Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Streamline for procedures in trabeculoplasty in open angle glaucoma.

Device Description

Pattern Scanning Laser Trabeculoplasty (PSLT) is a software option for the currently marketed PASCAL Streamline (K100019 and K111108). It represents an enhancement intended to simplify the laser trabeculoplasty procedure by applying a fixed pattern of locations to the trabecular meshwork instead of a single spot. Additionally, this modification offers greater multi-functionality for the management of glaucoma. PSLT provides rapid, defined, uniform and minimally traumatic (sub-visible) computer-guided treatment with exact abutment of the patterns readily align to the trabecular meshwork, allowing more rapid and easier applications. Once the software is enabled, the PSLT feature is always available.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the PSLT for PASCAL Streamline device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Clinical Endpoints)	Reported Device Performance
Primary Endpoint: Change in IOP from baseline to 1-month post-surgery as measured by tonometry.	The clinical investigation supported the indications for use by achieving clinical endpoints. "Both laser modalities [PSLT and SLT (implied from the study design where patients received both treatments)] had similar safety and efficacy profiles." The sample size calculation aimed to "reject the null hypothesis of an inter-group IOP difference of 3 mmHg."
Secondary Endpoint: Success at 1-month post-surgery as measured by tonometry and CLS derived parameters.	The clinical investigation supported the indications for use by achieving clinical endpoints. "Both laser modalities had similar safety and efficacy profiles."
Overall Safety and Effectiveness	"Clinical study conclusion confirms that the device is safe and effective as used according to the instructions for use."

Note: The document generally states that the device met the clinical endpoints and had similar safety and efficacy profiles to the comparator, but it does not provide specific numerical values for the achieved IOP reduction or success rate for the PSLT device itself. It only mentions the target difference for the sample size calculation (an inter-group IOP difference of 3 mmHg).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): 58 eyes.
Data Provenance: The study was a "prospective, randomized, controlled study" of patients with open-angle glaucoma. The text does not explicitly state the country of origin, but it implies a single investigational site ("standard criteria of the investigational site"). The study design describes patients requiring bilateral laser trabeculoplasty, suggesting each patient received both PSLT and a comparator treatment (likely standard SLT, though not explicitly named as "SLT" in the study design section, it's mentioned in inclusion/exclusion for prior procedures).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number of experts or their qualifications specifically used to establish ground truth for the test set beyond the general term "observational site" and patients' diagnosis of open angle glaucoma. Clinical endpoints were measured by tonometry and CLS derived parameters. It is implicitly assumed that ophthalmologists or trained clinical staff performed these measurements.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The clinical study was a patient-level comparative effectiveness study comparing two laser modalities (PSLT and an implied standard SLT) on clinical outcomes (IOP reduction and success rates), not a diagnostic study evaluating reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, the PSLT software is an enhancement to the PASCAL Streamline laser system, simplifying the laser application procedure. It assists the clinician in applying the laser, rather than performing an autonomous diagnostic or treatment decision. Therefore, a standalone performance study in the sense of an "algorithm-only" diagnostic AI was not applicable or performed.

7. Type of Ground Truth Used

The ground truth for the clinical study was based on clinical outcomes data measured directly from patients:

Change in Intraocular Pressure (IOP) from baseline, measured by tonometry.
"Success" at 1-month post-surgery, measured by tonometry and CLS derived parameters.

8. Sample Size for the Training Set

The provided text does not mention a training set because the PSLT is a software option for a laser surgical instrument, simplifying treatment delivery. It's not a machine learning model that requires a distinct training and test set in the traditional sense of AI diagnostics. The software capabilities were validated through a clinical performance study.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for an AI/ML model, the establishment of ground truth for a training set is not applicable here. The software's functionality was validated through engineering verification and validation, as well as the clinical study described.

