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510(k) Data Aggregation
(78 days)
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(191 days)
The Electroscope, Inc. Bipolar Electrosurgical Pencil is designed as a "Disposable" product. The Bipolar Electrosurgical Pencil is a device designed to be used in procedures involving cutting and coagulation of the soft body tissue.
The Electroscope, Inc. Bipolar Electrosurgical Pencil is designed as a "Disposable" product. The Bipolar Electrosurgical Pencil is a device designed to be used in procedures involving cutting and coagulation of the soft body tissue.
The provided document is a 510(k) premarket notification letter from the FDA to Electroscope, Incorporated, for a Bipolar Electrosurgical Pencil. This type of document does not contain details about specific acceptance criteria or a study proving the device meets those criteria.
The 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, not necessarily a demonstration of clinical efficacy or extensive performance studies with detailed acceptance criteria as would be found in a Premarket Approval (PMA) application or a clinical trial report.
Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval based on equivalence, not on a detailed performance study with acceptance criteria.
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(83 days)
The Bipolar Arthroscopic Probe is an electrosurgical device designed to be used in Arthroscopic procedures involving cutting and coagulation of soft body tissue. The Bipolar Arthroscopic Probe is indicated for use in patients requiring ine bipolar neurossoppf the joint i.e., wrist, knee, shoulder, ankle, and elbow.
The Bipolar Arthroscopic Probe is an electrosurgical device designed to be used in Arthroscopic procedures involving cutting and coagulation of soft body tissue.
I am sorry, but the provided text does not contain the information requested in your prompt. The text is a letter from the FDA to Electroscope, Incorporated regarding the 510(k) premarket notification for a Bipolar Arthroscopic Probe. It discusses the device's substantial equivalence and regulatory classification.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Details about a study proving the device meets acceptance criteria.
- Information on sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
The letter focuses on regulatory approval and indications for use, not on the performance details of a device demonstrated through studies.
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