(142 days)
Provide illumination at surgical site.
Clear silicone sleeve that transmits light originating from fiber optic channels contained in the phacofragmentation handpiece.
I am sorry, but the provided text describes a medical device called "Phacoilluminator™" for surgical illumination, specifically a clear silicone sleeve designed to transmit light during phacofragmentation procedures.
The text does not contain any information about acceptance criteria, device performance metrics, study details (like sample size, data provenance, expert qualifications, adjudication methods), statistical studies (MRMC, standalone), or ground truth establishment relevant to the questions you've asked. It is a very brief 510(k) summary from 1997 focusing on the device's description and equivalence to existing devices.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide details on the study design, as this information is absent from the provided input.
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FEB 2 6 1997
CONFIDENTIAL AND PROPRIETARY INFORMATION
Page Three
510(k) Summary per section 807.92(c)
Submitter Name: Michael Reynard, M.D. Address: 1301 - 20th Street #260, Santa Monica, CA 90404 Telephone: 310-453-0551 FAX: 310-315-0133 Contact Person: Michael Reynard, M.D. Date of Summary: 9/30/1996
Name of Device: Accessory Illuminating Infusion Sleeve
Tradename of Device: Phacoilluminator™
Equivalence: The subject device is a predicate silicone infusion sleeve without opaque or tint additives.
Description of Device: Clear silicone sleeve that transmits light originating from fiber optic channels contained in the phacofragmentation handpiece.
Intended Use of Device: Provide illumination at surgical site.
Comparison with predicate devices: Construction material is identical with currently manufactured silicone infusion sleeve except that opaque additives are omitted to allow for light transmission.
§ 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.