(186 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 penetrating arcuate cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea.
The VICTUS Femtosecond Laser Platform (hercafter referred to as the VICTUS Platform) is a precision ophthalmic surgical laser indicated for use in patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea.
The VICTUS Platform is an ophthalmic surgical femtosecond laser designed for cutting a penetrating arcuate cut of pre-selected depth, radius, opening angle, and position angle. The system works by first being programmed with the depth, radius, opening angle and position angle at which the penetrating arcuate cut is desired. The surgeon then fixates the eye with a sterile disposable PMMA contact lens (hercafter referred to as the Patient Interface) that is connected to the laser via a vacuum tube. Depths of -120µm, radius of 1500 - 4750 um, opening angles of 1-360°, and position angles of 0 - 359° are available.
Laser pulses are delivered through the sterile 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.
Here's a breakdown of the acceptance criteria and the study details for the VICTUS Femtosecond Laser Platform, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria in a table format for the arcuate cuts/incisions. However, the performance data section implies the following outcomes were evaluated and met a criteria of being "highly reproducible and accurate." The postmarket surveillance review indicates "comparability to the standard manual procedure" for clinical endpoints.
| Acceptance Criteria (Implied/Evaluated) | Reported Device Performance (VICTUS Femtosecond Laser Platform) |
|---|---|
| Bench/Pre-Clinical Testing: | |
| Reproducibility of rim depth | Highly reproducible |
| Accuracy of rim depth | Accurate |
| Reproducibility of diameter | Highly reproducible |
| Accuracy of diameter | Accurate |
| Reproducibility of open angle | Highly reproducible |
| Accuracy of open angle | Accurate |
| Reproducibility of position angle | Highly reproducible |
| Accuracy of position angle | Accurate |
| Reproducibility of centration | Highly reproducible |
| Accuracy of centration | Accurate |
| Visual comparison to predicate devices | Qualitatively comparable (based on scanning electron microscopy) |
| Postmarket Surveillance Review (Clinical): | |
| Post-surgical loss of lines of BCDVA | Comparable to standard manual procedure |
| Post-surgical overall change in refraction | Comparable to standard manual procedure |
| Postoperative induced cylinder | Comparable to standard manual procedure |
| Adverse events (rate and type) | Comparable to standard manual procedure |
| Serious adverse events (rate and type) | Comparable to standard manual procedure |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 49 eyes from 34 subjects.
- Data Provenance: Retrospective, single site in Europe.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The text states that "all surgeries were performed by the same surgeon" at the single clinical location. This surgeon's performance was compared between manual and laser-assisted procedures. While this surgeon's outcomes define the "ground truth" for the comparison within the study, the text does not specify the number of experts or their qualifications that established an independent "ground truth" for evaluating the quality of the surgical outcomes themselves. The comparison is against the surgeon's own manual technique.
4. Adjudication Method for the Test Set
The provided text does not specify an adjudication method (e.g., 2+1, 3+1). The "ground truth" appears to be the clinical outcomes as assessed by the operating surgeon and the postmarket surveillance review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study compared laser-assisted procedures to manual procedures performed by the same surgeon at a single site. The effect size of how much human readers improve with AI vs. without AI assistance is not applicable in this context as the device is a surgical laser, not an AI diagnostic tool.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was done
Yes, a standalone performance evaluation was conducted in the Non-Clinical Performance Data section. This involved bench testing using various materials (porcine eyes, agarose gel, PETG, and PMMA) and scanning electron microscopy to assess the laser's cutting accuracy and reproducibility. This evaluate the device's inherent mechanical and cutting capabilities independent of human intervention in the cutting process itself.
7. The Type of Ground Truth Used
- For Non-Clinical Performance Data: The ground truth was established through measurements (rim depth, diameter, open angle, position angle, centration) and visual assessment (scanning electron microscopy) of the cuts produced in various test materials (porcine eyes, agarose gel, PETG, PMMA).
- For Postmarket Surveillance Clinical Review: The ground truth was based on clinical outcomes data (post-surgical loss of best corrected distance visual acuity (BCDVA), post-surgical overall change in refraction, postoperative induced cylinder, adverse events, and serious adverse events) observed in patients after both laser-assisted and manual arcuate incisions, as assessed by the operating surgeon.
8. The Sample Size for the Training Set
The provided text does not mention a training set or details about its sample size. This device is a surgical laser, and the studies described are performance evaluations, not the development or training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (since this is not an AI/algorithm-driven device in the context of typical AI device submissions), this question is not applicable.
§ 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.