The Automated Disposable Keratome consists of two components: (a) disposable keratome, (b) power / suction supply and DC motor with foot actuated switch. The ADK is a keratome 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 controlled by foot switch. The keratome, which is fabricated from high density engineering plastic (except the blade and motor), has a one piece head that is pre-assembled with a fixed foot plate, and is available in two standard head sizes, 130 or 160 microns, depending upon the thickness of corneal section desired. The keratome head has dovetail guides, which correspond to guides on the suction ring that is placed upon the ocular globe. Tandem gears on both sides of the keratome head and corresponding gears on the suction ring automatically move the cutting blade along the dovetail guides. Whereas gears on competitive keratomes are exposed, the gears on the ADK are covered to minimize entrapment of lashes and lids. A DC motor controls the gears and blade movement via the foot switch control. The cutting principle is the same as with manual keratomes and other automated keratomes. The automatic movement of the keratome allows for a more uniform translation across the suction ring and thusly across the cornea. The power supply provides the power to both the keratome motor and the suction supply for holding the suction ring in place on the cornea. The ADK has three settings for vacuum control: "off", "low", "high"; whereas predicate devices have only two vacuum settings, "on" and "off". The vacuum suction of predicate devices in the "on" position is the same as the suction of the "high" setting of the ADK. The "low" suction setting of the ADK provides the option of using the suction ring to aid in globe fixation after the resection. Predicate devices require the surgeon to use the "off" position for globe fixation after resection, where residual suction declines variably back to 0 mmHg. The keratome is provided sterile in a sealed blister/Tyvek® tray and is discarded after single use.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies for the Automated Disposable Keratome (ADK):

It's important to note that this document is a 510(k) summary, not a full pre-market approval application. 510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical efficacy data as would be required for a novel, high-risk device. Therefore, the information provided reflects this regulatory pathway.

No explicit "acceptance criteria" for performance metrics are defined in this document, nor is there a detailed clinical study demonstrating the device meets specific numerical performance targets. The submission relies on substantial equivalence to predicate devices and general safety and effectiveness.

However, we can infer the implied acceptance criteria and the types of evidence used to support them.

Inferred Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) submission, the "acceptance criteria" are largely derived from the substantial equivalence concept and the demonstrated safety and effectiveness of the predicate devices. The "reported device performance" is descriptive, highlighting how the ADK maintains or improves upon these characteristics.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (ADK)
Similar Intended Use: Perform anterior lamellar circular corneal resections of a predetermined diameter and thickness.	Meets: The ADK is intended to shave a partial lamellar section of the cornea, fulfilling the same intended use.
Similar Technological Characteristics: Operates on the same principles (carpenter's plane, oscillating blade, DC-powered gear drive), similar power supply, blade oscillation, and vacuum control mechanism as predicate keratomes.	Meets/Improves: Uses the same cutting principle, DC-powered gear drive design (proven safe and effective), 110/120 AC electrical, 10,000 RPM motor, and AC-powered vacuum pump. Improvements: - Dual Parallel Drive Action: Adds a second gear and track to reduce torque-induced jamming (a potential drawback of single-sided drives like the Chiron ACS). - Covered Gears: Minimizes entrapment of lashes and lids, addressing a potential issue with exposed gears on competitive models. - Three Vacuum Settings ("low" option): Allows for globe fixation after resection, providing better control than predicate devices with only "on/off" settings.
Biocompatibility: Device materials are not toxic or irritating to ocular tissue.	Meets: High-density plastic materials, excluding the stainless steel blade, have been tested according to FDA Tripartite Guidelines and ISO 10993-1 Standard and are deemed biocompatible.
Sterility: Device can be provided sterile and maintain sterility.	Meets: Provided sterile in a sealed blister/Tyvek® tray, sterilized under a validated gamma irradiation cycle with a SAL of 10⁻⁶, and dosimetric release.
Electrical Safety: Conforms to electrical safety standards.	Meets: The ADK power supply conforms to the IEC-601-1 electrical safety standard.
Elimination of "Drawbacks" of Predicate Devices: Addresses issues associated with cleaning, re-assembly, component wear, and potential tissue jamming.	Meets: The ADK is pre-assembled, pre-sterilized, and disposable after single use, directly addressing human error during cleaning/assembly/wear, and reducing the potential for tissue jamming by covering gears.
Clinical Safety and Effectiveness: Associated with acceptable clinical results in terms of postoperative refraction and visual acuity, and minimal postoperative complications (as demonstrated by long-term use of predicate devices). (This is extrapolated from the general acceptance of keratomes over time).	Supported by Predicate History: A review of published literature on keratomes indicates acceptable clinical results and minimal complications. The ADK's design changes are argued not to affect safety and effectiveness as they do not alter the energy source, cutting parts, or principle of operation, but rather improve usability and reduce potential user-related errors.

