The VisiJet Hydrokeratome - Model 50 is a non-oscillating, non-mechanical microkeratome which utilizes a continuous high-velocity beam of sterile water for injection to effect a lamellar resection of the cornea. The major elements of this microkeratome are a system console, a footswitch and a handpiece with interchangeable suction rings. The operating principle of the water beam microkeratome is based on the ability to create high levels of static hydraulic pressure that is directed across the cornea, effecting a lamellar resection.

AI/ML Overview

The provided text describes the VisiJet™ Hydrokeratome™ and its premarket notification (K991124). However, it does not contain acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or detailed performance report would.

The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria. The "Brief summary of nonclinical tests and results" section ({2}) broadly states that the device was "found to perform equivalently to the predicate devices" and "as intended in all cases," but this is a high-level summary without specific data.

Therefore, I cannot populate the requested table or detail studies as requested, because the provided text does not contain this information.

Here's an explanation of what information is available and what is missing for each point you requested:

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

Acceptance Criteria: Not explicitly stated in the provided text.
Reported Device Performance: Only general statements are made, such as "found to perform equivalently to the predicate devices" and "as intended in all cases" ({2}). No specific numerical performance metrics (e.g., flap thickness accuracy, resection diameter consistency, complication rates) are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not mentioned.
Data Provenance: Not mentioned. The "nonclinical tests and results" ({2}) imply in-house testing or bench testing, but provide no details on where or how these tests were conducted, or on what kind of "test set" (e.g., ex vivo animal eyes, artificial cornea models) they were performed.

3. 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)

This information is not applicable and not present. The submission focuses on device comparison and basic functionality, not expert-adjudicated ground truth for a test set.

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

This information is not applicable and not present.

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

This information is not applicable. The device (a keratome) is surgical equipment, not an AI diagnostic tool intended to assist human readers.

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

This information is not applicable. The device is a surgical instrument.

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

Not explicitly defined. The "nonclinical tests and results" likely refer to engineering validation against design specifications and comparison to the performance of predicate devices, rather than a "ground truth" in a clinical data sense.

8. The sample size for the training set

Not applicable as this is not an AI/machine learning device. The "training set" concept is not relevant to this type of device submission.

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

Not applicable as this is not an AI/machine learning device.

Summary of available information related to performance/equivalence:

Predicate Devices: Barron Microkeratome System Model B2000 (K973317), Medjet HydroBrush (K971078), Hansa Automatic Corneal Shaper (ACS) (913697).
Basis of Equivalence: "The VisiJet Hydrokeratome was found to perform equivalently to the predicate devices, the Baron Microkeratome System, Automatic Corneal Shaper (ACS) and the Medjet Hydrobrush, and as intended in all cases." ({2})
Technological Comparison: A table ({3}) comparing characteristics like intended use, operating principle, thickness control, flap diameter, etc., is provided to highlight similarities and differences with predicate devices. For example, the VisiJet Hydrokeratome, like the Medjet HydroBrush, uses a "High-velocity water beam" as its operating principle, differentiating it from the blade-based predicate devices. It offers thickness control via "Clear applanation plate that is part of the suction-applanation rings (140u, 160u, 180u, 200u)" which is conceptually similar to the "Fixed Depth Keratome Head" or "Thickness Plates" of predicate devices.

In conclusion, the document emphasizes substantial equivalence through comparison of technological characteristics and general statements of equivalent performance rather than presenting a detailed study with specific acceptance criteria and performance data.

Summary

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K991124

VisiJet, Inc. VisiJet™ Hydrokeratome™

OCT 2 0 2000

March 29, 1999 Premarket Notification

SECTION 14 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 CFR 807.92.

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

a. Applicant:

VisiJet, Inc. 188 Technology Drive Suite D Irvine, CA 92718 (949) 450-1660 (949) 453-9652 (fax)

b. Contact Person:

Randy Bailey, President
Randall G. Bailey

c. Date Summary Prepared: March 26, 1999

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

Trade/Proprietary Name: VisiJet™ Hydrokeratome™- Model 50 a.
b. Classification Name: Keratome
1. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

Company:	Barron Precision Instruments, L.L.C.
Device:	Barron Microkeratome System Model B2000
510(k):	K973317

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Company: Medjet, Inc. Device: HydroBrush 510(k): K971078

Company: Device: 510(k):

Hansa Research and Development, Inc. Automatic Corneal Shaper (ACS) 913697

A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

5. Statement of intended use:

The VisiJet Hydrokeratome is intended for use in performing anterior lamellar circular corneal resections.

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

A summary of the comparative technological characteristics between the VisiJet Hydrokeratome and comparable legally marketed devices immediately follows this page.

