The LP1532 is a compact, solid state laser photocoagulator intended for ophthalmic use. It produces laser energy intended to be directed into the eye by a suitably qualified physician, via a range of laser delivery accessories namely;

Laser Endoprobes .
Laser Indirect Ophthalmoscope .
Slitlamp Delivery Systems .
The LP1532 is a frequency doubled Nd:YAG Laser operating in the visible green wavelength spectrum ( 532 nanometers ).

AI/ML Overview

The provided text is a 510(k) summary for the Laserex Model LP1532, a solid-state laser photocoagulator. This documentation is for regulatory clearance and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way a traditional scientific study would.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance simply does not exist within this document.

The document primarily focuses on technical specifications, intended uses, and a comparison to predicate devices to establish substantial equivalence.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary doesn't define specific "acceptance criteria" for clinical performance in the way a clinical study would. Instead, its acceptance criteria for clearance are based on demonstrating substantial equivalence to predicate devices. The "performance" reported is primarily the device's technical specifications and a direct comparison to those of the predicate devices.

Characteristic Compared	Predicate Devices (Range/Typical)	Laserex LP1532 Performance	Acceptance Status (vs. Predicate)
Intended Uses	Range of ophthalmic treatments (Retinal Photocoagulation, Pan Retinal Photocoagulation, Endophotocoagulation, Photocoagulation for Macular Degeneration, Laser Trabeculoplasty)	Same intended uses as predicate devices.	Equivalent
Laser Power (W)	1.2W - 3W	Up to 2W	Falls within or near the range of predicates; considered equivalent for intended use.
Laser Wavelength (nm)	532nm	532nm	Equivalent
Laser Class	IV	IV	Equivalent
Exposure Time (sec)	0.01 - 3 sec (some and CW)	0.01 to 2.0 sec	Within the typical range of predicates.
Aiming Laser Type	HeNe, Red Diode	Red Diode	Similar to some predicates.
Aiming Laser Power	0 - 1 mW	0.05 to 0.95 mW	Within the range of predicates.
Aiming Wavelength	630 - 670 nm	635nm	Within the range of predicates.
Electrical Supply	Various AC configurations	100-250VAC, 50/60 Hz	Standard electrical specs, comparable.
Power Consumption	300W - 3KW	450W	Falls within the range of predicates, specifically more efficient than some (e.g., Alcon Ophthalas 532).
Weight	8.1Kg - 99 Kg	17 Kg	Falls within the range of predicates.
Size	Various dimensions	W 31cm, D 51cm, H 19cm	Falls within the range of predicates.
Cooling	Air cooled, Internal water cooling	Air cooled	Similar to some predicates (Iris Occulite, Alcon EyeLyte).
Scientific Concepts	Green laser source, Yag laser, Diode/Arclamp pumping, fiberoptic delivery	Green laser source, Diode pumped Yag, air cooling, software control, fiberoptic delivery	Similar underlying technology principles to predicate devices.
Accessories	Endo Probes, LIO, Slitlamp Adaptors, Operating Microscope Filters	Equivalent range of accessories available and adaptable to common clinical equipment.	Equivalent
Spot Size	50-1000 microns	50-500 microns	Within the range of predicates.

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

Sample Size: Not applicable. This document does not describe a clinical study with a test set of patients or medical images. It's a technical submission for regulatory clearance based on substantial equivalence.
Data Provenance: Not applicable for clinical performance data. The "data" provided is primarily technical specifications and comparative analysis against existing, legally marketed devices.

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

Number of Experts: Not applicable. No clinical ground truth establishment process is described in this document.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set or adjudication process is 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: No, this document does not mention or present any MRMC comparative effectiveness study. The device is a laser photocoagulator, not an AI-assisted diagnostic or therapeutic system that would typically be evaluated in such a study.

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

Standalone Performance: Not applicable. The device is a medical device (laser system) operated by a physician, not a standalone algorithm.

