The model K-1000 keratome features a high speed, low torque nitrogen driven motor, which drives a reciprocating surgical blade will be a single-use, disposable device that will be filed under a separate 510k. The keratome head is preset to produce a corneal resection approximately 160 microns in depth with the corresponding blade insertion and flap diameter of approximately 10.0mm. The model K-1000 keratome system is battery operated and may also operate from its charger. The power unit provides on/off footswitch controls for the keratome head and drive assembly, and suction to the suction ring. Analog gauges located on the front panel of the unit indicate nitrogen pressure and suction level supplying the appropriate connectors.

AI/ML Overview

The K-1000 Keratome System does not contain information to completely answer the request; however, I can provide the following:

The provided document describes the Insight Technologies Instruments, LLC, Model K-1000 Keratome System, which is a medical device. The document is a 510(k) summary for premarket notification to the FDA. It compares the K-1000 Keratome System to previously marketed predicate devices (Plancon Instruments Lamellar Keratoplasty System Model L.K.S. and S.C.M.D. Keratomes of Arizona TurboKeratome System by SCMD Model MLK) to demonstrate substantial equivalence.

This document focuses on regulatory compliance, design characteristics, safety certifications (electrical safety, sterilization), and comparison with predicate devices, rather than a clinical study demonstrating performance against specific acceptance criteria. The device being described is a surgical instrument (keratome) used to create a corneal flap, not an AI or diagnostic device that would typically have the performance metrics requested in the prompt.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC study, standalone performance) are not applicable or available in this document.

However, I can extract information related to what constitutes "acceptance criteria" in the context of this device's regulatory submission, which primarily revolves around safety, design, and equivalence to predicate devices, rather than a clinical accuracy study.

Acceptance Criteria and Device Performance (Based on provided document)

Since this is a mechanical surgical instrument and not an AI or diagnostic device, the "acceptance criteria" are related to design specifications, safety standards, and demonstrated substantial equivalence to predicate devices. There isn't a "reported device performance" in terms of clinical accuracy or diagnostic metrics as typically seen for AI. Instead, the performance is implicitly accepted by meeting design specifications and safety standards.

Acceptance Criterion (Context of K-1000 Keratome)	Reported Device Performance / Compliance
Electrical Safety	Compliant: Designed and tested following ANSI/AAMI ES1-1993 suggested guidelines. Low frequency leakage currents are well within safe current limits for electromedical apparatus. Certified to be manufactured according to ANSI/AAMI ES 1-1993 "American National Standard for Electrical Safety" standard and to follow guidelines set by IEC 601-1, "Medical Electrical Equipment".
Biocompatibility	Compliant: Components that come in direct contact with tissue are made of surgical stainless steels commonly found in other surgical devices. (Implicitly accepted as safe due to common use in other surgical devices).
Sterilization Efficacy	Compliant (Method Provided): Components (keratome head, turbine, stop ring, suction ring) can be steam sterilized using gravity displacement at 250 degrees for 30 minutes. (Assumes effectiveness when user follows instructions).
Corneal Resection Depth Consistency	Specified Design Parameter: The keratome head is preset to produce a corneal resection approximately 160 microns in depth. (Performance is by design, not a measured outcome reported in this document).
Flap Diameter	Specified Design Parameter: Corresponding blade insertion and flap diameter of approximately 10.0mm. (Performance is by design, not a measured outcome reported in this document).
Turbine Speed	Design Specification: 14,000 rpm. (Matches predicate device Plancon, within range of S.C.M.D.).
Blade Angle	Design Specification: 25°. (Matches both predicate devices).
Substantial Equivalence	Determined by FDA: Reviewed Section 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices (Plancon Instruments L.K.S. and S.C.M.D. TurboKeratome System). This means it has the same intended use, and has the same technological characteristics as the predicate devices; or has different technological characteristics but does not raise different questions of safety and effectiveness, and is as safe and effective as the predicate.

Information Not Applicable or Not Available from the Document:

Due to the nature of the device (mechanical surgical instrument) and the type of document (510(k) summary for substantial equivalence), the following information is not applicable or not provided:

Sample size used for the test set and the data provenance: Not applicable. Performance data in a clinical trial sense is not presented for this type of device in a 510(k) summary, which relies on demonstrating equivalence to known safe and effective devices.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No clinical test set or ground truth establishment process is described.
Adjudication method for the test set: Not applicable. No clinical test set is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for diagnostic or AI-assisted devices, not a mechanical keratome.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
The type of ground truth used: Not applicable. No "ground truth" as typically defined for AI/diagnostic devices is mentioned. The "ground truth" for a mechanical device is its adherence to design specifications and safety standards, and its functional performance as intended.
The sample size for the training set: Not applicable. No AI model or training set is involved.
How the ground truth for the training set was established: Not applicable. No AI model or training set is involved.

The "study" that proves the device meets the acceptance criteria is primarily the design and testing adhering to specified electrical safety standards (ANSI/AAMI ES1-1993, IEC 601-1) and comparison to predicate devices to establish substantial equivalence. The FDA's review and concurrence of the 510(k) submission served as the ultimate "proof" in the regulatory context, allowing the device to be marketed.

