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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 LensAR Laser System is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively during the same surgery.

The LensAR Laser System is an ophthalmic surgical laser that has already been cleared for use in anterior capsulotomy in cataract surgery (K090633). It is now intended for additional use in anterior capsulotomy and laser phacofragmentation in cataract surgery, performed individually or consecutively during the same surgery.

The LensAR Laser generates ultrashort laser pulses that are scanned in a three-dimensional pattern in the eye to cut the anterior capsulotomy and to pre-cut the lens into small pieces for easy removal by conventional ultrasound phaco fragmentation. The fragmentation pattern is customized to the patient's eye based on precise measurement of the size, shape and position of the patient's lens by a built-in optical measuring system. During the measurement and subsequent application of the laser pulses, the eye is positioned and immobilized by an off-the-shelf suction ring assembly which is affixed to the eye and which is in turn docked to a refractive index matching eye docking (IMED) device mounted to the laser system.

Here's a breakdown of the acceptance criteria and study information for the LensAR Laser System, based on the provided text:

No acceptance criteria or reported device performance metrics (e.g., success rates, accuracy percentages, safety endpoints with specific thresholds) are explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through a clinical study rather than defining specific performance thresholds for acceptance.

However, it describes the clinical study that provided performance data to support the device's substantial equivalence.

Study that Proves the Device Meets the Acceptance Criteria (Implicitly, for Substantial Equivalence):

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

As mentioned above, no explicit quantitative acceptance criteria or reported device performance metrics are provided in the document. The study aimed to demonstrate the device's clinical performance in comparison to predicate devices, inferring safety and effectiveness for substantial equivalence.

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

• Sample Size (Test Set): 88 subjects (for the primary cohort, one eye per subject) and a control cohort of contralateral eyes in these subjects.
• Data Provenance: Prospective clinical study performed outside the U.S.

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 study describes the procedures performed (laser fragmentation/capsulotomy followed by phacoemulsification if needed) and a control group receiving conventional methods. It does not detail who established a "ground truth" or what that ground truth would specifically measure beyond the procedural outcomes themselves (e.g., successful fragmentation, clear capsulotomy).

4. Adjudication method for the test set

This information is not provided in the document.

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

• MRMC Study: No, this was not an MRMC study related to human reader performance with AI. The device is a surgical laser system, not an AI-assisted diagnostic or interpretation tool.
• Effect Size: N/A, as it's not an MRMC study with AI assistance.

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

The device itself is a standalone surgical laser system (an "algorithm" in the sense of its operational program). It performs the laser treatment. The clinical study evaluated the overall surgical procedure where the laser performs its function, followed by human intervention (phacoemulsification if needed). It's not a diagnostic algorithm that assists a human reader.

7. The type of ground truth used

The clinical study evaluated the clinical performance of the surgical procedures using the LensAR Laser System. The "ground truth" implicitly refers to the successful completion and clinical outcomes of anterior capsulotomy and laser phacofragmentation during cataract surgery, as observed by ophthalmologists. The document mentions:

• "Summary of Pre-Clinical Testing": "accuracy and reproducibility of capsulotomy and laser phaco fragmentation incisions in porcine eyes and plastic substrates."
• "Summary of Clinical Studies": describes patients undergoing procedures and follow-up.
  The criteria for "success" or "performance" are not explicitly defined as a specific "ground truth" metric but rather related to the procedural outcomes and comparative performance against conventional methods.

8. The sample size for the training set

This information is not provided in the document. The document describes pre-clinical testing and a clinical study but does not detail a "training set" in the context of machine learning or AI, as this is a surgical device.

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

N/A, as no "training set" in the AI/ML sense is mentioned or relevant for this type of medical device's submission summary. The product development likely involved extensive engineering and testing against design specifications, but this is not framed as a "training set" with ground truth in this context.

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