(117 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).
The provided document, a 510(k) summary for the Catalys Precision Laser System, focuses on demonstrating substantial equivalence to a predicate device (K141079) due to a software upgrade (cOS 3.90). It explicitly states that "there are no significant changes to the subject device other than the design changes resident in the software." As such, the document refers back to the testing performed for the predicate device to justify safety and effectiveness.
Because of this, the document does NOT contain information about acceptance criteria and a study proving the device meets those criteria, specifically concerning the clinical performance of the device's therapeutic functions. Instead, it refers to prior submissions.
Here's an analysis of what is available and what is missing based on your request:
Information Present in the Document (or deducible):
- Device: Catalys Precision Laser System
- Purpose of current submission: Software upgrade (cOS 3.90) providing additional surveillance of vacuum pressure and LOI suction during docking, and video monitoring for fluid loss during treatment.
- Study type mentioned: "Software specific bench testing of the Catalys System was conducted to demonstrate the System's ability to meet all intended design specifications related to the software design changes." This is a purely standalone test of the software's functionality, not related to clinical outcomes or human performance.
- General assertion: "The bench, animal and clinical performance testing provided in K141079, when coupled with the software verification and validation testing presented for the subject device, provides reasonable assurance that the System is safe and effective for its intended use and furthermore, that it is substantially equivalent to the identified predicate device." This indicates that detailed performance data would be in K141079.
- Ground Truth for software testing: For the software-specific bench testing, the "intended design specifications related to the software design changes" serve as the ground truth. This would involve comparing the software's output (e.g., reported vacuum pressure, fluid loss detection) against pre-defined correct operational parameters.
- Sample size for software testing: Not specified.
- Data provenance for software testing: Not specified, but generally, bench testing data would be internal development data.
- Training set: Not applicable for this type of software-specific bench testing as described. This is a validation of new software features, not a model requiring a training dataset.
Information NOT Present in the Document:
- Table of acceptance criteria and reported device performance (for clinical outcomes): Not provided. The document references prior submissions for clinical performance.
- Sample size used for the test set and data provenance (for clinical outcomes): Not provided; referenced in K141079.
- Number of experts and their qualifications (for clinical outcomes ground truth): Not provided; referenced in K141079.
- Adjudication method (for clinical outcomes): Not provided; referenced in K141079.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned for this submission. The device is a surgical laser system, not an AI diagnostic tool that assists human readers.
- Standalone (algorithm only) performance (for clinical outcomes): While software bench testing was performed, clinical standalone performance data is not explicitly detailed in this document; referenced in K141079.
- Type of ground truth used (for clinical outcomes): Not provided; referenced in K141079.
- Sample size for the training set (if applicable for AI/ML): Not applicable for the described software update. This is a rule-based software design change, not an AI/ML system that would require a 'training set'.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The document describes a 510(k) submission for a software upgrade (cOS 3.90) to an existing device, the Catalys Precision Laser System. The primary study described in this specific document is "Software specific bench testing" to verify the new software's ability to meet its intended design specifications related to vacuum pressure monitoring and fluid loss detection. This is a standalone test of the new software features.
For clinical efficacy and safety, the document explicitly states that the "bench, animal and clinical performance testing provided in K141079" (the predicate device's submission) is directly applicable due to "no significant changes to the subject device other than the design changes resident in the software." Therefore, details regarding acceptance criteria, sample sizes, ground truth establishment, or expert involvement for clinical outcomes would need to be sought in the K141079 submission, not in the provided text.
§ 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.