Search Results

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 VICTUS Femtosecond Laser Platform is a precision ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea or for patients undergoing anterior capsulotomy during cataract surgery.

The VICTUS Femtosecond Laser Platform is an ophthalmic surgical femtosecond laser designed for cutting a precise corneal flap of pre-selected thickness and diameter. The system works by first being programmed with the depth and diameter at which the flap should be made. The surgeon then fixates the eye with a PMMA contact lens (referred to hereafter as the Patient Interface) that is connected to the laser via a vacuum tube. Flap thickness of 110 to 200 microns can be achieved in diameters of 6.0 to 9.5 mm.

In addition to the above, the VICTUS Femtosecond Laser Platform allows anterior capsular dissection which is achieved through precise individual micro-photodisruption of fissue, measuring a few microns in diameter, created by tightly focusing ultrashort laser pulses into the targeted capsular tissue. Pre-programmed patterns produce capsular resections of predetermined diameter and height. Capsular cut depth of 2245 to 5000 microns below the corneal surface can be achieved in diameters of 3 to 7 mm.

For both indications for use, laser pulses are delivered through a sterile disposable Patient Interface, consisting of a contact lens and suction clip to provide suction. The contact lens and suction clip assembly creates a reference surface for depth control and fix the eye relative to the delivery of the laser beam. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location.

The provided text describes the VICTUS Femtosecond Laser Platform and its performance data. However, it does not explicitly state "acceptance criteria" in a table format with corresponding performance metrics for all aspects of the device. Instead, it presents an overall conclusion about the device's performance compared to predicate devices and manual methods.

Here's an analysis of the acceptance criteria and study information that can be extracted or inferred from the provided text, along with where the requested information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Cannot Be Determined from Text:

• Explicit, quantifiably defined "acceptance criteria" for many of the qualitative performance descriptions (e.g., "highly accurate" or "good"). These are described as outcomes rather than pre-defined thresholds.

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

• Anterior Capsulotomy (Clinical Study):
  • Sample Size: 119 eyes of 118 subjects.
  • Data Provenance: Prospective, single-center, multi-surgeon clinical study. Country of origin is not explicitly stated, but the study was described as "clinical performance was evaluated in a clinical study...".
• Flap Thickness (Clinical Data):
  • Sample Size: 18 eyes.
  • Data Provenance: Collected at a "VICTUS site located outside of the USA." This indicates retrospective perhaps, or a separate smaller clinical investigation.

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

• Anterior Capsulotomy (Clinical Study):
  • Ground Truth Establishment: "visual inspection during slit lamp examination" and "visual inspection at the day of surgery" were used to assess IOL centration, capsulotomy completeness, and centration. The study involved "multi-surgeon" participation.
  • Number of Experts/Qualifications: Not explicitly stated. The "multi-surgeon" aspect implies multiple surgeons were involved in both performing the procedures and potentially in the visual inspections, but their specific qualifications (e.g., years of experience, blinded assessment) are not detailed.
• Flap Thickness (Clinical Data):
  • Ground Truth Establishment/Experts: Not explicitly stated how "achieved flap thickness" was measured or validated, nor who made those measurements or assessments.

4. Adjudication Method for the Test Set

• Anterior Capsulotomy (Clinical Study): Not explicitly stated. The reliance on "visual inspection" by multiple surgeons might imply a consensus or individual assessment, but no formal adjudication method (like 2+1 or 3+1) is described.
• Flap Thickness (Clinical Data): Not stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

• Not applicable. This device is a femtosecond laser platform for surgical procedures, not an AI diagnostic or assistive device for human readers. The clinical study compares laser-assisted capsulotomy to manual capsulotomy, not human readers with and without AI.

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

• Partially applicable. The "Non-clinical performance data" section describes testing "without human-in-the-loop" in a surgical context, using inanimate materials (porcine eyes, agarose gel, PETG, PMMA) and scanning electronic microscopy to assess the laser's precision in creating capsulotomies and flaps. This demonstrates the device's inherent capability (akin to a standalone algorithm) to achieve specific physical outcomes.
• However, the clinical studies do involve human surgeons operating the device (human-in-the-loop), albeit comparing the device's laser-assisted method to manual surgical techniques.

7. The Type of Ground Truth Used

• Non-Clinical Data:
  • Direct Measurement/Visual Assessment: Scanning electronic microscopy for visual assessment of laser cuts, and measurements (mean values and 95% confidence intervals) against specified acceptance criteria using various inert materials.
• Clinical Data (Anterior Capsulotomy):
  • Clinical Outcomes/Expert Visual Inspection: Comparison of adverse events, severe adverse events, post-surgical complications, IOL centration, and capsulotomy completeness/centration. The "ground truth" seems to be the collective clinical judgment and observation by surgeons and clinical staff via slit lamp examinations and visual inspection.
• Clinical Data (Flap Thickness):
  • Direct Measurement (Implied): Comparison of "intended flap thickness" to "achieved flap thickness." The method for determining "achieved flap thickness" (which would be the ground truth here) is not detailed but would typically involve direct measurement techniques.

8. The Sample Size for the Training Set

• Not applicable/Not explicitly mentioned in the context of device performance studies. This device is a surgical laser, not an AI or machine learning algorithm that requires a "training set" in the traditional sense. Its design and functional parameters are based on scientific principles and engineering, not data-driven machine learning models.

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

• Not applicable, as there is no mention of a "training set" for an AI/ML algorithm within the provided text. The device's fundamental scientific technology and algorithms for laser patterns "remain unchanged from those previously cleared" predicate systems, implying established and validated physical principles rather than learned models.

Ask a specific question about this device