Study Information & Details:

A table of acceptance criteria and the reported device performance: (See above table)
Sample size used for the test set and the data provenance:
- No specific test set of patient data or clinical trial with a defined sample size is mentioned or reported for the ADK.
- The submission relies heavily on the historical performance and safety of its predicate devices (Automatic Corneal Shaper, Steinway-Barraquer In-Situ Microkeratome Set, Micro Refractive System Model 1000).
- The "evidence" is primarily based on a literature review regarding the general clinical acceptance of keratomes over 30-45 years, rather than a prospective study on the ADK itself.
- Provenance: "Published literature on keratomes," implying retrospective data from various sources (not specified, but likely international given medical literature) reflecting decades of use.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no specific "test set" and thus no experts were used to establish ground truth for a novel assessment of the ADK in this submission as typically seen in efficacy trials.
- The "experts" indirectly involved are the broader ophthalmic community whose published literature established the historical safety and efficacy of keratomes, which forms the basis of the substantial equivalence argument.
Adjudication method for the test set:
- Not applicable. No test set or clinical outcomes requiring adjudication were presented for the ADK.
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. This device is a surgical instrument (keratome), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a hardware surgical instrument. Performance is always "human-in-the-loop," as a surgeon operates it. The device itself does not perform any task "stand-alone" in a diagnostic or analytical sense.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the overall class of devices (keratomes) is established through historical clinical outcomes data from decades of use, supported by expert consensus reflected in the published literature.
- For the ADK specifically, the ground truth for its design changes relies on engineering principles (e.g., dual parallel drive reduces torque, covered gears prevent entanglement), biocompatibility testing (ISO 10993-1), and sterilization validation (gamma irradiation).
The sample size for the training set:
- Not applicable. No "training set" in the context of machine learning or deep learning was used. The device is a mechanical instrument.
How the ground truth for the training set was established:
- Not applicable. As no training set was used, no ground truth needed to be established for it.

Summary

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1774004

JAN - 8 1998

Summary of Safety and Effectiveness for 510(k) K974004

Submitter of Information 1.
LaserSight Technologies, Inc. 12249 Science Drive, Suite 160 Orlando, Florida 32826 Contact Person:

Charles W. Stewart, O.D. Executive Vice President Business Development Tel (407) 382-2700 Fax (407) 382-2701 e-mail: cstewart@lasetech.com

1. Name of Device:

Trade / Proprietary Name:	Automated Disposable Keratome (ADK)
Classification / Usual Name:	Keratome
Device Classification:	Class I, 86 HNO(21 CFR, Section 886.4370)

3. Predicate Devices:

The Automated Disposable Keratome for which marketing clearance is requested is substantially equivalent to the following predicate devices:

Automatic Corneal Shaper, manufactured and distributed by 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].

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Descriptions of Subject Device: 4.

Device Description: The Automated Disposable Keratome consists of two components: (a) disposable keratome, (b) power / suction supply and DC motor with foot actuated switch.

The ADK is a keratome 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 controlled by foot switch. The keratome, which is fabricated from high density engineering plastic (except the blade and motor), has a one piece head that is pre-assembled with a fixed foot plate, and is available in two standard head sizes, 130 or 160 microns, depending upon the thickness of corneal section desired.

The keratome head has dovetail guides, which correspond to guides on the suction ring that is placed upon the ocular globe. Tandem gears on both sides of the keratome head and corresponding gears on the suction ring automatically move the cutting blade along the dovetail guides. Whereas gears on competitive keratomes are exposed, the gears on the ADK are covered to minimize entrapment of lashes and lids. A DC motor controls the gears and blade movement via the foot switch control. The cutting principle is the same as with manual keratomes and other automated keratomes. The automatic movement of the keratome allows for a more uniform translation across the suction ring and thusly across the cornea.