Summary

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November 27, 2017

Topcon Medical Laser Systems, Inc. Sweta Srivastava Manager, Regulatory and Clinical Affairs 606 Enterprise Ct. Livermore, CA 94550

Re: K171488

Trade/Device Name: PSLT for PASCAL Streamline Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF, GEX Dated: October 11, 2017 Received: October 16, 2017

Dear Sweta Srivastava:

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 (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,

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) K171488

Device Name PSLT for PASCAL Streamline

Indications for Use (Describe)

Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Streamline for procedures in trabeculoplasty in open angle glaucoma.

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

PSLT for PASCAL Streamline

1. Submission Sponsor

Topcon Medical Laser Systems, Inc.
606 Enterprise Ct.,
Livermore,
CA, 94550
USA

Contact:	Sweta Srivastava
Title:	Manager, Regulatory and Clinical Affairs
Phone:	925.245.7721

Date Prepared
November 27, 2017

3. Device Identification

Trade/Proprietary Name:	PSLT for PASCAL Streamline
Common/Usual Name:	Laser surgical instrument
Classification Name:	Ophthalmic laser/ Powered laser surgical instrument
Regulation Number:	886.4390
Product Code:	HQF, Ophthalmic laser

Device Class: Class II

Classification Panel: Ophthalmic and General & Plastic Surgery

4. Legally Marketed Predicate Device(s)

Predicate Device: K100019, PASCAL® Streamline Classification Name: Ophthalmic laser

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Regulation Number: 886.4390 Product Code: HQF Classification: Class II

Predicate Device: K111108, PASCAL Streamline 577 (with accessories) Classification Name: Ophthalmic laser Regulation Number: 886.4390 Product Code: HQF Classification: Class II

Reference Device #1: K081704, Selecta Family of Laser Systems Classification Name: Powered Laser Surgical Instrument Regulation Number: 886.4810 Product Code: GEX, HQF Classification: Class II

Reference Device #2: K071687, IRIDEX IQ Laser Systems Classification Name: Powered Laser Surgical Instrument Regulation Number: 886.4810 Product Code: GEX Classification: Class II

5. Indication for Use Statement

Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Streamline for procedures in trabeculoplasty in open angle glaucoma.

6. Device Description

7. Substantial Equivalence Discussion

The PASCAL Streamline with PSLT option has similar performance characteristics, the same environment of use and patient populations as currently marketed predicate devices. The labeling and instructional information, including warning and caution statements, is similar to that of the predicate devices. The

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addition of this new feature does not raise new questions of safety and effectiveness for the PASCAL Streamline.

Manufacturer	TopCon Medical LaserSystems, Inc.	TopCon Medical LaserSystems, Inc.	Device Comparison
Trade Name	PASCAL Streamline PSLT	PASCAL Streamline
510(k) Number	K171488	K100019	--
Product Code	HQF	HQF	--
RegulationNumber	886.4390	886.4390	--
Regulation Name	Ophthalmic laser	Ophthalmic laser	--
Indications for Use	Intended for use withPASCAL Streamline forprocedures intrabeculoplasty in openangle glaucoma.	Intended for use in thetreatment of ocularpathology in the posteriorsegment. Retinalphotocoagulation,panretinalphotocoagulation, focalphotocoagulation and gridphotocoagulation forvascular and structuralabnormalities of theretina and choroidincluding:Proliferative andnonproliferativediabeticretinopathy Macular edema Choroidal	Different; the subjectdevice has differentindications for use, sameintended use. Theexpanded indications foruse was tested in a clinicalstudy.
Manufacturer	TopCon Medical LaserSystems, Inc.	TopCon Medical LaserSystems, Inc.	Device Comparison
Trade Name	PASCAL Streamline PSLT	PASCAL Streamline
		neovascularization Branch and central retinal vein occulusion Age-related macular degeneration Lattice degeneration Retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: Iridotomy trabeculoplasty
OutputWavelength (nm)	532 (green)	532 (green)	Same
Treatment LaserSources	Frequency doubled solid-state	Frequency doubled solid-state	Same
Treatment LaserPower	Up to 2W	Up to 2W	Same
Aiming Beam λ(power output)	635 nm; Direct diode(adjustable to < 1mW)	635 nm; Direct diode(adjustable to < 1mW)	Same
Type of deliverysystem	Slit lamp adapter withoptical fiber connected toa separate laser source	Slit lamp adapter withoptical fiber connected toa separate laser source	Same
Endpoint	Non-visible	Non-visible	Same
Spot size (μm)	100	50 - 400	Similar; The proposeddevice is different in SpotSize from the predicate,the proposed devices'pulse duration range is
Manufacturer	TopCon Medical LaserSystems, Inc.	TopCon Medical LaserSystems, Inc.	Device Comparison
Trade Name	PASCAL Streamline PSLT	PASCAL Streamline
			cover the predicates' andboth proposed device andpredicate has sameFluence, therefore, thisdifference will not affectthe substantialequivalence.
Pulse Duration	5 ms – 10 ms	10 ms – 1000 ms	Similar; less pulseduration, both have sameFluence, therefore, thisdifference will not affectthe substantialequivalence.
Number of spotsper pattern	39 spots (3 rows of 13spots)	Single spot	Different; total number ofspots more than predicatedevice, both have sameFluence, therefore, thisdifference will not affectthe substantialequivalence.
Total energydelivered	3.5J	3.5J	Same
Energy per pulse	3.3 mJ	3.3 mJ	Same
Fluence	42 J/cm²	42 J/cm²	Same
% of TM covered	63	63	Same

