Search Results

The Sof-Suction™ Fluid Evacuation System is used to remove excess irrigation fluids The Bot-Baction - Pland 24 assumed aring microscopic eye surgery to mitigate the effects n of the medial cannies of the eye aid as a see and to prevent stagnant irrigating fluid from entering the eye

Consists of a proximal portion consisting of a 11 mm x 7 mm x 7 mm polyvinyl acetal sponge tip fastened by heat bonding to a 7 mm 18Ga thin wall 301 stainless steel cannula friction attached to a 36'' 5 Fr polyvinyl acetate suction tubing, attached with medical grade adhesive to a ¼" standard suction tubing adapter. Included with the device is adhesive tape for fixating the suction tubing.

The provided text is a 510(k) summary for the Sof-Suction™ Fluid Evacuation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria as would be found for a novel device or AI-powered solution.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or algorithm performance for an AI/ML device.

Specifically:

• No table of acceptance criteria and reported device performance is present for the Sof-Suction™ system, as its approval is based on substantial equivalence rather than meeting specific performance metrics in a clinical study.
• No sample sizes for a test set or data provenance are mentioned.
• No number of experts or their qualifications for establishing ground truth are discussed.
• No adjudication method is described.
• No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned, as this is for human-AI interaction in diagnostic tasks.
• No standalone algorithm performance study is described, as the device is a physical fluid evacuation system.
• No type of ground truth used is specified, as there is no diagnostic or AI component.
• No sample size for a training set is applicable for this type of device.
• No method for establishing ground truth for a training set is relevant.

The document states: "We are simply combining two proven technologies in a new, safe and effective manner." This emphasizes the substantial equivalence approach, where existing approved components are combined, and thus extensive de novo safety and efficacy studies with acceptance criteria and performance metrics are not typically required in the same way as for a completely new or AI-driven technology.

Ask a specific question about this device