The LightMed TruScan 577 Laser System is intended for use in the treatment of ocular pathology in the posterior segment; Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structure abnormalities of the retina and choroid including:

1. Proliferative and Severe and very severe nonproliferative diabetic retinopathy
1. Clinically Significant Macular edema
1. Choroidal neovascularization
1. Branch and central retinal vein occlusion
1. The treatment of choroidal neovascularization associated with wet age-related macular degeneration
1. Lattice degeneration
1. Retinal tears and detachments

Device Description

LightMed TruScan 577 is an integrated system consisting of Laser Console utilizing a 577nm Optically Pumped Semiconductor (OPSL; solid state) laser cavity, TruScan integrated Slit Lamp technology controlled via a LCD touch panel and wheel chair accessible ophthalmic instrument table.
The TruScan module which is integrated Slitlamp with safety filter as Laser Delivery System, employs a traditional single spot treatment laser, as well as a semi-automated pattern generation method employing short 577mm laser pulse durations of typically 10ms; range of spot size from 50um to 400µm in a continuous adjustment.
The LightMed TruScan 577 Laser System is comprised of the following functional components:

LCD touch panel
Laser Console ●
Ophthalmic Instrument table
TruScan integrated CSO Slitlamp (K992836)

AI/ML Overview

The provided text describes a 510(k) premarket notification for the LightMed TruScan 577 Laser System, focusing on its substantial equivalence to a predicate device. The document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML device evaluating images or data for diagnostic purposes, nor does it present acceptance criteria and reported device performance in the format of a table as requested for such a study.

Instead, this document focuses on demonstrating that the LightMed TruScan 577 Laser System, a medical device for ophthalmic photocoagulation, is substantially equivalent to a legally marketed predicate device (PASCAL Streamline 577). The "performance data" referred to in Section VII are primarily bench testing, electrical safety, EMC, and software verification/validation, which are typical for traditional medical device clearances, not for AI/ML performance evaluation against a dataset with ground truth.

Therefore, most of the information requested in your prompt regarding acceptance criteria, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be extracted from this document because it describes a different type of medical device and regulatory submission.

Here's an analysis of what can be inferred or is explicitly stated:

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

Cannot be provided. The document does not define acceptance criteria and reported performance in the context of diagnostic accuracy, sensitivity, specificity, etc., against a ground truth dataset, as would be relevant for an AI/ML device. The performance data discussed are related to the device's physical and electrical functioning, not its ability to interpret medical images or data.

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/Not provided. No test set of patient data (e.g., images, clinical records) is described. The "test set" in this context refers to the device itself undergoing various engineering and safety tests.

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/Not provided. No ground truth for a test set of medical data is discussed.

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

Not applicable/Not provided. No adjudication of medical data for ground truth is discussed.

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/Not provided. This is a laser system, not an AI/ML diagnostic aid for human readers. No MRMC study is mentioned.

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

Not applicable/Not provided. This device is a treatment laser, operated by a human ophthalmologist. There is no "algorithm only" performance concept relevant here.

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

Not applicable/Not provided. No ground truth for medical data is discussed. The "ground truth" for this device would be its adherence to engineering specifications and safety standards.

8. The sample size for the training set

Not applicable/Not provided. No training set of medical data for an AI/ML algorithm is discussed.

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

Not applicable/Not provided. No training set of medical data for an AI/ML algorithm is discussed.

Summary of relevant information from the document:

Device Type: Ophthalmic Laser (LightMed TruScan 577 Laser System).
Purpose: Treatment of ocular pathology in the posterior segment (e.g., retinal photocoagulation for diabetic retinopathy, macular edema, choroidal neovascularization).
Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
Predicate Device: PASCAL Streamline 577 (K111108).
Performance Data Provided:
- Bench Testing (Finished Product final assembly quality inspection, System Adjustment, Calibration and Testing for Laser console and TruScan laser delivery unit).
- Electrical safety and electromagnetic compatibility (EMC) testing, complying with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2 standards.
- Software Verification and Validation Testing, considering the software as a "major" level of concern.
Conclusion: The non-clinical data (bench testing, electrical safety, EMC, software V&V) supported the safety and intended performance, demonstrating comparability to the predicate 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 27, 2015

Lightmed Corp. Ms. Angel Hsieh Regulatory Affairs Coordinator No.1-1, Ln1,Pao-An St., Shulin Dist New Taipei City, 23861 Taiwan, R.O.C.

Re: K142172 Trade/Device Name: Lightmed Truscan 577 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: January 27, 2015 Received: January 28, 2015

Dear Ms. Hsieh:

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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) 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,

Kesia Y. Alexander -S

for Malvina B. Eydelman, MD 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) K142172

Device Name

LightMed TruScan 577 Laser System

1. Proliferative and Severe and very severe nonproliferative diabetic retinopathy
1. Clinically Significant Macular edema
1. Choroidal neovascularization
1. Branch and central retinal vein occlusion
1. The treatment of choroidal neovascularization associated with wet age-related macular degeneration
1. Lattice degeneration
1. Retinal tears and detachments

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 is 510(K) summery in accordance with 21 CFR 807.92.

