The LADARWave® CustomCornea® Wavefront System is used for measuring, recording, and analyzing visual aberrations (such as myopia, astigmatism, coma and spherical aberration) and for displaying refractive error maps of the eye to assist in prescribing refractive corrections.

This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser where a wavefront-guided treatment is indicated.

This device can also export centration data and associated registration information for conventional phoropter-based refractive surgery with the LADAR6000™ System.

Device Description

The LADARWave® CustomCornea® Wavefront System is an aberrometer, utilizing Hartmann-shack wavefront sensing to measure the aberrations in the human eye. The device contains four major optical subsystems used in the clinical wavefront examination.

A fixation subsystem provides the patient with an unambiguous point of fixation. . Optics in this path automatically adjusts to correct for the patient's spherocylindrical error so that the target is clearly observed.
A video subsystem provides the device operator with a view of the eye at the . measurement plane. The operator uses the video imagery to position the eye for the measurement and to record the geometry of the wavefront relative to anatomical features.
A probe beam subsystem directs a narrow beam of eye-safe infrared radiation . into the eye to generate the re-emitted wavefront.
A wavefront detection subsystem images the re-emitted wavefront onto the . entrance face of the Hartmann-shack wavefront sensor.

These subsystems are all under control of the device software.

Once the wavefront examination is complete, the operator may export the exam data to removable media. The exported electronic file contains all information necessary to perform customized ablative surgery using either the LADARVision®4000 or LADAR6000" System. The information includes the wavefront measurement, essential patient identification information, and geometric registration data. The electronic file is in a proprietary format and is encrypted so that wavefront data cannot be exported for use by an incompatible treatment device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
The accuracy in translational (x,y) and cyclotorsional registration for the "overlay" method must be at least as good as with the current "sputnik" method to establish equivalence of the new automated registration process.	The results demonstrate that the "overlay" method is as good or better than the "sputnik" method in offset registration and rotational registration at all values of registration error (i.e. at all x-axis values). Additionally, system level software verification and validation were successfully completed in accordance with General Principles of Software Validation; Final Guidance for Industry and FDA Staff dated January 11, 2002.

Acceptance Criteria

Reported Device Performance

The accuracy in translational (x,y) and cyclotorsional registration for the "overlay" method must be at least as good as with the current "sputnik" method to establish equivalence of the new automated registration process.

The results demonstrate that the "overlay" method is as good or better than the "sputnik" method in offset registration and rotational registration at all values of registration error (i.e. at all x-axis values). Additionally, system level software verification and validation were successfully completed in accordance with General Principles of Software Validation; Final Guidance for Industry and FDA Staff dated January 11, 2002.

Study Details:

Sample Size used for the test set and the data provenance:
- The text states, "For each eye, one LADARWave wavefront session (centration photo and five wavefront measurements with associated photos) with eye marks and a session without eye marks were taken for the testing." This implies that multiple eyes were used, but a specific number is not provided.
- Data Provenance: Not explicitly mentioned (e.g., country of origin). The study appears to be retrospective or a controlled prospective study specifically for this submission, as it compares two methods ("sputnik" and "overlay") on the same eyes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The method of "comparing" the two registration methods ("sputnik" and "overlay") suggests a quantitative assessment rather than expert consensus for ground truth on registration accuracy directly.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document. The comparison seems to be based on direct measurement of registration accuracy between the two methods rather than an adjudication process involving human reviewers.
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 was not explicitly mentioned or described. The study focused on comparing two registration methods (manual "Sputnik" vs. automated "Overlay") for the device itself, rather than evaluating human reader performance with or without AI assistance. The "overlay" method is described as an "assisted" registration method, suggesting it might involve some automation, but the study design is not an MRMC study comparing human performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "overlay" method is described as an "assisted" registration method, implying some level of automation. The testing compared this "overlay" method to the "current manual 'Sputnik' method." The study's focus was on establishing the equivalence of the automated/assisted registration process, which is a standalone function of the software, to the existing manual method. Therefore, a standalone performance assessment of the "overlay" method's accuracy in registration, compared to a manual method, was performed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for registration accuracy appears to be derived from direct comparisons between the outcomes of the "sputnik" and "overlay" methods. The statement "The primary test was to establish equivalence of the two methods of registration by testing that the accuracy in translational (x,y) and cyclotorsional registration for the 'overlay' method are at least as good as with the current 'sputnik' method" suggests that the "sputnik" method provides a baseline or reference against which the "overlay" method's accuracy is measured. This implies a comparative ground truth derived from a reference method rather than an independent expert consensus, pathology, or outcomes data.
The sample size for the training set:
- This information is not provided in the document. The document describes testing the automated registration process, but does not detail the development or training of the "overlay" software.
How the ground truth for the training set was established:
- This information is not provided in the document. Since the training set size is not mentioned, the method for establishing its ground truth is also absent.