Summary

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

KCI14243

510K Summary Insight Technologies Instruments, LLC. Model K-1000 Keratome System

JAN 2 0 1998

Insight Technologies Instruments, LLC. 16 Higgins Drive Milford, CT 06460 Tel: 203-874-1832 Fax: 203-877-3762

Submitters Name:

Charles Vassallo

22 Dec 97

Date

Ref: 510K Premarket Notification

To: Document Control Clerk:

This summary of 510K safety and effectiveness information is being submitted for the Insight This banninaly of of of of the more, which an equivalence determination could be based.

Trade/Proprietary Name:	Model K-1000 Keratome System
Common/Usual Name:	Keratome
Classification Name:	Keratome
Establishment Registration Number:	In process at FDA

Performance Standard:

Designed and tested following the suggested guidelines ANSI/AAMI ES1-1993. The low frequency leakage currents are well within the safe current limits for electromedical apparatus.

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

The Insight Technologies Instruments, LLC, Model K-1000 Keratome is simular in design construction, and function to the devices as marketed by:

Plancon Instruments, . ANTONY FRANCE 92160 Lamellar Keratoplastv System Model L.K.S. Reference 510k: K970377
S.C.M.D. Keratomes of Arizona. FTN. HILLS. AZ 85268 TurboKeratome System by SCMD Model MLK Reference 510k: K935342

Descriptive Comparison:

Refer to "Attachment 1" for similarities and differences between the Insight Technologies Instruments LLC, Model K-1000 and the above predicated instruments.

Characteristics:

The model K-1000 keratome system is battery operated and may also operate from its charger. The power unit provides on/off footswitch controls for the keratome head and drive assembly, and suction to the suction ring. Analog gauges located on the front panel of the unit indicate nitrogen pressure and suction level supplying the appropriate connectors.

Certification of Standards:

Insight Technologies Instruments certifies that the model K-1000 keratome will be manufactured according to ANSI/AAMIES 1-1993 "American National Standard for Electrical Safety" standard. It will also follow guidelines set by IEC 601-1, "Medical Electrical Equipment"

Certification of Safety and Effectiveness:

When used according to the manufacturers' instructions, there are no adverse safety indications for the model K-1000 keratome.

Components that come in direct contact with tissue are made of surgical stainless steels commonly found in other surgical devices. These components can be steam sterilized using gravity displacement at 250 degrees for 30 minutes

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

Directions for Use:

Insight Technologies Instruments will enclose an operator's manual with every system. The power unit stenciling is located on the front and rear panels identify the system indicators, controls, fuse, and connectors. Affixed to the rear panel will be a self-stick label identifying the input power requirements, model number, part number, and serial number.

Labeling:

The head and drive assembly labeling will consist of the company logo. The individual footswitches will be identified with a self-stick label.

Sterilization Methodology:

The user can sterilize the keratome head, turbine, stop ring, and suction ring using steam.

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

"Attachment 1"

Comparison Chart Insight Technologies Instruments, LLC. Model K-1000 Keratome System

Characteristic	ITI Model K-1000	Plancon	S.C.M.D.
Turbine:	Nitrogen Gas	Nitrogen Gas	Nitrogen Gas
Oscillatory Speed:	14,000 rpm	14,000 rpm	14,000-20,000 rpm
Blade Direction:	Oscillatory Sideways	Oscillatory Sideways	Oscillator Sideways
Blade Angle	25°	25°	25°
Suction Ring:	Single, 10.0mm	3.5 to 10.5mm	3.5 to 10.5mm
Console Dimensions:	11 x 9 x 8 inches(28 x 23 x 20cm)	11.8 x 9.3 x 6.3 inches(30 x 23.5 x 16cm)	15 x 18 x 9 inches(38 x 46 x 23cm)
Console Weight:	20lbs (9kg)	18lbs(8kg)	19lbs (kg)
Mains Power Protection:	3.15 amp, slo-blo fuse	none	none
Input Voltage:	12 volts DC	12 volts DC	12 volts DC
Charger:	110 volts AC @ 60 Hz	110 volts AC @ 60 Hz100 volts AC @ 60 Hz	110 volts AC 60Hz

. •

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

Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body. The overall design is simple and conveys a sense of official authority.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 1998

Mr. Charles Vassallo Insight Technologies Instruments 16 Higgins Drive Milford, CT 06460

Re: K974243 Trade Name: Model K-1000 Keratome System Regulatory Class: I Product Code: 86 HMY Dated: November 10, 1997 Received: November 12, 1997

Dear Mr. Vassallo:

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.

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

Page 2 - Mr. Charles Vassallo

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

{6}------------------------------------------------

Indications for Use Insight Technologies Instruments, LLC. Model K-1000 Keratome System

510(k) Number (if known):

Device Name: Model K-1000 Keratome System

The Insight Technologies Instruments, Model K-1000 Keratome System is designed to produce a corneal flap.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Denis L. M Carthy
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. __

Prescription Use ✓_ OR Over The Counter Use _
(Per 21 CFR 801.109) (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.