(83 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 is an ophthalmic surgical laser system used in healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings. The Catalys® Precision Laser System is an electromedical device which 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 Catalys® Precision Laser System laser classification per 21 CFR 1040.10 and 21 CFR 1040.11 is Class 4.
This document describes the CATALYS® Precision Laser System, specifically focusing on the acceptance criteria and study that proves the device meets those criteria for a modified Liquid Optics Interface (LOI).
Here's an breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission describes bench testing performed to confirm the ability of the Gen3 LOI to meet its intended use. The acceptance criteria themselves are explicitly stated as "All acceptance criteria were met" for various tests, implying successful completion against predefined benchmarks. The document also states, "The acceptance criteria remain unchanged between Gen2 and Gen3 LOI." While specific quantitative criteria are not listed in a table format within the provided text, the document asserts that they were met. The reported performance is that the device did meet these (unspecified) criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterilization Cycle Validity | All acceptance criteria were met. (Minimum 10-6 SAL achieved) |
| Performance Testing (Baseline & Aged) | All acceptance criteria were met. |
| Biocompatibility (Colorant) | No leaching and no cytotoxicity for the minor colorant addition. |
| Overall Safety and Effectiveness | The device remains safe and effective for its intended use and is substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench testing" and "performance testing conducted for the Gen3 LOI." It indicates testing was done at "baseline time point T=0 (before aging) and at T=24 (after accelerated aging equivalent to 24 months)." However, the exact sample size for any of these tests is not specified in the provided text. The data provenance is stated as from the manufacturer's own internal testing, specifically AMO Manufacturing USA, LLC, which is a retrospective evaluation of a new manufacturing process for an existing component.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not describe the use of human experts to establish "ground truth" for the technical performance tests. These tests (sterilization, performance, biocompatibility) typically rely on standardized protocols and instrumental measurements against engineering specifications, rather than subjective expert assessment.
4. Adjudication Method for the Test Set
Not applicable, as the testing described focuses on objective technical performance criteria (e.g., sterilization assurance, mechanical integrity, biocompatibility) rather than subjective assessments requiring adjudication.
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 proposed device does not include any changes to the indications for use or intended use of the primary predicate device. It does not introduce any new harms or unacceptable risks, and therefore does not require clinical testing to assess safety and performance or to demonstrate equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an ophthalmic laser system for cataract surgery with a modified patient-user interface. It is a physical medical device, not an AI or algorithm-only product. Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable. The performance evaluated here is the physical and functional performance of the device's components.
7. The Type of Ground Truth Used
The ground truth for the evaluations conducted ("sterilization cycle validation," "performance testing," and "biocompatibility testing") would be established by:
- Sterilization Validation: Meeting a predefined Sterility Assurance Level (e.g., 10-6 SAL) through standard microbiological challenge tests as defined by ISO 11135 and AAMI TIR28.
- Performance Testing: Adherence to engineering specifications and design requirements for the Liquid Optics Interface (LOI), ensuring it functions correctly with the CATALYS® Precision Laser System.
- Biocompatibility Testing: Compliance with biocompatibility standards (e.g., ISO 10993) demonstrating no cytotoxic effects or leaching for the specified materials.
8. The Sample Size for the Training Set
Not applicable. This submission is for a modification to a physical medical device component, not for an AI/machine learning algorithm that requires a "training set." The changes involve manufacturing site, sterilization parameters, and a colorant change for a single-use interface.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/machine learning algorithm described in this 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.