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

Pattern Scanning Laser Trabeculoplasty (PSLT) is a software option for the currently marketed PASCAL Streamline (K171488). 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. 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.

The manufacturer, Topcon Medical Laser Systems, Inc., has leveraged a previous clinical study (K171488) conducted on the predicate device, PSLT for PASCAL Streamline, to support the substantial equivalence of the new devices, PSLT with PASCAL Synthesis and PSLT with PASCAL Synthesis TwinStar. This submission does not present a new study with specific acceptance criteria for a new AI/software algorithm performance assessment, but rather asserts that the performance of the new devices is similar to the predicate based on hardware similarities and shared software.

Therefore, many of the requested details about acceptance criteria and a new study proving the device meets those criteria are not explicitly provided or applicable in the context of this 510(k) summary, as it relies on equivalence to a previously cleared device. The summary emphasizes that the PSLT software feature's specifications and performance remain unchanged, and the laser modalities have similar safety and efficacy profiles.

However, I can extract information related to the previous clinical study for the predicate device (K171488), which serves as the basis for the current device's claimed safety and effectiveness.

Here's a breakdown of the requested information based on the provided text, indicating where information is not present or not directly applicable to a new performance study for the current submission:

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

• Acceptance Criteria: The K171488 study defined clinical endpoints as its primary and secondary measures of success.
  • Primary Endpoint: Change in Intraocular Pressure (IOP) from baseline to 1-month post-surgery, as measured by tonometry.
  • Secondary Endpoint: Success at 1-month post-surgery as measured by tonometry and CLS (likely "clinical") derived parameters.
• Reported Device Performance:
  • The document states: "Results of the clinical investigation support the indications for use of the PSLT with PASCAL Streamline for procedures in trabeculoplasty in patients with open angle glaucoma by achieving clinical endpoints. Therefore, the clinical study confirms that the device is safe and effective as used according to the instructions for use."
  • Specific numerical results or thresholds for "achieving clinical endpoints" are NOT provided in this summary. For example, it doesn't state "IOP reduction of X mmHg was considered successful" or list the average IOP reduction observed.

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: A sample size of 58 eyes was used.
• Data Provenance: The study was a "prospective, randomized, controlled study." The country of origin of the data is not specified in the provided text.

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

• This is not applicable to this study. The ground truth for this clinical study was based on physiological measurements (IOP, clinical parameters) and diagnosis of open angle glaucoma, not expert interpretation of images or other data requiring multiple readers for adjudication.

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

• This is not applicable as the ground truth was based on objective physiological measurements and predefined diagnostic criteria, not subjective interpretations requiring adjudication.

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 study was NOT done. This was a clinical effectiveness study assessing a laser treatment device, not an AI assistance tool for human readers.

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

• This is not applicable. The PSLT is a software option that guides a laser treatment. Its "performance" is in guiding the laser to achieve a clinical outcome in a patient, not in making a diagnostic prediction independently. The clinical study evaluated the device (laser with PSLT software) as a whole, not just the software in isolation.

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

• The ground truth was based on clinical outcomes data (change in Intraocular Pressure (IOP) and success measured by tonometry and CLS derived parameters) in patients with a diagnosis of open angle glaucoma.

8. The sample size for the training set

• This information is not provided and is likely not applicable in the context of this 510(k) submission which relies on clinical equivalence rather than a new machine learning algorithm that requires a distinct training and test set. The PSLT software applies "a fixed pattern of locations" - suggesting a rule-based or predefined algorithm rather than one that "learns" from a training set in the typical machine learning sense.

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

• This is not applicable for the reasons stated in point 8.

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

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.

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

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.

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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.

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.

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.

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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.

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.

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.

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The PASCAL® Laser Indirect Ophthalmoscope is intended for use with the PASCAL Streamline 577 laser or the PASCAL Streamline 532 laser when either of those lasers is used in the treatment of ocular pathology in the posterior segment; retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

532nm

• . macular edema
• age-related macular degeneration .
• . lattice degeneration
• . retinal tears and detachments

577nm

• proliferative and nonproliferative diabetic retinopathy .
• macular edema .
• choroidal neovascularization .
• . branch and central retinal vein occlusion
• . age-related macular degeneration
• . lattice degeneration
• retinal tears and detachments .
• retinopathy of prematurity .

Intended for use in the treatment of ocular pathology in the anterior segment including:

577nm

• iridotomv .
• trabeculoplasty .

