FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

· the creation of cuts / incisions in the comea in patients undergoing cataract surgery or other ophflaalmic treatment requiring cuts / incisions in the comea.

· laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

Device Description

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). The VICTUS has additionally been cleared for patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea (K122386), primary/secondary corneal incisions (K132534), and laser-assisted lens fragmentation (K140615). This submission does not add to the indications previously cleared for the VICTUS Platform. With the exception of a new patient interface suction clip, the VICTUS Platform hardware and software remain unchanged from that described and cleared via K141379.

A new patient interface suction clip for the VICTUS platform is being introduced within this premarket submission, the new suction clip is smaller in diameter and contains a colorant to aid in positioning on the cornea of the eye. 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. The contact lens portion of the patient interface remains unchanged from that previously cleared. 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 and indications for use remains the same as previously cleared for the VICTUS Femtosecond Laser Platform under K141379.

AI/ML Overview

The provided text describes the Victus Femtosecond Laser Platform, which is regulated as an Ophthalmic Laser. The document is a 510(k) premarket notification summary, indicating substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly provide a table of quantitative acceptance criteria for device performance. Instead, it states that the device was found to perform "equivalently to the predicate device" and that "the acquired test data successfully verified that the various parameters meet their pre-defined acceptance criteria." This implies that specific performance metrics and their acceptance thresholds exist but are not detailed in this summary.

However, based on the non-clinical and clinical performance data, we can infer some performance aspects:

Feature/Parameter Tested	Acceptance Criteria (Implied)	Reported Device Performance
Non-Clinical Performance
Consistency of lens fragmentation with new software (v3.2) vs. old software (v2.7 SP3)	Substantially equivalent results in lens fragmentation	Achieved substantially equivalent results.
Various parameters (e.g., cut quality, precision) across different materials (porcine eyes, agarose gel, PETG, PMMA)	Pre-defined acceptance criteria	Data successfully verified that parameters meet pre-defined acceptance criteria.
Clinical Performance
Intraoperative accuracy of biometry visualization (Lens Thickness, ACD, CCT) by VICTUS OCT vs. LENSTAR LS900	Correlation and agreement between VICTUS OCT and LENSTAR LS900 measurements	Results are "consistent" between VICTUS OCT and LENSTAR LS900.
Completion of laser-assisted capsulotomy without manual intervention	100% completion rate without manual intervention	All 113 laser-assisted capsulotomy procedures were completed fully without the need for manual intervention.
Absence of adverse events	No adverse or serious adverse events	No adverse or serious adverse events reported.
Absence of device malfunctions	No device malfunctions leading to adverse events	No device malfunctions reported which led or potentially led to adverse or serious adverse events.

2. Sample Size Used for the Test Set and Data Provenance

Non-Clinical Test Set:
- Sample Size: Not explicitly stated as a number of distinct "test sets" but mentions "four different materials" (porcine eyes, agarose gel, polyethylene terephthalate (PETG), and polymethyl methacrylate (PMMA)) were used for bench performance testing.
- Data Provenance: Retrospective (bench testing/lab data). Country of origin is not specified, but the applicant is based in Germany, so it's likely European or global.
Clinical Test Set:
- Sample Size:
  - Flap group: 58 eyes
  - Cataract group: 113 eyes
  - Total: 171 eyes
- Data Provenance: Prospective, single-center clinical study. The country of origin for the study is not specified but the applicant is based in Germany.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for either the non-clinical or clinical studies.

Non-Clinical: Ground truth for material testing (e.g., cut quality, precision) would likely be established by engineers or scientists performing the tests, comparing measurements to specifications.
Clinical: For biometry, the LENSTAR LS900 measurements served as a reference (ground truth proxy). For capsulotomy completion and adverse events, the operating surgeons/investigators would make those assessments, but their specific expert qualifications are not detailed beyond "multi-surgeon" and "investigators."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set data.

Biometry: The comparison was statistical ("correlation and agreement") between the VICTUS OCT and LENSTAR LS900.
Capsulotomy Completion/Adverse Events: These were reported by investigators, implying direct observation and recording without a separate adjudication process mentioned.

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, an MRMC comparative effectiveness study involving human readers improving with AI assistance was not conducted or described. This device is an ophthalmic laser for surgical procedures, not an AI diagnostic tool primarily interpreted by human readers. The clinical study focused on the device's accuracy for biometry and its effectiveness in performing specific surgical steps like capsulotomy and lens fragmentation. The "OCT subassembly" is part of the device's guidance system, not an AI assistance for human image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance of the VICTUS Femtosecond Laser Platform itself, as a device performing surgical actions (cuts, fragmentation, imaging), is inherently standalone in its operation. However, surgical procedures always involve a human surgeon in the loop for planning, supervision, and execution. The "standalone" aspect, in this context, would relate to the laser's ability to precisely execute its programmed actions and measurements.

Non-Clinical Tests: These were standalone tests of the device's physical performance characteristics.
Clinical Studies: The study confirmed the "intraoperative accuracy of biometry visualization performed by VICTUS optical coherence tomography (OCT)" and the laser's ability to complete capsulotomy. This can be considered evaluating the standalone performance of the device's functions, although within the context of a surgical procedure where a surgeon operates the device.

7. The Type of Ground Truth Used

Non-Clinical: The ground truth for bench testing would typically be established through precise metrological measurements and adherence to predefined engineering specifications. For material like porcine eyes, histopathology might be used to confirm laser effects, though not explicitly stated.
Clinical:
- Biometry: The LENSTAR LS900 was used as the reference standard for axial optical resolution accuracy (lens thickness, anterior chamber depth, and central cornea thickness). This acts as a proxy for ground truth, assuming the LENSTAR LS900 is accepted as an accurate measurement device.
- Capsulotomy Completion: The ground truth was observed clinical outcome, specifically whether the capsulotomy was completed fully by the laser without manual intervention.
- Adverse Events: The absence of reported adverse events constitutes the ground truth for safety in the study.
- Cataract Grades: Clinical assessment (implicitly by ophthalmologists) was the ground truth for cataract grading.

8. The Sample Size for the Training Set

The document does not mention any "training set." This summary pertains to the evaluation of a physical medical device (femtosecond laser) whose functionality is based on established physics and pre-programmed parameters, not a machine learning or AI algorithm that requires a training dataset in the conventional sense. The "software version 3.2" is updated device control software, not a trainable AI model in the common "training set" connotation.

9. How the Ground Truth for the Training Set Was Established

Since no training set for an AI/ML algorithm is mentioned, this question is not applicable based on the provided text. The device's "training" in a broad sense would be its design, calibration, and validation against engineering specifications during its development.

Summary

Regulation Number and Section

§ 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.