(217 days)
The Porex Electrosurgery Needle is an electrosurgery electrode for use in monopolar electrosurgical handpieces. It is a single-use device intended for cutting, dissecting, and cauterizing of soft tissue.
The Porex Surgical, Inc. Electrosurgery Needle is an electrosurgical electrode for use with monopolar electrosurgical accessories (cautery handpieces). It is constructed of a tungsten tip held by a gold plated stainless shaft/sleeve. The electrode shaft has two layers of insulation.
The provided text is a 510(k) summary for the Porex Electrosurgery Needle. It does not contain any information about acceptance criteria or a study proving device performance against those criteria. The document focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting performance data from a specific study against predefined acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text.
Specifically, the document contains:
- Device Identification: Name, submitter, contact, common name, classification details.
- Predicate Device Identification: List of devices to which the Porex Electrosurgery Needle is considered substantially equivalent.
- Description: Physical construction details of the needle.
- Intended Use: How the device is designed to be used (cutting, dissecting, cauterizing soft tissue).
- FDA Correspondence: Letter from the FDA confirming the 510(k) clearance and substantial equivalence determination.
- Indications for Use: Formal statement of the device's intended applications.
There is no mention of:
- A table of acceptance criteria or reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for training sets.
- How ground truth for training sets was established.
§ 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.