The Femtec Laser System for Capsulotomy is a precision ophthalmic surgical laser indicated for use in patients undergoing anterior capsulotomy during cataract surgery. Capsular dissection is achieved through precise individual micro-photodisruption of tissue, measuring a few microns in diameter, created by tightly focusing ultrashort laser pulses into the targeted capsular tissue. Surgical effects are produced by scanning thousands of individual pulses, producing a continuous incision. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location. Pre-programmed patterns produce capsular resections of predetermined diameter and height. Laser pulses are delivered through a sterile (disposable) Patient Interface, consisting of a contact lens and suction clip to provide suction. The contact lens and suction clip assembly creates a reference surface for depth control and fix the eye relative to the delivery of the laser beam.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Femtec Laser System for Capsulotomy, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Capsulotomy Completion	Capsulotomy completed in all eyes.	Successfully performed in all eyes.
Radial Tears	No radial tears observed intraoperatively or postoperatively.	No radial tears observed intraoperatively or postoperatively.
IOL Placement	Intraocular lens placed in each capsular bag.	Intraocular lens placed in each capsular bag.
Postoperative Course	Unremarkable postoperative course of follow-up.	Unremarkable postoperative course.
IOL Centration	Intraocular lens centered in all study eyes.	Intraocular lens centered in all study eyes.
Posterior Capsule Tears	No posterior capsule tears observed.	No posterior capsule tears observed.
Capsulotomy Centration	Well-centered capsulotomies (visually and quantitatively).	All capsulotomies were judged to be well-centered by the surgeon using visual inspection in the operating microscope. The system produced significantly more pupil-centered capsulorhexis compared to manual capsulotomy.
Capsulotomy Circularity	Circular capsulorhexis.	Produced significantly more circular capsulorhexis than the manual technique.
Capsular Edge Smoothness	Capsular edge at least as smooth as that created during anterior capsulotomy.	Data demonstrated the capsular edge created by the Femtec Laser system is also at least as smooth as that created during anterior capsulotomy (from preclinical data, not explicitly re-stated for clinical but implied by successful performance and comparison to manual technique).
Accuracy & Predictability	Accurate and predictable in size, shape, and centration.	The data demonstrated that the Femtec Laser System produces anterior capsulotomies that are accurate and predictable in size, shape, and centration over a range of depths (from preclinical data).

Study Details

Sample sizes used for the test set and the data provenance:
- Clinical Trial: The document states "A clinical trial of the Femter Laser System was conducted to evaluate the performance of the laser system..." and "Anterior capsulotomy was successfully performed in all eyes using the Femtec Laser System..." However, the exact number of eyes/patients in the clinical trial (the test set) is not explicitly stated in the provided text.
- Pre-clinical Testing: "Testing and analyses included accuracy and reproducibility of capsulotomy incisions in porcine eyes, as well as in plastic and agar gel optical phantoms." The specific number of porcine eyes, plastic phantoms, or agar gel phantoms used is not specified.
- Data Provenance:
  - Clinical Trial: The text implies a prospective clinical trial. The country of origin of the clinical data is not specified.
  - Pre-clinical Testing: The pre-clinical data was derived from bench testing using porcine eyes, plastic, and agar gel optical phantoms.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the clinical trial, "All capsulotomies were judged to be well-centered by the surgeon using visual inspection in the operating microscope." This indicates at least one surgeon acted as an expert. No specific number of experts beyond "the surgeon" is mentioned, and their specific qualifications (e.g., years of experience) are not detailed.
- For preclinical testing, there is no mention of experts establishing ground truth; it relies on objective measurements of physical properties.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify an explicit adjudication method for the clinical trial results beyond "judged to be well-centered by the surgeon." It does not mention multiple reviewers or a tie-breaking mechanism.
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, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This device is a laser system that performs the capsulotomy, not an AI diagnostic or assistance system for human interpretation. The comparison was between the automated Femtec Laser System and the manual technique for capsulotomy.
- Effect Size (Laser vs. Manual): The study found the Femtec Laser System produced:
  - "significantly more circular capsulorhexis than the manual technique"
  - "significantly more pupil-centered capsulorhexis compared to manual capsulotomy"
  - While the exact numerical effect sizes (e.g., specific metrics and p-values) are not provided in this summary, the use of "significantly more" indicates a statistically demonstrable improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The Femtec Laser System itself performs the anterior capsulotomy based on its internal programming and mechanical actions, without continuous human intervention during the laser firing sequence for the cut. The outcome metrics (circularity, centration, completeness, lack of tears) are direct performance indicators of the device on its own. While a surgeon initiates and monitors the procedure, the cutting itself is an automated function of the device that was evaluated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Trial: A combination of surgeon visual inspection (for centration), intraoperative and postoperative observations (for tears, IOL placement, overall course), and presumably objective measurements or assessments for circularity and pupil-centration (given the "significantly more circular" and "significantly more pupil-centered" statements, implying quantitative comparison).
- Pre-clinical Testing: Objective measurements (for size, shape, centration, smoothness) in porcine eyes and optical phantoms.
The sample size for the training set:
- The document does not specify a separate "training set" here, as this is a medical device for surgical intervention, not a machine learning model in the typical sense that would have a distinct training phase on a dataset of cases. The development process likely involved iterative design, bench testing, and optimization before the formal clinical trial. However, no specific "training set" figures are provided.
How the ground truth for the training set was established:
- As no explicit "training set" for an AI algorithm is mentioned, this question is not applicable in the context of this device's description. The "training" for such a system would typically involve engineering development, calibration, and iterative testing to meet design specifications, guided by ophthalmic expertise and performance requirements, rather than a labeled dataset in the AI sense.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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

