LENSAR LASER SYSTEM

• K Number: K090633
• Device Name: LENSAR LASER SYSTEM
• Manufacturer: LENSAR, INC.
• Date Cleared: 2010-05-13 ( 430 days)
• Product Code: OOE
• Regulation Number: 886.4390
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: K033354 , K993153 , K001211 , K002890 , K013941 , K031960 , K041893 , K060372 , K063682 , K073404 , K892058 , K001498 , K082947

Intended Use

The LensAR Laser System is intended for use in anterior capsulotomy during cataract surgery.

Device Description

The LensAR Laser System is an ophthalmic surgical laser intended for use in anterior capsulotomy in cataract surgery. The System employs a mode-locked Nd: Y VO4 laser which generates a high frequency series of ultrashort, low energy pulses at a wavelength of 1064 nm. The system is designed to cut the lens capsular tissue, with minimal collateral damage, by the mechanisms of plasma mediated ablation and photodisruption of targeted tissue at the beam focus. The precision capsulotomy is generated by computer-controlled scanning of the position of the laser beam focus in three dimensions at the target location of the anterior capsulotomy. The laser energy is delivered to the eye through a disposable, patient interface device consisting of an Index Matched Eye Docking device (IMED) designed to match the refractive index of the cornea to optimize beam targeting accuracy. The IMED device is docked to the eye via an accessory component comparable to those used with other ophthalmic lasers used as keratomes.

AI/ML Overview

This document describes the premarket notification 510(k) for the LensAR Laser System for Anterior Capsulotomy.

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria	Reported Device Performance
   Creation of uniform, accurate, and predictable anterior capsulotomies (size and depth).	The data demonstrated the LensAR produces anterior capsulotomies that are uniform, accurate, and predictable in size (based on testing in porcine eyes and plastic substrates). Clinical analysis included pointing accuracy and performance characteristics for achieving an effective anterior capsulotomy cut.
   Safety with respect to corneal endothelium (acoustic and thermal profile).	Evaluation on ex vivo porcine eyes confirmed the safety with respect to corneal endothelium.
   Successful performance of anterior capsulotomy, with successful intraocular lens placement.	Anterior capsulotomy was successfully performed in eyes using the LensAR Laser, with intraocular lenses successfully placed. Postoperatively, the course of follow-up through 3 months was unremarkable. The intraocular lens was centered in all study eyes. All capsulotomies were judged well-centered by visual inspection.
   Ease of removal of capsules comparable to or better than Continuous Curvilinear Capsulorhexis (CCC).	The ease of removal scores were 5 or better (on a scale of 1 to 10, where 1 = CCC/manual removal, 10 = easiest), with the most common score being 10.
   Anterior capsules from laser-treated eyes should be equivalent or better with respect to dimension and conformance to circularity than those done manually.	The removed anterior capsules from the laser-treated eyes were demonstrated to be equivalent or better with respect to dimension and conformance to circularity than those done manually.
   No significant difference in clinical outcomes from the sequelae of cataract surgery between treatment and conventional cataract surgery (CCC) populations.	No significant difference in clinical outcomes from the sequelae of cataract surgery was demonstrated between the Treatment and Treated Control populations.

2. Sample sizes used for the test set and data provenance

   • Test Set (Clinical): The study was a "prospective, single-center, multiple surgeon clinical trial." No specific sample size is provided for the number of eyes or patients in the LensAR Laser arm. The report mentions a "contralateral control population," suggesting at least some patients had one eye treated with LensAR and the other with CCC, but also states "not all fellow eyes underwent cataract surgery in the context of the clinical study."
   • Data Provenance: The clinical trial was a prospective, single-center study. The country of origin is not explicitly stated, but the submission is to the FDA in the USA.
   • Pre-Clinical Testing: Porcine eyes and plastic substrates were used for accuracy, reproducibility, acoustic, and thermal profile testing.

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 or their qualifications for establishing ground truth.
   • However, it does mention that "All capsulotomies were judged to be well centered by the surgeon using visual inspection in the operating microscope," indicating that the treating surgeons provided some form of assessment.

4. Adjudication method for the test set

   • The document does not describe a formal adjudication method (like 2+1 or 3+1). The assessment of capsulotomy centering was done by the operating surgeon via visual inspection.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical laser system, not an AI-assisted diagnostic or imaging device used by human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

   • Yes, the device's performance was evaluated in a standalone manner. The LensAR Laser System performs the anterior capsulotomy itself, and its performance characteristics (accuracy, reproducibility, safety, quality of cut) were assessed pre-clinically and clinically. The laser is a computer-controlled system for creating the cut.

7. The type of ground truth used

   • Clinical Ground Truth: Surgical success (successful capsulotomy and IOL placement, unremarkable postoperative course, centered IOLs), surgeon's visual inspection for capsulotomy centering, and subjective surgeon judgment for ease of capsule removal. The removed anterior capsules were also physically analyzed for dimension and circularity.
   • Pre-Clinical Ground Truth: Measurements of capsulotomy size and depth in porcine eyes and plastic substrates, and evaluation of acoustic and thermal profiles in ex vivo porcine eyes.

8. The sample size for the training set

   • No information is provided regarding a separate "training set" for the device itself. The device is a surgical instrument with computer control, not a machine learning algorithm that requires a distinct training dataset in the same sense as an AI diagnostic tool. The development process likely involved internal testing and refinement (bench testing and ex vivo studies) that could be considered analogous to iterative development, but it's not described as a formal "training set."

9. How the ground truth for the training set was established

   • As there's no explicitly defined "training set" in the context of an AI algorithm, details on how ground truth was established for it are not applicable here. The device's design and parameters were likely optimized through engineering and bench testing, for which the "ground truth" would be objective measurements of physical parameters and cut quality against design specifications.

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.