The LaFaci Surgical System is intended for use during LASIK procedures. The LaFaci Surgical System consists of a reusable Handpiece, Surgical Cart, and disposable Tubing Accessories. The LaFaci System provides ocular fixation and containment of surgical field, corneal flap placement and flap re-positioning, and is used for ophthalmic plume aspiration, fluid aspiration, and the delivery of micro filtered air to the surgical field.

Device Description

LaFaci™ Surgical System combines multiple functions commonly utilized during LASIK into a single hand piece allowing for the delivery of sterile balanced saline irrigation solution to the surgical field, fluid aspiration from the surgical field, delivery of micro-filtered air to the surgical field, and plume evacuation from the surgical field. All of these functions are generated and delivered from the LaFaci™ Surgical Cart to the LaFaci™ Handpiece through fourlumen surgical tubing.

LaFaci™ Handpiece also provides manual ocular fixation, and provides a platform for the temporary placement of the corneal flap during ablation. In addition the platform can be manually pivoted over the corneal bed thereby providing a spatula means to reposition the flap onto the stromal bed.

The LaFaci™ Surgical Cart accessories include an adjustable instrument tray, and handpiece tubing swing arm that provides sterile setup and operational efficiency during surgery. The LaFaci™ Surgical Cart disposable accessories include the LaFaci Handpiece Tubing Set (sterile) and the LaFaci Smoke/Fluid Evacuation Accessories (non-sterile).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the LaFaci™ Surgical System:

This device (LaFaci™ Surgical System) is a surgical apparatus, not an AI/ML device, and therefore the concepts of "acceptance criteria," "device performance," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set" in the context of diagnostic accuracy with AI are not applicable.

The submission is a 510(k) for a medical device that performs mechanical functions during LASIK procedures. The "acceptance criteria" for this type of device are primarily compliance with recognized safety standards (like electrical safety and biocompatibility) and functional bench testing to confirm its mechanical operation (e.g., plume evacuation, irrigation, aspiration, air delivery). The "study that proves the device meets the acceptance criteria" refers to these non-clinical bench tests and compliance with standards.

Here's a breakdown of the requested information based on the provided document, highlighting where the AI/ML-specific questions are not applicable:

Acceptance Criteria and Study for LaFaci™ Surgical System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Performance
Biocompatibility	Materials with patient contact are biocompatible.
Functional Performance	Bench testing of the Handpiece functions (plume evacuation, irrigation, aspiration, and air delivery) determined to be acceptable. (Specific quantitative metrics for "acceptable" are not detailed in this summary, but would be expected in the full submission).
Electrical Safety/EMC	Compliance with UL 60601-1 and EN 60601-1-1-2 electrical testing.
Clinical Performance	No clinical performance data was required or performed for approval based on substantial equivalence to predicate devices.

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

Not applicable for a non-AI/ML mechanical device. The "test set" in this context refers to the units of the device that underwent bench testing. The document does not specify the number of units tested, but it would be a small number of manufactured devices for engineering verification. Data provenance (country, retrospective/prospective) is not relevant here as no patient data was used.

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)

Not applicable for a non-AI/ML mechanical device. "Ground truth" in the context of diagnostic performance (which AI/ML often addresses) is not relevant here. The "truth" for this device's performance is objective measurements during bench testing (e.g., flow rates, pressure, filter efficiency, electrical safety parameters) and material testing for biocompatibility, assessed by engineers, technicians, and potentially lab specialists.

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

Not applicable for a non-AI/ML mechanical device. Adjudication methods are used to establish ground truth from expert opinions, which is not relevant for the functional and safety testing of this mechanical device.

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 for a non-AI/ML mechanical device. This type of study relates to the diagnostic performance of AI-assisted human interpretation, which is not what this device does.

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

Not applicable for a non-AI/ML mechanical device. There is no algorithm or 'standalone' performance in the AI/ML sense for this mechanical surgical system.

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

Not applicable for a non-AI/ML mechanical device in the diagnostic sense. The "ground truth" for this device's performance is based on:
- Objective Measurement Data: Electrical safety measurements, flow rate measurements, pressure measurements, filtration efficiency, and other engineering specifications verified during bench testing.
- Material Science Analysis: For biocompatibility.
- Regulatory Standards: Compliance with recognized consensus standards (e.g., UL, EN standards).

