Indicated Use is for scanning, mapping, and displaying the geometry of the anterior segment of the eye. Also indicated for the measurement and analysis of optical aberrations of the eye by use of wavefront technology.

Device Description

The NGDI Workstation comprises two individual measuring systems. The Anterior Segment Analyzer measures elevation and curvature on both the anterior and posterior surfaces of the cornea, full corneal pachymetry, white-to-white, anterior chamber depth and angle kappa. The Anterior Segment Analyzer in the NGDI Workstation is a diagnostic system that provides a complete analysis of the eye's optical system by utilizing slit scanning technology with an advanced Placido disc system. The slit scan is used to create the pachymetry model in the NGDI Workstation, which gives the thickness of the cornea and the location of the lens. The Aberrometer is a precision optical instrument which measures the deviation of light beams reflected off the eye's retina to define the wavefront deformation as a function of the position of the pupil. It uses a motor-controlled trombone to set up the optical path for the eye image to return through in complete focus. The Aberrometer function of the NGDI employs the principles of Hartman-Schack wavefront sensing in which a narrow illumination beam from a 785 mm, low power, laser diode goes into the eye and focuses into a diffraction limited point on the retina. The light reflects off the retina and comes back out the eye. The light exiting the eye is then passed through an array of tiny lenses (the lenslet array) that tak the exiting rays of light and breaks them into small points. With a normal, regular pattern, one can see where there is a plain wavefront with a uniform and symmetric grid and regular spacing between the points. Aberrated wavefronts are characterized by a distortion of the grid pattern after the light passes through the lenslet array.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NGDI (Next Generation Diagnostic Instrument) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for clinical performance. Instead, it presents a comparison of the NGDI's performance to a predicate device (Orbscan) in terms of repeatability and error statistics for keratometric power using test objects. The implicit acceptance is that the NGDI should perform comparably to or better than the predicate device.

Performance Metric	Acceptance Criteria (Implicit, based on Orbscan)	Reported NGDI Performance
RMS Repeatability of Average Power (Diopters) Sample: Test Objects	≤ 0.04 (Orbscan performance)	0.05
Error: Mean (Diopters) Sample: Test Objects	0.05 (Orbscan performance)	0.00
Error: Standard Deviation (Diopters) Sample: Test Objects	0.09 (Orbscan performance)	0.05
Error: Root Mean Square (Diopters) Sample: Test Objects	0.10 (Orbscan performance)	0.05

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document refers to "a number of test objects." A specific numerical count is not provided.
Data Provenance: Not specified. The study was non-clinical, using "test objects," not human patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. The ground truth was established by the known curvatures of the "test objects," which are physical standards, not human interpretations.
Qualifications of Experts: Not applicable.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Adjudication Method: Not applicable. The ground truth for the test objects was intrinsic (known curvature), not based on human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focused on instrument performance with test objects.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance: Yes, the study focused on the standalone performance of the NGDI and Orbscan instruments in measuring test objects. There was no human-in-the-loop component in this specific non-clinical test.

7. The Type of Ground Truth Used

Ground Truth Type: Known physical properties of "test objects" (specifically, their curvatures).

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This document describes a non-clinical testing phase for device comparison, not a machine learning algorithm that requires a training set. The device itself (NGDI) is an optical instrument, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there was no training set for an AI/ML algorithm.

Summary

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KO40913

Section 15 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 CRF 807.92.

1. Submitter's name, address, telephone number, contact person, and date summary prepared

Bausch & Lomb a. 180 Via Verde Dr. San Dimas, CA 91773 (909) 971-5104
David U, Thomas, M.S., R.A.C. b. Contact Person: Manager, Global Regulatory Affairs
Date Summary Prepared: December 19, 2003 C.

Name of device, including trade name and classification name: 2.

a.	Trade/Proprietary Name:	NGDI (Next Generation Diagnostic Instrument)
b.	Classification Name:	Ophthalmic Refractometer, AC Powered Keratascopy and AC Powered SlitLamp Biomicroscope

3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

Company:	Ortek, Inc
Device:	Orbscan II
510(k)	K984443
Date Cleared:	March 5, 1999
Company:	Bausch & Lomb, Incorporated
Device:	Zywave Wavefront Diagnostic System

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510(k)	K010992
Date Cleared:	Class I, Exempt
Company:	Bausch & Lomb, Incorporated
Device:	Documenting Laser Slit Lamp
510(k):	K012873
Date Cleared:	November 19, 2001

A description of the device that is the subject of the 510(k), including 4. explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The NGDI Workstation comprises two individual measuring systems.

The Anterior Segment Analyzer measures elevation and curvature on both the anterior and posterior surfaces of the cornea, full corneal pachymetry, white-towhite, anterior chamber depth and angle kappa.

The Anterior Segment Analyzer in the NGDI Workstation is a diagnostic system that provides a complete analysis of the eye's optical system by utilizing slit scanning technology with an advanced Placido disc system. The slit scan is used to create the pachymetry model in the NGDI Workstation, which gives the thickness of the cornea and the location of the lens.