The PASCAL Laser Indirect Ophthalmoscope (LIO) with eye safety filter is a non-sterile, multiple use, delivery device that is worn on the physician's head and is used in conjunction with a compatible hand held ophthalmoscopic examination lens to view and treat the patient's retina. LIOs are used to treat patients in a supine position or who could not otherwise be treated using a slit lamp delivery system.

This document is a 510(k) Pre-market Notification for a medical device called the PASCAL® Laser Indirect Ophthalmoscope. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the typical sense for AI/software devices.

Therefore, many of the requested sections regarding acceptance criteria and performance against those criteria, especially those pertaining to AI/software performance assessment like MRMC studies, standalone performance, and ground truth establishment, are not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in this 510(k) is framed around substantial equivalence to predicate devices rather than quantitative performance metrics for a novel functionality. The primary acceptance criteria for a 510(k) submission are that the new device has the same intended use and technological characteristics as a legally marketed device (predicate device) and does not raise new questions of safety and effectiveness.

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PASCAL® Streamline 577 (with Accessories) 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 structural abnormalities of the retina and choroid including:

• proliferative and nonproliferative diabetic retinopathy
• 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
• retinopathy of prematurity

Intended for use in the treatment of ocular pathology in the anterior segment including:

• iridotomy
• trabeculoplasty

The PASCAL® Streamline 577 (with Accessories) is an Optically Pumped Semiconductor Laser (OPSL: solid state) with integrated slit lamp that is intended for use in ophthalmic applications. The PASCAL® Streamline 577 system delivers 577 nm laser light (yellow) at a spot size range of 60 - 400 micrometers (um) to the focal plane of the slit lamp. The integrated slit lamp allows the physician (using a physician selected lens) to deliver the laser light to the treatment site. The treatment laser delivers single pulses or a scanned pattern of 100 to 2000 milliwatts (mW) per pulse duration of approximately 5 - 1000 milliseconds (ms) per pulse. A diode laser (635 nm) provides a visible aiming beam.

Laser light is delivered to the treatment site via the integrated slit lamp or via an optional Laser Indirect Ophthalmoscope (LIO) 577 with eye safety filter for ophthalmic indications.

The physician is able to control the delivery of laser energy using a footswitch.

The PASCAL® Streamline 577 (with Accessories) is comprised of the following functional components:

• Slit Lamp Table with integrated 577 nm laser system:
• 577 nm Laser system control electronics and power supply;
• Control Panel with LCD (liquid crystal display) Touchscreen;
• Keyswitch:
• Emergency Laser Stop Button;
• Footswitch;
• Door Interlock Plug;
• Power cable [4.6 m (15 ft.) long]
• Connector Ports for the table lift power connector, the table lift up/down control connector, the door interlock connector, the footswitch connector, and a USB connector for an optional printer.
• a Rolling base with lockable wheels.
• Printer (optional).
• Slit Lamp with integrated scanning pattern generator (and laser eye safety filter).

Accessories (Optional)

• Laser Indirect Ophthalmoscope (LIO) 577 with eye safety filter.
• Video Teaching System (VTS).
• Physician Elbow Rest.

The provided text does not contain acceptance criteria for a device, nor does it describe a study proving the device meets acceptance criteria in the way typically associated with algorithmic performance (e.g., sensitivity, specificity, AUC).

Instead, this document is a 510(k) Summary for a medical device (PASCAL® Streamline 577), which focuses on demonstrating substantial equivalence to existing predicate devices already on the market. The "study" referenced implicitly in this context is the comparison between the new device's technical characteristics and the predicate devices, rather than a clinical trial or performance evaluation against specific metrics like accuracy or error rates.

Here's how to interpret the provided information within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of "acceptance criteria" for performance metrics like sensitivity or specificity. Instead, the document provides a table comparing the technical characteristics of the new device (PASCAL Streamline 577) to its predicate devices. The "acceptance criteria" here are implicitly that the new device's technical specifications are similar enough to the legally marketed predicate devices to establish substantial equivalence.

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Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

• proliferative and nonproliferative diabetic retinopathy .
• macular edema ●
• choroidal neovascularization ●
• branch and central retinal vein occlusion .
• age-related macular degeneration .
• lattice degeneration .
• retinal tears and detachments .
• iridotomy, iridectomy and trabeculoplasty in angle closure and open angle . glaucoma.

