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

· in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;
· in the creation of full and partial thickness single-plane and multi-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.

Device Description

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-C™ (corneal) and IntelliAxis-L™ (lens) markers for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.

AI/ML Overview

This document describes the LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™, an ophthalmic surgical laser. The submission is a 510(k) for changes to an already cleared device (K173346), specifically the introduction of a new elliptical-shaped Patient Interface Device (PID) Kit, a software change related to Limbus detection, and a change in manufacturing process for the PMMA contact lens of the Curved Contact PID.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied/Derived)	Reported Device Performance
New elliptical PID Modification:
IOP Rise	Consistent with existing LENSAR PID (cleared in K173346).	The new proposed elliptical PID was consistent with LENSAR's existing PID regarding IOP pressure rise.
Eye Stability (during surgery)	Comparable minimum force necessary to detach the eye from the suction ring as existing LENSAR PID.	The minimum force necessary to detach the porcine eye from the suction ring was comparable to that of LENSAR's existing PID.
Corneal Folds	No visible corneal folds compared to existing LENSAR PID.	Using OCT images, no visible folds were noted.
Iris Registration and Limbus Detection	All specifications of Iris Registration and Limbus Detection functions achieved with elliptical PID.	The analysis incorporated images of eyes with the elliptical PID and showed that all specifications of the Iris Registration and the Limbus Detection functions were achieved.
Hazard Analysis	All potential hazards have acceptable levels of probability/severity characteristics with the proposed changes.	The hazard analysis demonstrates that all potential hazards have acceptable levels of probability/severity characteristics.
General Performance (new elliptical PID)	Meets all performance specifications and requirements.	All criteria for unit/system verification testing were met, and the results demonstrate that the LENSAR System with the new elliptical PID meets all performance specifications and requirements.
Biocompatibility:
New elliptical PID (materials)	No new biocompatibility testing deemed necessary (due to no material changes from existing PID).	Biocompatibility risk evaluation indicated no new biocompatibility testing was necessary.
Molded PMMA contact lens	Materials used are biocompatible, passing cytotoxicity, irritation, and sensitization tests.	Based on testing (cytotoxicity, irritation, and sensitization), no issues were found, and all testing passed.
Software Verification and Validation:
All changes and updates	Complies with specifications and requirements, follows FDA guidance.	Complete software verification and validation testing was conducted covering all cited changes and updates, and documentation was provided as recommended by FDA guidance. The software was considered "major" level of concern.

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

IOP Rise, Eye Stability, Corneal Folds: Tested in vitro using porcine eyes. The specific number of porcine eyes is not provided in the document.
Iris Registration and Limbus Detection: Analysis incorporated images of eyes with the elliptical PID. The specific number of images or eyes is not provided.
Biocompatibility (Molded PMMA): Testing was performed for cytotoxicity, irritation, and sensitization. The sample size or specific test protocols are not detailed.
Software Verification and Validation: Conducted through unit and system testing, implying internal testing and validation against specifications. No specific "test set" size in terms of patient data is mentioned for this aspect.

The data provenance for the in vitro studies (porcine eyes) is not specified further than "porcine eyes." No human patient data is mentioned for testing these specific device modifications.

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

The document does not detail the use of external experts to establish ground truth for the test set.

For the in vitro studies (IOP, stability, corneal folds), the assessment seems to be based on direct measurement or observation (e.g., OCT images for corneal folds) conducted by the manufacturer's testing personnel.
For Iris Registration and Limbus Detection, "specifications...were achieved," suggesting internal verification against defined parameters.
Hazard analysis was performed, likely by an internal risk management team.

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 results. The assessments appear to be based on internal testing and compliance with specifications.

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

There is no mention of an MRMC comparative effectiveness study or any study involving human readers and AI assistance. This submission focuses on hardware and software changes to an existing laser system, not an AI diagnostic or assistive tool for human interpretation.

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

The device is a surgical laser system; therefore, the concept of "standalone performance" for an algorithm in the typical sense (e.g., diagnostic AI) does not directly apply. The software performance described is integrated into the operation of the laser system (e.g., Limbus detection, Iris Registration). Its performance is evaluated within the context of the device's functional operation, not as a standalone interpretive algorithm.

7. The Type of Ground Truth Used

For IOP, eye stability, and corneal folds, the ground truth is derived from direct physical measurements and observations on porcine eyes, compared against the performance of the predicate device's existing PID.
For Iris Registration and Limbus Detection, the ground truth is adherence to pre-defined technical specifications for these functions.
For biocompatibility, the ground truth is the results of standardized biocompatibility tests (cytotoxicity, irritation, sensitization).

8. The Sample Size for the Training Set

This document does not describe the use of a "training set" in the context of machine learning or AI development. The software updates mentioned are likely modifications to existing algorithms or new implementations based on deterministic logic, rather than machine learning algorithms requiring large training datasets.

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

As no training set is described in the context of machine learning, this question is not applicable. The software changes are verified against internal specifications and by demonstrating that they do not compromise the safety and effectiveness of the existing system.

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.