The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segments.

Device Description

The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination. There are 3 models GR-SL36, GR-SL54, and GR-SL72. These models differ only in the supplied accessories. All models have the same operating characteristics and intended use.

AI/ML Overview

The provided document is a 510(k) premarket notification for the GILRAS Slit Lamp, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on providing performance data from a clinical study with acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it relates to clinical performance metrics like sensitivity, specificity, etc.

Instead, the document demonstrates substantial equivalence through a technological comparison and compliance with recognized standards.

Here's a breakdown of what the document does provide in relation to your request, and why it doesn't fit the typical "acceptance criteria and study" format you've outlined:

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

Acceptance Criteria: Not explicitly defined in terms of clinical performance (e.g., accuracy metrics). Instead, the "acceptance criteria" are implied by manufacturing specifications and compliance with recognized safety standards (ISO 10939:2007 and IEC 60601-1) and similarity of technological characteristics to the predicate device.

Reported Device Performance: The document provides a detailed comparison of theGILRAS Slit Lamp's technological characteristics against its predicate device, the 66 Vision-Tech YZ Slit Lamp. This comparison table effectively is the "performance" data in the context of this 510(k) submission, showing how the new device matches or is similar to the predicate.

Feature	GILRAS Slit Lamp (Reported Performance)
Intended Use	AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segments.
Method of Operation	AC-powered
Exposure Parameters	50000 Lux Maximum, Continuously adjustable from 0 to 50000 Lux
Maximum temperature of Parts Held by Operator	30°C
Eyepiece Power	12.5X
Total Magnification	GR-SL36 - 10X, 16X, 25X; GR-SL54 - 6X, 10X, 16X, 25X, 40X; GR-SL72 - 10X, 16X, 25X
Stereo Angle	13°
Diopter Adjustment	-6D to +6D
Pupillary Adjustment	55mm to 78.5mm
Slit Width	Continuous from 14mm to 0mm (at 14mm slit becomes a circle)
Slit Length	Continuous from 14mm to 0mm (at 14mm, slit becomes a circle)
Slit Angle	0 to 180 degree with horizontal scanning capability
Aperture Diameters	14, 8, 5, 3, 0.5, and 0.2mm
Filters	Heat-absorbing, Neutral Density, Cobalt Blue, and Red-Free
Slit Inclination	5°, 10°, 15°, and 20°
Illumination Lamp	6V, 20W halogen lamp
Fixation Target	Green LED
Brightness Controls	Continuously adjustable from 0 to 50000 Lux
Patient Contact Materials	Chin-rest paper, Forehead-rest - Polytetrafluoroethylene

2. Sample size used for the test set and the data provenance:

Not applicable. This document describes a comparison of device specifications, not a clinical study involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth established from experts for a test set. The "ground truth" here is essentially the predicate device's established technological characteristics and compliance with standards.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication process described.

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. This device is a basic optical instrument (slit lamp), not an AI-powered diagnostic tool. No MRMC study was conducted or described.

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

Not applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used:

For the purpose of this 510(k), the "ground truth" or benchmark is the legally marketed predicate device (66 Vision-Tech YZ Slit Lamp) and recognized industry standards (ISO 10939:2007 and IEC 60601-1). The entire submission hinges on demonstrating that the GILRAS Slit Lamp is "substantially equivalent" to this predicate and meets these standards.

8. The sample size for the training set:

Not applicable. No training set for an algorithm is mentioned or relevant to this device submission.

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

Not applicable. No training set.

Conclusion:

The K080776 document demonstrates the GILRAS Slit Lamp's "acceptance criteria" by showing its adherence to safety standards and its substantial equivalence in technological characteristics to a predicate device. It does not involve performance studies with clinical acceptance criteria, sample sizes, expert ground truth, or AI-related metrics as typically outlined in your request.

Summary

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K080776

Summary of Safety and Effectiveness for the GILRAS Slit Lamp

submitted by Al Weisenborn 19526 East Lake Drive Miami, Florida 33015 Phone: (305) 829-3437

SEP - 9 2008

on behalf of

USOphthalmic 7255 NW 68th Street Unit # 9 Miami, FL 33166 Phone: (305) 969-4545

Contact Person: Ezequiel D. Lukin Device Trade Name: GILRAS Slit Lamp Common Name: Slit Lamp Classification Name: Biomicroscope, Slit-lamp, AC-powered per 21 CFR § 886.1850

Identification of a Legally Marketed Predicate Device

The USOphthalmic GILRAS Slit Lamp is substantially equivalent to 66 Vision-Tech YZ Slit Lamp that is legally marketed and distributed by Suzhou 66 Vision-Tech Co., LTD pursuant to premarket notification K033190.

Device Description

Intended Use

The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eve segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segments.

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Summary of Technological Characteristics

An 23-point comparison of the technological characteristics of the USOphthalmic GILRAS Slit Lamp and the predicate devices was performed. The devices were found to be substantially equivalent as shown in the table below.

