(104 days)
The Bausch + Lomb Stellaris Elite vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal, and air/fluid exchange operations. The Stellaris Elite Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.
The Bausch + Lomb Stellaris Elite Vision Enhancement System is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, the Stellaris Elite Vision Enhancement System may be configured with a 532 nm laser module for photocoagulation.
The Stellaris Elite Vision Enhancement System is a rebranding of the currently cleared Stellaris (K133242) Vision Enhancement System and Stellaris PC (K133486) Vision Enhancement System. The system is based on the technology and the performance of the existing Stellaris and Stellaris PC Vision Enhancement Systems, and this traditional 510(k) incorporates software and hardware revisions to support the introduction of the new Vitesse vitrectomy feature (including 2 new Vitesse handpieces and supporting accessories). The new Vitesse vitrectomy feature is available on the Stellaris Elite Vision Enhancement System based on the configuration matrix listed in Table 1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.
This document describes the Bausch + Lomb Stellaris Elite Vision Enhancement System, a device intended for surgical procedures related to cataracts and vitrectomy, and its substantial equivalence to previously cleared predicate devices.
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 acceptance criteria for the Stellaris Elite Vision Enhancement System are based on compliance with various international electrical and medical device standards, and successful functional, simulated use, environmental, and transport testing. The reported device performance is that it met all these criteria.
| Acceptance Criteria (Standards and Testing Goals) | Reported Device Performance |
|---|---|
| Electrical Safety Standards: | Compliance Demonstrated: |
| IEC 60601-1:2005 + C1(2006) + C2(2007) + AM1(2012) or IEC 60601-1:2012 (General requirements for basic safety and essential performance) | Passed all referenced testing. |
| IEC 60601-1-2 ed3.0 (2007) (Electromagnetic compatibility) | Passed all referenced testing. |
| IEC 60601-1-6:2010 (Usability) | Passed all referenced testing. |
| IEC 60601-2-2:2009 (Particular requirements for high frequency surgical equipment) | Passed all referenced testing. |
| IEC 60601-2-22:2007 (Particular requirements for diagnostic and therapeutic laser equipment) | Passed all referenced testing. |
| IEC 80601-2-58:2008 (Particular requirements for lens removal devices and vitrectomy devices) | Passed all referenced testing. |
| Functional, Simulated Use, Environmental & Transport Testing: Ensure the device performs as intended in various conditions and scenarios. | Successfully completed on representative units, demonstrating compliance and substantial equivalence to predicate devices. Functional requirements have been met. |
| Software Verification and Validation: Compliance with EN ISO IEC 62304:2006 (Medical device software life cycle processes) | Software changes were verified and validated in accordance with Bausch + Lomb's software quality procedures, which comply with EN ISO IEC 62304:2006. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient data or
clinical cases. The testing conducted was primarily hardware and software performance verification. The non-clinical tests involved "representative units" of the device. There is no information regarding country of origin of data or whether it was retrospective or prospective, as the testing described is not clinical in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The listed tests are engineering and compliance standards, not clinical studies requiring expert ground truth establishment for patient data. Expert involvement would be in the form of engineers, quality assurance personnel, and regulatory specialists ensuring compliance with the standards.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in clinical studies when there's uncertainty about ground truth or disagreement among readers (e.g., radiologists). The testing described here is based on objective measurements against engineering and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through technical characteristics and compliance with standards, not on comparing human reader performance with and without AI assistance. This device is not an AI-powered diagnostic tool, but a surgical system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to the Stellaris Elite Vision Enhancement System. As a surgical system, it is inherently designed for human-in-the-loop operation. The "standalone" performance being assessed relates to the system's compliance with engineering and safety standards as an independent medical device, not as an algorithm performing a task without human intervention. The software verification and validation would be considered "standalone" in the sense of the software itself being tested, but in the context of contributing to the overall device's safety and functionality.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by its adherence and successful execution to various international engineering and medical device safety standards (e.g., IEC 60601 series, EN ISO IEC 62304). These standards define the acceptable performance, safety, and operational parameters for such medical equipment.
8. The Sample Size for the Training Set
This information is not applicable. This document describes a medical device, not an AI model that relies on training sets of data. The software within the device undergoes verification and validation, but this is distinct from machine learning model training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no mention of a "training set" for an AI model in the context of this device's submission.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.