Summary

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K062930

510(k) Summary LADARWave® CustomCornea® Wavefront System

Alcon Research Ltd., on behalf of Alcon RefractiveHorizons 2501 Discovery Drive, Suite 500 Orlando, FL 32826

A. Contact Person:

NOV - 8 2006

Janet G. Johnson Senior Manager Regulatory Affairs Telephone (407) 513-8954 Fax (407) 513-7855 Date Summary was Prepared: September 27, 2006

B. Device Information:

Proprietary Name:	LADARWave® CustomCornea® Wavefront System
Common Name:	Abberrometer, Ophthalmic
Classification Name	Ophthalmic Refractometer
and Regulatory Class:	21 CFR 886.7160 Class I
Product Code:	NCF

C. Substantial Equivalence Device (Predicate):

LADARWave® CustomCornea® Wavefront System (K023249)

D. Indications for Use:

The LADARWave® CustomCornead Wavefront System is used for measuring, recording, and analyzing visual aberrations (such as myopia, astigmatism, coma and spherical aberration) and for displaying refractive error maps of the eye to assist in prescribing refractive corrections.

This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser where a wavefront-guided treatment is indicated.

This device can also export centration data and associated registration information for conventional phoropter-based refractive surgery with the LADAR6000" System.

E. Device Description:

A fixation subsystem provides the patient with an unambiguous point of fixation. . Optics in this path automatically adjusts to correct for the patient's spherocylindrical error so that the target is clearly observed.

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A video subsystem provides the device operator with a view of the eye at the . measurement plane. The operator uses the video imagery to position the eye for the measurement and to record the geometry of the wavefront relative to anatomical features.
A probe beam subsystem directs a narrow beam of eye-safe infrared radiation . into the eye to generate the re-emitted wavefront.
A wavefront detection subsystem images the re-emitted wavefront onto the . entrance face of the Hartmann-shack wavefront sensor.

These subsystems are all under control of the device software.

F. Substantial Equivalence Comparison:

The LADARWave® CustomCornea® Wavefront System with Assisted Registration has the same indications for use, intended use, and same technological characteristics (i.e., design, material, chemical composition, energy source) as the current LADARWave® CustomCornea® Wavefront System.

The LADARWave® CustomCornea® Wavefront System with Assisted Registration software has automated the registration process, allows the option for LADARWave wavefront measurements (pre-op) to be performed on an alternate day than the surgery, and allows centration data and associated registration data, for conventional surgery, to be performed on the LADARWave and exported to the LADAR6000™ System.

G. Testing:

Eye images were collected to perform equivalence testing of the new automated registration process. For each eye, one LADARWave wavefront session (centration photo and five wavefront measurements with associated photos) with eye marks and a session without eye marks were taken for the testing. These images were compared using the current manual "Sputnik" method and the "Overlay" assisted registration method. The primary test was to establish equivalence of the two methods of registration by testing that the accuracy in translational (x,y) and cyclotorsional registration for the "overlay" method are at least as good as with the current "sputnik" method.

Additionally, system level software verification and validation were successfully completed in accordance with General Principles of Software Validation; Final Guidance for Industry and FDA Staff dated January 11, 2002.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alcon Research, Ltd. c/o Ms. Janet G Johnson Senior Manager, Regulatory Affairs 2501 Discovery Drive, Suite 500 Orlando. FL 32826

NOV - 8 2006

Re: K062930

Trade/Device Name: LADARWave® CustomCornea® Wavefront System Regulation Number: 21 CFR 886.1760 Regulation Name: Ophthalmic Refractometer Regulatory Class: I Product Code: NCF Dated: September 27, 2006 Received: September 28, 2006

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 misbrandijng and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your devire 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); 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 - Janet G. Johnson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egelmisi MD

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

Enclosure

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KO62930 510(k) Number (if known): Alcon LADARWave® CustomCornea® Wavefront System Device Name:

Indications for Use Statement

The LADARWave® CustomCornea® Wavefront System is used for measuring, recording, and analyzing visual aberrations (such as myopia, hyperopia, astigmatism, coma and spherical aberration) and for displaying refractive error maps of the eye to assist in prescribing refractive corrections.

This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser where a wavefront-guided treatment is indicated.

This device can also export centration data and associated registration information for conventional phoropter-based refractive surgery with the LADAR6000™ System.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Arnl L. Kouchi

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

510(k) Number K062930

Prescription Use: X (Per 21 CFR 801.109)

Over the Counter Use:

Regulation Number and Section

§ 886.1760 Ophthalmic refractometer.

(a)
Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.