(120 days)
The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification, removal of cataracts, and intraocular lens injection) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. 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 intraocular lenses. The AutoSert® is indicated for use with ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySoft® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Flex-Tip Laser Probes
· Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
o Proliferative and nonproliferative retinopathy (including diabetic);
o Choroidal neovascularization secondary to age-related macular degeneration;
o Retinal tears and detachments;
o Macular edema;
o Retinopathy of prematurity;
o Choroidal neovascularization;
o Leaking microaneurysms.
Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma.
· Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma.
· And other laser treatments including:
o Internal sclerostomy;
o Lattice degeneration;
o Central and Branch Retinal Vein Occlusion;
o Suturelysis;
o Vascular and pigmented skin lesions.
UltraVit Probes
· Vitreous aspiration & cutting.
Membrane cutting & aspiration.
· Lens removal.
Endoilluminator Probes
· Endoillumination
Valved Entry Systems
Scleral incision
· Canulae for posterior segment instrument access
· Venting (of valved cannulae)
Infusion Cannulas
Posterior segment infusion (liquid or gas)
The CONSTELLATION® 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, cautery, diathermy, and IOL Insertion.
The provided text describes a 510(k) premarket notification for the CONSTELLATION® Vision System, focusing on its substantial equivalence to predicate devices and adherence to various safety and performance standards. However, it does not include the detailed breakdown of acceptance criteria, device performance, or specific study information (like sample sizes, ground truth establishment, or expert qualifications) that you've requested.
The document primarily outlines:
- Indications for Use: The system is for anterior (phacoemulsification, cataract removal, IOL injection) and posterior (vitreoretinal) ophthalmic surgery. Specific probes and systems within CONSTELLATION® (e.g., Flex-Tip Laser Probes, UltraVit Probes, AutoSert® IOL Injector Handpiece) have their own detailed indications.
- Predicate Devices: Several previously cleared Alcon devices (e.g., K101285 CONSTELLATION® Vision System, K121555 CENTURION® Vision System) are listed as predicates.
- Nonclinical Tests and Results: The device's compliance with numerous international and industry standards for sterilization, risk management, electrical safety, electromagnetic compatibility, usability, and biocompatibility is stated.
Therefore, based solely on the provided text, I cannot complete your requested table and study details. The document focuses on regulatory compliance through adherence to standards and substantial equivalence, rather than presenting a performance study with specific acceptance criteria and outcome metrics for the device itself.
The information requested, such as specific performance metrics (e.g., sensitivity, specificity for a diagnostic device), sample sizes for test sets, details about ground truth, expert qualifications, or MRMC study results, are typical for AI/ML device submissions, but this document predates broad AI/ML medical device regulation and describes a surgical hardware system with accessories.
Here's a summary of what could be extracted and what is missing, based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as performance metrics. The closest are adherence to various safety, sterilization, and biocompatibility standards (e.g., EN ISO 11135-1 for sterilization, UL 60601-1 for electrical safety, ISO 10993-1 for biocompatibility). These are pass/fail criteria for compliance.
- Reported Device Performance: Not provided in terms of quantitative clinical performance (e.g., success rates, complication rates, or diagnostic accuracy). The document states "Safety tests... have demonstrated its compliance with applicable requirements of the following standards" and "Non-clinical testing... has demonstrated that the functional requirements have been met and that the modified device is equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document refers to non-clinical testing for compliance with standards, not a specific clinical test set with human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. No "ground truth" in the diagnostic sense is established in this document, as it's not a diagnostic AI/ML device study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No human adjudication of a test set is described.
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. This is not an AI/ML device. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided. "Ground truth" as a diagnostic reference standard is not relevant to the compliance testing described for this surgical system. The "truth" in this context is whether the device meets engineering specifications and safety standards.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is not an AI/ML device.
In conclusion: The provided document is a 510(k) summary for a surgical system, detailing its intended use and compliance with general medical device standards. It does not contain the specific study design, performance metrics, or "ground truth" information typically associated with the evaluation of AI/ML diagnostic or assistive devices, which is what your questions suggest.
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.