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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 separates 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 incisions 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 sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

The LenSx Laser System proposed in this 510(k) premarket notification is a modification of the previously cleared LenSx Laser System, manufactured by Alcon LenSx, Inc. (K101626). It is essentially the same laser system with the addition of a new indication for use, namely the creation of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LenSx Laser System:

Acceptance Criteria and Device Performance Study for LenSx Laser System (K120732)

The provided 510(k) summary (K120732) describes modifications to the LenSx Laser System, primarily to add the indication for creating corneal flaps in LASIK surgery. The performance testing focused on demonstrating that the modified device, including the new indication, meets established criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document implicitly defines acceptance criteria by stating that the modified device was evaluated against criteria established for the predicate LenSx Laser and that the output met these. However, the specific quantitative values for these acceptance criteria are not explicitly detailed in the summary. The summary refers to:

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample size used for the test set. It mentions "Evaluation of the accuracy and reproducibility" but does not give the number of tests performed or the number of samples (e.g., eyes, tissues) used in these evaluations.

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin. Given that it's a 510(k) submission for a device manufactured by Alcon LenSx, Inc. (USA) and evaluated for FDA clearance, it's likely the testing was conducted to meet US regulatory standards, possibly in the US or collaborating sites.

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

The document does not explicitly mention the use of experts to establish a ground truth for the test set in the context of human evaluation. The testing described appears to be objective, physical measurements of the laser's output (depths, geometry, surface quality, energy stability).

4. Adjudication Method for the Test Set

Since the described testing primarily involves physical measurements of laser output rather than subjective interpretation, an adjudication method in the traditional sense (e.g., 2+1, 3+1 for expert review) is not applicable or mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. The device is a surgical laser, and the testing focuses on its physical performance rather than diagnostic accuracy involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The studies described are inherently "standalone" in the sense that they evaluate the physical output of the laser system itself (accuracy, reproducibility, energy stability). The device is a surgical tool, and its efficacy is determined by its ability to perform precise cuts, not by an algorithm's diagnostic output requiring human interpretation.

7. Type of Ground Truth Used

The ground truth used for these performance evaluations would have been objective physical measurements rather than expert consensus, pathology, or outcomes data. For example:

• Depth and Geometry: Verified by high-precision metrology tools (e.g., optical coherence tomography, microscopy, or other precise measurement techniques) after laser application to an appropriate test material or ex vivo tissue.
• Surface Quality: Evaluated using microscopy or surface profilometry.
• Energy Stability: Measured using appropriate power meters and sensors.

8. Sample Size for the Training Set

The document does not specify a training set size. The device is a physical laser system, and its modifications are based on engineering changes and software updates. It's not a machine learning or AI algorithm that would typically require a distinct "training set" in the conventional sense. The "training" in this context would refer to the engineering and design iterations leading to the final device parameters.

9. How Ground Truth for the Training Set Was Established

As there's no explicitly mentioned "training set" in the context of data for an algorithm, the concept of establishing ground truth for it is not applicable as understood for AI/ML devices. The "ground truth" during device development (analogous to a training phase) would have been the engineering specifications and performance targets that the designers aimed to achieve. These targets would have been derived from clinical needs, existing predicate device performance, and scientific understanding of ophthalmic surgery.

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