(185 days)
The VICTUS Femtosecond Laser Platform is indicated for use for:
- 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.
The VICTUS Femtosecond Laser Platform (VICTUS) is a precision ophthalmic surgical laser and is cleared for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and for patients undergoing 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). This 510(k) expands the arcuate corneal incision by allowing the ability for primary and secondary corneal incisions. These cuts/incisions are performed for patients undergoing cataract surgery to allow direct access into the eye. The correct position and shape of the cuts is verified by the video image. The expansion of the corneal incision indication is supported by software version 2.7 SP2. In addition, an increased diameter patient interface is being introduced (referred to as PI125). The PI125 is a universal PI that allows the use for either corneal or cataract procedures. User request for a smaller diameter patient interface that can be used for both cataract and corneal procedures resulted in the qualification of the existing cataract patient interface as a universal smaller diameter patient interface. Lastly, the bottom end of the pulse duration range has been modified to be lower than that previously cleared in K120426 and K122386. 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 eve 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. The fundamental scientific technology remains the same as previously cleared for the VICTUS Femtosecond Laser Platform under K120426 and K122386.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, where available:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state quantitative acceptance criteria for device performance (e.g., a specific tolerance for depth, diameter, or angle of incisions). Instead, it describes general claims of performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reproducible depth, diameter, and angle of primary and secondary corneal incisions. | "laser-assisted primary and secondary incisions performed with the VICTUS Femtosecond Laser Platform resulted in highly reproducible and accurate depth, diameter, and angle." |
| Substantially equivalent performance to previously cleared patient interfaces for the larger diameter patient interface (PI125). | "Assessment of the larger diameter patient interface shows substantially equivalent results as compared to the predicate patient interfaces." |
| Compliance with applicable safety standards. | The device is "in compliance with applicable safety standards" listed. |
| Equivalent performance to predicate devices in patients undergoing ophthalmic surgery requiring arcuate cuts/incisions. | "The VICTUS Femtosecond Laser Platform has been found to perform equivalently to the predicate devices in patients undergoing ophthalmic surgery or other treatment requiring penetrating arcuate cuts / incisions in the cornea." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The text mentions "A variety of test procedures were conducted" and "Four different materials were used for the bench performance testing: porcine eyes, agarose gel, polyethylene terephthalate (PETG), and polymethyl methacrylate (PMMA)." It does not quantify the number of tests performed on these materials.
- Data Provenance: The study was a "Non-Clinical Performance Data" study, implying it was conducted in a laboratory setting (bench testing) using specified materials. The location of the testing is not mentioned, nor is it explicitly stated as retrospective or prospective, but given it's bench testing, it would inherently be "prospective" in the sense that the tests were designed and executed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study was non-clinical bench testing, not involving human subjects or expert assessment of clinical outcomes. Ground truth would be based on physical measurements of the incisions in the tested materials.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The study was non-clinical bench testing. Performance was evaluated by "comparing the mean values to the specified acceptance criteria and their 95% confidence intervals." This suggests quantitative measurement and statistical analysis rather than expert 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
No. This was a non-clinical bench study of a laser surgical device, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance of a device itself, which is what the bench testing aimed to assess. The device performance was evaluated independently without human intervention during the "cutting" process, as it is an automated laser system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the non-clinical testing appears to be based on direct physical measurements of attributes like depth, diameter, and angle of incisions in the various test materials (porcine eyes, agarose gel, PETG, PMMA). This would be established using appropriate metrology tools for precision measurement.
8. The sample size for the training set
Not applicable. This is not an AI-based system that requires a "training set" in the context of machine learning. The device is a laser platform; its "training" per se would relate to its engineering and calibration.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the machine learning sense for this device.
§ 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.