Table A – Comparison of Characteristics

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Table B – Comparison of Characteristics

Manufacturer	TopCon Medical LaserSystems, Inc.	TopCon Medical LaserSystems, Inc.	Device Comparison	Manufacturer	TopCon Medical LaserSystems, Inc.	TopCon Medical LaserSystems, Inc.
Trade Name	PASCAL Streamline PSLT	PASCAL Streamline 577		Trade Name	PASCAL Streamline PSLT	PASCAL Streamline 577
510(k) Number	K171488	K111108	--
Product Code	HQF, GEX	HQF	--
RegulationNumber	878.4810 and 886.4390	886.4390	--
Regulation Name	Powered Laser SurgicalInstrument andOphthalmic laser	Ophthalmic laser	--
Indications for Use	Intended for use withPASCAL Streamline forprocedures intrabeculopasty in openangle glaucoma.	Intended for use in thetreatment of ocularpathology in the posteriorsegment. Retinalphotocoagulation,panretinalphotocoagulation, focalphotocoagulation and gridphotocoagulation forvascular and structuralabnormalities of theretina and choroidincluding:• Proliferative andnonproliferativediabeticretinopathy• Macular edema• Choroidal neovascularization• Branch andcentral retinalvein occlusion• Age-relatedmaculardegeneration	Different; the subjectdevice has differentindications for use, sameintended use. Theexpanded indications foruse was tested in a clinicalstudy.

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Manufacturer	TopCon Medical LaserSystems, Inc.	TopCon Medical LaserSystems, Inc.	Device Comparison
Trade Name	PASCAL Streamline PSLT	PASCAL Streamline 577
		●Latticedegeneration●Retinal tears anddetachmentsIntended for use in thetreatment of ocularpathology in the anteriorsegment including:●Iridotomytrabeculoplasty●
OutputWavelength (nm)	577	577 (yellow)	Same
Treatment LaserSources	Frequency doubled solid-state	Frequency doubled solid-state	Same
Treatment LaserPower	Up to 2W	Up to 2W	Same
Aiming Beam λ(power output)	635 nm; Direct diode(adjustable to < 1mW)	635 nm; Direct diode(adjustable to < 1mW)	Same
Type of deliverysystem	Slit lamp adapter withoptical fiber connected toa separate laser source	Slit lamp adapter withoptical fiber connected toa separate laser source	Same
Endpoint	Non-visible	Non-visible	Same
Spot size (µm)	100	60 - 400	Similar; The proposeddevice is different in SpotSize from the predicate,the proposed devices'pulse duration range iscover the predicates' andboth proposed device andpredicate has sameFluence, therefore, thisdifference will not affectthe substantialequivalence.
Manufacturer	TopCon Medical LaserSystems, Inc.	TopCon Medical LaserSystems, Inc.	Device Comparison
Trade Name	PASCAL Streamline PSLT	PASCAL Streamline 577
Pulse Duration	5 ms – 10 ms	5 ms – 1000 ms	Similar; less pulseduration, both have sameFluence, therefore, thisdifference will not affectthe substantialequivalence.
Number of spotsper pattern	39 spots (3 rows of 13spots)	Single spot	Different; total number ofspots more than predicatedevice, both have sameFluence, therefore, thisdifference will not affectthe substantialequivalence.
Total energydelivered	3.5J	3.5J	Same
Energy per pulse	3.3 mJ	3.3 mJ	Same
Fluence	42 J/cm²	42 J/cm²	Same
% of TM covered	63	63	Same