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

Ground Truth: Not applicable for clinical performance. The "ground truth" for the 510(k) submission is the established safety and effectiveness of its predicate devices. The new device demonstrates "substantial equivalence" to these predicates.

8. The Sample Size for the Training Set

Sample Size: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device being developed through data training.

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

Ground Truth Establishment: Not applicable. No training set is mentioned.

Summary of Device Evidence for Substantial Equivalence (from the document):

The primary "study" proving the device meets its "acceptance criteria" (i.e., substantial equivalence) is a comparison of its technical specifications and intended uses to those of legally marketed predicate devices.

"Study" Methodology: A table-based comparison (Sections 5.4 and 7) of the Laserex LP1532's characteristics (e.g., laser power, wavelength, accessories, physical dimensions, electrical requirements, scientific concepts) against four predicate devices: Alcon Ophthalas 532, Alcon EyeLite, Iris Occulite, and Nidek Prima.
Key Findings: The document asserts, "There are no significant changes or modifications from the predicate products that affect safety, effectiveness, or the intended use of the product." The detailed comparative tables support this by showing that the LP1532's specifications fall within the range or are similar to those of the predicate devices.
Biocompatibility and Sterilization: For patient-contacting components (endo probes), the submission relies on the 510(k) approvals of the supplier (Creative Medical Products, Inc.) for those specific probes (K954307, K954308).
Software Validation: The document notes that software validation and verification processes are ongoing but believes equivalence can be determined before completion, with a commitment from the CEO to complete these processes (Section 9). The level of concern for the software was identified as "Minor to Moderate."

This 510(k) summary provides evidence of technical and functional equivalence to existing devices, which is the basis for regulatory clearance in the absence of new safety or efficacy questions. It is not designed to present de novo clinical performance data in the format of a research study.

Summary

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OCT - 3 1997

510 (K) SUMMARY

K972514

This is a 510(K) Summary in accordance with CFR 807.92.

SUBMITTERS NAME, ADDRESS: 1.

Taracan Pty Ltd trading in the USA as Laserex Systems 258 Halifax Street Adelaide, South Australia 5000 AUSTRALIA

Corresponding Official: Keith R. Degenhardt Managing Director/CEO 61-8-82236644 Telephone: Facsimile: 61-8-82326277

Signature

Date: 616 97

2. DEVICE NAME

Laserex Model LP1532.

3. PREDICATE DEVICE IDENTIFICATION

3.1 Name(s)

The predicate devices are:

1. Alcon Ophthalas 532.
1. Alcon EyeLite
1. Iris Occulite
1. Nidek Prima

3.2 Predicate Device Company

1. Alcon Surgical Inc
1. Alcon Surgical Inc
1. Iridex Corporation Inc
1. Nidek Medical Inc

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INTENDED USES 4.

4.1 The intended uses for this product are;

Retinal Photocoagulation .
Pan Retinal Photocoagulation .
Endophotocoagulation. ●
Photocoagulation for Macular Degeneration .
. Laser Trabeculoplasty

4.2 A General Description of these Treatments are;

The intended uses for this product are:

Retinal treatments, including;

. Retinal Photocoagulation
Pan Retinal Photocoagulation .
Endophotocoagulation .

These treatments involve the destruction of neovascular complexes, to obliterate areas of microinfarction or capillary closure.

Retinal Photocoagulation will be carried out using principally the Slitlamp Delivery System accessory.

Pan Retinal Photocoagulation will be carried out using either of the Laser Indirect Ophthalmoscope or the Slitlamp Delivery System accessory.

Endophotocoagulation will be carried out using any one of the three variants of the endoprobe accessories, namely Straight, Curved or Aspirating Endooccular Probes.

Photocoagulation for Macular Degeneration involves the destruction of leaking vessels in the macular and paramacular region, and ultimately to produce a chorioretinal adhesion that will resist ongoing vitreoretinal traction. This treatment will be carried out using the slitlamp microscope mounted Slitlamp Delivery System accessory.

