(29 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 OpticsTM 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 arccuts/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 OpticsTM [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 1040.11 is Class 4.
This document is a 510(k) premarket notification for the CATALYS® Precision Laser System. It is a submission for a modified device, comparing it to a previously cleared predicate device (K200056). The core of this submission is to demonstrate that the modified device remains substantially equivalent to its predicate.
Based on the provided information, the focus is on non-clinical performance data because clinical data was deemed not necessary for this submission. The device modifications are related to the Mobile Patient Bed, not the primary laser system itself.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable format for this specific submission. Instead, it relies on demonstrating that the modified device's performance is maintained and that the changes do not introduce new safety or efficacy concerns compared to the predicate device. The "acceptance criteria" in this context are implicitly that the modified Mobile Patient Bed performs its intended function safely and effectively within the CATALYS® System, consistent with the original cleared device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mobile Patient Bed Functionality: |
- Maintain consistent motor output for Z-motors when lifting maximum weight.
- Proper battery and charging management.
- Diagnostic data logging capability (field service accessible).
- Functional and tactile mechanical interface (pendant buttons, armrest, headrest). | Electronics/Circuits:
- Z-Motors: "Consistent motor output between MPB's when lifting maximum weight."
- Battery/Charging: "Vendor provided battery management module" (implies proper functionality).
Firmware/FPGA: - "Diagnostic data logging (only field service accessible)."
Mechanical: - "Tactile membrane switches on pendant."
- "Armrest attached to seat near backrest."
- "Simpler headrest assembly with only one articulation points." |
| System Integration and Safety: - No adverse effects introduced by the changes to the Mobile Patient Bed.
- Maintains same intended use, indications for use, and fundamental/scientific technology as the predicate device.
- No new harms or unacceptable risks. | "Design verification and validation testing was performed to verify the ability of the modified Mobile Patient Bed to meet its intended use with the Catalys System and to ensure that no adverse effects have been introduced due to the changes."
"The testings conducted and presented for the subject device, provides reasonable assurance that the System remains substantially equivalent for its intended use..."
"It does not introduce any new harms or unacceptable risks..." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a numerical sample size for the test set used in the design verification and validation testing. The testing refers to "subsystem level verification and regression testing, as well as system validation."
- Data Provenance: The data is internally generated by AMO Manufacturing USA, LLC, as part of their design verification and validation process for the device modifications. The geographic origin of the data is not specified, but it would typically be internal testing data from the manufacturer's facilities. It is retrospective in the sense that it's performed on the modified device before submission for clearance, but it's prospective in terms of testing the changes being proposed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the study described is a non-clinical device verification and validation study, not a study involving expert-derived ground truth (e.g., image interpretation). The "ground truth" here is the expected functional and safety performance of the device components, which is defined by engineering specifications and regulatory standards.
4. Adjudication method for the test set
This section is not applicable for the same reasons as above. There isn't a need for adjudication in the context of verification and validation testing of device components.
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
An MRMC comparative effectiveness study was not done. This device is an ophthalmic laser system for cataract surgery, not an AI-powered diagnostic or assistive tool for human readers. The clinical performance data was deemed "not necessary."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable in the context of an "algorithm only" performance. The device is a physical laser system with integrated software, not a standalone AI algorithm. The performance evaluation focuses on the entire system's functionality and safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As this is a non-clinical validation of device modifications, the "ground truth" for the tests performed (subsystem verification, regression testing, system validation) would be based on:
- Engineering specifications and design requirements: The modified components (electronics, battery, firmware, mechanical parts of the Mobile Patient Bed) must meet pre-defined engineering and performance criteria.
- Regulatory standards: Compliance with relevant medical device safety and performance criteria (e.g., ISO 15004-2:2007 mentioned for output power) is an implicit ground truth.
- Equivalence to predicate: The ultimate "ground truth" for this submission is demonstrating that the changes do not negatively impact the substantial equivalence to the already cleared predicate device.
8. The sample size for the training set
This section is not applicable as there is no mention of machine learning or an "AI algorithm" requiring a training set in the context of this 510(k) submission. The changes are hardware and associated firmware modifications to a component of an existing laser system.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
§ 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.