The UltraShaper™ System consists of the following components: (a) cutting head, (b) suction rings / handles, (c) motor handpiece, (d) handpiece-to-console cable, (e) suction tubing set, (g) blade assembly, and (h) console power / suction supply with foot actuated switches. The cutting head and suction rings / handles are constructed entirely from stainless steel. The UltraShaper™ System is designed to perform anterior lamellar circular corneal resections of a predetermined diameter and thickness based upon the principle of a carpenter's plane. A cutting blade emerges from the center of the keratome plane. The stainless steel blade oscillates by a small DC motor (in the motor handpiece) controlled by foot switch. The cutting head slides on dovetail guides on a circular suction ring. The cutting head contains a gear drive train that engages a gear rack on one side of the suction ring to drive the keratome head across the suction ring and cornea. The suction ring provides an annular vacuum chamber for temporary attachment to the ocular globe. The cutting head has a fixed foot plate and is available in three standard head sizes, 130, 160 and 180 microns, depending on the thickness of the corneal section desired. There are also three different suction ring / handle sizes available to accommodate the variations in corneal curvature from patient to patient. A (motor handpiece-to-console) cable is also supplied with each UltraShaper™ keratome. The UltraShaper™ Console Power Supply provides the power to both the keratome motor and the suction supply for holding the ring in place on the cornea. This is the same console which drives the company's ADK disposable keratome. The console has three vacuum suction settings, HIGH, LOW, OFF. The console will only permit the keratome to operate (transverse the cutting plane) while in the HIGH setting. While in the HIGH mode, the console, with its internal barometer, reacts to vacuum suctions values which are below the optimum by signaling the operator with audible and visual warnings. The UltraShaper™ Console Power Supply conforms to IEC-601-1 electrical safety standard. A sterile suction tubing set, which is generic to several keratome systems, is used to connect the suction ring / handle of the UltraShaper™ to the suction port on the console. Suction tubing sets are supplied sterile and are intended for single use. Likewise, keratome blades are supplied sterile and are intended for single use.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the UltraShaper™ System, rather than a detailed study report that establishes performance criteria with specific numerical targets and then measures against them. Therefore, many of the requested elements (like a specific acceptance criteria table, detailed sample sizes for test and training sets, expert adjudication methods, MRMC studies, and standalone performance metrics) are not explicitly present or are not applicable in the way they would be for a typical AI/software device evaluation.

The primary goal of this 510(k) submission is to demonstrate "substantial equivalence" to existing, legally marketed predicate devices, not to prove novel performance against pre-defined acceptance criteria through a specific study.

However, I can extract information related to the device's operational characteristics and the basis for its clearance, framed in the context of the requested questions.

1. A table of acceptance criteria and the reported device performance

The 510(k) notification does not present a formal table of acceptance criteria with numerical performance targets and reported results for the UltraShaper™ System itself. Instead, it argues for substantial equivalence based on technological characteristics and a history of acceptable clinical results for similar devices.

The "performance" is implicitly deemed acceptable if it meets the established safety and effectiveness of its predicate devices. The key performance characteristics mentioned are the ability to perform "anterior lamellar circular corneal resections of a predetermined diameter and thickness."

The document highlights these performance-related characteristics:

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (UltraShaper™ System)
Intended Use: Shave a partial lamellar section of the cornea, similar to predicate devices.	"The UltraShaper™ System is an AC-powered device that is intended to shave a partial lamella section of the cornea."
Precision of Section (Thickness): Ability to achieve predetermined corneal section thicknesses.	Fixed Depth Keratome Head available in 130, 160, and 180 μ.
Blade Oscillation Speed:	7,500 RPM (identical to Chiron ACS™).
Vacuum System Performance: Maintain adequate suction for secure attachment to the ocular globe during operation.	Console provides HIGH, LOW, OFF settings; only permits operation in HIGH setting; audible and visual warnings for vacuum suctions below optimum.
Electrical Safety: Conform to relevant electrical safety standards.	Conforms to IEC-601-1 electrical safety standard.
Mechanical Operation: Use a gear-drive mechanism for precise blade traverse.	Uses same primary drive mechanism (DC-powered gear drive) as Chiron ACS™.
Reproducibility/Measurement: Ability to verify blade height.	Measured in clinic with Micron-Scope (similar to predicate device; Allergan's doesn't specify, Micro Precision uses Digital Indicator).
Clinical Safety & Effectiveness Profile: Associated with acceptable clinical results in terms of postoperative refraction and visual acuity, and minimal postoperative complications (as demonstrated by predicate devices).	"A review of the published literature on keratomes indicates that these devices are associated with acceptable clinical results in terms of postoperative refraction and visual acuity, and minimal postoperative complications." (This refers to predicate devices and the general class of devices, not a specific study on the UltraShaper™).

