The PASCAL® Synthesis™ Ophthalmic Scanning Laser System is intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: (532nm) proliferative and non-proliferative diabetic retinopathy, macular-edema, choroidal neovascularization associated with wet age-related macular degeneration, age-related macular degeneration, lattice degeneration, retinal tears and detachments. (577nm) proliferative and non-proliferative diabetic retinopathy, macular edema, choroidal neovascularization associated with wet age-related macular degeneration, age-related macular degeneration, lattice degeneration, retinal tears and detachments. Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm) iridotomy, trabeculoplasty.

Device Description

The PASCAL® Synthesis™ Ophthalmic Scanning Laser System is a stand-alone laser delivery console for use with a slit lamp. LIO or probe delivery. Controls and displays include an I.CD/Touchscreen user interface and a slit lamp connector (SLC). The system is equipped with a three-position key switch that enables laser and controls as well as an emergency off switch. An externally connected wired footswitch activator is provided with a shrouded housing, and contains a set of redundant switches. An external door interlock connection allows the laser to be terminated with an open circuit.

AI/ML Overview

The PASCAL® Synthesis™ Ophthalmic Scanning Laser System, submitted under K123542, is a medical device designed for ophthalmic laser treatments. The acceptance criteria and the study proving its performance are focused on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics for novel AI algorithms.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a submission for a laser system, the "acceptance criteria" are primarily related to safety, technical specifications aligning with predicate devices, and demonstrating equivalent performance in a preclinical setting. The document doesn't explicitly state numerical acceptance criteria in terms of accuracy or clinical outcomes for a diagnostic AI. Instead, it relies on the established safety and efficacy of predicate devices and a comparative preclinical study.

Acceptance Criteria Category	Specific Criteria/Goal	Reported Device Performance (PASCAL® Synthesis™)
Safety	Compliance with relevant national and international standards (e.g., IEC 60601-1, -2-x; EN ISO14971-C; ASTM 4169-09&6653-01; ASTM D4169-09 for hardware, IEC 60601-1-2, -4, -6 for electromagnetic, EN 60601-1-4, 62304 for software).	All testing was conducted and established that the PASCAL® Synthesis system met or exceeded its design specifications and performed equally or better than the stated performance of the predicate. Conclusion: It is as safe as the predicate device.
Technical Equivalence	Substantial equivalence in technical characteristics (e.g., Type of Laser, Output Wavelength, Power output, Duty cycle, Exposure time, Repetition Rate, Pulse Counter, CDRH/European MDD Classification, Electrical Requirements) to predicate devices (K092621, K111108, K121475/K071687).	The technological characteristics of the PASCAL® Synthesis Ophthalmic Scanning Laser System are substantially equivalent to those of the predicate devices. The tables in Section VII list the specifications, and they are largely identical or within acceptable ranges for equivalence. For example, Output Wavelength (532 nm or 577 nm), Power output (0, 30 mW - 2000 mW), Duty cycle (100%), Exposure time (2 ms - 1000 ms), and Repetition Rate are all highly similar or identical to one or more predicate devices.
Clinical Performance Equivalence	Appearance and diameter of retinal laser lesions comparable to predicate device in a preclinical setting.	An animal study compared lesions produced by the PASCAL® Synthesis system with the predicate PASCAL Streamline system. When comparing lesions of the same clinical grades, the appearance was similar. The diameter of the lesions was <20% in mean diameter. Within lesions of the same clinical grade, the variability was approximately 10%. No systematic trend in lesion diameter was observed. Conclusion: The Streamline device and the Synthesis device were comparable in a preclinical setting.
Indications for Use	Same indications for use as predicate devices.	The PASCAL® Synthesis Ophthalmic Scanning Laser System shares the same indications for use as the predicate devices for both posterior and anterior segments (e.g., proliferative and non-proliferative diabetic retinopathy, macular edema, choroidal neovascularization, lattice degeneration, retinal tears and detachments, iridotomy, trabeculoplasty).

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

Test Set Description: The "test set" in this context refers to the animal model used for the preclinical comparison.
Sample Size: The study included two animals.
Data Provenance: The study was a prospective comparative study conducted in an animal model. The document does not specify the country of origin but states it was performed "in accordance with Good Laboratory Practices (GLP) standards and the local Animal Institutional Review Board."

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

Number of Experts: The ground truth (clinical grade of the lesions) was assigned by "the laser operator." The document mentions "laser operator" in the singular.
Qualifications of Experts: The specific qualifications of the "laser operator" are not detailed in the summary.

