(526 days)
The Alcon Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
The Alcon Vision System is a combined anterior and postcrior procedure ophthalmic system that is modular in design and serves as an enhanced version of the current Alcon Accurus® system. The Alcon Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, and illumination as well as irrigation, lens emulsification and fragmentation, cautcry and diathermy. The system was developed with a dual purpose: to make it simple to operate, and to allow the surgeon control and flexibility.
Acceptance Criteria and Study Details for Alcon Vision System (K063583)
This 510(k) summary for the Alcon Vision System focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria for a novel device. Therefore, a direct table of acceptance criteria and reported device performance, and details of a clinical study proving those criteria, are not present in the provided document in the typical sense of a new technology submission.
The document states that "Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed" and "Test data and documents were submitted that demonstrated the substantial equivalence of the IOP control features of the proposed and predicate devices." This implies that the 'acceptance criteria' were met by demonstrating that the new device performs equivalently to existing, legally marketed devices.
However, based on the provided text, we can infer the approach taken to meet regulatory requirements.
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative "acceptance criteria" and direct "reported device performance" are not presented for a de novo evaluation, the table below reflects the stated goal of the submission: substantial equivalence to predicate devices. The "Performance" column indicates the documented approach used to demonstrate this equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (as per document) |
|---|---|
| Compliance with relevant medical device standards | The device will comply with applicable sections of numerous standards including biological evaluation (ISO 10993 series), sterilization (AAMI/ISO 11135, 11137), risk management (ISO 14971), and electrical safety/EMC (UL/IEC 60601 series). Consumables are sterile (EtO or gamma), and reusable handpieces have validated reprocessing instructions. |
| Substantial equivalence of clinical performance to predicates | "Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed." "Test data and documents were submitted that demonstrated the substantial equivalence of the IOP control features of the proposed and predicate devices." |
| Substantial equivalence of Indications for Use | The indications for use for the Alcon Vision System ("ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery") are considered substantially equivalent to those of the predicate devices for vitreous aspiration & cutting and phacofragmentation. |
| Compliance with Quality System Requirements | "The Alcon Vision System will be developed and manufactured in compliance with FDA and ISO quality system requirements." |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical trial data with a specified sample size. The substantial equivalence argument relies on comparing the technological characteristics and intended use to already-marketed predicate devices.
The "test data and documents" mentioned for IOP control features are not detailed, so their provenance (country, retrospective/prospective) and sample size are unknown from this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given the nature of a 510(k) summary focused on substantial equivalence based on technological characteristics and safety standards, there is no mention of a "test set" requiring expert-established ground truth in a clinical performance measurement sense. The evaluation appears to be based on engineering and manufacturing compliance, as well as a comparison of device specifications and intended use against predicates.
4. Adjudication Method for the Test Set
Not applicable, as no external "test set" requiring expert adjudication for clinical performance is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This type of study typically evaluates the improvement in human reader performance (e.g., diagnostic accuracy) with or without AI/device assistance. Since this device is an ophthalmic surgical system, not a diagnostic imaging AI, such a study would not be relevant.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Alcon Vision System is a physical surgical system, not a standalone algorithm. Its performance is intrinsically linked to the human operator during surgery.
7. Type of Ground Truth Used
The "ground truth" for this submission is implicitly established by:
- Regulatory Standards: Compliance with an extensive list of AAMI/ISO, UL, and IEC standards for biological evaluation, sterilization, risk management, and electrical/medical equipment safety.
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (Alcon Accurus® Surgical System, Storz Premiere® II/Bausch and Lomb Millennium™, Alcon Infiniti® Vision System, Allergan Sovereign® Cataract Extraction System, Synergetics Photon Illuminator) serves as the benchmark against which the new device's "similar technological characteristics" and "substantial equivalence of IOP control features" are compared.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied.
§ 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.