PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System is intended for use to perform single-spot photocoagulation in the posterior segment (retina, choroid) and in the anterior segment (iris, trabecular meshwork) as well as pattern-scanning photocoagulation in the non-macular retina of the eye. Single-spot delivery may be performed using a slit lamp biomicroscope or an indirect ophthalmoscope. Pattern delivery may be performed using a slit lamp biomicroscope.

Device Description

PASCAL® Synthesis™ TwinStar™ is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally. At the physician's discretion, the system provides for a single laser spot treatment or the option of using a selectable pattern of delivering multiple laser spots simultaneously. Pattern scanning allows the physician to enhanced efficiency and reduced patient discomfort.

The PASCAL Synthesis™ Laser System (parent product to the PASCAL Synthesis Twinstar™) included 532 nm/577 nm wavelengths and was cleared via K123542. The subject device for this submission is a line extension named PASCAL Synthesis Twinstar and will include 577 nm/638 nm laser wavelengths.

AI/ML Overview

The provided document is a 510(k) summary for the PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance against them in the way an AI/ML device submission would.

Therefore, many of the requested points, especially those related to acceptance criteria, specific performance metrics (like sensitivity, specificity, F1 score), sample sizes for test/training sets with ground truth, expert adjudication, or MRMC studies for AI devices, are not present in this document.

This device is a physical laser system, not an AI/ML diagnostic tool. The "performance" discussed relates to its physical characteristics and biological effects on animal tissue, not its ability to interpret medical data or assist human readers.

However, I can extract information relevant to the study that was done to support the device and map it to the closest possible aspects of your request.

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

No explicit acceptance criteria in the form of numerical performance targets (e.g., sensitivity > X%) are stated. The study's conclusion of "similarity" is the implicit acceptance.

Criterion/Aspect	Reported Device Performance
Novel Feature Being Compared: 638 nm red treatment laser	Similarity of Lesion Morphology: No difference in lesion morphology between the subject device (PASCAL Synthesis TwinStar 638 nm red laser) and the reference predicate (Novus Multiwavelength 647 nm red laser) was observed funduscopically or in OCT for equivalent lesion ophthalmoscopic grade.
Lesion Width Measurement Difference (Quantitative Comparison):	In an analysis of OCT width measurements, the difference in lesion width for the predicate and subject device was <20% in all statistically significant single-eye comparative cases.
Compliance with Recognized Consensus Standards (Bench Testing):	Complied with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 60601-2-22, and IEC 60825-1.
Hardware and Software Validation:	Performed to ensure the device performed as intended; software documentation appropriate for the Major level of concern was provided.
Overall Conclusion (Animal Study):	The similarity in lesion character and size under matching delivery conditions supports substantial equivalence between predicate and subject devices for the red treatment laser.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Animal Study (Test Set): Not explicitly stated as a number of animals or eyes, but the study refers to "rabbit retinae" and "single-eye comparative cases." The common practice for such studies usually involves a small number of animals (e.g., 3-5 rabbits).
Data Provenance: The study was "in vivo" (live animal) and "prior to euthanasia," implying a prospective experimental design. Country of origin is not specified, but the sponsor is based in Livermore, CA, USA.

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)

The ground truth (lesion morphology and size) was established by "ophthalmoscopic evaluation, fundus photos, and SD-OCT measurements."
The number and qualifications of experts interpreting these evaluations are not specified in the document. It is implied these were performed by qualified personnel involved in the animal study.

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

No explicit adjudication method is described. The assessment likely involved expert interpretation of the ophthalmoscopic, fundus photo, and SD-OCT data, but details on how consensus or adjudication was achieved are not provided.

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, an MRMC comparative effectiveness study was not done. This device is a laser surgical instrument, not an AI diagnostic tool that assists human readers.

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

Not applicable. This is a laser device, not an algorithm. The "standalone" performance here refers to the device's ability to create comparable lesions to the predicate, irrespective of human interpretation beyond setting parameters and performing the procedure.

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

The ground truth was based on in-vivo assessments using:
- Ophthalmoscopic evaluation
- Fundus photos
- SD-OCT measurements
It primarily focused on lesion morphology and size immediately post-treatment in animal models.

8. The sample size for the training set

Not applicable. This device is a laser system and does not involve AI/ML requiring a training set. The "study" described is an animal performance test, not an AI model training or validation.

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

Not applicable, as there is no training set for an AI/ML model for this device.

Summary

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

September 12, 2017

Topcon Medical Laser Systems, Inc. % Pamela Buckman. MSN Regulatory Consultant 2800 Pleasant Hill Rd., Suite 175 Pleasant Hill, CA 94523

Re: K170409

Trade/Device Name: PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX, HQF Dated: August 4, 2017 Received: August 7, 2017

Dear Pamela 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.

