indications for Use

The SOLUTIS Laser is indicated for use in:

· Selective Laser Trabeculoplasty (SLT)

6. Substantial Equivalence

The SOLUTIS Laser shares the same intended use and technological characteristics as the predicate devices, the Lumenis Selecta Duet (K021550) and the Lumenis Family of Ophthalmic Laser Systems, Model SELECTA SLT (K081704) and therefore is substantially equivalent to the predicate devices. The SOLUTIS and the predicate devices are Q-switched, frequency doubled Nd: Y AG laser systems providing a wavelength of 532 nm. The maximum energy, repetition rate, pulse duration and other key technological characteristics are identical between the SOLUTIS and the predicate devices. No new questions of safety or effectiveness are raised. Therefore, the SOLUTIS is substantially equivalent to the predicate devices.

7. Performance Data

Laboratory testing was conducted to validate and verify that the SOLUTIS Laser met all design specifications and was substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes extending from its back, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 2, 2013

Quantel Medical % Ms. Maureen O'Connell President/Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

Re: K130933

Trade/Device Name: SOLUTIS Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF, GEX Dated: June 28, 2013 Received: July 05, 2013

Dear Ms. O'Connell:

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 reclassilied 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. Iisting 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 I'DA'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 device-related adverse events) { } CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Maureen O'Connell

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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.

Sincerely yours,

FOR

Peter D. Rumm -S

Mark N. Melkerson Acting 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): ____________________________________________________________________________________________________________________________________________________ K130933

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Device Name: SOLUTIS

Indications for Use:

Selective Laser Trabeculoplasty (SLT)

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

Over The Counter Use (Part 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)

Page 1 of 1

Joshua C. Nipper -S

(Division Sign-Off)

Division of Surgical Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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.