(53 days)
The OptiMedica® 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.
The Catalys Precision Laser System ("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).
This document describes a 510(k) premarket notification for the "Catalys Precision Laser System" (K172002). The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K170322). The changes primarily involve an upgraded software version (cOS 5.0) and the addition of a Mobile Patient Bed.
Based on the provided text, the following information can be extracted/inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical performance metrics for an AI/algorithm-based device. Instead, it focuses on demonstrating that the updated "Catalys Precision Laser System" with cOS 5.0 and the Mobile Patient Bed continues to meet its intended design specifications and performs as intended.
The acceptance criteria are implicitly related to the device's ability to "deliver incisions as intended" and continue to provide the functions (anterior capsulotomy, phacofragmentation, corneal incisions) with appropriate accuracy and precision, as established during the clearance of the predicate device (K170322).
Reported Device Performance:
- "Bench testing demonstrated that subject device with cOS 5.0 continues to deliver incisions as intended."
- "Bench testing of the predicate device with regards to the ability to deliver a variety of laser patterns intended for capsulotomy, phacofragmentation and corneal incisions with corresponding accuracy and precision is directly applicable to the subject device as there are no significant changes to the subject device other than the software change and the use of the Mobile Patient Bed with the Catalys Precision Laser System."
- The system complies with laser classifications per 21 CFR 1040.10 and 1040.11, and Class 4 lasers per ANSI Z136.1-2007.
- Biocompatibility testing confirmed the Mobile Patient Bed upholstery meets ISO 10993-1 requirements.
- Electrical safety and EMC testing ensured compliance with electrical safety standards.
2. Sample Size Used for the Test Set and Data Provenance
The document primarily describes bench testing and design validation. It does not mention clinical studies or test sets involving patient data (images, clinical records, etc.) in the context of an AI algorithm's performance on such data. The testing described is focused on the device's functional performance, hardware, and software.
- No specific sample size for a "test set" of patient data is provided, as the studies are not evaluating diagnostic or prognostic AI performance on patient data.
- The data provenance is from bench testing activities (e.g., software-specific bench testing, hardware-specific bench testing of the Mobile Patient Bed) rather than patient data. The country of origin of this testing is not explicitly stated, but the applicant (AMO Manufacturing USA, LLC) is based in Milpitas, CA, USA. The testing appears to be prospective in nature, conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
As the studies described are bench tests of hardware and software functionality and safety, and not an evaluation of an AI algorithm on patient data, the concept of "ground truth" derived from experts' review of patient data is not applicable here. The "ground truth" for these tests would be the design specifications and regulatory standards.
4. Adjudication Method for the Test Set
Not applicable as there is no mention of a test set involving human interpretation of data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study is not mentioned. This submission is for a laser surgical system, not a diagnostic or decision-support AI intended to assist human readers in interpreting medical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a "Precision Laser System" that employs "femtosecond laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics." It has "system software" (cOS 5.0) that "recognizes ocular surfaces" and uses "a computerized scanning system" to direct the laser.
While the system has automated functions and software, the description does not position it as a standalone AI algorithm in the sense of a diagnostic or prognostic tool that processes data independently to produce an output for human review in a clinical decision-making pathway. It's an automated surgical device. The "standalone" performance described is the system's ability to fulfill its intended surgical actions (capsulotomy, phacofragmentation, corneal cuts) based on its programming, without direct human intervention in each laser pulse, but still under the supervision and operation of a surgeon.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" is defined by:
- Design specifications: The intended performance parameters and requirements of the device.
- Regulatory standards: Compliance with standards like 21 CFR 1040.10, 1040.11, ANSI Z136.1-2007, and ISO 10993-1.
- Predicate device performance: The previously cleared performance of the K170322 system serves as a baseline for "accuracy and precision" in delivering laser patterns.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning. The software (cOS 5.0) for this device is described as an "upgraded software version" to provide "compatibility" and ensure continued performance, rather than a learning algorithm trained on a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable, as a machine learning training set is not described. The "ground truth" for the software's functionality would be its adherence to engineering specifications and safe operation relative to the established performance of the predicate device.
§ 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.