(189 days)
The Constellation® 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 Constellation® Vision System is a combined anterior and posterior procedure ophthalmic system that is modular in design and serves as an enhanced version of the Alcon Vision System. The Constellation® Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, and illumination as well as irrigation, lens emulsification and fragmentation, cautery and diathermy. The system was developed with a dual purpose: to make it simple to operate, and to allow the surgeon control and flexibility.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Alcon Constellation® Vision System:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, there are no specific quantitative acceptance criteria or reported device performance metrics listed in the document for clinical or diagnostic efficacy. The submission focuses on substantial equivalence to predicate devices and adherence to standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| None explicitly stated in terms of performance metrics for efficacy (e.g., accuracy, sensitivity, specificity). | The device conforms to the same standards as the original K063583 clearance. Regression testing for Electromagnetic Compatibility (EMC) was performed to verify changes to the touchscreen PCBA. |
The document primarily states:
- "Technological characteristics affecting clinical performance are similar to that of other ophthalmic devices."
- "Test data and documents were submitted that demonstrated that the functional requirements had been met and that the system specifications have been met prior to commercial product release."
This implies that the acceptance criteria are related to the successful completion of functional tests, compliance with electrical safety and EMC standards, and similarity to predicate device performance, rather than specific numerical efficacy targets.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set in the context of clinical or diagnostic performance evaluation. The testing mentioned is for:
- "regression testing for the Electromagnetic Compatibility (EMC) standard"
- "functional requirements" and "system specifications"
Therefore, sample size and data provenance (country of origin, retrospective/prospective) are not applicable or mentioned in the context of clinical efficacy for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there is no mention of a human-read test set or a clinical study for diagnostic or clinical performance that would require establishing ground truth by experts. The submission relies on technical testing and substantial equivalence.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a clinical test set requiring 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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an ophthalmic microsurgical system, not an AI-powered diagnostic or assistive tool for human readers that would necessitate such a study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable as the Constellation® Vision System is a surgical device, not a standalone algorithm. Its "performance" is primarily defined by its functionality, safety, and operational characteristics in a surgical context, rather than a diagnostic output.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the type of technical and functional testing described, the "ground truth" would be established by engineering specifications, regulatory standards compliance, and predefined functional outputs expected from the system. It would not be based on clinical outcomes data or expert medical consensus in the way a diagnostic device's ground truth is established.
8. The Sample Size for the Training Set
This information is not applicable. The device is a surgical system, not a machine learning or AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
§ 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.