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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 Novus Varia Ophthalmic Laser and Delivery Devices is intended for use in the treatment of ocular pathology. The Lumenis Varia is indicated for use in photocoagulation of both anterior and posterior segments including:

• Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
  • proliferative and nonproliferative diabetic retinopathy;
  • choroidal neovascularization;
  • branch retinal vein occlusion;
  • age-related macular degeneration
  • retinal tears and detachments
  • retinopathy of prematurity
• Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments: diabetic retinopathy (panretinal photocoagulation); retinopexy; segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; and, pediatric retinal repairs (under general anesthesia)

The Acculite Endoprobe is indicated for use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery, including panretinal photocoagulation, retinopexy, and treatment of neovascularization.

The Novus Varia Laser System is an air cooled, diode-pumped, solid state, Nd: Y AG, threecolor laser system (green, yellow and red) intended for use in the treatment of ocular pathology. A red diode laser provides a visible aiming beam. The Novus Varia system is comprised of the following functional components: a laser console; control and display panel; system microprocessor control electronics; two fiber ports for delivery systems; eye safety filter port; a covered footswitch; operating software; an optional remote control unit; an optional printer; delivery devices with accessories

Compatible delivery devices include: the LaserLink Z and LaserLink Z-1000 Slit Lamp Delivery Adapters; the Laser Indirect Ophthalmoscope (Heine and Keeler models) and the Acculite Endophotocoagulation Probe Delivery System.

The provided document is a 510(k) Summary Statement for the Novus® Varia™ Ophthalmic Laser and Delivery Devices. It focuses on establishing substantial equivalence to previously cleared predicate devices, rather than detailing a study with specific acceptance criteria and performance results for the Novus® Varia™ itself.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth cannot be extracted directly from this document.

Here's an analysis based on the information available:

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

This information is not provided in the document. The submission is a 510(k) for substantial equivalence, meaning it argues that the new device is as safe and effective as predicate devices based on similar technological characteristics and intended use, rather than presenting a de novo performance study against specific acceptance criteria.

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

This information is not provided as no specific "test set" for a performance study is described. The document relies on comparison to predicate devices, not on new clinical data or a specific test set.

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)

This information is not provided. Ground truth established by experts is typically relevant for studies evaluating diagnostic accuracy or image interpretation, which is not the focus of this 510(k) summary for a laser surgical instrument.

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

This information is not provided. As no specific test set or performance study is described, adjudication methods are not applicable.

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

An MRMC comparative effectiveness study is not mentioned or indicated. This document concerns a laser surgical device, not an AI-powered diagnostic or assistive tool for human readers.

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

A standalone performance study of an algorithm is not mentioned or indicated. The device is a laser surgical instrument, and the 510(k) submission doesn't describe any algorithmic components that would require such a study.

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

This information is not provided. Since no specific performance study is detailed, the type of ground truth used is not relevant to this submission. The 510(k) relies on the established safety and effectiveness of predicate devices.

8. The sample size for the training set

This information is not provided. As there's no mention of an AI algorithm or a training set for machine learning, this detail is not applicable.

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

This information is not provided. Similar to point 8, this is not applicable to the content of this 510(k) summary.

Summary of available information regarding performance:

• Rationale for Substantial Equivalence (Section VI): The Novus Varia Ophthalmic Laser with Delivery Devices and Accessories share the "same intended use, indications for use and the same or similar technological characteristics (including treatment wavelengths, laser active medium, pumping system, aiming beam, mode of operation, exposure duration, power, treatment intervals, spot sizes, controls and displays, laser energy delivery control (footswitch), and delivery systems)" as the predicate devices.
• Performance Data (Section VII):
  • "System and software hazard analysis information and software verification and validation information was submitted in conjunction with this Premarket Notification submission." (Details of these analyses are not included in the provided summary.)
  • "The determination of substantial equivalence was based upon the comparison of the technical characteristics between the Novus Varia Ophthalmic Laser with Delivery Devices and the predicate laser systems."

In essence, the document states that the device meets criteria for substantial equivalence due to its similarity in design and intended use to existing, legally marketed devices. It does not provide data from a specific performance study against defined acceptance criteria for the Novus® Varia™ itself, but rather implies that its performance is presumed adequate because it is substantially equivalent to predicates that have already demonstrated safety and effectiveness.

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