8. The sample size for the training set

Not applicable for a non-AI/ML mechanical device. This concept applies to AI/ML models that are trained on data. This device is a mechanical system, not a learning algorithm.

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

Not applicable for a non-AI/ML mechanical device. There is no "training set" or corresponding "ground truth" in the AI/ML sense for this device.

Summary

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MAY = 7 2004

510(k) Summary of Safety and Effectiveness

510(k) Summary	This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92.
Submitter	Vision Pro LLC4309 I-49 South Service RoadOpelousas, LA 70570
Contact Person	Julie PowellEmergo Group, Inc.2519 McMullen Booth RoadSuite 510-295Clearwater, FL 33761Phone: 727 797 4727Fax: 727 797 4757E Mail: jpowell@emergogroup.com
Date Prepared	April 7, 2004
Name of device	LaFaci™ Surgical System
Classification Names	Apparatus, air handling, room
Device Classification	Regulatory Class: IIProduct Code: FYDClassification Panels: General & Plastic SurgeryRegulation Number: 21 C.F.R. 878.5070

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Predicate Device(s)

510(k)Number	Device	Manufacturer


K924732 orK924731	Dell PlumeSafe and Plume Aspiration fixationRing Handpiece (PlumeSafe 601 or 1201)	Buffalo Filter / Asico
Unknown	Visx Star 3 Plume Evacuation	Visx, Inc.
K911808	Accurus Surgical System	Alcon Laboratories
K935218	Schuco-Vac Model 178 Aspirator	Schuco, Inc.
Exempt	Slade LASIK Aspiration Lid Speculum	ASICO
Exempt	Kritzinger-Udegraf LASIK Irrigation Cannula-16 guage	ASICO
K963434	Continuous Fluid Air Exchange	Escalon Trek Medical
K852649	Regulator, pressure, gas cylinder	C.R.Bard
Exempt	Gimble-Chayet LASIK Drain	Katina
Exempt	Melki Lasik Flap Stabilizer	Rhein Medical Inc.
Exempt	Maldonado LASIK Posterior AblationPlatform	Rhein Medical, Inc.
Exempt	Kraff Nasal Solid Blade Speculum	ASICO
Exempt	Whitten LASIK Fixation Ring	ASICO

Device Description

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Handpiece Tubing Set (sterile) and the LaFaci Smoke/Fluid Evacuation Accessories (non-sterile).

Indications

The LaFaci Surgical System is intended for use during LASIK for Use procedures. The LaFaci Surgical System consists of a reusable Handpiece, Surgical Cart, and disposable Tubing Accessories. The LaFaci System provides ocular fixation and containment of surgical field, corneal flap placement and flap re-positioning, and is used for ophthalmic plume aspiration, irrigation, fluid aspiration, and the delivery of micro filtered air to the surgical field.

Nonclinical

Performance

The materials with patient contact are biocompatible. Bench testing of the Handpiece and the plume evacuation, irrigation, aspiration, and air delivery functions have been tested and determined to be acceptable. The LaFaci Surgical System will comply with UL 60601-1 and EN

60601-1-1-2 electrical testing.

Clinical

Performance No clinical performance data was required or performed.

Conclusion The LaFaci Surgical System is substantially equivalent to the predicate devices that are currently being marketed.

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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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY = 7 2004

Emergo Group, Inc. C/O Julie Powell Senior Consultant 2519 McMullen Booth Road Suite 510-295 Clearwater, FL 33761

Re: K032400

Trade/Device Name: LaFaci Surgical System Regulation Number: 21 CFR 878.5070 Regulation Name: Air-handling apparatus for a surgical operating room Regulatory Class: Class II Product Code: FYD Dated: August 4, 2003 Received: August 8, 2003

Dear Ms. Powell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Julie Powell

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K032400

Device Name: LaFaci Surgical System

Indications for Use:

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

510(k) Number _K032400

Prescription Use _ V (Per 21 CFR 801.109) (Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises

510(k) Number
C.R. Butterman

the

Over Use

Counter

Regulation Number and Section

§ 878.5070 Air-handling apparatus for a surgical operating room.

(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.