(210 days)
The CENTURION® Vision System is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectorny, bipolar coagulation, and intraocular lens injection. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal.
The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert® IOL Injector Handpiece is indicated for use with ACRYSOF® lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved ACRYSOF® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
The CENTURION® Vision System is a phacofragmentation system similar to the Alcon INFINITI® Vision System (Evergreen II - K112425). It is designed for emulsification, separation, irrigation and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection.
The Alcon Laboratories, Inc. CENTURION® Vision System, an ophthalmic surgical device, received 510(k) clearance based on substantial equivalence to predicate devices and adherence to relevant safety and performance standards. The provided document focuses primarily on non-clinical testing and regulatory compliance rather than a clinical study evaluating the device's performance against specific acceptance criteria for diagnostic accuracy or effectiveness in the way an AI/ML product would be assessed.
Therefore, many of the requested elements for an AI/ML device study are not directly applicable or available in this submission. The "acceptance criteria" here refers to compliance with safety standards and demonstration of equivalence to existing devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Compliance with Standards/Equivalence to Predicates) | Reported Device Performance (Demonstrated Compliance/Equivalence) |
|---|---|
| Sterilization (Ethylene Oxide) ISO 11135-1: 2007 | Validated per standard |
| Sterilization (Radiation) ISO 11137-1: 2006, ISO 11137-2: 2007 | Validated per standard |
| Ophthalmic Implants - Mechanical Properties BS EN ISO 11979-3: 2006 | Not explicitly detailed, but implied by overall compliance. |
| Risk Management EN ISO 14971: 2007 | Compliance demonstrated |
| Medical Electrical Equipment - Safety (General, Collateral, Particular, Usability, High Frequency Surgical, Lens Removal/Vitrectomy) IEC 60601 series, IEC 80601-2-58: 2008 | Compliance demonstrated |
| Biocompatibility (Evaluation & Testing, In Vitro Cytotoxicity, Ethylene Oxide Sterilization Residuals, Irritation/Hypersensitivity, Systemic Toxicity, Sample Prep) ISO 10993 series | Evaluations performed to specified standards |
| Quality System Compliance 21 CFR 820 | Compliance stated |
| Substantial Equivalence to Predicate Devices (e.g., Alcon INFINITI® Vision System) | Demonstrated through non-clinical testing and comparison of technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not describe a "test set" in the context of clinical data for an AI/ML device. The testing involved non-clinical evaluations of the device's components and system against engineering and safety standards. Therefore, concepts like country of origin for data or retrospective/prospective are not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth as typically defined for AI/ML validation (e.g., diagnostic labels) is not part of this device's regulatory review, which focuses on hardware safety and performance.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" requiring adjudication in the context of clinical interpretation or diagnostic accuracy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a hardware surgical device, not an AI/ML diagnostic or assistive tool where human reader performance would be assessed with and without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is a surgical system that is operated by a human surgeon. It does not have a "standalone algorithm" that performs clinical tasks independently.
7. Type of Ground Truth Used
The "ground truth" in this context refers to established engineering standards, material specifications, and performance requirements for medical devices, particularly ophthalmic surgical systems. This includes:
- Standards Compliance: Adherence to ISO and IEC standards for sterilization, biocompatibility, electrical safety, risk management, and mechanical properties.
- Functional Equivalence: Demonstration that the new device performs its intended functions (e.g., emulsification, aspiration, IOL injection) similarly and safely compared to previously cleared predicate devices.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that uses a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.