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The Storz Ophthalmic Bipolar Cautery devices are used to control bleeding during ophthalmic surgical procedures using radiofrequency electric current. The D8200 Bipolar Forceps are used during ophthalmic procedures, coagulating extraocular tissue by pinching it between the forcep tips. The D8201 Bipolar Eraser is also used during surgery for cauterization of extraocular vessels, while the D8203 Bipolar Intraocular Eraser is used in posterior ophthalmic surgical procedures to cauterize vessels internal to the eye.

Storz D8200 series Ophthalmic Bipolar Cautery devices are accessories to Storz DAISY®, Protege®, and PREMIERE® Ophthalmic Microsurgical Systems. The D8200 is a reusable bipolar forceps, D8201 is a reusable bipolar eraser, and the D8203 is a reusable bipolar intraocular eraser. The D8202 bipolar cord is used to connect the three cautery instruments to the Storz DAISY® Microsurgical System; the D8204 bipolar cord is used to connect the three cautery instruments to the Storz Protege® and PREMIERE® Microsurgical Systems. All three instruments and both cords have Lemo™ locking connectors. The D8200 forceps are composed of surgical grade stainless steel; the D8201 and D8203 erasers are composed of surgical grade stainless steel and spring steel, and liguid crystal polymer insulation. These materials raise no questions of biocompatibility.

This 510(k) summary describes Storz Ophthalmic Bipolar Cautery Instruments and Bipolar Cords (models D8200, D8201, D8203, D8202, D8204). The submission demonstrates substantial equivalence to predicate devices, thus no specific acceptance criteria or studies proving device performance are explicitly stated in the provided text.

The document focuses on comparing the new Storz devices to existing predicate devices (Kirwan Ophthalmic Bipolar Forceps, Pencils, and Cord; and Mentor WET-FIELD Bipolar Forceps and Bipolar Hemostatic Erasers) based on their intended use, material composition, system compatibility, connector type, reusability, and sterility.

Therefore, many of the requested details about acceptance criteria and studies cannot be extracted from this summary.

Here's a breakdown of what can be inferred or directly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided. The document does not list specific performance metrics (e.g., coagulation time, temperature thresholds, tissue damage limits) or acceptance criteria for those metrics. Instead, it relies on substantial equivalence to predicate devices. The "reported device performance" is implicitly that it functions similarly to the predicates for ophthalmic bipolar cautery.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This document is a 510(k) summary for substantial equivalence, not a report of a new clinical or performance study for the Storz devices themselves to establish novel performance claims. The comparison is based on the design and intended use relative to predicates.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The comparison is based on device specifications and intended use, not on expert-adjudicated ground truth data from testing.

4. Adjudication Method

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is not mentioned as it's not relevant for a substantial equivalence determination for this class of device based on the information provided.

6. Standalone Performance Study (Algorithm Only)

No. This device is a physical medical instrument (cautery devices and cords), not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable / Implicit. For substantial equivalence, the "ground truth" is that the predicate devices are legally marketed and safe/effective for their intended use. The Storz devices are considered substantially equivalent if they share similar technological characteristics and intended use.

8. Sample Size for the Training Set

Not applicable. This pertains to AI/ML models, not a physical medical device submission for substantial equivalence.

9. How Ground Truth for Training Set Was Established

Not applicable. See point 8.

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