APPLICANT:	Technolas Perfect Vision GmbHMesserschmittstr. 1 +380992 Munich, GermanyTel: 49 174 3494062
CONTACT:	Betty M. JohnsonSr. Manager, Regulatory AffairsTechnolas Perfect Vision GmbHPO Box 17190Anaheim, CA 92817Ph: 714-273-8254Fax: 714-855-2794Email: b.johnson@technolaspv.com
TRADE NAME:	Femtec Laser System for Capsulotomy
COMMON NAME:	Ophthalmic Laser
CLASSIFICATIONNAME:	Ophthalmic Femtosecond Laser
DEVICECLASSIFICATION:	Class II
PRODUCT CODE	OOE (Ophthalmic Femtosecond Laser)
PREDICATEDEVICES:	LenSx 550 Laser System, LensAR Laser System for AnteriorCapsulotomy

PREDICATE DEVICES:

510(K) NUMBER	PRODUCT TRADE NAME	MANUFACTURER
K082947	LenSx 550 Laser System	LenSx Lasers / Alcon
K090633	LensAR Laser System forAnterior Capsulotomy	LensAR, Inc.
K060372	IntraLase FS Laser	Abbott Medical Optics
K040204	Zyoptix XP Microkeratome	Technolas Perfect Vision GmbH
K022560	Moria 2 Microkeratome	Moria

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Description of the Device Subject to Premarket Notification:

Laser pulses are delivered through a sterile (disposable) Patient Interface, consisting of a contact lens and suction clip to provide suction. The contact lens and suction clip assembly creates a reference surface for depth control and fix the eye relative to the delivery of the laser beam.

Indication for Use:

The Femtec Laser System for Capsulotomy is indicated for anterior capsulotomy during cataract surgery. The proposed indication for use is identical to the previously cleared LenSx 550 Laser (K082947) and LensAR Laser System for Anterior Capsulotomy (K090633).

Technical Characteristics Comparison:

The Femtec Laser System for Capsulotomy mode of operation and technology are very similar to the previously cleared LenSx 550 Laser (K082947) and LensAR Laser System for Anterior Capsulotomy (K090633). The Femtec Laser System for Capsulotomy utilizes ultrashort, high frequency laser pulses to create photodisruption in the anterior capsule, as do the predicate devices. The Femtec Laser system utilizes a curved patient interface as does the LenSx 550 laser predicate, while the LenAR Laser System utilizes a fluid-fluid interface. However, both patient interface configurations have the same function, which to provide a reference surface through which the laser pulses are delivered to the anterior capsule and are therefore substantially equivalent.

Brief Summary of Preclinical and Clinical Performance Test Results:

Technolas Perfect Vision developed the Femtec Laser system for use in anterior capsulotomy. Pre-clinical and clinical testing has included bench testing and a prospective clinical trial.

Performance Data:

Testing and analyses included accuracy and reproducibility of capsulotomy incisions in porcine eyes, as well as in plastic and agar gel optical phantoms. The data demonstrated that the Femtec Laser System produces anterior capsulotomies that are accurate and predictable in size, shape, and centration over a range of depths. The capsular edge created by the Femtec Laser system is also at least as smooth as that created during anterior capsulotomy.

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Clinical Trial:

A clinical trial of the Femter Laser System was conducted to evaluate the performance of the laser system in the creation of anterior capsulotomy during cataract surgery. Anterior capsulotomy was successfully performed in all eyes using the Femtec Laser System; i.e., the capsulotomy was complete in all eyes, with no radial tears observed intraoperatively or postoperatively, and with an intraocular lens placed in each capsular bag. Postoperatively, the course of follow-up in the study population was unremarkable. The intraocular lens was centered in all study eyes, and no posterior capsule tears were observed. All capsulotomies were judged to be well-centered by the surgeon using visual inspection in the operating microscope. While shown to be equally safe as manual capsulorhexis, the Femtec Laser System anterior capsulotomy procedure produced significantly more circular capsulorhexis than the manual technique, and significantly more pupil-centered capsulorhexis compared to manual capsulotomy.

Basis for Determination of Substantial Equivalence:

The technological and performance characteristics of the Femtec Laser System for Capsulotomy are substantially equivalent to the technological and performance characteristics of the LenSx 550 Laser System and the LensAR Femtosecond Laser, cleared under K082947 and K090633, respectively, for anterior capsulotomy during cataract surgery.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus.

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

Technolas Perfect Vision GMBH c/o Ms. Betty M. Johnson Sr. Manager, Regulatory Affairs, Americas PO box 17190 Anaheim, CA 92817

NOV 2 2 2 2011

Re: K110427

Trade/Device Name: Femtec Laser System for Capsulotomy Regulation Number: 21 CFR 886.4390 Regulation Name: Opthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: November 7, 2011 Received: November 8, 2011

Dear Ms. Johnson:

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. Betty M. Johnson

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); 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/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kevin Alexander

for

Mälvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ & 1 / 0 4 L 7

Device Name(s): Femtec Laser System for Capsulotomy

Indications for Use:

The Fentec Laser System for Capsulotomy is indicated for anterior capsulotomy during cataract surgery.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

signature

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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K11042.7

SIMIA Numb TECHNOLAS PERFECT VISION GMBH FEMTEC LASER SYSTEM FOR CAPSULOTOMY

PAGE 18 PREMARKET NOTIFICATION

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.