The SLIT LAMP is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal 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 segment of the eye.

Device Description

The slit lamp is an instrument consisting of a high-intensity light source that can be focus to shine a thin sheet of light into the eye. The binocular slit-lamp examination provides a stereoscopic magnified view of the eye structure in detail, enabling diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye. The device consists of a base plate, chin rest, fixation light, illumination light, slit project, focusing ring and other accessories that in aid of examination. The patients can rest their chin and forehead on a support to keep the head steady.

It is powered by the specified adapter (model: MDS-060BAS12A) which is certificated by ANSI/AAMI ES 60601-1 and considered as part of this equipment. Appliance coupled with US Plug.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "SLIT LAMP, Model: YF-100." This document outlines the device's technical specifications, intended use, and its comparison to a legally marketed predicate device to demonstrate substantial equivalence.

However, the document describes a traditional medical device (a physical slit lamp biomicroscope), not an AI/ML-driven device. As such, it does not contain information about acceptance criteria or a study proving an AI device meets those criteria. The testing performed is related to electrical safety, EMC compliance, environmental tolerance, and photo-biological safety of the hardware, not the performance of an algorithm or AI model in diagnostic tasks.

Therefore, I cannot extract the specific information requested regarding AI/ML device acceptance criteria and study data because the provided text does not describe such a device or study.

To address your request, if this were an AI/ML device, the sections would typically describe:

A table of acceptance criteria and the reported device performance: This would involve metrics like sensitivity, specificity, accuracy, AUROC, positive/negative predictive values, or agreement rates for a diagnostic task. The document would list the target values for these metrics and the actual achieved values from the study.
Sample size used for the test set and the data provenance: Details on the number of cases (e.g., images, scans, patient records) in the test set, and whether the data was collected retrospectively or prospectively, and its geographic origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For AI in medical imaging, this would involve radiologists, ophthalmologists, pathologists, etc., with specified experience levels (e.g., board-certified, years of experience).
Adjudication method for the test set: How disagreements among experts were resolved to establish the final ground truth (e.g., majority vote, senior expert arbitration, additional expert review).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: An MRMC study assesses the performance of human readers with and without AI assistance to quantify the improvement. The effect size (e.g., increase in sensitivity, decrease in false positives) would be reported.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Performance metrics of the AI algorithm operating independently, without human interaction.
The type of ground truth used: Whether it was expert consensus, pathology confirmation, clinical outcomes data, or a combination.
The sample size for the training set: The number of cases used to train the AI model.
How the ground truth for the training set was established: The process for labeling or annotating the training data to provide the AI with correct answers to learn from.

Given the content of the provided document, I must state that it does not contain the information necessary to fulfill your request for an AI/ML device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 16, 2017

Chongqing Yeasn Science-Technology Co., Ltd. % Ms. Iris Fung Official Correspondent SGS-CTSC Standards Technical Services Co., Ltd. 198 Kezhu Road, Scientech Park Guangzhou Economic & Technology Development District Guangzhou, CN Guangdong

Re: K161764

Trade/Device Name: Slit Lamp, Model: YF-100 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: December 3, 2016 Received: January 3, 2017

Dear Ms. Fung:

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.

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Page 2 - Ms. Iris Fung

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); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Denise L. Hampton -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

510(k) Number (if known) K161764

Device Name SLIT LAMP

Indications for Use (Describe)

The SLIT LAMP is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of trauma, which affect the structural properties of the anterior segment of the eye.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

Date of the summary prepared: February 10, 2017

1. Submitted Information

� 510(k) Owner's Name: CHONGQING YEASN SCIENCE-TECHNOLOGY CO., LTD
� Address: 5 Danlong Road, Nan An District, Chongqing Chongqing, CHINA 400060
Phone:(86 23)62797666-8050 �
Fax:(8623)62766200 �
Contact Person: Bing Hu/Managing Director �
Email: tech@yeasn.com �

2. Application Correspondent:

� Company Name: SGS-CSTC Standards Technical Services Co., Ltd.
Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & �

Technology Development District, Guangzhou, Guangdong, CHINA

Contact Person: Ms. Iris Fung �
Tel: +86-20-32136908 �
Email: Iris.Fung@sgs.com �

3. Subject Device Information

Trade Name: SLIT LAMP, Model: YF-100 �
Slit Lamp Common Name: �
AC Powered Slit Lamp Bio-microscope � Classification name:
Review Panel: Ophthalmic �
HJO Product Code: �

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Regulation Class: II �
21 886.1850 � Regulation Number:

4. Predicate Device Information

Sponsor	APPASAMY ASSOCIATES
Device Name	APPASAMY SLIT LAMP, model:A1A-11 AND A1A-12SERIES
510(k) Number	K082031
Product Code	HJO
RegulationNumber	21 886.1850
Regulation Class	2

5. Device Description

It is powered by the specified adapter (model: MDS-060BAS12A) which is certificated by ANSI/AAMI ES 60601-1 and considered as part of this equipment. Appliance coupled with US Plug.

6. Intended Use / Indications for Use

The SLIT LAMP is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule.

