(77 days)
The LensAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of single-plane and multi-plane cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
The predicate LensAR Laser System is an ophthalmic surgical laser that has been cleared by the Agency for use in anterior capsulotomy and laser phaco fragmentation in cataract surgery performed individually or consecutively during the same surgery under K 120214 (LensAR Laser System - fs 3D).
The current LLS-fs 3D uses the same laser and the same beam guidance system to deliver laser pulses to the eye as the predicate LensAR device cleared via 510(k) K120214. Also, the patient interface device (PID), controlled force docking mechanism and moveable optical head to dock the laser to the stationary patient are unchanged from that described in 510(k) K120214. The Indication for Use is now expanded to include creation of the incisions for entry to the eye in cataract surgery.
The LLS-fs 3D biometric system, which measures and constructs a three dimensional model of the optical surfaces within the eye, is unchanged from the predicate device except for software modifications to allow the system to analyze the shape and position of the peripheral cornea.
Here's a breakdown of the acceptance criteria and study information for the LensAR Laser System - fs 3D (LLS-fs 3D), based on the provided text:
Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical trial with specific performance metrics and acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are more about demonstrating safety and equivalence to established methods/devices, and the "reported device performance" reflects findings from comparative tests. Many of the requested details (like sample size for test set, number of experts, adjudication, effect size for human readers, etc.) are not explicitly stated in this type of regulatory document.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary, the "acceptance criteria" are implied to be achieving equivalence to or improvement over predicate devices and established manual methods in terms of safety and key performance aspects.
| Acceptance Criteria (Implied) | Reported Device Performance (LLS-fs 3D vs. Manual/Predicate) |
|---|---|
| Safety: | |
| Ocular safety | The femtosecond laser, biometric system scanning diode light source, and patient eye illumination were determined to be eye safe under all normal operating and known fault conditions. The optical radiation hazard analysis confirmed continuing ocular safety and equivalence to the predicate device (K120214). (Section 2, para 1) |
| Hazard analysis | A hazard analysis of all potential hazards (to patient, surgeon, other operators) considered all changes between current and predicate LLS-fs 3D, demonstrating all potential hazards have acceptable levels of probability/severity characteristics. (Section 2, para 5) |
| Effectiveness/Performance: | |
| Accuracy & Reproducibility of Corneal Incisions | Accuracy: Mean incision length for laser incisions was statistically significantly closer to the target length than for manual CCIs. Reproducibility: Variance of angles of entrance and exit planar incisions relative to the corneal surface showed laser incisions had statistically significantly lower variance for these geometry parameters compared to manual incisions. (Section 2, para 3) |
| Endothelial Cell Safety | On ex vivo porcine eyes, laser corneal incisions resulted in statistically smaller percentage losses of endothelial cells compared to the manual incision method when the exit of the incision was normal to the surface. No significant difference was observed when the exit incision geometry was at 45° to the surface. (Section 2, para 4) |
| Incision Seal Integrity & Wound Structure | No difference in susceptibility to leakage between laser and manual incisions for cataract surgery. Testing showed manual and laser methods are statistically equivalent in sealability, but the laser method produces more consistent wound geometry. (Section 2, para 5) |
| Equivalence to Predicate | The LLS-fs 3D laser technology and mechanism of laser-tissue interaction are unchanged from the femtosecond laser cleared under K120214. The indication for use statement for anterior capsulotomy and laser phacofragmentation is the same as predicate devices. Incision of the cornea in cataract surgery is the same as the LenSx laser (K101626). Differences between modified LLS-fs 3D and predicates are insignificant and do not affect safety or effectiveness. (Section 2, paras 1-4) |
| System Functionality | The biometric system, patient interface device (PID), controlled force docking mechanism, and moveable optical head are unchanged from the predicate K120214, except for software modifications to analyze peripheral cornea. (Section 0, Section 1) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The studies mentioned (e.g., "evaluation of the effect of the laser vs. manual incisions at the corneal periphery on endothelial cells of ex vivo porcine eyes") describe the type of study but not the number of samples/eyes used.
- Data Provenance:
- One study explicitly mentions "ex vivo porcine eyes," indicating animal tissue.
- Other studies (e.g., accuracy and reproducibility of planar corneal cuts/incisions, incision seal integrity) do not specify if they were performed on human eyes (cadaveric or live) or animal models, or a simulation. This information is usually more detailed in a full submission rather than a summary.
- The document implies lab-based testing rather than clinical trials with retrospective or prospective human patient data for the specific claims related to corneal incisions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not explicitly stated. The document describes technical performance evaluations and comparisons rather than expert-derived ground truth on clinical images. For instance, "mean incision length" or "variance of angles" are objective measurements rather than expert interpretations.
4. Adjudication Method for the Test Set
Not applicable/Not stated. Since the studies involved objective measurements of physical parameters rather than subjective interpretations needing reconciliation, an adjudication method for ground truth is not described.
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 device is an ophthalmic surgical laser system, not an AI-assisted diagnostic imaging device. Therefore, a MRMC study involving human "readers" (experts interpreting data) is not relevant or described.
- Effect Size of Human Reader Improvement: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence. The performance data presented (e.g., accuracy of laser incisions, endothelial cell loss, seal integrity) describes the device's performance itself (the laser system) in creating incisions compared to manual methods. This is an "algorithm only" or "device-only" performance in the sense that it's evaluating the system's capabilities to execute specific surgical tasks, rather than human interpretation.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests appears to be:
- Objective Measurements: Directly measured physical parameters like incision length, angle variance, percentage of endothelial cell loss, and leakage.
- Comparison to Established Manual Methods: The performance of the laser incisions was compared against "manual CCIs" (Corneal Clear Incisions/Corneal Cataract Incisions) as a benchmark or "ground truth" for comparison.
- Predicate Devices: The safety and some aspects of performance were compared to the cleared predicate LensAR Laser System (K120214) and the LenSx Laser System (K101626).
8. The Sample Size for the Training Set
Not applicable/Not stated. This medical device is a surgical laser system, not a machine learning or AI-based diagnostic tool that typically requires a "training set" for model development. The software modifications mentioned are likely deterministic algorithms for controlling the laser based on biometric measurements, not a learned model.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no described "training set" in the context of machine learning, there is no ground truth established for it.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.