(85 days)
Richard Wolf Bipolar Button Electrode with Suction Applicator is designed for use in plastic and reconstructive surgery. The device provides a method of coagulating small blood vessels that bleed as a result of blunt dissection of tissue subcutaneously. When used in conjunction with the suction applicator. smoke caused by the cauterization of tissue is evacuated from the operative site.
The Richard Wolf Bipolar Button Electrode with Suction Applicator consists of the suction applicator with a suction channel, a button electrode, and the bipolar connector.
The provided document is a 510(k) premarket notification for a medical device, the "Bipolar Button Electrode with Suction Applicator." It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.
However, the document does NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way envisioned by the request. This document is a regulatory submission for premarket clearance and focuses on establishing substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria and statistical analysis typical of clinical trials or AI/software validation studies.
Specifically, the document lacks the following key information requested:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or thresholds are mentioned.
- Sample sized used for the test set and the data provenance: No test set is described, beyond a general "Abrasion/Flaking testing."
- Number of experts used to establish the ground truth... and the qualifications: Not applicable as there's no clinical study with ground truth establishment.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: No such study is mentioned or implied.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical instrument, not an AI or software algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The only "performance data" mentioned is:
- "Abrasion/Flaking testing was performed to assure the integrity and bonding of the insulation material to the instruments."
And the "Conclusions Drawn" state:
- "These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual."
This indicates that some internal testing related to material integrity occurred, but no details on acceptance criteria, specific results, sample sizes, or a formal study are provided in this regulatory submission. The FDA clearance is based on substantial equivalence to a predicate device, not on extensive de novo performance data.
Therefore, I cannot populate the table and answer the questions as requested, as the necessary information is not present in the provided text.
§ 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.