Laser Trabeculoplasty, the photocoagulation of the trabecular meshwork to create apertures and increase the flow of the aqueous humor in order to treat open-angle glaucoma. This treatment will be carried out using the slitlamp microscope mounted Slitlamp Delivery System accessory.

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DEVICE DESCRIPTION 5.

5.1 General

Laser Endoprobes .
Laser Indirect Ophthalmoscope .
Slitlamp Delivery Systems .

The LP1532 is a frequency doubled Nd:YAG Laser operating in the visible green wavelength spectrum ( 532 nanometers ).

5.2 Specifications

Size:

Width:	12" (310 mm)
Length:	20" (510 mm)
Height:	7.5" (190 mm)
Weight:	37 lbs (17 kg)

Power/Electrical Requirements:

Voltage:	110 or 220 VAC
Frequency:	50 or 60 Hz
Electrical power:	450 Watts
Insulation class:	Class 1 (UL 2601-1)

Laser Characteristics:

Treatment laser beam
Laser class:	Class IV (4)
Laser wavelength:	532 nm
Laser power:	30 mW min, 2 W max.

Aiming laser beam

Laser class: Class II (2) Laser wavelength: 635 nm Laser power: 0.05 to 0.95 mW

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Significant Changes/Modifications from Predicate Device 5.3

There are no significant changes or modifications from the predicate products that affect safety, effectiveness, or the intended use of the product.

5.4 Accessories

The following accessories are intended for use with the LP 1532 laser :

Laser Endo Probes. .
Slitlamp Delivery System. ●
. Laser Indirect Ophthalmoscope.

Additional information is provided in the table below

	510 (K)DEVICE	PREDICATE DEVICE
CHARACTERISTICCOMPARED	LASEREXLP-1532	ALCONOPHTHALAS532	IRIS	NIDEK	ALCONEyeLite
Accessories
Endo Probes	Straight,curved andaspirating	Straight,curved andaspirating	Straight andcurvedavailable	EndoProbesavailable	Straight,curved andaspirating
Laser IndirectOphthalmo-scope	AdaptedHeine	AdaptedKeeler Fison	AdaptedHeine	Nidek LIO	AdaptedKeeler Fison
Slitlamp Adaptors	To fit• Zeiss• HaagStreit	To fit• Zeiss• HaagStreit	To fit• Zeiss• HaagStreit	To fit• Zeiss• HaagStreit	To fit• Zeiss• HaagStreit
	Combo foruse withLaserex YAG	Combo foruse withLaserex YAG		Combo foruse withNIDEKYAGs
Spot Size	50-500microns	50-1000microns	75- 500microns
OperatingMicroscopeFilters	• Zeiss• OPMI-6• Wild• Möeller				• Zeiss• OPMI-6• Wild• Möeller

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DEVICE LABELS 6.

Refer to Appendix A for all device labelling information including;

. Advertising brochure
. Description and directions for use
Product labels (including accessories) .

COMPARATIVE INFORMATION 7.

The following table displays the similarities and differences of the new device to the legally marketed devices to which equivalency is claimed.

