In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea;
In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;
In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty;
In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.

Device Description

The VisuMax Laser Keratome is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax Laser Keratome is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Carl Zeiss Meditec VisuMax Laser Keratome. It focuses on demonstrating substantial equivalence to predicate devices and expanding indications for use.

However, the document does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, sample sizes for test or training sets, information about ground truth establishment, expert qualifications, or MRMC study results. The information provided is primarily focused on the device's technical characteristics, intended use, and a summary of pre-clinical testing, which is often used to demonstrate substantial equivalence rather than explicitly proving performance against predefined acceptance criteria for a new device.

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text. I will indicate where information is missing or not applicable based on the document.

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it aims to demonstrate substantial equivalence in performance to predicate devices for expanded indications. The "reported device performance" in this context refers to the findings from the ex-vivo studies.

Acceptance Criteria (Not explicitly stated as numeric thresholds)	Reported Device Performance (from ex-vivo studies)
For Lamellar Keratoplasty Incisions:
Accuracy and Reproducibility	"Ex-vivo porcine eye studies demonstrate the accuracy and reproducibility of the VisuMax Laser Keratome for lamellar keratoplasty incisions and that the level of precision is maintained over a wide range of incision diameters and depths. The results further demonstrate that the proposed device performed equivalently to the predicate device."
For Full Penetrating Keratoplasty Performance:
Quality of Performance	"Ex-vivo study in human globes shows that the quality of the full penetrating keratoplasty performance of the VisuMax Laser Keratome and the predicate device are comparable."
General Equivalence to Predicate Devices	"The VisuMax Laser Keratome has the same operating characteristics as the predicate devices... Therefore, the VisuMax Laser Keratome is substantially equivalent to these legally marketed predicate devices." and "The VisuMax Laser Keratome is substantially equivalent to the predicate devices." (Conclusion section)

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text for either the porcine eye studies or the human globes study.
- Data Provenance:
  - "Ex-vivo porcine eye studies"
  - "Ex-vivo study in human globes"
  - The location of these studies (country of origin) is not specified.
  - Both are "pre-clinical" studies, implying they are not retrospective or prospective clinical studies on live patients.
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 specified. The studies are ex-vivo (on animal and human globes), and the evaluation of "accuracy," "reproducibility," and "quality" would likely involve objective measurements or expert assessment, but the number and qualifications of evaluators are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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 is a medical device (laser keratome), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study with human readers assisting/being assisted by AI is not relevant to this device's evaluation as described. The comparison is between the new device and predicate devices in performing surgical cuts.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance data presented refers to the device's ability to make incisions ("accuracy and reproducibility," "quality of performance") when compared to predicate devices, during ex-vivo studies. This evaluates the device's intrinsic function. The device's operation still requires a human operator, but the performance "testing" as described focuses on the machine's output in isolation (the cut it makes).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For "accuracy," "reproducibility," and "quality" of surgical incisions, the ground truth would likely be based on objective measurements (e.g., microscopy, optical coherence tomography to measure incision depth, diameter, smoothness, and morphology against predefined surgical targets) possibly interpreted or confirmed by expert ophthalmologists/pathologists, but this is not detailed in the summary.
The sample size for the training set:
- Not applicable. This device is a surgical laser, not a machine learning model, so there is no "training set" in the sense of data used to train an algorithm. The device's design and engineering would have involved extensive testing and calibration during development, but this is distinct from "training data" for an AI.
How the ground truth for the training set was established:
- Not applicable (as it's not an AI/ML device with a training set).

Summary

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510(K) SUMMARY

JUL - 8 2010

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:	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-527740 JenaGermany
b.	Contact Person:	Judy BrimacombeCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, CA 94568USAj.brimacombe@meditec.zeiss.comTel: (925) 557-4616Fax: (925) 557-4259
c.	Date Prepared:	April 28, 2010

NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME

a.	Trade/Proprietary Name:	VisuMax Laser Keratome
b.	Common/Usual Name:	VisuMax Laser Keratome
c.	Classification Name:	Laser Instrument, Surgical, PoweredKeratome, AC-powered
d.	Classification Code(s):	21 CFR 886.4390; 79 HFQ21 CFR 886.4310; 79 HNO

