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HI-880DG Plus Electrocoagulator unit is to be used in order to cut and coagulate (burn) the skin in and during minor and general surgery.

HM-880DG Plus Electrocoagulator

The provided document is a 510(k) clearance letter from the FDA for a device called "HM-880DG Plus Electrocoagulator." This letter indicates that the device has been found substantially equivalent to a predicate device already on the market.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The information provided is purely administrative, confirming the device's clearance for marketing based on substantial equivalence. Therefore, I cannot fulfill your request for a table of acceptance criteria and study details using only the provided text. This type of information is typically found in the 510(k) submission itself, or in a separate clinical or performance study report, not in the FDA's clearance letter.

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The Boston Scientific Tissue Coagulation System is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Tissue Coagulation System may also be used to coagulate blood and soft tissues to produce hemostasis.

The Boston Scientific Tissue Coagulation System is comprised of an Electrosurgical Unit (ESU), Electrosurgical Probe, and accessories for the application of radiofrequency energy to tissue. The ESU supplies up to 150 watts of radiofrequency energy in unipolar mode to the electrodes of the Electrosurgical Probe under temperature control while continuously monitoring and displaying actual power delivered, actual electrode temperature, and time of power duration. User controls are provided for setting desired temperature, maximum power output, and duration of power delivery. ESU safety features include overvoltage, overcurrent, and overpower shutdowns.

This 510(k) submission for the Boston Scientific Tissue Coagulation System does not contain a study section with acceptance criteria and a detailed report of device performance against those criteria.

The provided documents are primarily a 510(k) summary and the FDA's clearance letter. These documents attest to the device's substantial equivalence to predicate devices but do not detail the specific performance studies that a manufacturer typically conducts to demonstrate this equivalence.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text.

To answer your request, I would need a different type of document, such as a "Special Controls Guidance Document" from the FDA for electrosurgical devices, or the original submission's testing and performance data.

Ask a specific question about this device