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	510(k)DEVICE	PREDICATE DEVICES
CharacteristicCompared	LASEREXLP-1532	ALCONOPHTHALAS532	IRISOCCULITE	NIDEKPRIMA	ALCONEyeLyte
Laser Power(W)	Up to 2W	Up to 3W	Up to 1.2W	1.5W	Up to 1.7W
LaserWavelength(nm)	532nm	532nm	532nm	532nm	532nm
Laser Class	IV	IV	IV	IV	IV
ExposureTime (sec)	0.01 to 2.0sec	0.01 to 2.0sec and CW	0.05 to 1.0sec	0.02 to 3 sec	0.01 to 2.0sec and CW
Aiming LaserType	Red Diode	HeNe	Red Diode	Red Diode	Red Diode
Aiming LaserPower	0.05 to 0.95mWcontinuouslyvariable	4 intensitiesselectable upto 1 mw	0 to1mW	0.2 to 0.8mW	Continuouslyvariable up to1 mw
AimingWavelength	635nm	633nm	set between630 - 650nm	633nm	670nm
ElectricalSupplyVoltage	100-120VAC220-250VACsingle phase50/60 Hz	220 VACsingle phase	90-240 VAC50/60 Hz	100/120/230 VAC50/60 Hz	100-120 VAC8 A singlephase220-240 VAC4 Asingle phase
ElectricalPowerConsumption	450W	3K W	300W	1500W	800 W
Weight	17Kg	99Kg	8.1Kg	32Kg	16Kg
Size	W 31cmD 51cmH 19cm	W 36cmD 81cmH 80cm	W.30cmD 15cmH 30cm	W 30cmD 42cmH 70cm	W 38.7cmD 44.6 cmH 21.8 cm
Environment
Temperature	15 - 35degrees C	15 - 30degrees C	not specified	5 - 35degrees C	15 - 35degrees C
Humidity	Up to 85%RH	Up to 85% RH	not specified	5 - 95% RHnoncondensing	Up to 85%RH

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RepeatIntervalDuration	Selectable0.1,0.2,0.3,0.5,0.6,0.7,0.8,0.9,1.0sec	Selectable0.2, 0.5, 0.7,0.9 sec	Selectable	0.2 to 1.0 secin to 0.1 secintervals	Selectable0.1, 0.2, 0.3,0.4, 0.5, 0.6,0.8, 0.9,1.0sec
Cooling	Air cooled	Internalwatercoolingsystem	Air cooled	Internal watercoolingsystem	Air cooled
Scientificconcepts thatform thebasis for thedevice	- Green laser source- Generated by meansof a laser diodepumped, frequencydoubled Yag laser.- Diode pumpingconfiguration veryefficient, permitting aircooling- Energy controlledby means of anoperator by means ofa software drivencontrol system- Energy delivered totarget tissue by arange of fiberopticbeam deliverysystems	- Green laser source- Generated by meansof an arclamp pumped,frequency doubled Yaglaser.- Arclamp pumpingconfiguration relativelyinefficient, requiringclosed loop watercooling- Energy controlled bymeans of an operatorby means of a softwaredriven control system- Energy delivered totarget tissue by a rangeof fiberoptic beamdelivery systems	- Green laser source- Generated bymeans of a laserdiode pumped,frequency doubledYag laser.- Diode pumpingconfiguration veryefficient, permittingair cooling- Energy controlledby means of anoperator by means ofa software drivencontrol system- Energy delivered totarget tissue by arange of fiberopticbeam deliverysystems	- Green laser source- Generated by meansof an arclamppumped, frequencydoubled Yag laser.- Arclamp pumpingconfiguration relativelyinefficient, requiringclosed loop watercooling- Energy controlled bymeans of an operatorby means of asoftware driven controlsystem- Energy delivered totarget tissue by a rangeof fiberoptic beamdelivery systems	- Green laser source- Generated by meansof a laser diodepumped, frequencydoubled Yag laser.- Diode pumpingconfiguration veryefficient, permitting aircooling- Energy controlled bymeans of an operatorby means of asoftware driven controlsystem- Energy delivered totarget tissue by a rangeof fiberoptic beamdelivery systems
IntendedUses	RetinalphotocoagulationPanretinalphotocoagulation,Photocoagulation forMacular DegenerationTrabeculoplastyEndophotocoagulation	Panretinalphotocoagulation,Photocoagulation forMacular DegenerationSubretinalneovascularization,Trabeculoplasty,Pneumatic retinopexy,Retinal tears,Retinal detachments,Transscleralcyclophotocoagulation,Endophotocoagulation	Retinalphotocoagulation,Anterior segmentprocedures.	Retinalphotocoagulation,Subretinalneovascularization,Closing of retinalarteriols.	Panretinalphotocoagulation,Photocoagulation forMacular DegenerationSubretinalneovascularization,TrabeculoplastyPneumatic retinopexyRetinal tearsRetinal detachmentsEndophotocoagulation

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BIOCOMPATIBILITY AND STERILIZATION INFORMATION 8.

