(45 days)
The Lenstec IOL Injection System is intended for use in implantation of the Lenstec Softec Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.
The system consists of the following components: Cartridge LC604220 used with Injector I 9000 for Nominal Incision Size (mm) 2.8 and Used with Softec Intraocular Lenses Power Range (D) 26.5D to 42.0D; Cartridge LC604240 W/LS604500 used with Injector I 9007 for Nominal Incision Size (mm) 2.2 and Used with Softec Intraocular Lenses Power Range (D) -5.0D to 26.0D. Two types of injectors are provided: both injectors are syringe based and are reusable and autoclavable. The cartridges/silicone cushion are single-use and provided sterile.
The provided document is a 510(k) summary for the Lenstec Injector System for Softec Intraocular Lenses. It does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria related to its performance metrics as an AI/ML powered medical device.
Instead, this document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is a regulatory pathway for certain medical devices in the US. The "performance data" section explicitly states "Non-clinical tests: All contact materials have been tested for biocompatibility. The system was tested with Softec intraocular lenses." and "Clinical tests: Not required."
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to a physical medical device (an injector system for intraocular lenses) and its regulatory clearance based on substantial equivalence, not an AI/ML powered medical device with performance metrics related to diagnostic accuracy, sensitivity, specificity, etc. The "performance data" refers to biocompatibility and physical compatibility with the lenses, not algorithmic performance.
§ 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.