(59 days)
The EyeGility Inserter for enVista preloaded is indicated for folding and inserting of enVista IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.
The EyeGility Inserter is a sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye. The Inserter provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.
The provided text describes the EyeGility™ Inserter for Preloaded enVista® IOLs and its non-clinical testing to demonstrate substantial equivalence.
Here's the information broken down as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Category | Test | Standards | Acceptance Criteria (Implied by "Pass") | Reported Device Performance |
|---|---|---|---|---|
| Delivery Verification Testing and Stability Testing | Fold and Recovery Test | ISO 11979-3 | Met established requirements | Pass |
| Dioptric Power and Image Quality Post Delivery | ISO 11979-2 | Met established requirements | Pass | |
| Lens Dimensions Post Delivery | ISO 11979-3 | Met established requirements | Pass | |
| Surface and Bulk Homogeneity | ISO 11979-3 | Met established requirements | Pass | |
| Cosmetic Inspection | N/A | Free from specified cosmetic defects | Pass | |
| Biocompatibility | Biocompatibility Assessment | ISO 10993-1 | Biocompatible | Pass |
| Particulate Study | ISO 10993-1 | Within acceptable particulate levels | Pass | |
| Coating Transfer Study | ISO 10993-1 | No unacceptable coating transfer | Pass | |
| Leachable Extractions | ISO 10993-18 | Within acceptable leachable limits | Pass | |
| EO Sterilization | Validation Product Adoption Analysis | ISO 11135 | Sterilization validated | Pass |
| EO Residuals | ETO/ECH Transfer Engineering Study | ISO 10993-7 | Within acceptable residual limits | Pass |
| Bacterial Endotoxin | Bacterial Endotoxin Test | ANSI/AAMI ST72 | Within acceptable endotoxin limits | Pass |
| Packaging | Transport Stability Testing | ISO 11607-1, ISO 11979-6, ASTM F2096 | Maintained integrity and sterility after transport | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test. It broadly mentions "functional testing" and "nonclinical testing." The data provenance is not mentioned, but given it's a premarket notification for the US market (FDA), such tests are typically conducted by the manufacturer in a controlled laboratory setting. The study is prospective in the sense that the device was designed and then tested against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is an inserter for Intraocular Lenses (IOLs) and the testing performed is non-clinical, focusing on the physical performance, biocompatibility, and sterility of the device against established standards (e.g., ISO standards). Ground truth, in the context of expert review, is typically relevant for interpretative devices (e.g., AI for medical imaging diagnosis), which is not the case here.
4. Adjudication Method for the Test Set
Not applicable, as this is a non-clinical device that is tested against objective, measurable performance standards rather than expert adjudication.
5. 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
No. The provided text explicitly states: "No clinical testing was completed in support of the subject device." This implies no human readers or AI assistance was involved in a clinical comparative effectiveness study for this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device (an inserter) and does not involve an algorithm or AI.
7. The type of ground truth used
The "ground truth" for the non-clinical testing of this device is defined by the acceptance criteria established by international standards (e.g., ISO, ANSI/AAMI, ASTM) for medical devices and IOLs. These standards dictate acceptable performance for parameters like folding and recovery, optical quality, dimensions, biocompatibility, sterilization, and packaging integrity.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.