(128 days)
The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use:
- · in the creation of an anterior capsulotomy;
- · in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;
- · in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea;
- in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/incisions in the cornea; and
- · in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea.
The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create 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 device is also intended for use in the creation of pocket cuts/ incisions in the cornea in patients undergoing ophthalmic surgery, and in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea, each of which may only be performed individually.
Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; the size, architecture, and location of full thickness incisions within the cornea; the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea; and the size, architecture, and depth of pocket and flap cuts.
The LENSAR Laser System – fs 3D (LLS-fs 3D) with Streamline™ includes the integration with pre-op analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis" corneal and capsule marking for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.
This document describes the LENSAR Laser System - fs 3D (LLS-fs 3D) and its performance data in support of its 510(k) submission (K173346) for new indications: creation of corneal pockets and corneal flaps.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Accuracy of depth | Achieved depth within established requirements | Achieved depth well within established requirements for both pocket and flap. |
| Parallelism of bed | Achieved depth at multiple points (tangential/sagittal planes) within specification of measured depth | Achieved depth at several points of both tangential and sagittal planes (i.e., parallelism) was well within the specification of the measured depth for both the pocket and flap. |
| Effect on endothelial cells | No loss of endothelial cell density | No loss of endothelial cell density when a sufficiently large residual corneal bed is maintained (from a previous study). |
| IOP rise | Consistent with commercially available applanating PIDs | Consistent with other commercially available applanating PIDs. |
| Eye stability during surgery | Minimum force to detach eye from suction ring for new PID higher or equivalent to existing PID | Minimum force necessary to detach the porcine eye from the suction ring was higher for the curved contact PID versus that of LENSAR's existing PID. |
| Retinal burn hazard | No increase in hazard | No increase in hazard following a retinal burn hazard analysis for the addition of corneal pockets and flaps. |
| Incision quality (Pocket/Flap) | Acceptable ease of opening, ease of separation, smoothness of bed surface | Judgement of a board-certified ophthalmic surgeon indicated "Yes" for acceptability for each factor, consistent with the predicate device. |
| Bed smoothness (Pocket/Flap) | Consistent with predicate device | Judgement of the same surgeon indicated bed smoothness was consistent with that of the predicate device using donor eyes. |
| Corneal folds | No visible folds | No visible folds noted in OCT images when compared to a commercially available applanating PID. |
2. Sample Size Used for the Test Set and Data Provenance:
The study primarily utilized a porcine ex vivo eye model for most of the performance evaluations related to corneal pockets and flaps. Specific sample sizes for each test are not explicitly provided in the document.
Data provenance is retrospective as it refers to testing done in support of the submission. The origin of the porcine eyes is not specified. For some tests, human donor eyes were also used, but their provenance is not detailed either.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
For the evaluation of incision quality and bed smoothness, the ground truth was established by:
- A board-certified ophthalmic surgeon.
The document does not specify the number of years of experience of the surgeon, nor if multiple surgeons were involved for different assessments.
4. Adjudication Method for the Test Set:
For the human-graded assessments (incision quality and bed smoothness), the adjudication method appears to be none, as the decisions were based on the "judgement of the surgeon," implying a single expert opinion without a formal consensus or tie-breaking process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done to assess the improvement of human readers with AI vs. without AI assistance. The device is a surgical laser system, not an AI-assisted diagnostic tool for human readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Yes, a standalone study was conducted as the performance data directly assesses the capabilities of the laser system itself (e.g., accuracy of depth, parallelism, incision quality) rather than its interaction with human interpretation or decision-making in a diagnostic context. This is a surgical device performing physical actions.
7. Type of Ground Truth Used:
The ground truth used was a combination of:
- Measurement against intended specifications: For objective metrics like depth accuracy, parallelism, and IOP rise.
- Expert subjective assessment: For qualitative metrics like incision quality (ease of opening, separation, smoothness) and bed smoothness, evaluated by a board-certified ophthalmic surgeon.
- Imaging (OCT): For assessing corneal folds.
- Biological effects: For endothelial cell density, based on previous studies.
8. Sample Size for the Training Set:
This information is not provided in the document. The document describes performance testing for new indications, not a machine learning model that would typically have a separate training set. The "software verification and validation testing" refers to the system's software, not an AI/ML algorithm that is trained on a dataset.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned for an AI/ML model, this information is not applicable. The ground truth establishment described above pertains to the validation of the device's physical performance characteristics.
§ 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.