(67 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 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. 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; as well as the size, architecture of incisions within the cornea, and depth of arcuate incisions. The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline" includes the integration with preop analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis" corneal marking for simple alignment of Toric IOLs as well as corneal treatment planning tools for precision guided laser treatments.
Here's an analysis of the provided text regarding the LENSAR Laser System - fs 3D (LLS-fs 3D), specifically focusing on the Iris Registration feature and its performance data:
The document describes performance data for the Iris Registration feature after an update that includes:
- Addition of Topcon Aladdin, OCULUS Pentacam® HR, and Pentacam® AXL topographers.
- An additional routine to the Iris Registration function to improve robustness to pupil center drift and gaze direction for cyclotorsion angle identification.
- Updated software for improved user interaction.
The study presented focuses only on the performance evaluation of the Iris Registration feature, not the overall device. Clinical performance data was not required for the changes described.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the reported performance metrics. The goal is for the algorithm to correctly determine the cyclotorsion angle and minimize cases where it cannot determine an angle or determines an incorrect one.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Modified Algorithm) |
|---|---|---|
| i-Optics Cassini Topographer | ||
| Correct Cyclotorsion Angle | High (e.g., ≥ 97%) | ≥ 98.97% |
| Cannot Determine an Angle | Low (e.g., ≤ 3%) | ≤ 1.03% |
| Incorrect Cyclotorsion Angle | Very Low (e.g., ≤ 0.01%) | ≤ 0.002% |
| Nidek OPD Scan Topographer | ||
| Correct Cyclotorsion Angle | High (e.g., ≥ 97%) | ≥ 98.52% |
| Cannot Determine an Angle | Low (e.g., ≤ 3%) | ≤ 1.48% |
| Incorrect Cyclotorsion Angle | Very Low (e.g., ≤ 0.01%) | ≤ 0.002% |
| Topcon Aladdin Topographer | ||
| Correct Cyclotorsion Angle | High (e.g., ≥ 97%) | ≥ 97.17% |
| Cannot Determine an Angle | Low (e.g., ≤ 3%) | ≤ 2.83% |
| Incorrect Cyclotorsion Angle | Very Low (e.g., ≤ 0.01%) | ≤ 0.002% |
| OCULUS Pentacam® HR Topographer | ||
| Correct Cyclotorsion Angle | High (e.g., ≥ 97%) | ≥ 97.50% |
| Cannot Determine an Angle | Low (e.g., ≤ 3%) | ≤ 2.50% |
| Incorrect Cyclotorsion Angle | Very Low (e.g., ≤ 0.01%) | ≤ 0.002% |
| OCULUS Pentacam® AXL Topographer | ||
| Correct Cyclotorsion Angle | High (e.g., ≥ 97%) | ≥ 98.33% |
| Cannot Determine an Angle | Low (e.g., ≤ 3%) | ≤ 1.67% |
| Incorrect Cyclotorsion Angle | Very Low (e.g., ≤ 0.01%) | ≤ 0.002% |
Note: The document states "All criteria were met" (page 5), implying these reported values meet the internal specifications.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of images or patients) used for the test set for any of the topographers. It refers to "re-running the respective data sets," implying pre-existing datasets were used.
Data Provenance: Not specified. It's unclear if the data is retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The method for establishing the "correct cyclotorsion angle" (ground truth) is not described.
4. Adjudication Method for the Test Set
The adjudication method is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The performance data specifically evaluate the algorithm's performance (standalone) for Iris Registration, comparing it to an "Original Algorithm" in some tables, but not involving human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study of the algorithm's performance was done. The tables clearly present the performance metrics of the algorithm itself in determining the cyclotorsion angle. The comparison tables for i-Optics Cassini and Nidek OPD Scan also show the performance of the "Original Algorithm" versus the "Modified Algorithm," indicating an algorithm-to-algorithm comparison.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated. It can be inferred that it relates to the "Correct Cyclotorsion Angle," but how this "correct" angle was determined (e.g., by manual expert annotation, a different validated instrument, or pathology) is not described.
8. Sample Size for the Training Set
The sample size for the training set is not provided. The document details changes to an existing algorithm and its performance, but not its development or training details.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document.
§ 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.