(126 days)
The CATALYS® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of 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.
Catalys® Precision Laser System ophthalmic surgical laser system used in healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings. The System is an electromedical device that contains software. System components include a single-use Liquid Optics™ Interface and optional Mobile Patient Bed.
The Catalys® Precision Laser System (also referred to as the Catalys® System or System) is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates 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 System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus).
The information provided is about the CATALYS® Precision Laser System for cataract surgery, specifically a software update (K200056), and does not describe a device that uses AI or machine learning. Therefore, many of the requested categories related to AI performance, such as sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable.
The document indicates that the device itself is a laser system used in ophthalmic surgery. The update discussed in this document relates to software revisions to improve workflow efficiency, advanced astigmatism management, and additional improvements to existing features, including the addition of software modules to support patient exam import and iris registration.
Here's an analysis of the provided text based on the questions, with "N/A" for criteria not applicable to this type of device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a table format with corresponding reported performance metrics for the software updates. Instead, it states that "Software verification and validation testing in addition to bench testing was performed to verify the ability of the software to meet its intended use and to ensure that no adverse effects were introduced due to the software changes." and "The modified device employs additional tests to verify the performance of the laser’s ability to execute the intended trajectory."
The non-clinical performance data section effectively serves as the "study" that proves the device meets (implied) acceptance criteria, by demonstrating that the software changes do not negatively impact safety and efficacy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software ability to meet all intended design specifications | Software-specific bench testing conducted to demonstrate the System's ability to meet all intended design specifications related to the software design changes. |
| No adverse effects introduced due to software changes | Software verification and validation testing, in conjunction with bench tests and simulated use testing, was performed to ensure no adverse effects were introduced. |
| Performance of the laser’s ability to execute the intended trajectory | The modified device employs additional tests to verify the performance of the laser's ability to execute the intended trajectory. |
| Overall safety and efficacy for intended use remains | Bench testing, coupled with software regression testing, verification, and validation testing, provides reasonable assurance that the System remains safe and effective for its intended use and is substantially equivalent to the primary predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The testing involved "hardware and software bench tests, in conjunction with simulated use testing."
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing described as "bench testing" and "simulated use testing" implies a controlled, laboratory-type environment rather than patient data. The submission is from AMO Manufacturing USA, LLC, suggesting the testing was likely conducted in the US. The term "retrospective or prospective" is not applicable as this was bench and simulated use testing, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of expert consensus is typically relevant for interpretative devices (like AI for image analysis). This document describes a surgical laser system with software updates, and the testing focuses on functional performance and adherence to design specifications through bench and simulated use testing, not on expert interpretation of output.
4. Adjudication method for the test set
Not applicable, as expert adjudication of results is not relevant for this type of technical device performance testing.
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
Not applicable. This device is a laser system for surgery, not an AI-powered diagnostic or interpretive tool where human readers would be assessing cases with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The software changes are part of a surgical laser system, which inherently involves a human operator (surgeon). The testing described focuses on the software's ability to control the laser and execute its functions as designed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for AI/diagnostic devices (e.g., pathology, clinical outcomes) is not directly applicable. For this device, the "ground truth" would be established by engineering specifications, validated measurements, and successful execution of intended laser trajectories and software functions during bench and simulated use testing. For example, "the performance of the laser's ability to execute the intended trajectory" would be verified against its programmed design.
8. The sample size for the training set
Not applicable. This document describes software updates for an existing medical device, not a machine learning model that requires a training set. The changes involve workflow improvements, astigmatism management, and patient data import/iris registration functionalities.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device requiring a training set.
§ 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.