The Aberrometer is a precision optical instrument which measures the deviation of light beams reflected off the eye's retina to define the wavefront deformation as a function of the position of the pupil. It uses a motor-controlled trombone to set up the optical path for the eye image to return through in complete focus.

The Aberrometer function of the NGDI employs the principles of Hartman-Schack wavefront sensing in which a narrow illumination beam from a 785 mm, low power, laser diode goes into the eye and focuses into a diffraction limited point on the retina. The light reflects off the retina and comes back out the eye. The light exiting the eye is then passed through an array of tiny lenses (the lenslet array) that tak the exiting rays of light and breaks them into small points. With a normal, regular pattern, one can see where there is a plain wavefront with a uniform and symmetric grid and regular spacing between the points. Aberrated wavefronts are characterized by a distortion of the grid pattern after the light passes through the lenslet array.

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Statement of intended use: 5.

Indicated use is for scanning, mapping, and displaying the geometry of the anterior segment of the eye. Also a diagnostic instrument indicated for the automated measurement and analysis of optical aberrations of the eye by use of wavefront technology.

6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

CHARACTERISTICS	Bausch & LombNGDI	ORBSCANIE	ZAWAVE
Indications for use	Indicated use is forscanning, mapping, anddisplaying the geometryof the anterior segmentof the eye. Also adiagnostic instrumentindicated for theautomated measurementand analysis of opticalaberrations of the eye byuse of wavefronttechnology.	Indicated use is forscanning, mapping, anddisplaying the geometryof the anterior segment ofthe eye.	Automated measurementand analysis of opticalaberrations of the eye byuse of wavefronttechnology.
Operating principle	Hartmann-Schack	N/A	Same
Measurement range	Sphere -12 to +6 dioptersCylinder 0 to 6 dioptersAxis 0-180 degrees		Sphere -8 to +6 dioptersCylinder 0 to -6 dioptersAxis 0-180 degrees
Acquisition Head	Same except for lightsource (see below).	Scanning slitHiRes video CCD cameraFully coated opticsCoaxially fixation lightOptical Positioning Aid
Light Source	Laser slit technology (red,660 nanometer)	Incandescent Light sourceusing mechanical aperture togenerate slits.
	Trombone Laser Injection780 nanometers 1millimeter off axis.		Direct Laser Injection 780nanometers 1 millimeter ofaxis.

Table A - Comparative Technological Characteristics

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Brief summary of nonclinical tests and results: 7.

Repeatability data was collected for a number of test objects. This was done for the NGDI and Orbscan. The comparisons were made in terms of average Keratometric Power (referred to as Diopters and abbreviated as D in this document), which is related to the Radius of Curvature by the formula

Px = 337.5/ Rc(mm)

Presented in Table B are the Power results of the repeatability study for test objects.

	RMS Repeatability of AveragePower, Diopters
	Orbscan	NGDI
Root Mean SquareRepeatability	0.04	0.05

Table B - Overall Repeatability of Keratometric Power (Test Objects)

Instrument repeatability represents only a portion of the total error. Systematic errors can occur for a variety of reasons, and as a result, the variances for absolute error are generally larger than the Root Mean Square repeatability. Because the curvatures of the test objects are known, the error statistics can be computed. The results are presented in Table C.

Table C - Error Statistics (Test Objects)

Statistic	Error, Diopters
	Orbscan	NGDI
Mean	0.05	0.00
Standard Deviation	0.09	0.05
Root Mean Square	0.10	0.05

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling human figures or birds in flight, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

Bausch & Lomb c/o Intertek Testing Services Daniel W. Lehtonen, Staff Engineer 70 Codman Hill Rd. Boxborough, MA 01779

Re: K040913

Trade/Device Name: NGDI (Next Generation Diagnostic Instrument) Regulation Number: 21 CFR 886.1850 Regulation Name: Biomicroscopes Regulatory Class: Class II Product Code: MXK; HJO; NCF Dated: July 9, 2004 Received: July 13, 2004

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have roviewed your betermined the device is substantially equivalent (for the indications ferenced about and sure) to legally marketed predicate devices marketed in interstate for use bared in the enactment date of the enactment date of the Medical Device Amendments, or to conniner that have been reclassified in accordance with the provisions of the Federal Food, Drug, de rices that have been rotation of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, ateres, missions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding 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 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 or ury 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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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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Kalipi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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47913

Indications for Use

510(k) Number (if known):

Device Name: NEXT GENERATION DIAGNOSTIC INSTRUMENT (NGDI) Indications For Use:

Indicated Use is for scanning, mapping, and displaying the geometry of the anterior segment of the eye.

Also indicated for the measurement and analysis of optical aberrations of the eye by use of wavefront technology.

Prescription Use (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)

Concurrent ffice of Device Evaluation (ODE)

Elmon R. Rees

(Division Sign-om)
Divisien ef Ophthalmic Ear,
Nese and Threat Devises

510(k) Number KD40913

Page 1 of _

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.