4. Adjudication method for the test set:

Adjudication Method: Not applicable/not specified. Since a single "laser operator" assigned clinical grades, there was no multi-reader 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:

MRMC Study Done?: No. The provided summary is for a laser system, not an AI-powered diagnostic device designed to assist human readers. The preclinical study was a direct comparison of lesion characteristics between two laser systems.
Effect size of human reader improvement with AI: Not applicable, as no AI assistance or human reader study was conducted.

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

Standalone Performance Done?: No. This device is a laser system, not an algorithm. Its performance is evaluated through its physical output and biological effects, not as a standalone algorithm.

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

Type of Ground Truth: The ground truth for the animal study was the clinical grade assigned by the laser operator(s) (which the document states as "the laser operator" suggesting a single operator) on a 5-point scale. This is a form of expert assessment or grading.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This device is a physical laser system, not an AI model that requires a training set. The "design specifications" and performance were established indirectly through reference to predicate devices and an animal study.

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

Ground Truth Establishment for Training Set: Not applicable, as there is no AI model or training set described.

Summary

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510 (K) SUMMARY - K123542

General Information I.

Submitter:

Topcon Medical Laser Systems, Inc. 3130 Coronado Drive Santa Clara, CA 95054, USA

Contact Person:	Pamela M. Buckman
	Regulatory Consultant
	T 925 980 7007
	F 925 705 7381
	pmbuckman@gmail.com

May 12, 2013 Summary Preparation Date:

Names II.

Device Name(s):	PASCAL® Synthesis™ Ophthalmic Scanning LaserSystem
Common Name:	Laser, Ophthalmic
Classification Name(s):	Laser Surgical Instrument for use in General and PlasticSurgery and Dermatology; Laser, Powered

Predicate Devices III.

Optimedica Ophthalmic Scanning Laser System (K092621) .
. Topcon Ophthalmic Scanning Laser System (K111108)
Iridex TxCell Adaptor/Photocoagulator System (K121475) .

Product Description IV.

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V. Summary of Non Clinical Tests

Topcon utilized hardware testing (60601-1, -2-x; EN ISO14971-C; ASTM 4169-09&6653-01; ASTM D4169-09). electromagnetic testing (IEC 60601-1-2. 4. 6) software testing (EN 60601-1-41 62304 and animal testing to establish a basis for the determination of equivalence. The PASCAL® Synthesis performance characteristics were established by referencing the known performance characteristics of the predicate device. Specifications for the PASCAL® Synthesis system were established to assure that the predicate system and the Synthesis system performed in an equivalent manner. Performance specifications were set utilizing national and international standards for such devices with respect to output, indications for use, safety features and electromagnetic interference where it was established as suitable for the environment of use. All testing was conducted and established that the PASCAL® Synthesis system met or exceeded its design specifications and performed equally or better than the stated performance of the predicate.

The objective of the animal study was to compare the appearance of retinal laser lesions produced by the PASCAL Synthesis system with the predicate PASCAL Streamline system in an animal model. This prospective comparative study included delivery of laser lesions to two animals in accordance with Good Laboratory Practices (GLP) standards and the local Animal Institutional Review Board. Multiple lesions using varying spot sizes and intensities were created with each of the two lasers and assigned a clinical grade by the laser operator on a 5 point scale. When comparing lesions of the same clinical grades, the appearance of the lesions was similar. The diameter of the lesions was <20% in mean diameter. Within lesions of the same clinical grade, the variability was approximately 10%. Lesions were created using spot sizes of 100, 200 and 400 micron (50 micron was not part of the investigation). Powers ranged from 70 mW to 450 Endpoint Management algorithms were not used as part of this investigation. No mW. systematic trend in lesion diameter was observed. The Streamline device and the Synthesis device were comparable in a preclinical setting.

Conclusions drawn from these non-clinical tests demonstrate that the device is as safe, as effective and performs at least as safely and as effectively as the legally marketed device identified in this Summary.

VI. Indications for Use

The PASCAL® Synthesis Ophthalmic Scanning Laser System is intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

(532nm)

proliferative and non-proliferative diabetic retinopathy .
. macular-edema
choroidal neovascularization associated with wet age-related macular degeneration .
age-related macular degeneration t
. lattice degeneration
retinal tears and detachments .

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(577nm)

proliferative and non-proliferative diabetic retinopathy ●
. macular edema
choroidal neovascularization associated with wet age-related macular degeneration �
age-related macular degeneration .
lattice degeneration .
. retinal tears and detachments

Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm)

iridotomy .
trabeculoplasty. .

VII. Summary of Technological Characteristics .

The technological characteristics of the PASCAL® Synthesis Ophthalmic Scanning Laser System are substantially equivalent to those of the predicate.