2. Sample sized used for the test set and the data provenance

The document does not describe a "test set" in the context of a new, clinical performance study for the UltraShaper™ System. It relies on the established performance and safety record of predicate devices. There is no mention of sample size or data provenance (country of origin, retrospective/prospective) for a study specifically testing the UltraShaper™. The "data provenance" for the claims of safety and effectiveness comes from "published literature on keratomes," generally.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No specific test set with a ground truth established by experts for the UltraShaper™ System is described in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No specific test set requiring adjudication is described.

5. 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

Not applicable. The UltraShaper™ System is a mechanical surgical device (keratome), not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-assistance effectiveness is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical surgical device, not an algorithm. Performance is inherently tied to human operation; however, its automated features (like blade traverse, oscillation) are designed to provide consistent mechanical operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the UltraShaper™ System itself, no new "ground truth" was established through a specific study described here. The implicit "ground truth" for demonstrating substantial equivalence is the long-term, accepted clinical performance of similar keratomes observed in published literature and general clinical use, encompassing outcomes data (postoperative refraction, visual acuity) and complication rates.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/machine learning model. The device's design is based on established engineering principles and the successful design of predicate devices.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" or "ground truth" establishment in the context of an AI/machine learning model for this device. The design principles are based on established medical device engineering and historical clinical experience with keratomes.

Summary

{0}------------------------------------------------

K990227

JAN 31 2000

Summary of Safety and Effectiveness for 510(k)

Submitter of Information: 1.
LaserSight Technologies, Inc. 3300 University Boulevard, Suite 140 Winter Park, Florida 32792 Michael P. Dayton, MS, RAC Contact Person: Senior Vice President Chief Technical Officer Tel (407) 678-9900 Fax (407) 671-0180
Device Name: 2.

Trade / Proprietary Name:	UltraShaper™ System
Classification / Usual Name:	Keratome
Device Classification	Class I, 86 HNO (21 CFR, Section 886.4370)
Performance Standards	N/A

1. Predicate Devices:
  The UltraShaper™ Keratome for which marketing clearance is requested is substantially equivalent to the following predicate devices:
Automatic Corneal Shaper, manufactured and distributed bv Chiron Vision . Corporation, 9342 Jeronimo Road, Irvine, CA [cleared under K941550].
Steinway-Barraquer In-Situ Microkeratome Set, manufactured and distributed by . Steinway Instrument Company, Inc., San Diego, CA. This device is identical to the Allergan Medical Optics Barraquer-Krumeich Refractive Set [cleared under K860001].
Micro Refractive System Model 1000, manufactured and distributed by Micro Precision . Instrument Company, 2323 N. Central Avenue, Suite 2105, Phoenix, AZ [cleared under K903912].
1. Description of Device:

Device Description: The UltraShaper™ System consists of the following components: (a) cutting head, (b) suction rings / handles, (c) motor handpiece, (d) handpiece-to-console cable, (e) suction tubing set, (g) blade assembly, and (h) console power / suction supply with foot actuated switches.

The cutting head and suction rings / handles are constructed entirely from stainless steel. The UltraShaper™ System is designed to perform anterior lamellar circular corneal

{1}------------------------------------------------

resections of a predetermined diameter and thickness based upon the principle of a carpenter's plane. A cutting blade emerges from the center of the keratome plane. The stainless steel blade oscillates by a small DC motor (in the motor handpiece) controlled by foot switch. The cutting head slides on dovetail guides on a circular suction ring. The cutting head contains a gear drive train that engages a gear rack on one side of the suction ring to drive the keratome head across the suction ring and cornea. The suction ring provides an annular vacuum chamber for temporary attachment to the ocular globe. The cutting head has a fixed foot plate and is available in three standard head sizes, 130, 160 and 180 microns, depending on the thickness of the corneal section desired. There are also three different suction ring / handle sizes available to accommodate the variations in corneal curvature from patient to patient. A (motor handpiece-to-console) cable is also supplied with each UltraShaper™ keratome.

The UltraShaper™ Console Power Supply provides the power to both the keratome motor and the suction supply for holding the ring in place on the cornea. This is the same console which drives the company's ADK disposable keratome. The console has three vacuum suction settings, HIGH, LOW, OFF. The console will only permit the keratome to operate (transverse the cutting plane) while in the HIGH setting. While in the HIGH mode, the console, with its internal barometer, reacts to vacuum suctions values which are below the optimum by signaling the operator with audible and visual warnings. The UltraShaper™ Console Power Supply conforms to IEC-601-1 electrical safety standard.

