(175 days)
The LensAR Laser System is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively during the same surgery.
The LensAR Laser System is an ophthalmic surgical laser that has already been cleared for use in anterior capsulotomy in cataract surgery (K090633). It is now intended for additional use in anterior capsulotomy and laser phacofragmentation in cataract surgery, performed individually or consecutively during the same surgery.
The LensAR Laser generates ultrashort laser pulses that are scanned in a three-dimensional pattern in the eye to cut the anterior capsulotomy and to pre-cut the lens into small pieces for easy removal by conventional ultrasound phaco fragmentation. The fragmentation pattern is customized to the patient's eye based on precise measurement of the size, shape and position of the patient's lens by a built-in optical measuring system. During the measurement and subsequent application of the laser pulses, the eye is positioned and immobilized by an off-the-shelf suction ring assembly which is affixed to the eye and which is in turn docked to a refractive index matching eye docking (IMED) device mounted to the laser system.
Here's a breakdown of the acceptance criteria and study information for the LensAR Laser System, based on the provided text:
No acceptance criteria or reported device performance metrics (e.g., success rates, accuracy percentages, safety endpoints with specific thresholds) are explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through a clinical study rather than defining specific performance thresholds for acceptance.
However, it describes the clinical study that provided performance data to support the device's substantial equivalence.
Study that Proves the Device Meets the Acceptance Criteria (Implicitly, for Substantial Equivalence):
1. A table of acceptance criteria and the reported device performance
As mentioned above, no explicit quantitative acceptance criteria or reported device performance metrics are provided in the document. The study aimed to demonstrate the device's clinical performance in comparison to predicate devices, inferring safety and effectiveness for substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): 88 subjects (for the primary cohort, one eye per subject) and a control cohort of contralateral eyes in these subjects.
- Data Provenance: Prospective clinical study performed outside the U.S.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study describes the procedures performed (laser fragmentation/capsulotomy followed by phacoemulsification if needed) and a control group receiving conventional methods. It does not detail who established a "ground truth" or what that ground truth would specifically measure beyond the procedural outcomes themselves (e.g., successful fragmentation, clear capsulotomy).
4. Adjudication method for the test set
This information is not provided in the document.
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
- MRMC Study: No, this was not an MRMC study related to human reader performance with AI. The device is a surgical laser system, not an AI-assisted diagnostic or interpretation tool.
- Effect Size: N/A, as it's not an MRMC study with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone surgical laser system (an "algorithm" in the sense of its operational program). It performs the laser treatment. The clinical study evaluated the overall surgical procedure where the laser performs its function, followed by human intervention (phacoemulsification if needed). It's not a diagnostic algorithm that assists a human reader.
7. The type of ground truth used
The clinical study evaluated the clinical performance of the surgical procedures using the LensAR Laser System. The "ground truth" implicitly refers to the successful completion and clinical outcomes of anterior capsulotomy and laser phacofragmentation during cataract surgery, as observed by ophthalmologists. The document mentions:
- "Summary of Pre-Clinical Testing": "accuracy and reproducibility of capsulotomy and laser phaco fragmentation incisions in porcine eyes and plastic substrates."
- "Summary of Clinical Studies": describes patients undergoing procedures and follow-up.
The criteria for "success" or "performance" are not explicitly defined as a specific "ground truth" metric but rather related to the procedural outcomes and comparative performance against conventional methods.
8. The sample size for the training set
This information is not provided in the document. The document describes pre-clinical testing and a clinical study but does not detail a "training set" in the context of machine learning or AI, as this is a surgical device.
9. How the ground truth for the training set was established
N/A, as no "training set" in the AI/ML sense is mentioned or relevant for this type of medical device's submission summary. The product development likely involved extensive engineering and testing against design specifications, but this is not framed as a "training set" with ground truth in this context.
§ 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.