(168 days)
joimax® Bipolar Electrosurgical Instruments
The joimax® bipolar Vaporflex and Legato electrosurgical instruments are used for coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator. The joimax® bipolar electrosurgical instruments have not been shown to be effective for tubal coagulation for sterilization procedures and should not be used for these procedures.
joimax® Monopolar Electrosurgical Instruments
The joimax® monopolar Legato electrosurgical instruments are used for cutting and/or coagulating soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator.
The joimax® monopolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
The joimax® Electrosurgical Instruments are comprised of a series of instruments to facilitate the delivery of electrical energy from an RF generator to the patient tissue for use in cutting and/or coagulation of tissue.
The joimax® Electrosurgical Instruments use Radio Frequency (RF) energy to induce thermal effects on tissue. The radio frequency is generated by high oscillating electrical current received from a commercially available RF generator.
The joimax® Probes are available in both monopolar and bipolar probe configurations. All joimax® Probes are designed for specific use with joimax® Handpieces. The joimax Handpieces can be used with compatible commercially available surgical generators.
The provided text discusses the joimax® Electrosurgical Instruments and their substantial equivalence to predicate devices, focusing on safety and performance. However, it does not explicitly detail a study with specific acceptance criteria and detailed performance metrics as one might expect for an AI/ML device. The document primarily focuses on demonstrating that the electrosurgical instruments meet general safety and performance standards equivalent to existing legally marketed devices.
Based on the provided text, here's a breakdown of the requested information, noting where specific details are not available for this type of device (e.g., sample sizes for AI/ML models, expert ground truth for image interpretation).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance results in a quantitative manner for a comparative study against a specific numerical target. Instead, it confirms compliance with various standards and qualitative comparisons to predicate devices. The "acceptance criteria" are implied by adherence to these standards and the demonstration of similar performance to predicates.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | The device was evaluated according to FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Testing included Cytotoxicity, Irritation, Sensitization, and Acute Systemic Toxicity. The joimax® electrosurgical instruments are considered direct tissue contacting for |
§ 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.