The KH Ophthalmic Slit-lamp Microscope is an AC-powered slitlamp 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 affects the structural properties of the anterior eye segment.

Device Description

The KH Ophthalmic Slit-lamp Microscope 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. The KH Ophthalmic Slitlamp Microscope is composed of the following components: microscope unit, illumination unit, base unit, chinrest, and table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.

AI/ML Overview

The provided text is a 510(k) summary for an ophthalmic slit-lamp microscope (SLM-1ER, SLM-2ER). It describes the device, its intended use, a comparison to a predicate device, and non-clinical testing performed to support substantial equivalence.

Based on the content, this document does not describe an AI/ML-driven medical device, nor does it detail a study that proves a device meets acceptance criteria related to AI/ML performance metrics (like sensitivity, specificity, or AUC). The acceptance criteria described are for a traditional medical device (slit-lamp biomicroscope) and focus on safety, EMC, biocompatibility, and general performance standards.

Therefore, it is not possible to provide the requested information about acceptance criteria for an AI/ML model and a study proving device performance against those criteria, including details on sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, or effect sizes for human readers.

The document focuses on demonstrating substantial equivalence to a predicate device (Keeler Slit Lamp H-Series, K131589) by showing compliance with established medical device standards for safety and performance of an ophthalmic slit-lamp.

Here's an overview of what is in the provided text, related to its acceptance:

Acceptance Criteria and Reported Device Performance (as per the document):

The acceptance criteria are implied by the compliance to various international standards. The "reported device performance" is essentially that the device met these standards.

Acceptance Criteria (Implied by Standards Compliance)	Reported Device Performance (as stated in document)
Safety: Compliance with IEC 60601-1:2005 + CORR.1(2006) + CORR.2(2007) + AM1(2012) or IEC 60601-1:2012	Met the requirements.
EMC (Electromagnetic Compatibility): Compliance with IEC 60601-1-2:2007	Met the requirements.
Biocompatibility: Compliance with ISO 10993-1:2009 for contact materials (Cytotoxicity, Skin irritation, Vaginal irritation, Sensitization)	Passed each biocompatibility test.
General Ophthalmic Instruments Requirements: Compliance with ISO 15004-1:2006	Met the requirements.
Light Hazard Protection: Compliance with ISO 15004-2:2007 (Device classification)	Device found to be a Group 2 instrument. (This is a classification based on the standard, implying compliance).
Slit-lamp Microscope Specific Requirements: Compliance with ISO 10939:2007	Complies with the requirements of the standard.
Photobiological Safety: Compliance with IEC 62471:2006	No explicit pass/fail statement, but listed as testing performed, implying compliance within the scope of the others. The text does mention "As a result of photo-toxicity testing to ISO 15004-2 maximum exposure increased from 13 to 17 minutes for bulb option," which is a performance characteristic derived from this testing.

Regarding the other requested information (which is not applicable to this document as it's not an AI/ML device study):

Sample size for the test set and data provenance: Not applicable. The testing is for compliance with physical and electrical standards, not diagnosis or detection using a dataset.
Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth for AI/ML performance is not relevant here.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable. This is not an AI/ML diagnostic aid.
Standalone (algorithm only) performance: Not applicable. This is a physical device, not an algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable. There is no AI/ML model trained here.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the submission for a traditional ophthalmic slit-lamp biomicroscope, not an AI/ML diagnostic or assistive device. Therefore, the requested information pertaining to AI/ML acceptance criteria and performance studies cannot be extracted from this text.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 21, 2017

Chongqing Kanghua Ruiming S&T Co., Ltd. Xi You Production Manager No.5, Road1, Tongjiaxi Industrial Park, Beibei Chongqing, 400070 CHINA

Re: K171877

Trade/Device Name: SLM-1ER, SLM-2ER, SLM-3ER Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: November 1, 2017 Received: November 1, 2017

Dear Xi You:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley S. Cunningham -S

for Malvina B. Eydelman, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below,

51D(k) Number (if known) K171877

Device Name KH Ophthalmic Slit-lamp Microscope Model: SLM-1ER, SLM-2ER

Indications for Use (Describe)

The KH Oplithalmic Slit-lamp Microscope is an AC-powered slittamp biomicroscope intended for use in eye examination of the anterior eye segment, from the comes epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eve segment.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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FORM FDA 3881 (8/14)

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510(k) SUMMARY (K 171877)

KH Ophthalmic Slit-lamp Microscope

Submitter's Information 1.