The power supply provides the power to both the keratome motor and the suction supply for holding the suction ring in place on the cornea. The ADK has three settings for vacuum control: "off", "low", "high"; whereas predicate devices have only two vacuum settings, "on" and "off". The vacuum suction of predicate devices in the "on" position is the same as the suction of the "high" setting of the ADK. The "low" suction setting of the ADK provides the option of using the suction ring to aid in globe fixation after the resection. Predicate devices require the surgeon to use the "off" position for globe fixation after resection, where residual suction declines variably back to 0 mmHg. The keratome is provided sterile in a sealed blister/Tyvek® tray and is discarded after single use.

న్. Intended Use of the Subject Device:

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

ல் Comparison of Technological Characteristics with Predicate Devices:

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

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gear and track which creates a dual parallel drive action across the cornea. Torque induced by single sided drives, such as the Chiron ACS, may allow inadvertent jamming of the drive mechanism. Refer to TABLE 1 for a comparison of features for substantially equivalent devices.

The primary drawbacks of the presently marketed keratomes are: (1) human error during 3. cleaning, re-assembly and final intra-operative assembly of the keratome, (2) wearing out of keratome parts as a function of re-use, and (3) the potential for residual tissue to jam or disrupt the gears during the resection procedure. The ADK eliminates these drawbacks by providing the keratome pre-assembled and pre-sterilized in a copolyester tray sealed with a Tyvek® lid, where the keratome is disposed of after single use. The sterilization of the ADK is performed under a validated gamma irradiation cycle, with a sterility assurance level (SAL) of 104, and dosimetric release. Certain parts of the keratome, except the stainless steel blade, have been replaced with high density plastic materials which have been tested according to FDA Tripartite Guidelines and the ISO 10993-1 Standard and are deemed The ADK power supply conforms to the IEC-601-1 electrical safety biocompatibile. standard.
Together with the proven reliability of the DC-powered gear drive mechanism and the elimination of the problems associated with cleaning, tedious assembly and component wear, the ADK offers an improvement over currently available keratomes. These differences between the ADK and currently marketed devices do not affect the safety and effectiveness of the device since they do not alter the energy source, cutting parts or principle of operation.

7. Discussion of Clinical Tests:

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.

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		Company
	Parameter	LaserSight	Chiron Vision	Allergan Medical	Micro Precision
MajorComponents	Console	Console	Console	Console	Console
		1 Fixed HeightSuction Ring	1 AdjustableHeight SuctionRing	25 Suction Rings	25 Suction Rings
		Fixed DepthKeratome Head(130μ or 160 μ)	AdjustableKeratome Head	Keratome Headwith ThicknessPlates	AdjustableKeratome Head
		Electric Motor12 v DC	Electric Motor12 v DC	Electric Motor12 v DC	Turbine Motor
		Blade Oscillation10,000 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
	Motor RPM	10,000 RPM	10,000 RPM	10,000 RPM	0-20,000 RPM
	Vacuum Pump	AC Powered	AC Powered	AC Powered	Nitrogen GasVenturi TypePump
	Blade HeightVerification	At Factory withMicron OpticalComparator	Clinic Measuredwith Micron-Scope	None	Clinic measuredwith DigitalIndicator
	Foot Controls	DC Powered	DC Powered	DC Powered	Pneumatic

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Image /page/4/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's emblem, which is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 8 1998

Charles W. Stewart, O.D. LaserSight Technologies, Inc. 12249 Science Drive, Suite 160 Orlando, Florida 32826

Re: K974004 Trade Name: Automated Disposable Keratome (ADK) Regulatory Class: I Product Code: 86 HNO Dated: December 19, 1997 Received: December 22, 1997

Dear Dr. Stewart:

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.

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Page 2 - Charles W. Stewart, O.D.

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 Roerl Rosenthal

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

Enclosure

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510(k) Number: K974004

Device Name: Automated Disposable Keratorne (ADK)

Indications for Use: ADK (Automated Disposable Keratome) is intended to perform anterior, lamellar, circular corneal resections of a predetermined diameter and thickness.

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

Ada C. Callaway

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Image /page/6/Picture/7 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CRR 801.109)" in a smaller font. There is a check mark above the text, indicating that the prescription use is being acknowledged. The text is likely part of a form or document related to medical prescriptions.

Over-The-Counter Use

(Optional Format 1-2-96)

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.