(140 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 phacofragmentation, 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. In addition to the laser classifications per 21 CFR 1040.10 and 1040.11, the Catalys™ Precision Laser System complies with the requirements for Class I lasers per ANSI Z136.1-2007.
Here's an analysis of the provided text regarding the acceptance criteria and study for the OptiMedica Catalys Precision Laser System:
Acceptance Criteria and Device Performance Study for OptiMedica Catalys™ Precision Laser System
This document describes the bench and animal performance testing conducted to demonstrate the substantial equivalence of the OptiMedica Catalys™ Precision Laser System.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing (Corneal Incision Accuracy & Precision) | ±75um relative to the intended cut dimensions for all corneal incision patterns. | "All measured values met the test protocol acceptance criteria of ±75um relative to the intended cut dimensions." |
| "The spectrum of pattern testing validated the system capability to cut a variety of single plane and multi-plane arc cuts/incisions patterns within specified limits for accuracy and precision." | ||
| Animal Testing (Corneal Safety - Histology) | Histological acceptance criteria when compared to standard manual surgical incisions histology. | |
| (Note: Specific quantitative criteria are not provided in the summary, but it implies successful comparison to a gold standard). | "Each and all laser created corneal incisions met the histological acceptance criteria when compared to manual surgical incisions histology." | |
| Cadaver Eye Testing (Qualitative Incision Effectiveness) | Qualitative acceptance criteria for effectively cutting a variety of tissue types. | |
| (Note: Specific qualitative criteria are not provided, but implies successful tissue cutting). | "Each and all laser created corneal incisions met the qualitative acceptance criteria." |
2. Sample Size and Data Provenance
- Bench Testing: "Multiple samples for a given test pattern were created in a test substrate." The exact number is not specified.
- Animal Testing: The exact number of animals or incisions is not specified.
- Cadaver Eye Testing: The exact number of cadaver eyes or incisions is not specified.
- Data Provenance: The studies appear to be prospective in nature, conducted specifically for this 510(k) submission to demonstrate the device's performance. The country of origin of the data is not explicitly stated, but it's presumed to be the United States, given the FDA submission context.
3. Number of Experts and Qualifications for Ground Truth
- Bench Testing: The ground truth was established by "cross-sectioning and measured using a NIST-traceable reticule, under magnified digital image analysis." This implies technical experts performing measurements, but no specific number or qualifications are provided beyond the NIST traceability.
- Animal Testing: The comparison was against "standard manual surgical incisions histology." This implies veterinary pathologists or similar experts would have evaluated the histology, but no details on their number or qualifications are provided.
- Cadaver Eye Testing: The ground truth was based on "qualitative acceptance criteria." This would likely involve expert assessment of the incision quality, but no details on the number or qualifications of these experts are provided.
4. Adjudication Method for the Test Set
The reported studies do not describe a specific adjudication method like 2+1 or 3+1. The ground truth appears to be derived directly from measurements (bench testing) or comparative histological/qualitative assessments (animal and cadaver testing), implying single expert or consensual assessment rather than a multi-reader adjudication process with conflict resolution.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information suggesting a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done is present in the provided text. The studies focus on the device's technical performance and safety, not on human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The device, the OptiMedica Catalys Precision Laser System, is an ophthalmic surgical laser system. Its "performance" refers to the accuracy, precision, and safety of the laser actions (capsulotomy, phacofragmentation, corneal incisions) it performs directly, not an AI algorithm that provides diagnostic or assistive outputs for a human. Therefore, a standalone algorithm performance study in the typical sense (e.g., for an imaging AI) is not applicable. The device itself is the "standalone" entity whose performance is being evaluated.
7. Type of Ground Truth Used
- Bench Testing: Metrology (NIST-traceable reticule measurements of physical cuts).
- Animal Testing: Histopathology (comparison of laser-created incisions to manual incisions).
- Cadaver Eye Testing: Qualitative expert assessment of incision effectiveness.
8. Sample Size for the Training Set
The document describes performance testing, not the development or training of an AI algorithm. Therefore, there is no mention of a "training set" in the context of machine learning. The system presumably relies on pre-programmed parameters and control algorithms rather than a learned model from a training set.
9. How the Ground Truth for the Training Set Was Established
As stated above, this document does not describe a machine learning model, and thus, no training set or ground truth establishment method for a training set is applicable or provided.
§ 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.