(93 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, 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.
This document is a 510(k) premarket notification for a medical device called the "RxSight Insertion Device." It outlines the device's characteristics, intended use, and demonstrates substantial equivalence to a previously cleared predicate device.
Let's break down the information relevant to acceptance criteria and study proof for this specific device.
Analysis of the Provided Text:
The provided text describes a medical device, the "RxSight Insertion Device," which is an Intraocular Lens (IOL) injector. The FDA document clears this device based on its substantial equivalence to a predicate device.
However, the nature of this particular device (an IOL insertion tool) and the detailed information provided in the 510(k) summary do not involve the kind of AI-driven diagnostic or image analysis performance that would typically have acceptance criteria presented as sensitivity, specificity, or AUC, nor "ground truth" derived from expert consensus on images.
Instead, the "performance" here relates to the mechanical function of the device and its biological safety (e.g., impact on endothelial cell density).
Therefore, I cannot directly fill in a table for AI performance metrics like sensitivity, specificity, etc., or answer questions about multi-reader multi-case studies, training sets, or expert adjudicated ground truth in the way one would for an AI diagnostic algorithm.
Based on the provided text, here’s how we can infer relevant "acceptance criteria" for this mechanical device and the study proving it meets them:
1. Acceptance Criteria and Reported Device Performance (Inferred):
Since this is a mechanical insertion device, the acceptance criteria are not in terms of diagnostic accuracy, but rather in terms of its ability to safely and effectively deliver an IOL without causing significant harm to the eye.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Mechanical Performance: IOL integrity post-injection (dimensions, sagitta) | Met: "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." This implies that the IOL maintained its intended shape and optical properties after being folded and injected by the device. |
| Optical Properties: IOL surface and bulk homogeneity post-injection | Met: "Optical properties including overall surface and bulk homogeneity were tested pre- and post-lens injection per ISO 11979-2:2014." This suggests the insertion process did not adversely affect the optical quality of the IOL. |
| Coating Stability: Durability of the cartridge coating over shelf-life | Met: "Additionally, a particulate analysis was performed on aged product to demonstrate coating stability of the sterile insertion device coating following shelf-life aging." This indicates the coating remains intact and does not shed harmful particulates throughout its shelf life, which is crucial for preventing complications during surgery. |
| Clinical Safety: Non-inferiority in post-operative Endothelial Cell Density (ECD) loss compared to predicate/control IOL insertion devices. | Met: "The analysis presented in the 510(k) shows similar rates of ECD loss in eyes implanted with either device, supporting the safety of insertion of the LAL with the RxSight Insertion device." This is a key safety measure, demonstrating the device does not cause excessive damage to the cornea's endothelial cells during insertion, a vital aspect of maintaining corneal clarity. The predicate device's performance implicitly serves as an "acceptance criterion" benchmark for safety. |
2. Sample Size and Data Provenance (for clinical safety study):
- Sample Size: The document states "post-operative endothelial cell density (ECD) data was collected in a prospective clinical study." It doesn't specify the exact number of patients or eyes.
- Data Provenance: "prospective clinical study." No country of origin is specified, but typically for FDA submissions, studies are conducted in a way that aligns with US clinical study requirements (e.g., IRB approval).
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable in the typical sense of AI ground truth. For this device, "ground truth" for the mechanical tests would be derived from precisely measured physical properties (e.g., using calipers, optical instruments) and analytical chemistry tests (e.g., particulate analysis).
- For the clinical safety study (ECD), the "ground truth" is measured physiological data (endothelial cell count and density) obtained via clinical instruments, not subjective expert assessment of images.
4. Adjudication Method for the Test Set:
- Not applicable in the typical AI sense. For mechanical tests, the results are objective measurements. For the ECD clinical study, the outcome is quantitative physiological data, not requiring multiple human adjudicators for "ground truth."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, not specified or relevant for this type of device. MRMC studies are typically for diagnostic imaging AI tools comparing human reader performance with and without AI assistance. This device is a surgical insertion tool, not a diagnostic aid.
6. Standalone (Algorithm only) Performance:
- Not applicable. This device is a mechanical tool. There is no "algorithm only" performance separate from its mechanical function.
7. Type of Ground Truth Used:
- Quantitative Measurements and Clinical Outcomes: For mechanical aspects, the ground truth was based on:
- Precise measurements of IOL dimensions and sagitta before and after insertion (ISO 11979-3:2012).
- Evaluation of optical properties (ISO 11979-2:2014).
- Particulate analysis.
- For clinical safety, the "ground truth" was endothelial cell density (ECD) measurements, which are objective physiological data.
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set for model development. The mechanical tests and clinical safety study are for device validation, not for training a model.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set for an AI model.
§ 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.