The submitter of this special pre-market notification is:

Name:	Chongqing Kanghua Ruiming S&T Co., Ltd.
Address:	No.5, Road1, Tongjiaxi Industrial Park, Beibei,Chongqing, ChinaZip Code:400070
Company Phone No:	+86-23-63227332
Company Fax No:	+86-23-63227336
Contact Person:	Xi You
E-mail:	doumeki2007@163.com
Date summary prepared:	April 15, 2017

2. Device Identification

Device Trade Name:	KH Ophthalmic Slit-lamp MicroscopeModel: SLM-1ER, SLM-2ER
Classification Name	AC- Powered Slit-Lamp Biomicroscope
Regulation Number:	21 CFR 886.1850
Regulation Name:	AC Powered Slit lamp Bio-microscope
Regulation Class:	II
Product Code:	HJO

Predicate Devices 3.

Model: SLM-1ER, SLM-2ER, the predicate cited is the Keeler Slit Lamp H-• Series of the same instrument:

Device Trade Name:	Keeler Slit Lamp H- Series
510(k) Number;	K131589
Common Name	AC Powered Slit lamp Bio-microscope
Class:	II
Classification Panel:	86
Product Code:	HJO
Regulation Number:	886.1850

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Device Description 4.

Intended Use / Indications for Use 5.

Feature	H-Series SlitLamp [K131589]	KH Ophthalmic Slit-lamp Microscope	Discussion
Intend use	As stated	As stated	No changes
Bio-microscope
Bio-microscope	Galileanconvergingbinoculars withdetachableeyepiece head	• SLM-1ER,Convergingbinoculars withdetachable eyepiecehead• SLM-2ER, Galileanconvergingbinoculars withdetachable eyepiecehead	As head can be separatedfrom the body,intervention of moduledoes not change theseelements
Digital Camera Module	Not fitted	• SLM-1ER, SLM-2ER: Not fitted	Same
Image capture button	Not fitted	• SLM-1ER, SLM-2ER: Not fitted	Same
Camera ExposureButtons	Not fitted	Not fitted	Same
Slit Lamp illuminationOptions	6VDC 20Whalogen bulb /LED	12V/50W halogenbulb	Required for slit lampillumination with somelight used for backgroundlighting
BackgroundIlluminationadjuster	Not fitted	• Not fitted	Same
Background LightSource Options	Not fitted	• Not fitted	Required for higherbackground light outputbut still conforms torequirements of 15004-2Photo toxicity with slightlylonger exposure time.
Background lightingduty cycle - halogenbulb option only	Not applicable	50% duty cycle atmaximum brightness.	Ensures body of lightsource does not exceed62.3 °C limit demanded byIEC 60601-1 compliance
Duration of illumination	Maximumexamination timesaccording to ISO15004-2 and ISO10939	Maximum examinationtimes according toISO 15004-2 and ISO10939	As a result of photo-toxicity testing to ISO15004-2 maximumexposure increased from13 to 17 minutes for bulboption (LED maximumexposure is unchanged at12.5 minutes).
Input voltage	AC 100-240 V,50/60 Hz	AC 110 V, 50/60 Hz	Same

Comparison to predicate device 6.

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Non-Clinical testing 7.

Safety and EMC:

Safety and EMC test was performed in according to the

IEC60601-1:2005 + CORR.1(2006)+CORR.2(2007)+AM1(2012) or IEC 60601--1:2012
-IEC 60601-1-2:2007 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.

Biocompatibility :

Biocompatibility testing was performed to evaluate the biocompatibility of the contact materials in accordance with ISO 10993-1:2009, the device passed each biocompatibility test indentified below:

Cytotoxicity testing in according to ISO 10993-5:2009 -
Skin irritation testing in according to ISO 10993-10:2010
-Vaginal irritation testing in according to ISO 10993-10:2010
Sensitization testing in according to ISO 10993-10:2010 -

Performance Data:

The following bench testing was conducted in order to support substantial equivalence:

-ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments. The testing found that the product met the requirements of ISO 15004-1:2006.
-ISO 15004-2:2007 Ophthalmic Instruments - Fundamental requirements and test methods - Part 2: Light hazard protection. The testing found that the device is a Group 2 instrument.
-ISO 10939:2007 Ophthalmic Instruments - Slit-lamp microscopes found that the KH OPHTHALMIC SLIT-LAMP MICROSCOPE complies with the requirements of the standard.
-IEC 62471:2006 Photobiological safety of lamps and lamp systems

8. Conclusions:

The KH Ophthalmic Slit-lamp Microscope (Model: SLM-1ER, SLM-2ER) is substantially equivalent to the predicate device in indications for use and construct, Safety and EMC testing to IEC60601-1 and IEC 60601-1-2, and performance testing to ISO 15004-1, ISO 15004-2 and ISO 10939, Based on the information provided in this submission, the KH Ophthalmic Slit-lamp Microscope(Model: SLM-1ER, SLM-2ER) is substantially equivalent to the predicate devices(K131589).

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.