This DEVICE is an AC powered device consisting of three main parts: CONTROL BOX, HAND PIECE, and FOOT PEDAL. The CONTROL BOX has LED indicators, a pressure gauge, self test button, and connectors. The HAND PIECE contains the blade running and reversing mechanism, oscillation mechanism, attachment slot for the Suction Ring, Blade Holder, and a connector for the Control Box. It includes a Blade Holder, Applanation Plate (determining flap thickness), a disposable Blade, and a Single Suction Ring (fixing to the eyeball under suction). The FOOT PEDAL has switches for controlling suction, forward motion and oscillation of the blade, and reverse motion of the blade, and a cable for connection to the Control Box.

AI/ML Overview

The provided text describes the Nidek Keratome, MK-2000, a Class I medical device, and its 510(k) submission for market clearance. However, it explicitly states that no clinical performance data or non-clinical performance data was provided to demonstrate the device's effectiveness.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information can be extracted:

No Acceptance Criteria or Reported Device Performance: The document does not define specific acceptance criteria (e.g., precision of flap thickness, success rate of flap creation) nor does it provide any reported device performance metrics against such criteria.
No Study Data: The document explicitly states: "No clinical performance data has been provided" and "None provide" for non-clinical performance data.

Information that can be extracted from the provided text, related to your prompt, but indicating a lack of the requested data:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: Not provided in the document.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable, as no test set data was provided.
- Data Provenance: Not applicable, as no data was provided.
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):
- Number of Experts/Qualifications: Not applicable, as no ground truth for a test set was established (no test data provided).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable, as no test set data requiring adjudication was provided.
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:
- MRMC Study: No, the device is a Keratome (surgical instrument), not an AI diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. The device is a surgical instrument operated by a human, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable, as no performance data with associated ground truth was provided.
The sample size for the training set:
- Sample Size for Training Set: Not applicable, as no training data for an algorithm was used or described.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as no training data was used or described.

Summary of the document's approach to effectiveness:

The document states that the effectiveness of the device "was confirmed by use of QWF050B, Nidek MK-2000 Keratome Validation Test Procedure." However, the details or results of this procedure are not provided in the 510(k) summary. The basis for substantial equivalence is primarily stated as:

Intended Uses and Operating & Cutting Principles are the same as six predicate devices.
Operational Features are the same or similar to predicate devices.
Safety Features are the same or very similar to predicate devices.
Compliance with electrical standards (UL2601-1, IEC601-1-1, IEC601-1-2) and inclusion of operational safety features (Vacuum Level Gauge, low suction LED and tone, automatic cutting stop, foot pedal controls).

Therefore, the claim for effectiveness and safety is largely based on equivalence to already marketed devices and compliance with safety standards, rather than new performance data presented within this 510(k) summary.

Summary

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K990900

SEP 2 4 1999

APPENDIX III

510(k) SUMMARY

[As required by 21 CFR 807.93]

I GENERAL INFORMATION

Applicant's Name & Address: Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539-7474

Mr. Jerry Tsutsumi Regulatory/Quality Manager

Date Summary Prepared:

16 March 1999

DEVICE NAME II

Contact:

Trade or Proprietary Name: Model Number:

Nidek Keratome, MK-2000 MK-2000

Common/Classification Name: Class: Classification Panel: Regulation Number:

Keratome Class I 86 886.4370

III PREDICATE DEVICES

The Nidek MK-2000 Keratome is claimed to be substantially equivalent to the following currently Marketed Predicate Devices:

Submitter	Model	510(k) Number	Date
Hansa R&D*	AUTOMATED CORNEAL SHAPER	K912697	05-Nov-91
Hansa R&D	HANSATOME	K972808	24-Oct-97
Innovative Optics	INNOVATOME	K973294	03-Oct-97
MORIA	CARRAZIO BARRAQUER	K981141	24-Jul-98
Hawken Industries	FLAPMAKER	K981155	14-Aug-98
LaserSight Tech.	ADK	K974004	08-Jan-98

The 510(k) for the AUTOMATED CORNEAL SHAPER was submitted by Hansa Research and Development, Inc., but his product is currently being sold by CHIRON INTRAOPTICS as identified in APPENDIX VII.

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IV PRODUCT DESCRIPTION

This DEVICE is an AC powered device consisting of three main parts:

1. CONTROL BOX: The FRONT PANEL consists of:
- LED for Power Indicator, Suction Indicator, Confirmation Indicator. .
- Pressure Gauge with a pointer for suction pressure. .
- Self Test button to perform a pre-test. .
- Hand Piece Connector ●
- Connector for suction and suction pressure monitoring .

