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The VICTUS Femtosecond Laser Platform is 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
• 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 Platform (hereafter referred to as the VICTUS Platform) is a precision ophthalmic surgical laser indicated for use the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and for anterior capsulotomy during cataract surgery (via K120426). In addition, the VICTUS has been cleared for patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea (via K122386), and for corneal incisions (via K 132534). This 510(k) expands the list of indications for use to include laser-assisted lens fragmentation during cataract surgery for nuclear cataracts.

For all 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.

Safety margins are built into the software, including an anterior capsule safety margin of 500 um, a posterior capsule safety margin of 700 um, and a pupil safety margin of 500 um. The graphical user interface is used to mark the anatomical boundaries and the software automatically calculates the safety margins. The safety margins are not modifiable by the end user.

The fundamental scientific technology remains the same as previously cleared for the VICTUS Femtosecond Laser Platform under K122386 and K132534.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: 136 eyes from 110 subjects (26 patients treated bilaterally). 68 eyes in the VICTUS (laser) group and 68 eyes in the standard (manual) treatment group.
   • Data Provenance: The text does not explicitly state the country of origin. It mentions "multi-center, multi-surgeon clinical study," implying various clinical sites, but no geographical location is specified. It was a prospective study.

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

   • The study design describes a "randomized, controlled, open, prospective, multi-center, multi-surgeon clinical study" comparing the VICTUS device to manual methods. The "ground truth" in this context refers to the clinical outcomes and observations recorded during the study, rather than an independent expert review of images or data to establish a reference standard. The study data (e.g., EPT, adverse events, IOP, BCVA, slit lamp findings) were collected through standard clinical procedures by the participating surgeons and study personnel. The document does not specify a number of independent experts for ground truth establishment outside of the primary treating physicians and clinical staff who recorded the outcomes.

3. Adjudication method for the test set:

   • The document does not describe a specific adjudication method (like 2+1 or 3+1) for the test set results. Clinical outcomes were collected by the participating centers. Adverse events were observed and reported, but the process of determining their relation to the intervention was clinical (e.g., "All adverse events in the laser group were determined to be related to the cataract surgery and not to the use of the VICTUS Femtosecond Laser."). This implies a clinical judgment by the investigators, not an independent adjudication committee.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study compares a surgical device (VICTUS Femtosecond Laser Platform) to a manual surgical technique, not an AI or imaging-based diagnostic tool requiring human reader interpretation. Therefore, there's no mention of human reader improvement with/without AI assistance or effect sizes related to such a comparison.

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

   • This is not applicable as the device is a surgical laser platform, not an algorithm for diagnosis or image analysis. The "standalone" performance mentioned refers to the device's ability to perform specific surgical actions (e.g., lens fragmentation) as intended, which was evaluated through the clinical study and non-clinical bench testing. The outcomes were compared to manual surgical techniques, which inherently involve human-in-the-loop performance.

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

   • The "ground truth" primarily consisted of clinical outcomes data (e.g., Effective Phacoemulsification Time (EPT), adverse event rates, intraocular pressure (IOP), best corrected visual acuity (BCVA), slit lamp examination findings, intra-operative complications) obtained directly from the patients in a prospective clinical study. Non-clinical bench testing also established a "ground truth" for the device's physical performance parameters against established acceptance criteria.

7. The sample size for the training set:

   • This device is a surgical instrument and does not rely on a "training set" in the context of machine learning. Therefore, a training set sample size is not applicable. The device's design and parameters are based on engineering principles and prior iterations (as evidenced by its substantial equivalence to previous VICTUS and predicate devices).

8. How the ground truth for the training set was established:

   • As explained above, there is no "training set" for this type of device. The functionality and safety were established through mechanical/bench testing and clinical trials, not through learning from a dataset with established ground truth labels.

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The LenSx Laser System is indicated for use:

• In the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
• In the creation of a lamellar cut/resection for lamellar keratoplasty, and in the creation of a penetrating cut/incision for penetrating keratoplasty.
• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

The LenSx Laser System uses focused femtosecond laser pulses to create incisions and separate tissue in the lens capsule, crystalline lens, and the cornea. Individual photodisruption locations are controlled by repeatedly repositioning the laser focus. The light pulse is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incision or tissue separation. The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through a Patient Interface accessory that is placed on the surface of the cornea and fixes the eye with respect to the delivery system. This 510(k) premarket notification is being submitted to seek clearance for an additional patient interface accessory to be offered for use with cataract procedures in addition to the original patient interface accessory to the LenSx Laser System (cleared under K120732 for cataract and lamellar resection procedures). The SoftFit Patient Interface differs from the original Patient Interface (K120732) in that it has an extended suction ring skirt that enables positioning of a soft contact lens against the internal surface of the patient interface glass. The soft contact lens is similar to a standard daily wear contact lens indicated for the correction of ammetropia, with a slightly modified edge to enable fitting into the SoftFit Patient Interface. The materials and manufacturing processes used for the soft contact lens component of the proposed SoftFit Patient Interface accessory are identical to the processes used for the predicate daily wear soft contact lens (K100244). With the soft contact lens insert in place, the SoftFit Patient Interface is then mounted onto the LenSx laser system for docking onto the eye in a manner that is identical to the original LenSx Laser Patient Interface. As a result, use of the soft contact lens substantially reduces intraocular pressure (IOP) during the laser procedure, enhancing comfort and addressing potential concerns in patients with a history of glaucoma. For cataract procedures, either a LenSx Laser Patient Interface or a SoftFit Patient Interface may be used. The original LenSx Laser Patient Interface is used for keratoplasty and corneal flaps.

The provided text describes a 510(k) premarket notification for an additional patient interface accessory (SoftFit Patient Interface) for the LenSx Laser System. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device and to show that the new accessory does not raise new questions of safety or effectiveness.

Here's an analysis of the acceptance criteria and study information based only on the provided text:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly define formal "acceptance criteria" in a quantitative manner (e.g., "accuracy must be >X%"). Instead, it describes performance evaluations conducted to demonstrate substantial equivalence to the predicate device, particularly focusing on the differences introduced by the SoftFit Patient Interface.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes used for the performance evaluations (e.g., number of eyes, number of procedures).

The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin.

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

This information is not provided in the document. The type of performance evaluation described (holding force, IOP, accuracy of laser patterns) suggests objective measurements rather than expert consensus on a diagnostic outcome.

4. Adjudication method for the test set:

Not applicable, as the performance tests described involve objective measurements rather than subjective assessments 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:

Not applicable. This device is a surgical laser system with a patient interface accessory, not an AI-assisted diagnostic or imaging device that would typically involve a multi-reader multi-case study to assess human reader improvement.

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

Not applicable. The "device" in question is a surgical laser system designed for in-vivo use with human intervention, not a standalone algorithm. The performance tests assessed the physical and mechanical aspects of the new patient interface.

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

The "ground truth" for the performance evaluations would be:

• Intraocular Pressure (IOP): Direct measurement using appropriate medical devices.
• Holding Force: Direct measurement using mechanical testing methods.
• Accuracy and Reproducibility of Cataract Treatment Patterns (depths and geometry): Measurement of the laser's physical output (e.g., incision depth, shape) using precision instruments (e.g., optical coherence tomography, microscopy, or other metrology tools).

8. The sample size for the training set:

Not applicable. The device described is a medical device (laser system accessory) and not an AI/ML model that requires a "training set."

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

Not applicable, as there is no training set for this type of medical device submission.

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