Search Results

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) 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 multiplane 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 phaco fragmentation treatment within the lens; as well as the size, architecture of incisions within the cornea, and depth of arcuate incisions.

Here's an analysis of the acceptance criteria and study information for the LENSAR Laser System - fs 3D (LLS-fs 3D), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set. It mentions "Verification and validation testing were completed," but the number of cases or images analyzed for the Iris Registration feature is not provided.

The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The method for establishing ground truth for the "correct cyclotorsion angle" is not described.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The study focused on the performance of the Iris Registration feature itself, not on human reader improvement with or without AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study was done for the Iris Registration feature. The reported device performance in the table above reflects the algorithm's performance without human intervention in determining the cyclotorsion angle.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. For the "correct cyclotorsion angle," it would typically involve a reference standard established by a highly accurate measurement technique or expert consensus, but the detail is missing.

8. Sample Size for the Training Set:

The document does not provide information about the sample size used for the training set. It refers to "Verification and validation testing," but no details on training data are given.

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

This information is not provided in the document.

Summary of the Study:

The provided 510(k) summary focuses on the LENSAR Laser System - fs 3D (LLS-fs 3D) and specifically addresses the validation of its Iris Registration feature with the Nidek OPD Scan Topographer. The study was a performance evaluation of this particular feature.

The key aspects of the study as reported are:

• Objective: To demonstrate that the Iris Registration feature, particularly with the Nidek OPD Scan Topographer, meets predefined specifications and requirements.
• Methodology: Verification and validation testing were conducted.
• Results: The Iris Registration algorithm demonstrated a high accuracy rate in determining the correct cyclotorsion angle (≥ 99.26%) when used with the Nidek OPD Scan Topographer. It also had a very low incidence of determining an incorrect angle (≤ 1.81 * 10-3 %).
• Conclusion: The company concluded that the Iris Registration feature meets all performance specifications and requirements, and that the LENSAR Laser System - fs 3D is substantially equivalent to its predicate device (K143010) with this additional validated feature.
• Clinical Studies: No clinical evaluations were deemed necessary for this specific submission because the additional feature did not change the device's indications for use.

Missing Information:

Crucially, the document lacks detailed information on the methodology of the validation study, including:

• The exact number of cases/samples in the test set.
• How the "correct cyclotorsion angle" (ground truth) was determined for these cases.
• Details about the dataset's origin (e.g., retrospective/prospective, demographics).
• Any information regarding the training dataset for the algorithm.

Ask a specific question about this device