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The CENTURION® Vision system (Active Sentry™) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, 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 function of intraocular lenses. The AutoSert IOL Injector Handpiece is indicated for use with the ACRYSOF lenses SN6OWF. SNWAD1. 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.

Alcon's CENTURION ® Vision System is an ophthalmic surgical instrument designed for use in cataract extraction using the CENTURION® OZil® handpiece, the CENTURION® Active Sentry® handpiece, and the INFINITI® OZil® handpiece.

The CENTURION® Vision System is intended for use in small incision cataract lens extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate the lens in the eye, while replacing aspirated fluid and lens material with balanced salt solution. This process maintains a stable (inflated) eye chamber volume. Using system controls, the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration, vacuum, and the flow of BSS® irrigating solution. The system includes a footswitch to enable the surgeon to control flow of fluidics, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.

This document describes the Centurion Vision System (Active Sentry™), a phacofragmentation system for cataract surgery. The submission to the FDA is for a modified version of an existing device, emphasizing its substantial equivalence to the predicate device. Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating safety and performance comparison to the predicate, rather than establishing de novo clinical performance metrics against a defined acceptance criteria for a novel device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a modified device, the "acceptance criteria" are implicitly met by demonstrating equivalence to the predicate device's established safety and performance. The performance data presented primarily focuses on non-clinical testing.

• Cytotoxicity (ISO Elution Method 1X MEM, ISO MTT Method)
• Sensitization (ISO Maximization Sensitization Study)
• Acute Systemic Toxicity (ISO Acute Systemic Toxicity Study)
• Ocular Irritation (ISO Intraocular Injection Method)
• Material Characterization (Leachables) |
  | Electromagnetic Compatibility (EMC): Device operates without causing or being susceptible to electromagnetic interference. | PASS in all conducted electromagnetic compatibility and electrical safety tests, including:
• EN 60601-1 (General requirements for basic safety and essential performance)
• EN 60601-1-2 (Electromagnetic compatibility)
• EN 60601-2-2 (Safety of high frequency surgical equipment)
• EN 60601-1-8 (Alarm systems)
• EN 80601-2-58 (Lens removal and vitrectomy devices)
• IEC 60601-1-6 (Usability)
• IEC 62366 (Usability engineering) |
  | Electrical Safety: Device meets electrical safety standards. | PASS in all conducted electrical safety tests (as part of EN 60601-1, EN 60601-2-2, etc.). |
  | Functional Equivalence: Device performs its intended functions similarly to the predicate. | Demonstrated through comparison of technological characteristics (same intended use, operating principle, basic phaco handpiece, consumables, technology, design, materials, shelf life, packaging, and sterilization). No specific quantitative functional performance metrics are provided in this summary, implying functional equivalence was accepted based on design and non-clinical testing. |

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable in the context of this submission. The "test set" here refers to non-clinical laboratory testing, not human clinical trials with a defined patient sample size. The biocompatibility tests used cell lines (L-929 Mouse), guinea pigs, and rabbits. Electrical and EMC tests were performed on the device itself.
• Data Provenance: The data provenance is from laboratory testing performed by Alcon Research, Ltd. or its contracted labs. The country of origin of the data is not explicitly stated but is implicitly where Alcon conducted its R&D and testing. The data is prospective in the sense that these tests were conducted specifically for this submission, but they are not clinical prospective studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This question is not applicable to this type of submission. "Ground truth" in the context of expert consensus or clinical outcomes is relevant for diagnostic or AI-driven systems. For device safety and performance testing like biocompatibility, EMC, and electrical safety, the "ground truth" is established by adherence to recognized international standards (e.g., ISO, EN, IEC) and the expertise of certified laboratory personnel. No clinical experts were involved in establishing the "ground truth" for the non-clinical tests described.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among multiple human readers or experts, typically in clinical studies or image interpretation tasks. The tests described here are laboratory-based and follow standardized protocols, yielding objective pass/fail results.

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

• Not applicable. This device is a surgical system, not a diagnostic imaging device or an AI-driven system requiring human-in-the-loop performance evaluation. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a hardware and software medical device for surgical procedures, not a standalone algorithm.

7. The Type of Ground Truth Used

• For biocompatibility: The "ground truth" is established by the accepted physiological responses and safety profiles defined in the ISO standards for biological evaluation of medical devices.
• For electrical safety and EMC: The "ground truth" is established by the specifications and limits defined in the international electrical safety and EMC standards (e.g., IEC 60601 series).
• For functional aspects: The "ground truth" for functional equivalence is the performance and operating characteristics of the predicate device.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI that would require a "training set" of data in the conventional sense. The development and verification process involves engineering design, prototyping, and testing, not algorithmic training on large datasets.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" for an AI algorithm.

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