(28 days)
The Bausch + Lomb Injector System is indicated for the folding and insertion of Bausch + Lomb intraocular lenses cleared or approved for use with this IOL Injector system.
The Bausch + Lomb Injector System is used for folding and delivering validated IOLs into the eye. The system is composed of two items: a single-use, sterile, disposable cartridge and a reusable handpiece. The handpiece has two elements: a plunger and a body. The cartridge snaps into the handpiece.
This document is an FDA 510(k) premarket notification for a medical device (Bausch + Lomb Injector System) and does not contain the detailed information necessary to answer the request.
The request asks for specific details about acceptance criteria, study design (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), and performance metrics (reported and a comparative effectiveness study with AI assistance). This type of information is typically found in study reports, clinical trial summaries, or detailed technical documentation that usually accompanies a 510(k) submission, but is not present in the summary provided.
The document primarily focuses on establishing "substantial equivalence" to a predicate device, which usually involves comparing design, materials, and intended use, rather than presenting new detailed performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The text only states:
- "Performance bench testing was completed on the Bausch + Lomb Injector System and results show the system to be in conformance with the requirements set forth in respective standards." (Section 5, page 4)
This statement indicates that testing was done and standards were met, but it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance.
- Number or qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study with AI (the device appears to be a physical injector system, not an AI-assisted diagnostic tool).
- Standalone algorithm performance (again, not applicable to this type of device).
- Type of ground truth (not explicitly stated beyond "respective standards").
- Training set sample size (not applicable as this is not an AI/ML model being trained).
- How ground truth for the training set was established (not applicable).
To answer your request, you would need access to the actual "performance bench testing" report and "respective standards" referenced in the document.
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.