The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for the use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the comea at a varying depth with respect to the corneal surface.

In addition, the FEMTO LDV Z6 Surgical Laser is intended for use in patients undergoing cataract surgery for the creation of single-plane, multi-plane, partial thickness and full thickness cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Device Description

Corneal dissection with the FEMTO LDV Z6 Femtosecond Surgical Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical pulses which are delivered through an applanation window assembly while fixating the eye under a vacuum.

AI/ML Overview

The provided text describes the submission of a 510(k) summary for the FEMTO LDV Z6 Femtosecond Surgical Laser but lacks detailed information regarding specific acceptance criteria, study methodologies, and performance metrics typically found in a comprehensive clinical or non-clinical study report.

Based on the information provided, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

The document states that "Results of the software validation and the in-vitro validation show that the design changes made to the device are substantially equivalent." And specifically, that "An in-vitro validation was performed that demonstrated the accuracy and precision of the new incisions."

However, no specific quantitative acceptance criteria or reported performance values (e.g., specific accuracy percentages, precision ranges, or success rates) are provided within the given text. The document broadly states that the validation "demonstrated the accuracy and precision," but does not detail what those demonstrated values were or against what specific benchmarks they were measured.

Acceptance Criteria	Reported Device Performance
Not specified	Demonstrated accuracy and precision (no quantitative values provided)

Study Details

Sample size used for the test set and the data provenance:
- The document mentions "an in-vitro validation was performed." This implies a test set was used, but the sample size for this test set is not provided.
- Data provenance is not explicitly stated, but "in-vitro" suggests a laboratory-based study rather than data from human subjects. This would typically mean no specific country of origin, and it is by nature a prospective design for the experimental setup.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. Since the validation was "in-vitro" and focused on "accuracy and precision of the new incisions," the ground truth would likely be established through precise metrological measurements (e.g., using calipers, microscopy, or other optical measurement tools) against pre-defined design specifications, rather than expert human interpretation. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense is not relevant here.
Adjudication method for the test set:
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation where there might be disagreement among readers. For an in-vitro validation of accuracy and precision, the measurements performed would be objective and rely on verified instruments and procedures, not human adjudication.
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. The provided text does not describe an MRMC comparative effectiveness study. The device is a surgical laser, and the validation described is an "in-vitro validation" of its physical performance (accuracy and precision of incisions), not a diagnostic AI system requiring evaluation of human reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The "in-vitro validation" focusing on the accuracy and precision of incisions produced by the laser itself, without human intervention in the cutting process (beyond initial setup and operation), can be considered analogous to a standalone performance evaluation of the device's cutting capabilities. There is no AI algorithm being evaluated for diagnostic performance, but rather the physical output of the device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the "in-vitro validation" of incision accuracy and precision would have been pre-defined engineering specifications or physical measurements from a highly accurate reference system (e.g., specific dimensions, depths, or shapes of the incisions as intended by the device design).
The sample size for the training set:
- Not applicable / Not specified. This device is a surgical laser, and the validation described is for its mechanical/optical performance. It is not an AI/ML algorithm that requires a "training set" in the conventional sense for model development. The "software changes" mentioned relate to the control software for the laser, which would undergo traditional software validation and verification, not machine learning training.
How the ground truth for the training set was established:
- Not applicable / Not specified. As there is no AI/ML training set in the context of this device and validation, the concept of establishing ground truth for a training set does not apply.

Summary

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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).

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

a) Applicant: SIE AG, Surgical Instrument Engineering Allmendstrasse 11 CH-2502 Port Switzerland Phone: +41 32 332 70 70 Fax: +41 32 332 70 71
OCT 0 9 2013
Kevin Walls, RAC b) Contact person: Principal Consultant Regulatory Insight, Inc. Phone: +1-720-962-5412 Fax: +1-720-962-5413 Email: kevin@reginsight.com
c) Date of summary preparation: 10/03/2013

NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME:

Trade/Proprietary Name: FEMTO LDV Z6 Femtosecond Surgical Laser Common/Usual Name: Ophthalmic Laser Classification Name: Laser, Ophthalmic Classification Code: HQF

IDENTIFICATION OF THE PREDICATE DEVICE OR LEGALLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED:

510(k) # Trade Name K112154 FEMTO LDV Z-Generation Femtosecond Surgical Laser

Manufacturer SIE AG. Surgical Instrument Engineering

A DESCRIPTION OF THE DEVICE THAT IS THE SUBJECT OF THE 510(K), INCLUDING EXPLANATION OF HOW THE DEVICE FUNCTIONS, BASIC SCIENTIFIC CONCEPTS, SIGNIFICANT PHYSICAL AND PERFORMANCE CHARACTERISTICS (DESIGN, MATERIAL, PHYSICAL PROPERTIES):

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STATEMENT OF INTENDED USE:

The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for the use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface.

In addition, the FEMTO LDV Z6 Surgical Laser is intended for use in patients undergoing cataract surgery for the creation of single-plane, multi-plane, partial thickness cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARE TO THOSE OF THE PREDICATE OR LEGALLY MARKETED DEVICE:

The latest release includes a new SW module, based on the existing software interface of FEMTO LDV Z6 and combination of existing cutting patterns. The module provides two new types of corneal incisions, i.e., Arcuate Corneal Incisions (arc) and Clear Corneal Incisions (CCI). The other two independent sub-modules SW (Safety System and Z-Safety System) remained unchanged. The SW architecture is the same as in the predecessor 510(k) K112154.

BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS:

Results of the software validation and the in-vitro validation show that the design changes made to the device are substantially equivalent. The following is a summary of nonclinical tests and results:

. The software changes included all of the documentation, including validation, as per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
. An in-vitro validation was performed that demonstrated the accuracy and precision of the new incisions.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

October 9, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Centre - WOb6-Golly Silver Spring, MI) 20993-0002

SIE AG. Surgical Instrument Engineering % Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127

Re: K131207

Trade Name: Femto LDVTM Z6 Femtosecond Surgical Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: August 22, 2013 · Received: August 26, 2013

Dear Mr. Walls:

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. Ilisting 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 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.

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Page 2 - Mr. Kevin Walls, RAC

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) (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 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,

Kesia Y. Alexander -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic, and Ear, Nose, 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): K131207

Device Name: FEMTO LDV Z6 Femtosecond Surgical Laser

Indications for Use:

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

Over-The-Counter Use (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)

Andrew Yang -S
20.13.10.03
16:55:07 -04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) number: K131207

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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.