TechnicalCharacteristics	K092621	K111108	K121475/K071687	K123542PASCAL®Synthesis
Type of Laser	OPSL -OpticallyPumpedSemiconductorLaser; DiodePumped; SolidState	OPSL -OpticallyPumpedSemiconductorLaser; DiodePumped; SolidState	OPSL - OpticallyPumpedSemiconductorLaser; DiodePumped; Solid State	OPSL -OpticallyPumpedSemiconductorLaser; DiodePumped; SolidState
OutputWavelength	532 nm	577 nm	532 nm or 577 nm	532 nm or 577nm
Power output	0, 100 mW -2000 mW	0, 100 mW -2000 mW	0-2000 mW	0, 30 mW - 2000mW
Duty cycle	100%	100%	Variable	100%
Exposure time	5 ms - 1000 ms	10 ms - 1000 ms	0.05 ms - 3000 ms	2 ms - 1000 ms
Repetition Rate(available withsingle spotpattern only)	Off, 1.0hz,1.5hz, 2.0hz,3.0hz, 4.0hz,5.0hz, 6.0hz,7.0hz, 8.0hz	Off, 1.0hz,1.5hz, 2.0hz,3.0hz, 4.0hz,5.0hz, 6.0hz,7.0hz, 8.0hz	Available only withsingle spot pattern	Off, 1.0hz,1.5hz, 2.0hz,3.0hz, 4.0hz,5.0hz, 6.0hz,7.0hz, 8.0hz
Pulse counter	0 - 99,999 withAutomatic reset	0 - 99,999, resetavailable	Not Reported	0 - 99,999, resetavailable
CDRHClassification	Class IV	Class IV	Class IV	Class IV
European MDDClassification	Class 4	Class 4	Class 4	Class 4
Type	Direct diode	Direct diode	Direct diode	Direct diode

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TechnicalCharacteristics	K092621	K111108	K121475/K071687	K123542PASCAL®Synthesis
Wavelength	635 nm	635 nm	635 nm	635 nm
Power output	Adjustable to <1mW	Adjustable to <1mW	Adjustable to <1 mW	Adjustable to <1mW
CDRH laserClassification	Class II	Class II	Class II	Class II
Electrical Requirements
Voltage	100-240 VAC ±10%	100-230 VAC ±10%	100-240 VAC ±10%	100-230 VAC ±10%
Frequency	50/60 Hz, single-phase	50/60 Hz, single-phase	50/60 Hz	50/60 Hz, single-phase
Current	<5 Amperes	<10 Amperes	Not Reported	<10 Amperes

VIII. Rationale for Substantial Equivalence

The PASCAL® Synthesis Ophthalmic Scanning Laser System shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

IX. Safety and Effectiveness Information

The review of the indications for use and technical characteristics demonstrates that the PASCAL® Synthesis Ophthalmic Scanning Laser System is substantially equivalent to the predicate devices. No new safety or effectiveness questions are applicable.

X. Conclusion

The PASCAL® Synthesis Ophthalmic Scanning Laser System was found to be substantially equivalent to the predicate devices. The PASCAL® Synthesis Ophthalmic Scanning Laser System shares the same indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002

May 15, 2013

Topcon Medical Laser Systems, Inc. % Buckman Company, Inc. Ms. Pamela M. Buckman Regulatory Consultant 2800 Pleasant Hill Road, Suite 175 Pleasant Hill, California 94553

Re: K123542

Trade/Device Name: PASCAL® Synthesis" Ophthalmic Scanning Laser System . Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF, GEX Dated: April 15, 2013 Received: April 22, 2013

Dear Ms. Buckman:

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

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Page 2 - Ms. Pamela M. Buckman

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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, For

Peter D Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K123542
Device Name:	Topcon PASCAL® Synthesis Ophthalmic Scanning Laser System

The PASCAL® Synthesis Ophthalmic Scanning Laser System is intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation. focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: .

(532nm)
proliferative and non-proliferative diabetic retinopathy
macular edema t
choroidal neovascularization associated with wet age-related macular degeneration .
. age-related macular degeneration
. lattice degeneration
. retinal tears and detachments

(577nm)

. proliferative and non-proliferative diabetic retinopathy
. macular édema
. choroidal neovascularization associated with wet age-related macular degeneration
. age-related macular degeneration
◆ lattice degeneration
� retinal tears and detachments

Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm)

iridotomy �
trabeculoplasty .

X Prescription Use

(Per 21CFR 801 Subpart D)

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

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

Neil R Ogdens 2013.05.15 11:05:52 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123542

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.