(107 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") 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 2[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 the Catalys Precision Laser System, an ophthalmic surgical laser. The information provided heavily emphasizes bench and cadaver testing for the patient interface component and system functionality, rather than presenting a clinical study involving human patients with clear acceptance criteria and performance metrics typically found in AI/ML device submissions.
Therefore, many of the requested items (e.g., acceptance criteria for clinical performance, sample size for test set with human data, number of experts for ground truth, MRMC study, training set details) cannot be extracted from the provided text. The text focuses on engineering and bench testing to demonstrate design verification and validation for minor design changes to an existing device, not on demonstrating clinical performance of an AI/ML algorithm.
However, I can extract information related to the bench and cadaver testing that was performed.
Here's the closest possible interpretation of your request based on the provided text, focusing on the available information regarding testing:
Device: Catalys Precision Laser System (Ophthalmic Laser)
Purpose of Submission (K170322): This 510(k) submission is for minor design changes to the Patient Interface Component (Liquid Optics Interface - LOI) of an already cleared predicate device (Catalys Precision Laser System; K161455). The study aims to demonstrate that the redesigned LOI, and the system as a whole with the updated LOI, continues to meet intended design specifications and performs as intended.
Acceptance Criteria and Reported Device Performance (based on Bench and Cadaver Testing):
| Acceptance Criteria Category (Implied from Testing) | Specific Test/Evaluation | Reported Performance (Summary from Text) |
|---|---|---|
| Functional Verification (LOI & System) | Installation of LOI onto Catalys system | Verified functional requirements for the subject device as a complete assembly with the system. |
| Sub-assembly Testing (LOI components) | Disposable lens, suction ring, fluid reservoir subassemblies | Functional requirements successfully met on a sub-assembly level. |
| Design Validation (LOI & System with Software) | Functionality with Catalys System and cOS 3.90 software | Validated subject device requirements and its functionality. |
| Cadaver Eye Model Performance | Eye fit | Product continues to perform as intended. |
| Intraocular pressure rise at the eye | Product continues to perform as intended. | |
| Suction ring's ability to maintain vacuum and seal when attached to the eye | Product continues to perform as intended. | |
| Packaging Integrity | Packaging validation | Meets requirements for maintaining sterile barrier integrity, product functionality, and labeling. |
| Shelf-Life | Shelf-life testing | Successfully performed to verify and validate the shelf life of the subject device and associated packaging. |
| Laser Incision Delivery | (Implicitly, as design changes are to LOI, not laser engine) | "Bench testing demonstrated that subject device with the Catalys system continues to deliver incisions as intended." (Relies on prior K161455 data for detailed laser performance). |
Study Details (for this 510k submission, K170322):
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Sample Size Used for the Test Set and Data Provenance:
- Bench Testing: Not explicitly quantified in terms of "sample size" for a dataset, but multiple functional tests, sub-assembly tests, and design validation tests were performed. The "test set" here refers to the physical units/components under evaluation.
- Cadaver Eye Model Testing: Not explicitly quantified in terms of number of cadaver eyes, but performed to demonstrate performance.
- Data Provenance: The location of the testing is not specified, but the applicant (OptiMedica Corporation) is based in Milpitas, CA, USA. The testing appears to be prospective in the sense that it was conducted specifically for this submission to verify new design changes.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of clinical AI/ML ground truth. The "ground truth" for this device's performance is established by engineering specifications, functional requirements, and physical measurements/observations during bench and cadaver testing. The experts involved would be engineers and technical personnel conducting the tests.
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Adjudication Method for the Test Set:
- Not applicable. This testing is focused on objective engineering performance and physical verification, not subjective human interpretations requiring adjudication.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is relevant for diagnostic imaging AI/ML devices where human readers' performance is being evaluated with and without AI assistance. This submission is for a surgical laser device and its physical components.
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If a Standalone Performance Study Was Done (Algorithm Only Without Human-in-the-Loop Performance):
- Not applicable in the AI/ML sense. The "algorithm" (software for the laser system) is integrated and operates the device. The testing described focuses on the device's physical performance, not on a standalone AI algorithm's diagnostic accuracy. The text does state that "Bench testing of the predicate device (resident in K161455) 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 design changes made to the LOI." This implies that the core laser control "algorithm" was validated previously.
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The Type of Ground Truth Used:
- Engineering Specifications / Design Requirements: The primary ground truth for the device's performance. Tests confirm that the device meets its predefined functional and performance specifications.
- Physical Measurements/Observations: During bench testing (e.g., maintaining vacuum, sterile barrier integrity).
- Cadaver Eye Performance: Demonstrating that the system functions as intended with biological tissue regarding physical interactions (eye fit, pressure, seal).
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The Sample Size for the Training Set:
- Not applicable. This submission is not for an AI/ML algorithm that requires a "training set" in the conventional machine learning sense. The device's operation is based on pre-programmed designs and physical principles, not on learned patterns from a dataset.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set was used.
In summary, the provided document details the verification and validation of minor design changes to a surgical laser system's physical components through bench and cadaver testing, rather than the clinical evaluation of an AI/ML algorithm for diagnostic purposes.
§ 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.