(64 days)
The Storz S2050 series of bipolar forceps are used to control bleeding during surgical procedures, using high frequency electric current. Several of the forceps are designed for ophthalmic procedures specifically, while others are marketed for ENT procedures, neurosurgery, and/or plastic and reconstructive surgery. The forceps function by pinching tissue between the forcep tips, and allowing electric current to pass through it. The affected tissue is coagulated, and bleeding is arrested.
The Storz S2050 series of bipolar forceps consists of twenty-one reusable devices for use with Storz DAISY™, Protege®, and PREMIERE® Microsurgical Systems, and Storz S2080 Bipolar Coagulator. All forceps are of the same basic design with differences in tip configurations and handle dimensions. The patient contact portion of the S2050 series of forceps is composed of stainless steel. Some models have a nylon insulation on the handle region of the forceps.
This is a medical device premarket notification (510(k)) summary. It describes a device and compares it to predicate devices to demonstrate substantial equivalence. 510(k) submissions typically do not contain the type of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, MRMC studies, etc.) that your request is asking for.
The purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to provide extensive clinical trial data demonstrating performance against specific acceptance criteria in the way a PMA (Premarket Approval) submission would.
Therefore,Based on the provided text, I cannot extract the information you've requested regarding acceptance criteria and performance study details. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results with acceptance criteria.
Here's why the information is unavailable:
- Acceptance Criteria and Reported Device Performance: This document states the intended use of the device ("control bleeding during surgical procedures") and describes its function ("pinching tissue between the forcep tips, and allowing electric current to pass through it. The affected tissue is coagulated, and bleeding is arrested."). However, it does not provide any quantitative acceptance criteria or reported device performance metrics that would typically be found in a formal performance study (e.g., successful coagulation rates, coagulation time, adverse event rates, etc.). The comparison table focuses on device characteristics, not performance data.
- Study That Proves the Device Meets Acceptance Criteria: There is no mention of a specific study designed to prove the device meets acceptance criteria. A 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices, often through design comparison and sometimes bench testing or limited clinical data if necessary, but not typically a large-scale performance study with defined acceptance criteria.
Therefore, I cannot populate the table or answer the subsequent questions based on the provided text. The document's purpose is to establish equivalence, not to detail performance studies against acceptance criteria.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.