(141 days)
The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.
The Easy-Load Lens Delivery System is used for folding and delivering a Bausch + Lomb three-piece silicone IQL into the eye. An IOL is placed into the loading area and the drawer is closed. This compresses the IOL. The plunger is advanced until it stops at a detent position. The distal end is filled with viscoelastic or balanced salt solution and placed through an incision into the eye. The haptic puller is used to place the leading haptic in the correct loading position. Once the tip is in the eye, the plunger is advanced until the lens is fully expressed into the capsular bag.
Here's a breakdown of the acceptance criteria and study information for the Easy-Load Lens Delivery System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | New materials found to be biocompatible (Implicit: no adverse biological reactions) | New materials for the Easy-Load Lens Delivery System were found to be biocompatible. |
| Bench Testing | Met acceptance criteria (Implicit: no damage to IOLs, successful delivery, proper visual appearance of injector) | All nonclinical tests met the acceptance criteria. |
| Surface Homogeneity of Delivered IOLs | (Not explicitly stated, but implied as satisfactory) | (Covered under "All nonclinical tests met the acceptance criteria.") |
| Bulk Homogeneity of Delivered IOLs | (Not explicitly stated, but implied as satisfactory) | (Covered under "All nonclinical tests met the acceptance criteria.") |
| Delivery Outcome | (Not explicitly stated, but implied as successful and effective) | (Covered under "All nonclinical tests met the acceptance criteria.") |
| Injector Visual Inspection | (Not explicitly stated, but implied as satisfactory) | (Covered under "All nonclinical tests met the acceptance criteria.") |
| Sterility Assurance Level | 10^-6 | 10^-6 |
| Shelf Life | 12 months | 12 months |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for each bench test or biocompatibility test. It generally refers to "the new Easy-Load Lens Delivery System materials" and "Easy-Load Lens Delivery Systems with the new materials."
The data provenance is retrospective, as the testing was performed on the device prior to submission and regulatory review. The country of origin for the data is not mentioned, but given the submission to the FDA, it is likely that the studies were either performed in the US or in a manner compliant with US regulatory requirements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document describes bench and biocompatibility testing, which are typically performed in laboratories according to established protocols, rather than relying on expert consensus for "ground truth" in the same way clinical imaging studies might.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are making subjective assessments, such as interpreting medical images. Bench and biocompatibility testing rely on objective measurements and predefined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices where human interpretation interacts with AI, and this device is a surgical delivery system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A (Not Applicable). This device is a manual intraocular lens delivery system, not an algorithm or AI-powered system. Therefore, the concept of "standalone algorithm performance" does not apply. The device's performance is inherently "human-in-the-loop" as it is operated by a surgeon.
7. The Type of Ground Truth Used
The ground truth for the performance of the Easy-Load Lens Delivery System was established through objective laboratory testing and measurements.
- For biocompatibility, the ground truth is the absence of biological reactivity or toxicity, verified through standardized assays and tests.
- For bench testing (surface and bulk homogeneity of delivered IOLs, delivery outcome, and injector visual inspection), the ground truth is established by design specifications and performance requirements (e.g., IOL delivered undamaged, correct placement, injector integrity), verified by direct observation, measurement, and functional testing.
8. The Sample Size for the Training Set
N/A (Not Applicable). As this is a mechanical medical device, there is no "training set" in the context of an algorithm or AI system. The device design and manufacturing processes are likely informed by engineering principles, material science, and previous product iterations, but not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
N/A (Not Applicable). Since there is no training set for an algorithm, there is no ground truth established for it in this context.
§ 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.