The PASCAL Streamline Photocoagulator is an integrated system comprising of solid state aiming and treatment lasers, control electronics, graphical user interface, slit lamp and table. It is intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

{
"1. A table of acceptance criteria and the reported device performance": "The provided text does not contain specific acceptance criteria or detailed device performance metrics in a tabular format. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with quantified performance measures against pre-defined criteria.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document states that "All necessary bench testing was conducted" but does not specify sample sizes for any test set or provide details on data provenance (country of origin, retrospective/prospective nature). The focus is on bench testing to show substantial equivalence, not clinical study data.",
"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)": "No information about experts, ground truth establishment, or their qualifications is provided in the document. This is likely due to the nature of the submission being for a medical device (laser system) where substantial equivalence is primarily based on technical specifications and safety rather than a diagnostic algorithm's performance against human experts.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "No information regarding an adjudication method is present, as there is no mention of a test set requiring such a process.",
"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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device is a photocoagulator, a treatment laser, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this device.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The device described is a photocoagulator (a laser instrument) and not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "There is no mention of ground truth in the context of diagnostic accuracy, as the device is a treatment laser. The testing described is bench testing to determine substantial equivalence based on function, intended use, and performance relative to a predicate device, not diagnostic accuracy against a ground truth standard.",
"8. The sample size for the training set": "The document does not refer to a 'training set', as the submission is for a medical device (laser system) and not an AI/ML algorithm requiring a training phase.",
"9. How the ground truth for the training set was established": "Not applicable, as there is no training set mentioned or a requirement for ground truth establishment for a training set in this context."
}

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The Pascal Photocoagulator indications for use are the following:

Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

• proliferative and nonproliferative diabetic retinopathy
• macular edema
• choroidal neovascularization
• branch and central retinal vein occlusion
• age-related macular degeneration
• lattice degeneration
• retinal tears and detachments
• Iridotomy, iridectomy and trabeculoplasty in angle closure and open angle glaucoma.

The Pascal laser photocoagulator is an integrated system comprising solid state aiming and treatment lasers, control electronics, graphical user interface, slit-lamp, and table. It is intended for use in the treatment of ocular pathology.

This document describes a 510(k) premarket notification for the Pascal™ Photocoagulator. A 510(k) submission seeks to demonstrate "substantial equivalence" to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth for a study proving device performance is not applicable in this context.

Here's a breakdown of the available information:

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

• Not Applicable. This 510(k) submission does not establish or report against specific performance acceptance criteria from a clinical trial in the way a PMA submission might. Instead, it seeks to demonstrate substantial equivalence to previously cleared predicate devices. The "performance" demonstrated is that the device has "the same or similar technological characteristics" as the predicate devices.

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

• Not Applicable. No clinical "test set" and corresponding sample size are mentioned for proving specific performance criteria of the Pascal™ Photocoagulator in this document. The submission relies on non-clinical tests and comparison to predicates.

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. No ground truth establishment by experts for a clinical study is described in this document.

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

• Not Applicable. No adjudication method for a clinical test set 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

• Not Applicable. The Pascal™ Photocoagulator is a laser surgical instrument, not an AI-assisted diagnostic or assistive device that would typically involve a multi-reader multi-case study for human reader improvement.

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

• Not Applicable. This is a medical device (laser photocoagulator) and not an AI algorithm. Therefore, a "standalone algorithm performance" study is not relevant.

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

• Not Applicable. As no clinical study to prove novel performance criteria is detailed, no specific ground truth for such a study is mentioned. The "truth" in a 510(k) context is that the device is substantially equivalent to legally marketed predicate devices, based on technological characteristics and intended use.

8. The sample size for the training set

• Not Applicable. This document does not describe a machine learning algorithm or a "training set."

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

• Not Applicable. Not applicable as there is no training set mentioned.

Summary of what is available from the document:

• Device Name: Pascal™ Photocoagulator
• Intended Use: Treatment of ocular pathology in both the posterior and anterior segments (detailed list provided).
• Basis for Clearance: Substantial equivalence to predicate devices (Lumenis Novus Varia, Laserex LP1 532, Iridex Oculight SL/SLx, Iridex Medical Oculight GL, Infinitech Slit Lamp Laser Adapter).
• Technological Characteristics Compared: Treatment wavelengths, laser active medium, pumping system, aiming beam, mode of operation, exposure duration, power, treatment intervals, spot size, semi-automatic repeat mode, controls and displays, laser energy delivery control (foot switch), and slit lamp delivery.
• Nonclinical Tests: Performance test results, system and software hazard analysis information, and system and software verification and validation information were submitted. These are non-clinical and relate to safety and basic functional performance, not clinical efficacy or specific acceptance criteria met in a patient study.

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