(267 days)
Electrosurgical Generator is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.
Bipolar Polypectomy Snare Combination has been designed to be used with endoscope and electrosurgical unit for the removal of sessile polyps, pedunculated polyps, tissue and foreign bodies from within the GI tract using high-frequency current.
Single Use Electrosurgical Knife Combination has been designed to be used with endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.
The Electrosurgical System comprises:
- ◆ Electrosurgical Generator;
- ◆ Bipolar polypectomy snare combination;
- Single use electrosurgical knife combination.
The Electrosurgical Generator is designed to deliver bipolar high-frequency current for the purpose of cutting and coagulating tissue. It consists of High frequency generator, footswitch, bipolar connecting cable and power cord. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activated the bipolar high-frequency current output for cut; the other pedal activates the bipolar high-frequency current output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by AGS for generating and controlling the two energies delivered. The Bipolar connecting cable connects electrosurgical instruments to the Electrosurgical Generator, it transfer electrical energy - without changing the energy - from devices to instruments. The Electrosurgical Generator, Footswitch, Bipolar connecting cable and Power cord are non-sterile and reusable.
Bipolar polypectomy snare combination is an accessory to Electrosurgical Generator. It is a sterile device consists of Polypectomy snare (Bipolar) and Distal attachment. It is for endoscopic use. It is used for removal of polyps within the digestive tract using high-frequency current. EO sterilization and use for single use only.
Single use electrosurgical knife combination is an accessory to Electrosurgical Generator. It is a sterile device consists of Single use electrosurgical knife and Distal attachment. It is for endoscopic use. It is used for cutting tissues within the digestive tract using high-frequency current. EO sterilization and use for single use only.
The provided text is a 510(k) summary for an Electrosurgical System, comprising an Electrosurgical Generator, a Bipolar polypectomy snare combination, and a Single use electrosurgical knife combination. However, the document does not describe a study involving acceptance criteria and associated device performance for an AI/ML-based medical device.
Instead, it focuses on demonstrating substantial equivalence to predicate electrosurgical devices through:
- Comparison of Technology Characteristics: This section details differences in output parameters for the electrosurgical generator (e.g., frequency, voltage, power) and differences in the principles of operation, energy use, and structure for the accessories (bipolar vs. monopolar, materials).
- Performance Testing: This section lists the types of performance testing conducted to address the differences between the proposed device and predicate devices. These tests are primarily focused on electrical safety, thermal effects on tissue, biocompatibility, and bench testing.
Crucially, the document explicitly states "No Clinical test is included in this submission" (Page 12, Section 5.9). This strongly indicates that the device's clearance was based on demonstrating equivalence through non-clinical performance data and comparison to existing predicate devices, rather than a clinical study evaluating its acceptance criteria in human subjects, especially not a study involving human readers or AI assistance.
Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test set with provenance, number/qualifications of experts, adjudication method, MRMC study details, standalone performance, ground truth type for test set, training set details) because the document does not describe an AI/ML device or a clinical study that would have generated such data in the context of human-in-the-loop performance or diagnostic accuracy.
The provided text pertains to a traditional electrosurgical device, not an AI/ML-driven solution that would involve complex data analysis or human reader performance studies.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).