The CeeMax™ Slit Lamp (Halogen Lamp Series/LED Illumination series) is an AC powered microscope and accessories intended for the use in the examination of the anterior eye segment, from cornea, endothelium to posterior capsule. Slit Lamp which is intended for that is used to aid the diagnosis of diseases or traumas which affect the structure or properties of the eye.

Device Description

The CceMax™ Slit Lamp's (Halogen Lamp Series/LED Illumination series) with models of 801, 802, 901, 902, 8015S, 802SS, 901SS, 902SS are similar in design, function, materials, operation, and electro-optical electro-optical performance to other conventional AC-powered slit lamp biomicroscope.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the CeeMax™ Slit Lamp:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is limited in its explicit detail of acceptance criteria with numerical targets. Instead, it relies heavily on demonstrating substantial equivalence to predicate devices for key characteristics. The performance testing section mentions "certifications of electrical safety, flammability, and bench test of radiation outputs." This implies that the acceptance criteria for these aspects were met by adhering to established standards.

Acceptance Criteria Category	Specific Criteria (Inferred/Stated)	Reported Device Performance (CeeMax™ Slit Lamp)
Intended Use	Same as predicate devices: Examination of anterior eye segment, aid diagnosis of diseases/trauma affecting eye	"Same" as predicate devices (YZ5F (K033190) and SL-15 (K061330)). Intended for use in examination of anterior eye segment, from cornea, endothelium to posterior capsule; aids diagnosis of diseases or traumas.
Method of Operation	Similar to predicate device (tabletop)	"Same as the predicate device YZ5F (K033190) table top."
Exposure Parameters	Halogen lamp exposure same as predicate; LED exposure similar to predicate	Halogen lamp exposure parameters are the same as predicate device. LED exposure parameters are similar to the predicate device (detailed description provided).
Flammability	Uses Thermosetting phenol formaldehyde resin for specific parts (e.g., lamp cap)	Uses Thermosetting phenol formaldehyde resin.
Brightness Control	From zero to full power illumination control	"Same" as predicate (implies from zero to full power illumination control).
Light Source	Halogen lamp and/or white LED	Halogen lamp and white LED.
Beam Geometry	Standard slit opening range same as predicate	"The same as the YZ5F (K033190)."
Radiation Safety	Halogen lamp exposure same as predicate; LED exposure similar to predicate	Halogen lamp exposure parameters are the same as predicate device. LED exposure parameters are similar to the predicate device (detailed description provided).
Optical Radiation Hazard	No hazard / warning in manual for specific conditions	"No, Warning in the manual regarding the caution and particularly for the aphakic diagnostic."
Electrical Safety	Compliance with EN(IEC) 60601-1	Complies with EN(IEC) 60601-1.
Electrical EMC	Compliance with EN(IEC) 60601-1-2, EN6100-3-2, EN6100-3-3	Complies with EN(IEC) 60601-1-2; EN6100-3-2; EN6100-3-3.
Light Output Wavelength	Halogen: Visible light 460nm-700nm; LED: 450nm-650nm	Halogen Lamp emits Visible light covers 460nm to 700nm. The LED light source covers 450nm to 650nm.
Light Source Power	Halogen: 12V, 30W; LED: 12V, 10W (similar to predicate's 12V, 6W)	Halogen: 12V, 30W; LED: 12V, 10W.

2. Sample Size Used for the Test Set and Data Provenance

The summary focuses on bench testing and compliance with standards rather than clinical performance data involving a "test set" of patients or cases. Therefore:

Sample Size: Not applicable in the context of clinical cases. The testing would have involved individual units of the device and components.
Data Provenance: Not applicable in the context of clinical cases. The testing is described as premarket "performance testing" including "certifications of electrical safety, flammability, and bench test of radiation outputs." This implies laboratory-based testing on the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The study does not involve clinical data that would require expert-established ground truth. The "ground truth" here is compliance with engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or subjective interpretations requiring adjudication are 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

No. This device is a Slit Lamp, a diagnostic instrument that aids human examination. It does not incorporate AI, nor does the submission describe any MRMC study comparing human performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a manual optical instrument; it does not have a standalone algorithm component.

7. The Type of Ground Truth Used

The "ground truth" for this submission is compliance with recognized electrical safety (EN(IEC) 60601-1), EMC (EN(IEC) 60601-1-2, EN6100-3-2, EN6100-3-3) and radiation output standards, along with demonstrated equivalence of design and function to legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is an optical instrument, not an AI/machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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

K 072861

JUN 2 4 2008

510(k) Summary of Safety and Effectiveness for the CeeMax Slit Lamp™ (Halogen Lamp Series/LED Illumination series) (per 21CFR807.92)

1. SPONSOR

CeeMax Ophthalmic Division of Achevé Technology, Inc 17100 Gillette Ave. #113 Irvine, CA 92614 Telephone: 949-885-8875 949-854-2388 Fax: E Mail: choujs@sbcglobal.com Contact Person: Jim-Son Chou, Ph.D.