Feature	GILRAS Slit Lamp	66 Vision-Tech YZ Slit Lamp
Manufacturer	Manufacturer: ShanghaiMediWorks Precision Instruments,LTDRelabeler: USOphthalmic	Suzhou 66 Vision-Tech Co., LTD
Trade name	GILRAS Slit Lamp	66 Vision-Tech YZ Slit Lamp
510(k) Number	K080776	K033190
Intended use	The GILRAS Slit Lamp is an AC-power slit lamp biomicroscopeintended for use in eye examinationof the anterior eye segment, from thecornea epithelium to the posteriorcapsule. It is used to aid in thediagnosis of diseases or trauma whichaffect the structural properties of theanterior eye segments.	The 66 Vision-Tech YZ Slit lamp isan AC-power slit lamp biomicroscopeintended for use in eye examinationof the anterior eye segment, from thecornea epithelium to the posteriorcapsule. It is used to aid in thediagnosis of diseases or trauma whichaffects the structural properties of theanterior eye segment.
Method of Operation	AC-powered	AC-powered
Exposure Parameters	50000 Lux MaximumContinuously adjustable from 0 to50000 Lux	75000 Lux at position ¼150000 Lux at position ½300000 Lux at position 1
Data Collection and/orDisplay Systems	None	None
Flammability ofMaterials	Non-combustion supporting materials	Non-combustion supporting materials
Maximum temperatureof Parts of the DeviceHeld by the Operator orAccessible to the	30°C	30°C
Eyepiece Power	12.5X	12.5X
Total Magnification	GR-SL36 - 10X, 16X, 25XGR-SL54 - 6X, 10X, 16X, 25X, 40XGR-SL72 - 10X, 16X, 25X	6X, 10X, 16X, 25X, 40X
Stereo Angle	13°	13°
Diopter Adjustment	-6D to +6D	-5D to +3D
Pupillary Adjustment:	55mm to 78.5mm	55mm to 78.5mm
Slit Width	Continuous from 14mm to 0mm (at14mm slit becomes a circle)	Continuous from 9mm to 0mm (at14mm slit becomes a circle)
Feature	GILRAS Slit Lamp	66 Vision-Tech YZ Slit Lamp
Slit Length	Continuous from 14mm to 0mm (at14mm,slit becomes a circle)	Continuous from 9mm to 0mm (at14mm, slit becomes a circle)
Slit Angle	0 to 180 degree with horizontalscanning capability	0 to 180 degree with horizontal scan-ning capability
Aperture Diameters	14, 8, 5, 3, 0.5,and 0.2mm	9mm, 8mm, 5mm, 3mm, 2mm, 1mm,0.2mm
Filters	Heat-absorbing, Neutral Density,Cobalt Blue, and Red-Free	Heat absorption, gray, red-free, andblue
Slit Inclination	5°, 10°, 15°, and 20°	5°, 10°, 15°, and 20°
Illumination Lamp	6V, 20W halogen lamp	12V, 30W halogen lamp
Hruby Lens	Not available	Optionally Available
Fixation Target	Green LED	Red LED
Brightness Controls	Continuously adjustable from 0 to50000 Lux	3-mode: low, medium and high
Patient ContactMaterials	Chin-rest paper	Chin-rest paper
	Forehead-rest -Polytetrafluoroethylene	Forehead-rest -Polytetrafluoroethylene
Beam Splitter	GR-SL36 - No
	GR-SL54 - No	Optional
	GR-SL72 - Yes

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Summary of Performance Data

The USOphthalmic GILRAS Slit Lamp complies with the requirements of listed FDA Recognized Consensus Standards.

ISO 10939:2007, Ophthalmic instruments -- Slit-lamp microscopes .
IEC 60601-1, Medical Electrical Equipment Part 1: General . Requirements for Safety

The USOphthalmic GILRAS Slit Lamp is substantially equivalent to the 66 Vision-Tech YZ Slit Lamp that is legally marketed and distributed by Suzhou 66 Vision-Tech Co., LTD. This has been demonstrated through a 8-point technological comparison of features.

Because the USOphthalmic GILRAS Slit Lamp meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device.

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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 consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2008

USOphthalmic, LLC c/o Al Weisenborn 7255 NW 68th Street, Unit #9 Miami, FL 33166

Re: K080776

Trade/Device Name: GILRAS Slit Lamp, Models GR-SL36, GR-SL54 and GR-SL72 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slit-lamp Biomicroscope Regulatory Class: II Product Code: HJO Dated: August 14, 2008 Received: August 15, 2008

Dear Mr. Weisenborn:

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 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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarlee, Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Eggersta, und

Malvina B. Eydelman, M.L 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

Page 1 of 1

510(k) Number (if known):

Device Name: GILRAS Slit Lamp

Indications for Use:

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Danid L. Kaushn

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K080776

Page 1 of 1

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.