(131 days)
The Bausch & Lomb™ Stellaris Microsurgical System device is intended for the emulsification rno basion of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for use in both untonor und polonialion, bipolar, coaxial, and bipolar coagulation, vitrectorny, phaooomalions in ingaoval and air/fluid exchange operations. Use only Bausch & Lomb disposable packs and handpieces designated for use with the system.
The Bausch & Lomb Stellaris Microsurgical System is an integrated ophthalmic microsurgical System designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting- anterior vitrector vitrectorny. The Stellaris system is a next generation system based on the Millennium phacoemulsification System, and has been cleared under K063331 for anterior segment procedures including anterior vitreous (posterior). The modification to the current Stellaris system is to provide a pressurized infusion pump system for the bottle assembly which was heretofore placed on the IV provide a pressuntzed only requires a nouver connections assembly which was heretofore plac pole requires a power generated action to raise and lower the pole to gain appropriate pressure for the delivery of BSS saline during intraocular surgery. The pressurized infusion system alleviates this necessity by allowing the IV pole to remain stationary. A bottle hangar assembly is attached to the 1000.) by and might to Toman Stationaly. In bothe nangal assembly by line in the appropriate and desired in a claim to allow don't it in this from the non the nout by the all the intention and of the infraccular surgery procedure. The infusion system embedded in the integral part of the Stellaris system that has not been activated previously. The current Stellaris system incorporates both vacuum and flow-based fluidics system (peristallic The carrent of clians of commission of anterior and posterior procedures. The compressor pullip) to meet ourinn and fearly nechanical and pneumatic interfaces to the pressurized infusion system.
The Stellaris Microsurgical System by Bausch & Lomb is not a medical AI device, but rather an ophthalmic surgical system. Therefore, most of the requested information about acceptance criteria, study design for AI models, and human-in-the-loop performance is not applicable.
Here's a breakdown of the available information relevant to a non-AI medical device:
1. Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It indicates that the system will be manufactured in compliance with FDA and ISO quality systems and relevant standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with FDA and ISO quality systems and device-related international, domestic, and industry standards and requirements. | "System verification and validation will demonstrate that the functional requirements and system specifications will have been met prior to commercial release and distribution." (General statement, no specific data) |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is a hardware surgical system undergoing a 510(k) clearance based on substantial equivalence to a predicate device, not a software AI model tested on a dataset.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. Ground truth assessment by experts is for data-driven models, which this device is not.
4. Adjudication Method:
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is for evaluating observer performance with and without an AI assistant, which is not relevant for this surgical system.
6. Standalone Performance:
The device's performance is inherently "standalone" in the sense that it operates independently as a surgical system. However, "standalone performance" in the context of AI usually refers to the algorithm's performance without human interaction in a diagnostic or screening task. For this surgical device, performance is evaluated through its functional capabilities for procedures like phacoemulsification and vitrectomy.
7. Type of Ground Truth Used:
For a hardware device like this, the "ground truth" is typically defined by its ability to perform its intended surgical functions safely and effectively, as demonstrated through design verification and validation tests and comparison to a predicate device. This is not about medical diagnoses or pathology results.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI model that undergoes a "training set." Its design is based on engineering principles and previous device generations.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of the 510(k) Submission for the Bausch & Lomb Stellaris Microsurgical System (Pressurized Infusion Pump):
The 510(k) submission (K082473) for the Bausch & Lomb Stellaris Microsurgical System focused on adding a pressurized infusion pump system for the bottle assembly. This modification aimed to improve the convenience and stability of fluid delivery during intraocular surgery by allowing the IV pole to remain stationary, eliminating the need for manual adjustment to gain appropriate pressure.
The FDA cleared the device based on substantial equivalence to its predicate devices, specifically the Bausch & Lomb NGX Microsurgical System (K063331) and the Bausch & Lomb Premiere II Millennium Microsurgical System (K961310). The argument for substantial equivalence rested on the fact that the Stellaris system is a "next generation system" based on the Millennium, sharing similar core technology and fluidics systems, with the new pressurized infusion being an activation of an integral part of the system that was previously inactive.
The submission stated that clinical investigations were deemed not necessary due to the extensive clinical and surgical use of the previous generation Millennium Microsurgical System and the nature of the modification (an enhancement to fluidics rather than a fundamental change in surgical mechanism). "System verification and validation" (presumably engineering and functional testing) were stated to be conducted to ensure the device met functional requirements and specifications.
§ 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.