2. DEVICE NAME and Classification

Proprietary Name:	CceMax™ Slit Lamp (Halogen Lamp Series/LEDIllumination series)
Common/Usual Name:	Slit Lamp
Classification Name:	AC-powered slit lamp biomicroscope
Regulation Number:	886.1850
Product Code:	HJO
Class:	II

PREDICATE DEVICES 3.

(1) Reichert PSL Slit Lamp ----- FDA 510K K061330 (2) VISION-TECH YZ SLIT LAMP ---- FDA 510K K033190

4. DEVICE DESCRIPTION

INTENDED USE 5.

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

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Side by Side Comparison of the CeeMax™ Slit Lamp (Halogen Lamp Series/LED Illumination series) with Predicate Devices

	Submission Device	Predicate Device
	CeeMaxTM Slit Lamp(Halogen Lamp Series/LEDIllumination series)	Slit Lamp'sYZ5F (K033190)
		SL-15 (K061330)
Indicationsfor Use	Same.	AC powered microscope andaccessories intended for theuse in the examination of the
		anterior eye segment, fromcornea, endothelium toposterior capsule. Slit Lampwhich is intended for that isused to aid the diagnosis ofdiseases or traumas whichaffect the structure or
		properties of the eye
Method ofoperation	Same as the predicate deviceYZ5F (K033190) table top	YZ5F (K033190) Table TopSL-15 (K061330) Hand held
Exposureparameters	The Halogen lamp exposureparameters are the same as thepredicate device.The LED exposure parametersare similar to the predicate	Halogen lamp:YZ5F (K033190)LED: ReichertSL-15(K061330)
	device, detailed descriptionwas also provided.
Flammability	Thermosetting phenolformaldehyde resin.	Thermosetting phenolformaldehyde resin for the
		lamp cap YZ5F (K033190)
Brightnesscontrol	From zero to full powerillumination control	Same
Light source	Halogen lamp and white LED	Halogen lamp for the YZ5F(K033190)LED for the SL-15(K061330)
Beam	The same as the YZ5F	The standard slit opening
geometry	(K033190)	range YZ5F (K033190)
Radiationsafety	The Halogen lamp exposureparameters are the same as thepredicate device.The LED exposure parametersare similar to the predicatedevice, detailed descriptionwas also provided.	Halogen lamp:YZ5F (K033190)LED: ReichertSL-15(K061330)
Opticalradiationhazard	No, warning in the manualregarding the caution andparticularly for the aphakicdiagnostic	No
Electrical	Safety: EN(IEC) 60601-1	Safety: IEC 60601-1
Electrical	EMC: EN(IEC) 60601-1-2EN6100-3-2EN6100-3-3	EMC: EN(IEC) 60601-1-2
Light OutputWavelength	The Halogen Lamp emitsVisible light covers 460nm to700nm. The LED light sourcecovers 450nm to 650nm.	The Halogen Lamp emitsVisible light covers 460nm to650nm. The LED light sourcecovers 450nm to 650nm.
Light SourcePower	Halogen: 12V, 30WLED: 12V, 10W	Halogen(Vision Tech):12V, 30WLED(Reichert): 12V, 6W

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

PERFORMANCE TESTING 7.

Testing provided in this premarket notification includes certifications of electrical safety, flammability, and bench test of radiation outputs.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2008

Jim-Son Chou, Ph.D. President CeeMax Ophthalmic Division of Achevé Technology, Inc 17100 Gillette Ave. #113 Irvine, CA 92614

Re: K072861

Trade/Device Name: CceMax Slit Lamp (Halogen Lamp Series/LED Illumination Series) Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slit lamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: May 22, 2008 Received: May 23, 2008

Dear Dr. Chou:

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.

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

Page 2 - Jim-Son Chou, Ph.D.

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 Postmarket 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,

Mahina Eggleston, und

Malvina B. Eydelman, M. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): K 072861

Device Name: CeeMax™ Slit Lamp (Halogen Lamp Series/LED Illumination series)

Indications For Use:

The CeeMax™ slit-lamp series is an AC-powered slit-lamp biomicroscope intended for use in eye examination of the anterior 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 segment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

x 6/18/2008

510(k) Number K072861

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.