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

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;
in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea;
in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and
in the creation of partial thickness single-plane radial cuts/incisions in the cornea.

Device Description

The 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, in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea, and in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments, each of which may only be performed individually. Additionally, the device is also intended for use in the creation of partial thickness single-plane radial cuts/incisions in the cornea which may be performed individually or consecutively with arcuate incisions.

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. flap, and tunnel cuts.

The 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

Acceptance Criteria and Study for LENSAR Laser System - fs 3D (LLS-fs 3D)

The information provided describes the performance evaluation conducted for the LENSAR Laser System - fs 3D (LLS-fs 3D) to support its substantial equivalence, particularly concerning new indications for use related to corneal ring segments and radial incisions.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Corneal Tunnel Depth Accuracy	Achieved depth was "well within the established requirements" for corneal tunnel depth.
Corneal Tunnel Incision Quality & Ease of Opening	Demonstrated "ease of opening and quality of incision quality that was acceptable."
Radial Incision Depth Accuracy (individual or with arcuate incisions)	Achieved depth was "well within the established requirements" for radial incision depth.
Radial Incision Quality & Ease of Opening (individual or with arcuate incisions)	Demonstrated "ease of opening and quality of incision quality that was acceptable."
Effect on Endothelial Cells from Partial Thickness Incisions	"No loss of endothelial cell density when a sufficiently large residual corneal bed is maintained."
Hazard Analysis	All potential hazards have "acceptable levels of probability/severity characteristics."
Software Verification and Validation	All criteria were met, demonstrating the software meets all performance specifications and requirements.

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

Sample Size: Not explicitly stated as a number of eyes, but the studies were conducted on porcine ex vivo eye models.
Data Provenance: The data is from pre-clinical testing on porcine ex vivo eye models. This indicates an in vitro or ex vivo setting, not human clinical data.

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

For the assessment of incision quality (corneal tunnel and radial incisions), a "trained biomedical scientist" was used.
No further details are provided regarding the number of scientists, their specific qualifications, or years of experience.

4. Adjudication Method for the Test Set

Not explicitly stated. For the incision quality assessment, it mentions "A trained biomedical scientist... assessed the acceptability," implying a single assessor or a consensus not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "The addition of the added indications for use and other minor changes... did not require clinical performance data to demonstrate substantial equivalence to the predicate device."
Therefore, there is no effect size of human readers improving with or without AI assistance.

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

The performance data presented focuses on the device's ability to create precise cuts and tunnels. While the device uses software and imaging for guidance (Iris Registration, IntelliAxis, CustomFrag), the performance evaluation described directly assesses the physical outcomes of the laser treatment on anatomical models. It does not describe a "standalone" algorithmic performance in the typical sense of an AI model making diagnostic or prescriptive decisions without human oversight or direct intervention. The device itself is a surgical tool controlled by a surgeon.

7. The Type of Ground Truth Used

Instrumental measurements: For depth accuracy, an optical coherence tomographer was used.
Expert assessment: For incision quality, a trained biomedical scientist performed the assessment.
Biological assessment: Evaluation of endothelial cells of ex vivo eyes for cell density loss.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for any training set. The performance data presented is for verification and validation testing, which often refers to testing on a held-out set after development. There is no information provided about how the device's algorithms or parameters (e.g., for depth placement, cut patterns, image analysis) were internally trained or developed.

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

This information is not provided in the document. As no training set size is stated, the method for establishing its ground truth is also absent. The document focuses on the validation studies performed to demonstrate the device meets specifications, rather than the internal development or training processes of its embedded software/algorithms.

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.