(111 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 Device Description: used in healthcare facilities such as hospitals. Ambulatory Surgerv Centers (ASCs) and surgeon office settings. The 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 threedimensional 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 1040.11 is Class 4.
Here's an analysis of the acceptance criteria and study information for the CATALYS™ Precision Laser System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list quantitative acceptance criteria for the device's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technical characteristics and software changes.
The "reported device performance" is described qualitatively as "the System's ability to meet all intended design specifications related to the software design changes" and that "the System remains safe and effective for its intended use".
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "hardware and software bench tests" and "simulated use testing", but does not provide details on the number of tests or specific data samples used for these tests.
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. The testing involved "bench testing" and "simulated use testing", suggesting a controlled environment rather than real-world patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The testing described primarily focuses on technical and software verification, not clinical performance based on expert review of outcomes.
4. Adjudication Method for the Test Set
This information is not provided as the type of testing described (bench and simulated use) does not typically involve expert adjudication in the way clinical studies or image-based AI studies do.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Data was deemed not necessary for the Catalys™ Precision Laser System."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a laser system with integrated software, not purely an algorithm that provides a diagnostic output. The "standalone" performance in this context would refer to the laser system's ability to execute its functions (capsulotomy, phacofragmentation, corneal cuts) according to its design specifications.
The document states, "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 have been introduced due to the software change." This implies standalone testing of the software's functionality within the system.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance data appears to be based on engineering and design specifications. The software's ability to meet its "intended design specifications" was verified. For the laser's physical actions, the ground truth would be precise measurements of the cuts/fragmentation against pre-defined parameters.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a laser system, not an AI model trained on a large dataset in the conventional sense (e.g., for image analysis). The software updates are for workflow efficiency, astigmatism management, and iris registration, which are likely based on engineering development and calibration rather than machine learning training sets.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided 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.