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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 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 (DICE) 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 (DICE) 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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Indications for Use

510(k) Number (if known) K170409

Device Name

PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System

Indications for Use (Describe)

PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System is intended for use to perform single-spot photocoagulation in the posterior segment (retina, choroid) and in the anterior segment (iris, trabecular meshwork) as well as pattern-scanning photocoagulation in the non-macular retina of the eye. Single-spot delivery may be performed using a slit lamp biomicroscope or an indirect ophthalmoscope. Pattern delivery may be performed using a slit lamp biomicroscope.

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)

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510(K) SUMMARY

K170409

1. General Information

Submission

Sponsor: Topcon Medical Laser Systems, Inc. 606 Enterprise Court Livermore CA- 94550 USA T 925 245 8300 F 925 245 7723 Contact Person: Sweta Srivastava
Submission Correspondent:

Pamela M. Buckman, MSN 2800 Pleasant Hill Rd., Suite 175 Pleasant Hill, CA 94523 T 925 980 7007 F 925 705 7381

Date Prepared: September 1, 2017

2. Device Identification

Device Name:	PASCAL® Synthesis™ TwinStar™ Ophthalmic ScanningLaser System
Classification Name:	Laser Surgical Instrument for use in General and PlasticSurgery and Dermatology; Laser, Ophthalmic
ClassificationRegulation:	21 CFR 878.481021 CFR 886.4390
Classification Panel:	Ophthalmology/General and Plastic Surgery
Product Code:	GEX, HQF
Device Class:	Class II

3. Predicate Devices

Primary Predicate Device

PASCAL® Synthesis™Ophthalmic Scanning Laser System (K123542)

Reference Predicate Device

NOVUS Multiwavelength Omni (K932468)

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4. Device Description

5. Intended Use

PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System is intended for use to perform single-spot photocoagulation in the posterior segment (retina, choroid) and in the anterior segment (iris, trabecular meshwork) as well as pattern-scanning photocoagulation in the non-macular retina of the eye. Singlespot delivery may be performed using a slit lamp biomicroscope or an indirect ophthalmoscope. Pattern delivery may be performed using a slit lamp biomicroscope.

6. Comparison of Technological Characteristics

The technological characteristics of PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System are substantially equivalent to those of the Primary predicate and the Reference predicate devices.

The Pascal Synthesis Twinstar that is the subject of K170409 is a modification of Pascal Synthesis (primary predicate) with an added option of red treatment wavelength. Pascal Synthesis Twinstar is a combination wavelength device that offers two treatment wavelengths, i.e., 577nm and 638 nm.

Using red laser for the treatment of eye disease, the Pascal Synthesis Twinstar uses 638 nm red laser to perform single-spot photocoagulation. The Novus Multiwavelength (reference predicate) has been cleared for the use of similar red laser wavelength (647 nm) for the treatment of eye disease.

The following Table compares the technological characteristics of the Pascal Synthesis Twinstar to the Primary Predicate as well as the Reference Predicate.