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VisiJet, Inc. VisiJet™ Hydrokeratome™

March 29, 1999 Premarket Notification

Brief summary of nonclinical tests and results: 7.

The VisiJet™ Hydrokeratome™ has been designed and will be tested to applicable safety standards. All components in contact with tissue are manufactured from known biocompatible material. All motors are UL approved. The specifications and intended use of the VisiJet Hydrokeratome are the same or very similar to predicate devices. In addition, the VisiJet Hydrokeratome was found to perform equivalently to the predicate devices, the Baron Microkeratome System, Automatic Corneal Shaper (ACS) and the Medjet Hydrobrush, and as intended in all cases. Therefore, the technological differences between the VisiJet Hydrokeratome and the predicated devices do not raise any new issues of safety, effectiveness, or performance of the product.

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March 26, 1999
Premarket Notification

VisiJet, Inc.
VisiJet™ Hydrokeratome™

omparative Technological Characteristic

CHARACTERISTICS	Barron - MicrokeratomeSystem	Hansa - Automatic CornealShaper	Medjet, Inc. - HydroBrush	VisiJet™ HydrokeratomeTM
Intended Use	Partial Anterior CircularLamellar Corneal Resections	Lamellar Corneal Resections	Corneal Epithelial Removal	Lamellar Corneal Resections
Operating Principle	Electrically driven oscillatingblade	Electrically driven oscillatingblade	High-velocity water beam	High-velocity water beam
Suction Ring	1 Fixed Height Suction Ring(Disposable - Stainless Steel)	Adjustable Height Suction Ring(Reusable Stainless Steel)	N/A	Suction-applanation Ring(Disposable - polysulfone)
Blade Drive Source	Electric Motor 9V DC(Disposable)	Electric Motor 12V DC(Reusable)	Electric Motor(Reusable)	Electric motor 12V DC(Reusable)
Thickness Control	Fixed Depth Keratome Head(130u, 160u, or 180u)	Thickness Plates	Angle of impingement on flatplate	Clear applanation plate that ispart of the suction-applanationrings (140u, 160u, 180u, 200u)
Blade Speed	Blade Oscillation 20,000 RPM	Blade Oscillation 7,500 RPM	NA	NA
Blade/Fluid Beam Angle	25°	25°	7 - 9°	0°
Blade Movement	Reciprocating Sideways	Reciprocating Sideways	Manual, Variable	Non-reciprocating Tranlsation
Blade Material	Stainless Steel	Stainless Steel	High-velocity fluid beam(Sterile solution or WFI); 35micron cross-section	High-velocity fluid beam(Sterile solution or WFI); 35micron cross-section
Flap Diameter	Fixed at 8 or 9.5 mm	Variable at 9 mm	N/A	8 - 10 mm
Flap Width	Unknown	Unknown	N/A	Variable, programmable anddetermined by user. Between 0- 10 mm
Keratome Head Movement	Manual	Automatic		Automatic
Console Details
Electrical	Universal AC - 85V to 260V	110/120 AC		Universal AC - 85V to 260V
Vacuum Pump	DC Powered	AC Powered		DC Powered
Blade Height Verification	At factory with OpticalComparator	Clinic Measured withMicroscope		At factory with OpticalComparator
Foot Controls	DC Powered	DC Powered		DC Powered

୧ର

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its head turned to the left, and its wings forming three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 20 2000

Visijet, Inc. c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 18732 Saginaw Irvine, Ca 92614

K991124 Re:

Trade Name: VisiJet™ Hydrokeratome™ Model 50 Regulatory Class: I Reserved Product Code: 86 MYD Regulation: 886.4370 Dated: September 15, 2000 Received: September 15, 2000

Dear Dr. Gordon:

We have reviewed your Section 510(t) 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- Judy F. Gordon, D.V.M.

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow you to begal mainsance of your device to a legally marketed notification. The FDA inding of substantial equireatios on your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific atyice for your doiled of contact the Office of Compliance at (301) additionally 607.10 for the may accessor on the promotion and advertising of your device, please 374-0415. Nuditionaly, for questions only 59-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information "Misbranding by reletence to phants may be obtained from the Division of Sinsion of Sinish Manufacturers
on your responsibilities under the Aca 100 cm 11 cm 1200 cm commended on your responsibilities and its the 100 %38-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

A. Ralph 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

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VisiJet, Inc. VisiJet™ Hydrokeratome™

K991124

March 26, 1999

Premarket Notification

SECTION 6 INDICATIONS FOR USE

The VisiJet Hydrokeratome is indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.

Eneue HR Beem
(Division Sign-Off)

Division of Ophthalmic Devices 510(k) Number J

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.