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The ESA is a hand-held surgical instrument intended for use as a trocar/cannula for establishing an entry site conduit for passing ophthalmic instruments/accessories used to perform posterior ophthalmic surgical procedures.

Bausch & Lomb's Entry-Site Alignment system (ESA) is a 25ga disposable cannula system used to access the posterior segment of the eye for various ophthalmic surgical procedures. The ESA system is used to establish and maintain a surgical orifice for infusion as well as insertion and removal of surgical instruments used during posterior ophthalmic surgical procedures.

The ESA system will be EtO sterilized with a minimum SAL level of 10°. The ESA system will be provided sterile, single-use in the following configuration:

(3) Insertion tool assemblies (needle/cannula)
(3) Cannula pluas
(1) Infusion line

The ESA insertion tool assembly is constructed of polycarbonate handle with a thin wall stainless steel needle affixed to the distal tip of the insertion tool handle. via a medical grade adhesive. The intravenous point of the needle allows for ease of piercing through the conjunctiva and sclera vs. the traditional dissection of the conjunctiva and sclera.

The cannulas are constructed of thin-wall stainless steel with an polycarbonate hub and are manually attached to the ESA insertion tool and locked (via a slight twist) into place (provided pre-assembled). The cannula lumen is designed to accommodate passage of various 25ga surgical instruments for posterior surgical procedures.

The cannula plugs are constructed of a medical grade ABS polymer and are intended for insertion into the entry-site cannula(s) to seal the cannula port when not in use.

The silicone infusion line, connected to a chosen surgical entry site, is intended to infuse through cannula port while performing surgical procedure.

During use, the ESA svstem is manually advanced through the conjunctiva and sclera. Once an incision is established, the insertion tool/needle is removed and the cannula remains in place at the chosen surgical entry site(s). Following placement of the trocar(s), a chosen cannula port is utilized as an infusion site for which the infusion tube is attached. The desired posterior segment procedure is performed advancing and removing surgical instruments through the lumen of the positioned cannulas. After the procedure is completed the cannulas are simply removed from the eye using forceps.

The provided text describes a 510(k) premarket notification for the Entry-Site Alignment System (ESA), a 25ga disposable cannula system. While it outlines the product description, indications for use, and regulatory classification, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on receiving 510(k) clearance by demonstrating substantial equivalence to a predicate device (Alcon/Grieshaber Trocar Cannula Set), rather than detailing specific performance studies with quantitative acceptance criteria and results. The clearance process for Class I devices like this often relies on demonstrating similar design, materials, and intended use as legally marketed predicate devices, and may not require extensive clinical performance studies to the same extent as higher-risk devices.

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