(127 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint: Effective phacoemulsification time (EPT) in the laser group (pooled from all cataract grades) should be lower than or equal to that in the manual group. | Met: Effective phacoemulsification time (EPT) in the laser group (pooled from all cataract grades) was lower than or equal to that in the manual group. |
| Secondary Endpoint: Less or equal adverse events in the laser group compared with the manual group. | Met: Less or equal adverse events in the laser group compared with the manual group. |
| Safety Margins: Anterior capsule safety margin of 500 um, posterior capsule safety margin of 700 um, and pupil safety margin of 500 um. (Implied, as these are "built into the software" and not user-modifiable, suggesting they must be maintained.) | Implied Met: "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 text indicates these are programmatically enforced, not reported as a result. |
| Reproducibility and Accuracy (Bench Testing): Laser-assisted lens fragmentation performed with the device must meet established acceptance criteria for lens fragmentation for various parameters (upper/lower depth, cross/open angle, spot/line spacing, decentration). | Met: "The testing showed that laser-assisted lens fragmentation performed with the VICTUS Femtosecond Laser Platform met the established acceptance criteria for lens fragmentation." "resulted in highly reproducible and accurate treatments". |
| Intraocular Pressure (IOP): Pre- and post-operative IOPs should be similar between the VICTUS and manual groups. | Met: Pre- and post-operative IOPs were similar between the VICTUS and manual groups at all time points during the study for the complete study group and when stratified by cataract grade. |
| Best Corrected Visual Acuity (BCVA): BCVDA should be similar between the VICTUS and manual groups. | Met: Best corrected visual acuities (BCVDA) were similar between the VICTUS and manual groups at all time points during the study for the complete study group and also when stratified by cataract grade. |
| Slit Lamp Examinations: Slit lamp examinations in the laser group should be consistent with the manual group. | Met: Slit lamp examinations in the laser group were consistent with the manual group at all time points for the complete study group and also when stratified by cataract grade. |
| Intra-operative Complications: (Implied: Acceptable rate, or no increase compared to manual). | Met/Favorable: The only intra-operative complications were two anterior capsule tears in the manual group; no other operative complications were recorded for either the manual or the laser group. |
| Post-operative Observation Rates (Corneal edema, flare, trace anterior chamber): Comparable between laser and manual groups. | Met: The post-operative observation rates of corneal edema, flare and trace anterior chamber in the laser group were comparable to those in the manual group. |
| OCT Image Correlation with Biometric Data: OCT images through the PI should correlate well with biometric data for lens thickness and anterior chamber depth. | Met: OCT images through the PI correlate well with biometric data obtained from OCT images for lens thickness and anterior chamber depth for the complete study group and also when stratified by cataract grade. |
| VICTUS OCT Image Precision: High level of precision for lens thickness and anterior chamber depth. | Met: VICTUS OCT images were found to have a high level of precision for lens thickness (both pooled and stratified by cataract grade) and anterior chamber depth (pooled only). |
Study Details:
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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.
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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.
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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.
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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.
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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.
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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.
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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).
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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.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.