(154 days)
This product is indicated for use with the Alcon Series 20,000 Legacy Phacoemulsifier. It may be utilized in phaco procedures in which either combined or segregated automated irrigation and aspiration is deemed appropriate.
Not Found
This looks like a 510(k) clearance letter for the "Surgin Kit" and "Ophthalmic Kit." The document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA did not require clinical trials or performance studies demonstrating specific acceptance criteria for the Surgin Kit, because substantial equivalence typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different characteristics that do not raise new questions of safety and effectiveness.
Therefore, for your request, I cannot provide the following information from the given document:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided, as performance studies were not a requirement for this specific 510(k) clearance based on substantial equivalence.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method: Not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not provided.
- If a standalone performance study was done: Not provided.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
The document is purely a regulatory clearance letter based on substantial equivalence to a predicate device, and thus does not contain the detailed performance data or study design information that your questions are asking for.
§ 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.