PREDICATE DEVICES FOR THE VISUMAX LASER KERATOME

PREDICATE DEVICE	MANUFACTURER	510(k) CLEARANCE NUMBER	CLEARANCE DATE
HORUS Laser Keratome	Carl Zeiss Meditec	K062314	December 22, 2006
IntraLase FS Laser	Abbott Medical Optics	K041893	July 29, 2005

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DEVICE DESCRIPTION

STATEMENT OF INTENDED USE

The VisuMax Laser Keratome is indicated for the following:

. In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea;
In patients undergoing surgery or other treatment requiring initial lamellar . resection of the cornea;
In the creation of a lamellar cut/resection of the cornea for lamellar . keratoplasty:
In the creation of a cut/incision for penetrating keratoplasty and corneal . harvesting.

TECHNOLOGICAL CHARACTERISTICS COMPARISON

The VisuMax Laser Keratome laser is substantially equivalent to the HORUS Laser Keratome also by Carl Zeiss Meditec (K062314), as well as the IntraLase FS Laser (K041893) by Abbott Medical Optics.

The VisuMax Laser Keratome has the same operating characteristics as the predicate devices, the HORUS (5062314), and the IntraLase FS Lasers (K993153, K001211, K002890. K013941. K031960. K041893. K060372. K063682. and K073404). Therefore, the VisuMax Laser Keratome is substantially equivalent to these legally marketed predicate devices.

SUMMARY OR PROPOSED MODIFICATIONS INCLUDED IN THIS 510(K) PREMARKET NOTIFICATION

The subject of this traditional premarket notification 510(k) is the expansion of the indications for use of the predicate device (HORUS Laser Keratome) to include lamellar keratoplasty and penetrating keratoplasty, consistent with the indication for use of the predicate device for other commercially available femtosecond lasers. The indications for use for the VisuMax Laser Keratome would be the same as those for the predicate device (the IntraLase FS Laser).

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Additionally, modifications have been introduced to the device hardware and software specifications in order to allow for the addition of the lamellar and penetrating keratoplasty capability and to enhance the laser's usability in the clinic setting.

These modifications include:

An increase in pulse repetition rate from 200 kHz to 500 kHz to allow the . femtosecond resections and/or incisions to be performed with acceptable procedure times
An increase in the maximum average laser power as a result of the higher pulse . repetition rate, however the total laser energy delivered to the eye is unchanged
Reduction of the maximum laser pulse peak power and the therapy pulse energy .
The addition of a trackball and touch screen to the GUI .
Improved ergonomics of the Patient Supporting System and to the laser housing . to facilitate the ease of use
An additional slit projector to facilitate better patient handling .
An additional IR light source to improve illumination of the surgical field .

BRIEF SUMMARY OF PRE-CLINICAL AND CLINICAL PERFORMANCE TESTING

The VisuMax Laser keratome has been designed and tested to applicable safety standards. The performance data supporting safety and substantial equivalence of the VisuMax Laser Keratome to the predicate devices are summarized as follows:

Ex-vivo porcine eye studies demonstrate the accuracy and reproducibility of the . VisuMax Laser Keratome for lamellar keratoplasty incisions and that the level of precision is maintained over a wide range of incision diameters and depths. The results further demonstrate that the proposed device performed equivalently to the predicate device.
Ex-vivo study in human globes shows that the quality of the full penetrating . keratoplasy performance of the VisuMax Laser Keratome and the predicate device are comparable.

CONCLUSION

The VisuMax Laser Keratome is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting and promoting the health and well-being of Americans.

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

Carl Zeiss Meditec AG c/o Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfinsten Road Northbrook, IL 60062

Re: K100253

Trade/Device Name: VisuMax Laser Keratome Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: II Product Codes: HQF, HNO Dated: June 22, 2010 Received: June 23, 2010

Dear Mr. Devine:

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.

JUL -- 8 2010

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. 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

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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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Kesia Alexander

Malvina 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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K100293 510(k) Number (if known):

Device Name(s): VisuMax Laser Keratome

Indications for Use:

The VisuMax Laser Keratome is indicated for the following:

· In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea;
· In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;
· In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty;
· In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page l of

e Evaluation (ODE)

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

510(k) Number K100253

510(K) PREMARKET NOTIFICATION CARL ZEISS MEDITEC

VISUMAX LASER KERATOME Volume 1, Page20

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.