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8. Non-Clinical Performance Data

Software verification and validation testing was performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (2005). The results of all verification and validation testing demonstrate that all design and system requirements for the PASCAL Streamline with PSLT option have been met.

9. Clinical Performance Data

A clinical study was conducted to evaluate safety and efficacy of the PSLT for PASCAL Streamline to for procedures in trabeculoplasty in patients with open angle glaucoma. The study was a prospective, randomized, controlled study of patients with open angle glaucoma that required bilateral laser trabeculoplasty for intraocular pressure control. The overall design of the clinical study is shown as follows:

. Clinical Endpoints - (primary endpoint) change in IOP from baseline to 1-month post-surgery as measured by tonometry and (secondary endpoint) success at 1-month post-surgery as measured by tonometry and CLS derived parameters.

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. Subject Criteria – The target population includes subjects fulfilling the standard criteria of the investigational site, who have given informed consent to participate in the study.
. Subject Inclusion/Exclusion – Inclusion - diagnosis of open angle glaucoma (OAG) including pseudo-exfoliative and pigmentary glaucoma; patients requiring bilateral laser trabeculoplasty for IOP control; structural glaucomatous damage and/or documented glaucomatous VF damage (in the previous 12 months with mean defect (MD) > 2.5 dB; no or stable anti-glaucomatous drug therapy since at least 3 months. Exclusion – refractory glaucoma, patients having undergone ocular laser procedures (SLT, LPI) or intraocular surgery for the treatment of glaucoma; corneal or conjunctival abnormality precluding contact lens adaptation; or severe dry eve syndrome.
Study Monitoring - primary endpoints were evaluated at the 1, 3, 6, and 12-month endpoint
Data Analysis – the modified intent to treat was used in the analysis to the data. Data were analyzed statistically using a 2-tailed unpaired t test, chi-square test, Mann-Whitney U test, repeated-measures analysis of variance. Kaplan-Meier survival analysis with Mantel-Cox logrank test was used to compare outcomes between groups. The sample size of 58 eyes was calculated to have sufficient power (at least 80% and two-sided alpha of 0.05) to detect to reject the null hypothesis of an inter-group IOP difference of 3 mmHg with a standard deviation of 3.5 mmHg at 1 month. The chief outcome measure was absolute change in IOP from baseline.

Results of the clinical investigation support the indications for use of the PSLT for PASCAL Streamline to for procedures in trabeculoplasty in patients with open angle glaucoma by achieving clinical endpoints. Both laser modalities had similar safety and efficacy profiles. Clinical study conclusion confirms that the device is safe and effective as used according to the instructions for use.

10. Conclusion

The PSLT for PASCAL Streamline has similar intended use and technological characteristics as the predicate device, and therefore, is substantially equivalent to the predicate device. Preclinical and clinical study results demonstrate the substantial equivalence as well as the safety and effectiveness of the PSLT for PASCAL Streamline laser for use in trabeculoplasty. Additionally, the new device does not raise additional questions regarding its safety and effectiveness when compared to the predicate device(s).

The PSLT for PASCAL Streamline, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).

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.