(54 days)
The RxSight® Insertion Device (Model 63002) is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device (Model 63002) is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, and IOL models validated for use with this device in IOL approved labeling.
The RxSight Insertion Device (Model 63002) is a sterile, single-use device to be used to fold and insert intraocular lenses (IOL) into the eye through a small incision during cataract surgery. The RxSight Insertion Device (Model 63002) consists of:
- A single-use, disposable, sterile IOL inserter with a non-pyrogenic cartridge
- A single-use, disposable, sterile haptic puller.
The provided text describes the 510(k) summary for the RxSight® Insertion Device (Model 63002). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with specific acceptance criteria and detailed performance data often seen for novel AI/ML devices. As such, information regarding AI-specific acceptance criteria, test set details (sample size, provenance, expert adjudication, MRMC studies), ground truth establishment for training and test sets, and separate standalone algorithm performance is not present in this submission.
The device in question, an intraocular lens insertion device, does not appear to be an AI/ML product. The performance testing is described as non-clinical and pertains to the physical manipulation and integrity of the intraocular lenses after insertion, following ISO standards.
Here's a breakdown of the available information based on your request, with N/A for criteria not addressed in the provided document, as it is not an AI/ML device submission:
Acceptance Criteria and Device Performance
The submission focuses on demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical performance testing. The "acceptance criteria" are implied by adherence to ISO standards for IOLs, indicating that the device should not adversely affect the IOL's mechanical dimensions, sagitta, optical properties, or homogeneity.
| Acceptance Criteria (Implicit from ISO Standards) | Reported Device Performance (Summary) |
|---|---|
| Maintenance of IOL mechanical dimensions and sagitta post-injection (per ISO 11979-3:2012) | "mechanical dimensions and sagitta were verified following lens delivery and compared to the measurements performed prior to the lens delivery per ISO 11979-3:2012." Conclusion: Testing established safety and effectiveness. |
| Maintenance of IOL optical properties post-injection (per ISO 11979-2:2014) | "optical properties... were tested pre and post lens injection per ISO 11979-2:2014." Conclusion: Testing established safety and effectiveness. |
| Maintenance of IOL overall surface and bulk homogeneity post-injection (per ISO 11979-2:2014) | "overall surface and bulk homogeneity were tested pre and post lens injection per ISO 11979-2:2014." Conclusion: Testing established safety and effectiveness. |
| Device ensures safe and effective delivery of specified IOLs (e.g., RxSight Light Adjustable Lens, Light Adjustable Lens+). | "Non-clinical data establish that the device is safe and effective in the delivery of the RxSight Light Adjustable Lens and Light Adjustable Lens+ and is shown to be substantially equivalent to the predicate devices." |
Study Details (as applicable for a non-AI/ML device submission)
-
A table of acceptance criteria and the reported device performance: See table above.
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for specific tests, but general non-clinical performance testing was conducted.
- Data Provenance: Not specified, but generally, non-clinical lab testing data.
- Retrospective or Prospective: N/A (for non-clinical lab testing).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. This is a non-clinical device; "ground truth" as you'd define it for AI/ML diagnostics (e.g., disease presence as determined by experts) does not apply. Performance is measured against physical and optical standards.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Not relevant for this type of non-clinical device testing.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. This is not an AI/ML device.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI/ML device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context refers to the defined specifications and standards for IOLs (e.g., mechanical dimensions, optical properties, homogeneity) as outlined in ISO 11979-2:2014 and ISO 11979-3:2012.
-
The sample size for the training set: N/A. This is not an AI/ML device, so there is no "training set."
-
How the ground truth for the training set was established: N/A. Not an AI/ML device.
§ 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.