(77 days)
The Dyonics ElectroBlade is indicated for use in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues and for coagulation of bleeding.
The Dyonics ElectroBlade combines the rotary cutting technology of Dyonics Arthroscopic Surgery Blades with the electrosurgical capabilities of a monopolar electrosurgery probe. The inner rotational blade is electrified by connection to a standard electrosurgical generator. Insulation on the outer blade isolates the electrical energy to the inner tube where it is exposed to tissues at the cutting window of the blade. The Dyonics ElectroBlade operates in conjunction with the standard Dyonics shaver system and standard monopolar electrosurgical generator systems. The Dyonics ElectroBlade requires the use of an electrosurgical dispersive pad.
I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a 510(k) summary for the Dyonics ElectroBlade, a medical device. This type of submission to the FDA focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a performance study with detailed acceptance criteria.
Here's a breakdown of why this information is missing and what the 510(k) summary does cover:
- Acceptance Criteria and Device Performance: These are typically found in detailed performance studies or clinical trials, which are not part of this 510(k) summary. The document simply describes the device's function and intended use.
- Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Sample Size/Ground Truth: All of these points relate to the methodology of a performance study, which is absent from this 510(k) summary.
The 510(k) summary focuses on:
- Device Description: What the Dyonics ElectroBlade is and how it works.
- Intended Use: The medical procedures and tissues it's designed for.
- Predicate Devices: Identifying already-approved devices that are similar.
- Comparison of Technological Characteristics: Arguing that the new device is "substantially equivalent" to predicate devices, meaning it doesn't raise new questions of safety or effectiveness. This is the core of the 510(k) pathway.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text. The document's purpose is to demonstrate substantial equivalence, not to present a detailed performance study against specific 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.