A sterile suction tubing set, which is generic to several keratome systems, is used to connect the suction ring / handle of the UltraShaper™ to the suction port on the console. Suction tubing sets are supplied sterile and are intended for single use. Likewise, keratome blades are supplied sterile and are intended for single use.

ડ. Intended Use for Subject Device:

The Automated Disposable Keratome is an AC-powered device that is intended to shave a partial lamellar section of the cornea.

Comparison of Technological Characteristics with Predicate Devices: 6.

The UltraShaper™ Keratome operates on the same principles and has the same technological characteristics as other legally marketed keratomes. However, the UltraShaper™ is most similar to the Chiron Automated Corneal Shaper™ (ACS). The UltraShaper™ shares the same primary drive mechanism as the Chiron ACS. Historically, the DC-powered gear drive mechanism, which automatically draws the blade across dovetail guides, has proven itself safe and effective in producing precise sections of corneal tissue.

The motor handpiece for the UltraShaper™ device uses the same DC motor in the Chiron ACS™. The connect point between the UltraShaper™ motor handpiece is similar to the ACS™ system. The UltraShaper™ motor handpiece, like the ACS™ motor handpiece, is disinfected by cleaning with alcohol. Refer to TABLE 1 for a comparison of features for substantially equivalent devices.

Image /page/1/Picture/8 description: The image shows the binary number 000010. The number is written in a bold, sans-serif font. The digits are evenly spaced and aligned horizontally. The image is simple and clear, with no other elements present.

{2}------------------------------------------------

The differences between the UltraShaper™ and currently marketed devices, particularly the Chiron ACS device, are insignificant and do not affect the safety and effectiveness of the device since they do not alter the energy source, materials or principle of operation.

Discussion of Clinical Tests: 7.

The techniques and instrumentation for lamellar keratoplasty were introduced 45 years ago. Keratomes have been in use for nearly 30 years, beginning with the introduction into commercial distribution of the Steinway/Barraquer In Situ Microkeratome Set in 1965. A review of the published literature on keratomes indicates that these devices are associated with acceptable clinical results in terms of postoperative refraction and visual acuity, and minimal postoperative complications.

TABLE 1
INFORMATION ON SUBSTANTIALLY EQUIVALENT PRODUCTSCOMPARISON OF FEATURES
	Company
Parameter	LaserSightUltraShaper™System	Chiron VisionAutomated CornealShaper™	Allergan MedicalBarraquer-KrumeichRefractive Set™	Micro PrecisionMicro Refractive™System Model 1000
MajorComponents	Console	Console	Console	Console
	1 Suction Rings	1 AdjustableHeight SuctionRing	25 Suction Rings	25 Suction Rings
	Fixed DepthKeratome Head(130, 160, 180 μ)	AdjustableKeratome Head	Keratome Headwith ThicknessPlates	AdjustableKeratome Head
	Electric Motor12 v DC	Electric Motor12 v DC	Electric Motor12 v DC	Turbine Motor
	Blade Oscillation7,500 RPM	Blade Oscillation7,500 RPM	Blade OscillationNot known	Blade Oscillation0-20,000 RPM
Console Details
Electrical	110/120 AC	110/120 AC	110/120 AC	None
Vacuum Pump	DC Powered	DC Powered	AC Powered	Nitrogen GasVenturi TypePump
Blade HeightVerification	Measured inClinic withMicron-Scope	Measured inClinic withMicron-Scope	None	Measured inClinic withDigital Indicator
Foot Controls	DC Powered	DC Powered	DC Powered	Pneumatic

000011

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

JAN 31 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sam A. Mirza Manager, Regulatory Affairs LaserSight Technologies, Inc. 3300 University Boulevard, Suite 140 Winter Park, Florida 32792

Re: K990227 Trade Name: UltraShaper™ System Regulatory Class: I Product Code: 86 HNO Regulation: 886.4370 (Keratome) Dated: January 12, 2000 Received: January 13, 2000

Dear Mr. Mirza:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

{4}------------------------------------------------

Page 2 - Mr. Sam A. Mirza

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

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

Enclosure

{5}------------------------------------------------

510 (k) NUMBER (IF KNOWN) : K990227

UltraShaper™ System DEVICE NAME :

INDICATIONS FOR USE :

The UltraShaper™ System is an AC-powered device that is intended to shave a partial lamella section of the cornea.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
--	--------------------------------------------------------

	Bruce Drum
	(Division Sign-Off)
	Division of Ophthalmic Devices
510(k) Number	K990227

Prescription Use	X	OR	Over-The-Counter-Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

000000

Regulation Number and Section

§ 886.4370 Keratome.

(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.