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It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye.

7. Test Summary for SLIT LAMP

YF-100 has been evaluated the safety and performance by lab bench testing as following:

� The YF-100 was evaluated to IEC 60601-1:2005 (3rd edition) for electrical safety, and passed.
� The YF-100 was evaluated to IEC 60601-1-2 for EMC compliance, and passed at Class A radiated emissions limits.
� The YF-100 was evaluated to ISO 15004-1 for environmental tolerance of ophthalmic devices and passed.
� The YF-100 was evaluated to ISO 15004-2 for assessment of photo-biological safety of light intensity limits, and passed.
The YF-100 was evaluated to ISO 10939, which requires assessment to ISO 15004-1, � 15004-2, and IEC 60601-1, and passed.

8. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of SLIT LAMP is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Remark
Basic Unit Characteristics
Device Name andModel	SLIT LAMP, Model: YF-100	APPASAMY SLIT LAMP, model:A1A-11 AND A1A-12 SERIES	--
Elements ofComparison	Subject Device	Predicate Device	Remark
510 (K) Number	K161764	K082031	--
Intended Use	The SLIT LAMP is intendedfor use in eye examination ofthe anterior eye segment,from the cornea epithelium tothe posterior capsule. It isused to aid in the diagnosis ofdiseases or trauma whichaffects the structuralproperties of the anterior eyesegment.	Slit Lamp is an AC-poweredslit lamp biomicroscopeintended for use in eyeexamination of the anterioreye segment, from the corneaepithelium to the posteriorcapsule. It is used to aid in thediagnosis of diseases ortrauma which affects thestructural properties of theanterior eye segments.	SE
Microscope type	Galileo binocular converging	Galilean type	SE
Exposureparameters	1. Magnification Change:Continuous by manual zoom2. Eyepieces:12.5×3. PD Range:55mm to 80mm4. Slit Width:0mm to 14mmcontinuous (become a circle at14mm)5. Slit Apertures: φ0.3mm、φ5.5mm、φ9mm、φ14mm6. Slit Angles: 0° to 180°continuous adjustable fromvertical to horizontal direction7. Diopter adjustment:-5.00Dto +5.00D8. Working Distance: 100mm9. Longitudinal(In/Out) :Movement 100mm10. Lateral(Left/Right) :	1. Magnification Change:Continuous by manual zoom2. Eyepiece: 12.5x3. PD Range: 55mm to 75mm4. Slit Width: 0mm to 14mm5. Slit Apertures: 0mm to 14mm,φ0.2, φ1, φ3, φ4, φ6, φ10, φ14mm6. Slit Angles: 0° to 180°7. Diopter adjustment: -6D to+6D8.Working Distance: 100mm9. Longitudinal(In/Out) :Movement 99mm10. Lateral(Left/Right) :Movement 118mm11. Vertical(Up/Down) :Movement 30mm12. Chin Rest vertical:55mm	Note 1
Elements ofComparison	Subject Device	Predicate Device	Remark
Movement 100mm11.Vertical(Up/Down) :Movement 30mm12. Horizontal:Movement 10mm13.Chin Rest Elevation :70mm
Filters	Heat aborption, redfree, cobalt blue	Heat absorbing, Green,Cobalt Blue	SENote 1
Total Magnification	$6.4 \times,10 \times,16 \times,25 \times,40 \times$	5.5x to 35.0x	SENote 1
Fixation Light	Red LED (620nm~720nm)	LED	SENote 1
Data collectionand/or displaysystem	N/A	N/A	SE
Flammability ofmaterials	This instrument is not suitablefor use in a flammableatmosphere. Do not use thisinstrument if any flammablegases are present.	This instrument is not suitable foruse in a flammable atmosphere.Do not use this instrument if anyflammable gases are present.	SE
Max. temperatureof parts of thedevice held by theoperator oraccessible to thepatient	No parts of device withpatient/operator contact isenergized and remains atambient temperature.	No parts of device withpatient/operator contact isenergized and remains atambient temperature.	SE
Brightness Control	3V LED lamp	12V 30W halogen bulb	SENote 1
Duration ofillumination	Maximum examination timesaccording to ISO 15004-2 andISO 10939	Maximum examination timesaccording to ISO 15004-2 andISO 10939	SE
Compliancewith	IEC 60601-1-2	IEC 60601-1	--
Elements ofComparison	Subject Device	Predicate Device	Remark
Safety Standards	IEC 60601-1:2005	ISO 10939:2007
	ISO 15004-1	ISO 15004-2:2007
	ISO 15004-2
	ISO 10939
Input Voltage AC	230 / 110V - 50 / 60 Hz	230 / 110V - 50 / 60 Hz	SE
Power Rating	60W	45W	SENote1

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Note 1:

Although the Brightness Control, Power Rating, Filters, Total Magnification Light of subject device are a little different from the predicate devices, they are all compliant with requirements of IEC 60601-1, ISO 15004-2, ISO 10939 and Guidance for Slit Lamp. So the differences of the function specifications will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject device "SLIT LAMP" is Substantially Equivalent to the predicate device.

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.