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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.

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.

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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.

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

Not applicable. This is a hardware device submission demonstrating substantial equivalence, not a performance study on a test set of data. There is no "test set" of patient data in the context of evaluating an algorithm.

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

Not applicable. There is no test set or ground truth established by experts for algorithmic performance in this submission.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication method described for an algorithm.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (a laser indirect ophthalmoscope), not an AI/software algorithm intended to aid human readers in diagnostic tasks.

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

No, a standalone algorithm performance study was not done. This device is a delivery system for laser treatment, used by a physician (human-in-the-loop is inherent in its intended use), and does not involve AI or algorithms running independently.

7. The Type of Ground Truth Used

Not applicable. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for evaluating diagnostic or predictive algorithms. This submission is for a laser delivery device, where the "ground truth" relates to its physical and functional specifications meeting pre-defined engineering and safety standards, and its equivalence to devices already on the market.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an algorithm for this device.

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

Not applicable. There is no training set or ground truth for algorithmic development in this submission.

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