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The VICTUS Femtosecond Laser Platform is indicated for use for:
· the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
• for anterior capsulotomy during cataract surgery.
· the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.
· laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

The VICTUS Femtosecond Laser is a precision ophthalmic surgical laser indicated for use in patients undergoing ophthalmic surgery in the anterior segment of the eye. The VICTUS Femtosecond Laser system produces scanned patterns designed to create flaps, produce corneal incisions, arcuate incisions, capsulotomy cuts, and crystalline lens fragmentation patterns for use in cataract surgery. The patient is treated while supine on a patient bed that the physician can position electromechanically via simple controls. The physician controls the VICTUS laser system itself through a touchscreen display and other user controls. Laser emission and of PI suction vacuum are actuated by the physician using separate footswitch pedals.

The mode of operation for the VICTUS Platform is using Yb:KYW Femtosecond laser to produce Laser-Induced Optical Breakdown (LIOB) of the corneal tissue. Scanned patterns of laser pulses from the VICTUS are delivered through a sterile, disposable Patient Interface (PI). The PI consists of two components: (i) a contacting lens, and (ii) a suction clip. Together, the suction clip and contacting lens connect to make a single assembly during a VICTUS procedure. The surface of the contacting lens that contacts the eye is spherically curved to match the curvature of the human eye. The suction clip assembly gently immobilizes the eye with respect to the VICTUS laser beam and optical visualization systems. The PI contacting lens and suction clip together allow for proper optical coupling of the laser and optical paths into the patient's eye and create a precise opto-mechanical reference surface for depth control of the scanning laser beam.

The provided text focuses on the 510(k) premarket notification for the VICTUS Femtosecond Laser Platform, specifically regarding modifications to its Patient Interface. It primarily discusses the technological comparison and non-clinical performance data to establish substantial equivalence to a previously cleared device. Therefore, the information regarding in-depth acceptance criteria and a standard study that proves the device meets those criteria (especially in the context of AI/ML performance) is not available in the provided document.

However, based on the non-clinical performance data section, we can infer some aspects related to acceptance criteria and the study performed, even though it's not presented in a typical AI/ML study format.

Here's an attempt to structure the answer based on the available information, noting where specific details are absent:

Acceptance Criteria and Study for VICTUS Femtosecond Laser Platform (Modified Patient Interface)

This submission describes changes to the Patient Interface (PI) of the VICTUS Femtosecond Laser Platform. The study's primary goal was to demonstrate that these modifications do not negatively impact the device's performance compared to the previously cleared version, thus establishing substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each non-clinical test. The document mentions "All bench testing results" without detailing the number of tests performed or the quantities of PI kits/cuts analyzed for each criterion (fidelity, quality, docking behavior).
• Data Provenance: The studies are described as "Non-Clinical Performance Data" and "bench testing." This implies internal laboratory studies conducted by the manufacturer (Technolas Perfect Vision GmbH). The country of origin is not specified but is likely within the company's operational regions (e.g., Munich, Germany or San Francisco, CA where the contact person is located). It is retrospective in the sense that it evaluates a modified component against an existing, cleared component.

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

• Not Applicable / Not Mentioned: This type of information (number of experts, qualifications) is typically relevant for studies involving human interpretation or clinical endpoints, especially in AI/ML performance evaluation. The presented data is from bench testing, where "ground truth" would be established by objective measurements (e.g., precise measurements of cut parameters, biocompatibility assay results). Experts would be involved in interpreting the objective data, but not in establishing a subjective "ground truth" in the way radiologists might for medical images.

4. Adjudication Method for the Test Set

• Not Applicable / Not Mentioned: Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies among multiple human readers. This was a non-clinical bench testing study comparing device performance metrics, not human expert assessments.

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: No MRMC or human-in-the-loop study was done. This notification is for a hardware modification (Patient Interface) of a laser platform, not an AI/ML algorithm requiring human reader performance evaluation. The document explicitly states: "There was no clinical study performed to support substantial equivalence of this premarket notification." Additionally, "No new software testing was performed to support this premarket notification."

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

• No: This is not an AI/ML algorithm. The performance evaluation focuses on the mechanical and optical characteristics of a physical device component (Patient Interface).

7. The Type of Ground Truth Used

• The ground truth for the non-clinical performance data appears to be objective measurements and laboratory assays comparing the modified Patient Interface (PI) to the predicate PI. This includes:
  • Quantitative measurements of cut pattern fidelity and quality (e.g., dimensions, regularity).
  • Biocompatibility assay results (pass/fail criteria per ISO standards).
  • Endotoxin concentration measurements.
  • Measurements related to docking behavior outcomes (IOP, suction integrity).

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI/ML device, so there is no "training set."

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

• Not Applicable: As there is no training set for an AI/ML algorithm involved, this question is not relevant.

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