The REAR PANEL consists of a AC Power Inlet, Power Switch and a Foot Pedal Connector. The MOTOR CONTROL is Bi-directional control (forward/reverse), one way control for oscillation.

1. HAND PIECE: The Handpiece contains the blade running and reversing mechanism, the oscillation mechanism, an attachment slot for the Suction Ring, the Blade Holder, and a connector for the Control Box. The Handpiece is made of aluminum.
- Blade Holder: is made of Stainless Steel .
- Applanation Plate: that determines the thickness of the incised cornea ● (flap) and is fixed to the top of the blade holder. Three Applanation Plates are available dependent on the desired flap thickness (130, 160 & 180 um).
- Blade: the keratome blade is pre-sterilized and made of "Stainless Steel" . and is a one-time-use disposable blade.
- Single Suction Ring: fixes the hollow part of the suction ring to the eyeball ● under suction. 2 suction ports, one to monitor suction pressure and a second to provide suction. Three suction ring sizes are available, dependent on the desired flap diameter (8.5 mm, 9.5 mm or 10.5 mm). There are NO gear mechanism or sliding guide around the suction ring.

2. FOOT PEDAL: Consists of:

"SUCTION SWITCH" to control the applying and stopping of the suction . pressure to the suction ring.
"FORWARD SWITCH" to control the running and oscillation of the blade. .
"REVERSE SWITCH" control the reverse motion of the blade. ●
"CABLE" allow connection to the Control Box. .

INDICATIONS FOR USE V

Intended Use: The Nidek MK-2000, Keratome is intended to make a flap by incising the cornea at a pre-selected thickness and diameter.

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VI CLINICAL PERFORMANCE DATA

No clinical performance data has been provided.

VII NON-CLINICAL PERFORMANCE DATA

None provide.

VIII RATIONAL FOR SUBSTANTIAL EQUIVALENCE

Our claim of Substantial Equivalence is based on the following;

The INTENDED USES and the OPERATING & CUTTING PRINCIPLES of the . Nidek MK-2000 Keratome is the same as the SIX predicate devices.
The OPERATIONAL FEATURES of the Nidek MK-2000 Keratome are the same . or similar to those offered on one or more of the predicate devices.
The SAFETY FEATURES of the Nidek MK-2000 Keratome are the same or very ● similar to those offered on one or more of the predicate devices.

IX SAFETY AND EFFECTIVENESS

This device is designed to comply with the electrical standards of the Underwriters Laboratories UL2601-1, International Electro-technical Commissions IEC601-1-1 and IEC601-1-2 which reasonably assures the device to be Safe when used as directed for its prescribed intended use. Additionally several operational safety features are designed into this device (Vacuum Level Gauge, a low suction LED and "audible tone" indicators, automatic cutting stop if vacuum level drops, and forward & reverse foot pedal controls). The effectiveness of the device was confirmed by use of QWF050B, Nidek MK-2000 Keratome Validation Test Procedure.

CONCLUSION ×

The data submitted in this 510(k) Premarket Notification, for the Nidek MK-2000 Keratome demonstrates that this product is substantially equivalent with respect to the indications for use, operating principles, operational features, and safety features, to other legally market predicate devices. With the information provided, the safety and effectiveness of this product can be reasonably assured, and thus we believe that this device clearly meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(k) guidelines.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1999

Mr. Jerry Tsutsumi Regulatory/Quality Manager Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539-7474

Re: K990900 Trade Name: Nidek Keratome, MK 2000 Regulatory Class: I Product Code: 86 HNO Dated: August 26, 1999 Received: August 27, 1999

Dear Mr. Tsutsumi:

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 - Mr. Jerry Tsutsumi

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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 tollfree number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Alvey L. 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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APPENDIX II

Trade or Proprietary Name: Common or Classification Name: Model Number: Class: Classification Panel: Product Code: Regulation Number:

Nidek MK-2000 Keratome Keratome MK-2000 Class I ૪૯ 886.4370

INDICATIONS FOR USE:

The Nidek MK-2000, Keratome is intended to make a flap by incising the cornea at a The Nidek NIT 2007 Relates and diameter using a high speed oscillation blade of stainless steel.

Denis L. McCarthy

Division Sign-Off) Division of Ophthalmic Devices 510(k) Number. 9900

YES Prescription Use . (Per 21 CFR 801.109)

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.