(46 days)
The Bausch & Lomb™ NGX Microsurgical System device is intended for the emulsification and removal of cataracts, anterior segment vitrectorny. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, irrigation/aspiration, bipolar, coaxial, and bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. Use only Bausch & Lomb disposable packs and handpieces designated for use with the system.
The Bausch & Lomb NGX Microsurgical System is an integrated ophthalmic microsurgical system designed for use in anterior segment surgery including phacofragmentation and vitreous aspirating and cutting- anterior vitrectomy. The NGX system is the next generation Millennium phacoemulsification system. The new system is based on the technology and the performance of the existing Millennium system and is designed to improve surgical efficiency, surgeon ergonomics, more reliable control of fluidics, which will help IOP control, better data collection capability, and improved aesthetics. The system incorporates both vacuum and flow-based fluidics system (peristaltic pump) to meet current and future needs of anterior and posterior procedures. This enhances the ability to perform as one combined system for increased efficiency. The ultrasound lens removal system extends and improves upon existing technologies with new and improved designs in the phaco hand-piece.
This document describes the Bausch & Lomb NGX Microsurgical System, an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgeries, including phacofragmentation, vitreous aspirating, and cutting.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria in terms of specific performance metrics (e.g., accuracy, precision, flow rates, vacuum levels) with corresponding target values. Instead, it states a general acceptance criterion related to compliance with standards and functional requirements.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| System manufactured in compliance with FDA and ISO quality systems and device-related international, domestic, and industry standards and requirements. | The NGX System "will be manufactured in compliance with FDA and ISO quality systems and device related international, domestic, and industry standards and requirements." |
| Functional requirements and system specifications met prior to commercial release and distribution. | "System verification and validation will demonstrate that the functional requirements and system specifications will have been met prior to commercial release and distribution." |
2. Sample Size and Data Provenance
The submission primarily focuses on non-clinical testing against various standards rather than clinical studies with patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the traditional sense of a clinical performance study involving patient data.
The "test set" in this context refers to the device itself and its components undergoing engineering and safety tests against various standards. No patient data or clinical samples were used for performance evaluation in this specific submission.
3. Number of Experts and Qualifications for Ground Truth
Given that clinical data and patient samples were not used for performance evaluation, the concept of "ground truth established by experts" for a test set is not applicable. The ground truth for the non-clinical tests would be the specifications and requirements of the various international and domestic standards listed.
4. Adjudication Method
Since no clinical studies with human readers or assessments of a test set are reported, an adjudication method for such a test set is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this submission. The device is a surgical system, not an AI diagnostic tool, so such a study comparing human readers with and without AI assistance is not relevant to its premarket notification.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
The Bausch & Lomb NGX Microsurgical System is a physical surgical device, not an algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The system is designed for use by surgeons.
7. Type of Ground Truth Used
The primary ground truth for the performance evaluation in this submission is the compliance with established international, domestic, and industry standards and requirements for medical devices, electrical safety, biocompatibility, packaging, and software. This is demonstrated through "System verification and validation" against these standards.
8. Sample Size for the Training Set
Since this submission concerns a physical microsurgical system and not a machine learning algorithm, the concept of a "training set" and its sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for a machine learning algorithm, this question is not applicable.
Summary of Device Performance Study:
The primary study type reported is non-clinical testing for performance data (standards-based). The device's performance is demonstrated through its compliance with a comprehensive list of international and domestic standards (e.g., IEC, ISO, ASTM, UL, MIL-STD, EN). These standards cover aspects such as electrical safety, electromagnetic compatibility, biocompatibility, sterilization, packaging, and software development. The submission states that "System verification and validation will demonstrate that the functional requirements and system specifications will have been met prior to commercial release and distribution."
Clinical Data:
The submission explicitly states that "Clinical investigations were deemed as not necessary for the planned marketing of this system." This decision is based on the fact that the NGX Microsurgical System is considered "the next generation of the Millennium Microsurgical System," implying substantial equivalence to a predicate device with extensive clinical and surgical use.
§ 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.