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ITEM	NOVUS Multi-Wavelength(K932468)Reference Predicate	PASCAL® Synthesis™(K123542)Primary Predicate	PASCAL SynthesisTwinStar(K170409)
Type	Treatment Laser:Coherent superINNOVA CeramicCoolDisk, AimingLaser: InGaAIP Diode	OPSL- OpticallyPumped SemiconductorLaser; Diode Pumped;Solid State	OPSL - OpticallyPumped SemiconductorLaser; Diode Pumped;Solid State (577)Diode Laser (638)
OutputWavelength3	521 and 531 nm(Green)647 nm (Red)568 nm (Yellow)521, 531 and 568 nm(Yellow-Green)	532 nm (Green)577 nm (Yellow)	577 nm (Yellow)638 nm (Red)
Power Output4	Green: 50 - 900 mWRed: 50 – 1000 mWYellow: 75 - 600 mWYellow-Green: 75 -1500 mW	0, 30 mW - 2000 mW	0, 30 mW - 2000 mW(577)0 to 600mW (638)
Duty Cycle	100%	100%	100%
Exposure Time	10 ms - 1000 ms, andcontinuous	2ms -1000 ms	2ms -1000 ms
Repetition Rate(Available withsingle-spotpattern only)	Available settingsrange from 1 Hz to 9Hz depending on rateand exposure timesettings	Off, 1.0 Hz, 1.5 Hz, 2.0Hz, 3.0 Hz, 4.0 Hz, 5.0Hz, 6.0 Hz, 7.0 Hz, 8.0Hz	Off, 1.0 Hz, 1.5 Hz, 2.0Hz, 3.0 Hz, 4.0 Hz, 5.0Hz, 6.0 Hz, 7.0 Hz, 8.0Hz
Pulse Counter	0 - 9999, resetavailable	0-99,999, reset available	0-99,999, reset available
CDRHClassification	Class IV	Class IV	Class IV
EuropeanClassification	Class 4	Class 4	Class 4
Aiming LaserType	InGaAIPDiode(Direct Diode)	Direct Diode	Direct Diode
Wavelength	670 nm	635 nm	670 nm
Power Output	Adjustable to <1mW	Adjustable to <1mW	Adjustable to <1mW
CDRHClassification	Class IIIa	Class II	Class II
MDDClassification	Class 3a	Class 2	Class 2
ITEM	NOVUS Multi-Wavelength(K932468)Reference Predicate	PASCAL® Synthesis™(K123542)Primary Predicate	PASCAL SynthesisTwinStar(K170409)
Level ofConcern	Unknown	Major	Major
Spot Diameter	50 μm – 500 μmdelivered to the focalplane of the slit lampin the air (withLaserLink Z Slit LampAdapter) There is alaser diametermagnification factor forthe contact lensutilized.	50 μm – 400 μmdelivered to the focalplane of the slit lamp inthe air. There is a laserdiameter magnificationfactor for the contactlens utilized.	50 μm – 400 μm (577);60, 200um (638)delivered to the focalplane of the slit lamp inthe air. There is a laserdiameter magnificationfactor for the contactlens utilized.
Intensity Profile	Top Hat	Top Hat	Top Hat
Spot Spacing	Not applicable (non-scanning)	Adjustable, with aminimum center-to-center spacing of 1 spotdiameter.	Adjustable, with aminimum center-to-center spacing of 1 spotdiameter.
Scan Field	Not applicable (non-scanning)	4 mm X 4 MM (in air)	4 mm X 4 mm (in air)
Scan Rate	Not applicable (non-scanning)	≤ 100 Hz	≤ 100 Hz
Electrical Requirements:
Voltage	200-240 VAC or380 to 415 VAC	100-230 VAC ± 10%	100-230 VAC ± 10%
Frequency	50/60 Hz, singlephase or three-phase	50,60 Hz, single-phase	50,60 Hz, single-phase
Current	20, 35, or 60 A	< 10 Amperes	< 10 Amperes

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7. Substantial Equivalence

PASCAL® Synthesis™ TwinStar™ 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. Performance and animal testing confirmed that the PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System is substantially equivalent to the identified predicates.

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Safety and Effectiveness information 8.

The review of the indications for use and technical characteristics as well as animal study results and performance testing demonstrate that the PASCAL® Synthesis™ Twinstar™ Ophthalmic Scanning Laser System is substantially equivalent to the predicate devices. No new safety and effectiveness questions are applicable.

9. Non Clinical Testing

Performance Testing - Bench

Performance testing was conducted in order to demonstrate compliance with recognized consensus standards:

• AAMI/ANSI ES60601-1:2005/(R) 2012 + A1:2012, C1:2009(R) 2012 and A2:2010/(R) 2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance

· 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

• IEC 60601-1-6:2010+A1:2013 Medical electrical equipment-Part 1-6: General requirements for safety-Collateral Standard Usability

· IEC 62366-1 Medical Devices-Part 1: Application of usability engineering to medical devices • IEC 60601-2-22: 2007 (Third Edition) + A1:2012 Medical Electrical Equipment Part 2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

· IEC 60825-1 2nd Edition Part 1: Safety of laser products-Part 1: Eguipment classification and requirements Additionally, hardware and software validation activities were performed to ensure the device performed as intended and software documentation appropriate for the Major level of concern was provided.

Performance Testing - Animal

An animal study was performed for the novel features of the subject device relative to the PASCAL® Synthesis: the 638 nm red treatment laser. In the study grids of mild to moderate grade retinal lesions were delivered to rabbit retinae in vivo with both the subject device and the reference predicate (the Novus Omni compared with the red treatment laser).

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In the case of the red laser study, both 60um and 200um spot-sizes were used. Ophthalmoscopic evaluation, fundus photos, and SD-OCT measurements were taken in vivo immediately after treatment, prior to euthanasia. No difference in lesion morphology between predicate and subject device was observed funduscopically or in OCT for equivalent lesion ophthalmoscopic grade. In an analysis of OCT width measurements, the difference in lesion width for predicate and subject device was <20% in all statistically significant single-eye comparative cases. The similarity in lesion character and size under matching delivery conditions supports substantial equivalence between predicate and subject devices for the red treatment laser.

10. Clinical Performance

There was no clinical testing required to support this medical device as the indications for use and technology are equivalent to those of the predicate devices.

11. Statement of Substantial Equivalence

A device is substantially equivalent when the subject device has the same intended use and the same technological characteristics as the previously cleared predicate device(s). The addition of the red laser to the PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System does not alter either of these characteristics and does not raise any new questions of safety or efficacy as compared to the predicates.

12. Conclusion

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

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.