(103 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 full and partial thickness single-plane and multi-plane arc 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 K120214 (LENSAR Laser System - fs 3D). In K122829, the laser expands the Indication for Use to single-plane and multi-plane clear corneal cuts/incisions. This expansion of the Indication for Use is for partial as well as full thickness single-plane and multi-plane arc cuts/incisions in the cornea.
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 and K 122829. 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 510(k) K120214 and K122829.
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. To improve the accuracy of incision placement in the cornea, a new functionality called "Localized Imaging" has been added to the system. Localized Imaging is a process whereby the biometric camera is positioned to observe the corneal incision site and a very small laser mark (at low energy) is made at the center of the stroma. By imaging and measuring the position of the mark relative to the cornea anterior and posterior surfaces, the system mitigates any potential of incorrect laser beam placement due to eve movement. The corneal incision surgery is performed immediately after Localized Imaging and results in accurate incision depth in the cornea (
Acceptance Criteria for LENSAR Laser System - fs 3D (LLS-fs 3D)
Based on the provided 510(k) summary, the acceptance criteria for the LLS-fs 3D, specifically regarding the new indication of partial thickness corneal incisions, revolve around demonstrating comparable or superior accuracy and safety compared to conventional manual techniques and the previously cleared predicate devices.
The primary performance metric evaluated for the new indication of partial thickness corneal incisions appears to be accuracy of incision depth. The goal was to show that laser-created partial thickness incisions (PTIs) achieved depths much closer to the target than manually-created PTIs, and that there was no significant difference in accuracy or variance between human and porcine eyes, and no detrimental effect on endothelial cells.
Here's a breakdown of the acceptance criteria and reported device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in the summary) |
|---|---|
| Accuracy of Incision Depth for Partial Thickness Corneal Incisions (PTIs): Laser PTIs must demonstrate superior or comparable accuracy to target depth compared to manual methods. (Target depth explicitly mentioned as 600 µm for testing) | "The accuracy of the depth of conventional manual versus laser-generated partial thickness corneal incisions (PTIs) was tested... A comparison of the depth accuracy of manual and laser PTIs demonstrated that the laser PTIs had measured depths much closer to the target 600 um depth than the manually-created PTIs." |
| "The results showed that the mean errors in target accuracy were not different and the variance of the error in incision depth was also about the same [between porcine and human donor globes]." | |
| "Overall, the testing showed that PT's created by the LLS-fs 3D were more accurate and precise than those made using a diamond blade with the conventional manual technique." | |
| Safety - Effect on Endothelial Cells: No significant loss of endothelial cell density due to laser PTIs. | "Evaluation of the effect of the laser partial thickness incisions on endothelial cells of ex vivo eyes showed that the laser method resulted in no loss of endothelial cell density when the residual corneal bed is maintained at >85um." |
| Safety - Absence of new hazards or acceptable probability/severity for existing hazards: The addition of partial thickness arc cuts/incisions should not introduce new, unacceptable hazards, or exacerbate existing ones to unacceptable levels. | "The addition of partial thickness arc cuts/incisions did not result in additional hazards although the probabilities and severities of some of the hazards identified for the predicate device were changed." (Implies these changes were within acceptable levels based on the overall conclusion of substantial equivalence). |
| Optical Radiation Hazard: Device must be eye safe under normal operating and fault conditions. | "An analysis of the optical radiation hazard to non-target tissue demonstrated that the current LLS-fs 3D femtosecond laser, biometric system scanning diode light source, and patient eye illumination (light emitting diodes) are eye safe under all normal operating and known fault conditions." |
| General Hazard Analysis: All potential hazards to patient, surgeon, and operators must have acceptable probability/severity. | "A hazard analysis of all potential hazards to the patient, surgeon and other system operators was performed to consider all changes between the current LLS-fs 3D and predicate LLS-fs 3D device. The hazard analysis demonstrates that all potential hazards have acceptable levels of probability/severity characteristics." |
2. Sample Sizes and Data Provenance
- Test Set Sample Sizes:
- Porcine ex vivo eyes: "The accuracy of the depth of conventional manual versus laser-generated partial thickness corneal incisions (PTIs) was tested using a porcine ex vivo eye model." (Specific number of eyes not quantified, but tested).
- Human donor globes: "The laser PTIs in porcine eyes were compared to a smaller number of laser PTIs in human donor globes." (Specific number of globes not quantified, but referred to as "smaller number").
- Endothelial cell study: "Evaluation of the effect of the laser partial thickness incisions on endothelial cells of ex vivo eyes..." (Source of ex vivo eyes not specified, but likely porcine or human donor as implied by other tests. Specific number not quantified).
- Data Provenance:
- The studies were "ex vivo," meaning performed on excised tissues, not live subjects.
- The origin (e.g., country) of the porcine or human donor eyes is not specified.
- The studies were likely retrospective in nature, as they utilize ex vivo samples for controlled measurements. They are presented as performance tests supporting a 510(k) submission, typical of pre-market validation.
3. Number of Experts and Qualifications for Ground Truth
- The document does not specify the number of experts used to establish ground truth for the test set.
- It also does not specify the qualifications of any experts involved in defining or adjudicating the ground truth. The ground truth ("measured depths") was established using an "optical coherence tomographer" which implies objective measurement, rather than expert interpretation of images.
4. Adjudication Method for the Test Set
- The document does not mention any adjudication method for the test set. The ground truth for incision depth was established through objective measurement using "an optical coherence tomographer," which typically involves automated or semi-automated measurement, reducing the need for human adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The studies described were primarily technical performance evaluations (e.g., measuring incision depth accuracy), and safety assessments (e.g., endothelial cell integrity), rather than studies evaluating the impact of AI assistance on human reader performance. This device is not an AI-assisted diagnostic tool that would typically warrant such a study.
6. Standalone Performance Study (Algorithm Only)
- Yes, in essence, standalone performance was assessed for the laser's ability to create incisions. The studies evaluated the LLS-fs 3D's performance in creating incisions (accuracy of depth, effect on tissue) in ex vivo eyes, independent of a human surgeon's real-time interaction beyond initiating the procedure. The "Localized Imaging" functionality, which uses the biometric system to image and analyze laser marks to guide subsequent incisions, represents the device's internal "algorithm" controlling the laser's output. The accuracy reported for laser PTIs and the "Localized Imaging" feature ("
§ 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.