(24 days)
The RxSight® Insertion Device 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 is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.
The provided text is a 510(k) summary for the RxSight® Insertion Device. This document evaluates the device's substantial equivalence to a legally marketed predicate device, rather than proving that it meets specific, novel acceptance criteria through a new clinical study.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this particular document. The device is a Class I medical device (Intraocular Lens Guide), which typically relies on demonstrating equivalence to existing devices rather than extensive new clinical trials for market approval.
Here's an analysis based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table of quantitative acceptance criteria and corresponding performance metrics for a new study. Instead, it demonstrates substantial equivalence to a predicate device. This means the "acceptance criteria" are implicitly that the proposed device performs comparably to the predicate device for its intended use, without raising new questions of safety or effectiveness.
The document states:
- "The descriptive characteristics are well-defined and adequate to ensure substantial equivalence of the RxSight Insertion Device with the predicate device."
- "The RxSight Insertion Device has the same intended use as the legally marketed predicate devices identified in this 510(k) premarket notification and other IOL injectors regulated under 21 CFR 886.4300."
- "This device continues to meet all product design requirements and applicable standards and embodies technological characteristics similar to the predicate device."
The comparison table provided in the document highlights the identical characteristics between the proposed device and its predicate (K192926):
| Characteristic | RxSight Insertion Device (Proposed Device) | RxSight Insertion Device (Predicate Device - K192926) | Performance/Acceptance Detail (Implied) |
|---|---|---|---|
| Product Code | MSS | MSS | Same classification, indicating no change in regulatory requirements. |
| Indications for Use | Folding and insertion of 3-piece silicone IOLs into the human eye through a surgical incision, for specific IOL models (RxSight LAL, LAL+, Bausch & Lomb LI61A0, and other validated models). | Identical phrasing, indicating no change in clinical purpose or target population. | |
| Operating Principle | IOL placed in loading cartridge, cartridge snapped into handpiece, screw plunger advances IOL through cartridge (folds IOL, advances into eye). | Identical, indicating identical mechanism of action. | |
| Pre-loaded IOL | No | No | Same non-preloaded design. |
| Material (Injector) | Titanium | Titanium | Same biocompatible material. |
| Material (Cartridge) | Polypropylene | Polypropylene | Same biocompatible material. |
| Cartridge Coating | LubriMATRIX™ | LubriMATRIX™ | Same coating for lubrication. |
| How Supplied (Reusable/Single Use) | Handpiece - Reusable; Cartridge - Single Use, supplied sterile | Handpiece - Reusable; Cartridge - Single Use, supplied sterile | Same supply and use model. |
| Method of Sterilization | Handpiece - Autoclave; Cartridge - Ethylene Oxide to SAL 10-6 | Handpiece - Autoclave; Cartridge - Ethylene Oxide to SAL 10-6 | Same validated sterilization methods. |
The "performance" documented here is the sameness or equivalence across all these characteristics, leading to the conclusion that the device performs as expected based on its predicate.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable and not provided in the document. This is not a study that involved a "test set" in the context of clinical or algorithmic performance evaluation. The submission relies on comparing the technical characteristics and intended use to a previously cleared device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided. Ground truth establishment by experts is typically relevant for studies evaluating diagnostic accuracy, image interpretation, or treatment outcomes, which is not the nature of this 510(k) submission.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. Adjudication methods are used in studies involving multiple readers or complex endpoints, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI on human reader performance, which is not relevant for this device (an IOL insertion tool).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No, a standalone algorithm performance study was not done. This device is a manual surgical tool, not an AI algorithm.
7. The Type of Ground Truth Used:
Ground truth, in the sense of expert consensus, pathology, or outcomes data, was not used for this 510(k) submission. The "truth" being established is the substantial equivalence of the proposed device to its predicate, based on its identical design, materials, manufacturing, indications for use, and operating principle. The ground truth, in a broader sense, is the already established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. There is no "training set" as this is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided.
§ 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.