The laser endo probe accessories are the only components of the device that are patient contacting and supplied sterilized.

We are sourcing these probes from:

Creative Medical Products, Inc 5988 Mld Rivers Mail Drive Suite 236 St Charles MO 63304

Owner/Operator Registration No. 9023612 Establishment Registration No. 1933418

They have provided the following information to us regarding the 510(K) approvals for these probes;

FDA 510(K) approval number #K954307 applies to the straight and curved . probes.
. FDA 510(K) approval number # K954308 applies to the aspirating laser probes.

These are the only probes we will be supplying with the device. Additional information provided by Creative Medical Products Inc is contained in Appendix B.

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SOFTWARE VALIDATION & VERIFICATION 9.

In accordance with the Reviewer Guidance for Computer Controlled Medical Devices a review of the level of concern for the LP-1532 has been identified to be Minor to Moderate. Operation of the LP-1532 directly affects the patient such that failures or latent design flaws may result in Minor to Moderate patient injury.

The software development process has not yet been completed but we believe that an equivalence determination can be made prior to completion. The following data is provided in Appendix C. *

System and software requirements and design .
. Software development
. Verification and validation

I certify that in my capacity as Managing Director/CEO of Taracan Pty Ltd, I will ensure that the described processes will be completed and the following will be completed;

Test results and analysis
Software certification
Signed:__. The text is a signature.

Name: Keith R. Degenhardt Position: Managing Director Date:

Derived from 510(K) Memorandum # K91-1 Software Documentation Matrix.

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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of a human figure with three faces in profile, stacked on top of each other. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" printed around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 1997

Mr. Keith R. Degenhardt Managing Director Laserex Systems 258 Halifax Street Adelaide, South Australia 5000 AUSTRALIA

K972514 Re: Laserex LP1532 Photocoagulator Trade Name: Requlatory Class: II Product Code: HOF June 6, 1997 Dated: Received: July 7, 1997

Dear Mr. Degenhardt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Keith R. Degenhardt

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours

to colle

Witten, Ph.D., M.D. a M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K972514

vice Name: LASEREX LP1532 PHOTOCOAGULATOR

Indications For Use:

INDICATIONS FOR USE

The indication for use for this product are;

· Retinal Photocoagulation
· Pan Retinal Photocoagulation
· Photocoaqulation for Macular Degeneration · Laser Trabeculoplasty
· Endophotocoagulation.

A General Description of these Treatments are;

The indications for use for this product are: Retinal treatments, including;

Retinal Photocoaqulation .
. Pan Retinal Photocoaqulation
. Endophotocoagulation

These treatments involve the destruction of neovascular complexes, to obliterate areas of microinfarction or capillary closure.

Retinal Photocoagulation will be carried out using principally the Slittamp Delivery System accessory.

Pan Retinal Photocoagulation will be carried out using either of the Laser Indirect Ophthalmoscope or the Slitlamp Delivery System accessory.

Endophotocoagulation will be carried out using any one of the endoprobe accessories. namely Straight, Curved or Aspirating Endooccular Probes.

Photocoagulation for Macular Degeneration involves the destruction of leaking vessels in the macular and paramacular region, and ultimately to produce a chorioretinal adhesion that will resist ongoing vitreoretinal traction. This treatment will be carried out using the sittlamp microscope mounted Slittlamp Delivery System accessory.

Laser Trabeculoplasty, the photocoagulation of the trabecular meshwork to create apertures and increase the flow of the aqueous humor in order to treat open-angle glaucoma: This treatment will be carried out using the slitlamp microscope mounted Slitlamp Delivery System accessory.

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

Concurrence of CDRH, Office of Device Evaluation (

Acseffe

(Division Sign-On)
Division of General Restorative Devices
510(k) Number K972814

Prescription Use
(21 CFR 801.109)

Over-The-Counter 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.