I. SUBMITTER

LightMed Corporation No1-1, Ln1, Sec. 3 Pao-An St., Shulin Dist., New Taipei City 23861, Taiwan, R.O.C. TEL: +886 2 2688 1726 FAX: +886 2 2676 4920 Establishment registration number: 3008156177 Contact person in Taiwan: Angel Hsieh, Regulatory Affairs Coordinator Summary Preparation Date: February 25 2015

II. DEVICE

Trade name: LightMed TruScan 577 Laser System The common name of the device: Laser Instrument, surgical, powered & Laser, ophthalmic The classification name: 21 CFR 886.4390, Class II Product code: HQF Performance Standards: 21 CFR 1040.10 & 21 CFR 1040.11

III. PREDICATE DEVICE

PASCAL Streamline 577 (with Accessories), K111108 This predicate has not been subject to a design-related recall .

IV. DEVICE DESCRIPTION

The TruScan module which is integrated Slitlamp with safety filter as Laser Delivery System, employs a traditional single spot treatment laser, as well as a semi-automated pattern generation method employing short 577mm laser pulse durations of typically 10ms; range of spot size from 50um to 400µm in a continuous adjustment.

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The LightMed TruScan 577 Laser System is intended for use by ophthalmologist for treatment of ocular pathology.

The LightMed TruScan 577 Laser System is comprised of the following functional components:

LCD touch panel
Laser Console ●
Ophthalmic Instrument table
TruScan integrated CSO Slitlamp (K992836)

V. INDICATIONS FOR USE

Proliferative and Severe and very severe nonproliferative diabetic retinopathy
Clinically Significant Macular edema
Choroidal neovascularization
Branch and central retinal vein occlusion
The treatment of choroidal neovascularization associated with wet age-related macular degeneration
Lattice degeneration
Retinal tears and detachments

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

TruScan 577 is compared with predicate as STANDARD type of Pascal Streamline 577 only.

K number	K142172	K111108	Comparison ofSame orDifference
Companyname	LightMed Corporation	TOPCON Medical LaserSystems	Similar
Device name	LightMed TruScan 577	PASCAL Streamline 577
Indicationsfor Use	Proliferative and severeand very severenonproliferativediabetic retinopathy	The PASCAL® Streamline577 (with Accessories) isintended for use in thetreatment of ocularpathology in the posteriorsegment; Retinalphotocoagulation, panretinalphotocoagulation, focalphotocoagulation and gridphotocoagulation forvascular and structuralabnormalities of the retinaand choroid including:
	Macular edema	* proliferative andnonproliferative diabeticretinopathy
	Clinically SignificantChoroidalneovascularization	*macular edema
	Branch and centralretinal vein occlusion	*choroidalneovascularization
	The treatment ofchoroidalneovascularizationassociated with wetage-related maculardegeneration	*branch and central retinalvein occlusion
	Lattice degenerationRetinal tears anddetachments	the treatment of choroidalneovascularizationassociated with wetage-related maculardegeneration lattice degeneration*retinal tears anddetachments
* retinopathy of prematurityIntended for use in thetreatment of ocularpathology in the anteriorsegment including:* iridotomy* trabeculoplasty
Treatment Laser
Wavelength	577nm	577nm	Same
Laser Type	OPSL-Optically PumpedSemiconductor Laser	OPSL-Optically PumpedSemiconductor Laser	Same
Power Output	50-2000mW	30-2000mW	Difference
Pulse Duration	10ms to 3s, continuous	5-1000ms	Difference
Pulsing System	Continuous	Continuous	Same
Integrated SlitlampMulti Spot size	50(single spotonly),100,200,300,400 μmselectable on Zoomassembly of Delivery unit	Slitlamp Microscope(integrated)60,100,200,300,400 μmdelivered to the focal planeof the slitlamp in air	Difference
Laser Safety Class	Class IV	Class IV	Same
Cooling method	Fan cooled and TEC's forLaser Diode and Crystal	TEC/ Air cooled	Same
Aiming Beam
Wavelength	635nm red laser diode	635nm Direct Diode	Same
Power output	Maximum of 1.0mW	Adjustable to <1mW	Same
Laser Safety Class	Class II	Class II	Same
Other
Interface	LCD Touch panel	LCD Touch panel	Same
General Electrical Input	100-230 Vac	100-240 Vac	Difference
Computer control	Yes	Yes	Same
Can userchangecomputerprogram	No	No	Same

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The Indications for Use statement for the LightMed TruScan 577 device is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. The performance data to account for the differences listed in the table are provided in Section VII of this summary below.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Bench Testing

Bench Testing were completed including the Finished Product final assembly quality Inspection, System Adjustment, Calibration and Testing for Laser console and TruScan laser delivery unit on TruScan 577 Laser System.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the TruScan 577 device, consisting of the laser console and TruScan module integrated Slitlamp. The system complies with the IEC 60601-1, IEC 60601-2-22 and IEC 60825-1 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

VIII. CONCLUSIONS

The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the TruScan 577 Laser System should perform as intended in the specified use conditions. The clinical evaluation data demonstrate that the TruScan 577 Laser System performs comparably to the predicate device that is currently marketed for the same intended use.

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.