(87 days)
The ARIS Wand, used with the WEREWOLF COBLATION System, is Indicated for ablation, resection and coaqulation of soft tissue and hemostasis of blood vessels in otorhinolarynqology (ENT) surgery including; nasal airway obstruction of hypertrophic nasal turbinates and submucosal tissue shrinkage.
The ARIS COBLATION Turbinate Reduction Wand (Figure 1) is a single-use, disposable, bipolar, radio frequency, electrosurgical device intended for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including nasal airway obstruction by reduction of hypertrophic nasal turbinates and submucosal tissue. There are no changes to the WEREWOLF Controllers or Irrigation pump for use with ARIS Wand.
The ARIS Turbinate Reduction Wand consists of three integrated lines built into the handpiece that allow the wand to work as intended:
- An integrated suction line with universal barb allows connection to suction source within the operating environment.
- An integrated saline tube set designed to be compatible with the WEREWOLF controller . pump module allows connection with saline source within the operating environment.
- . An integrated cable to be compatible with the WEREWOLF controller.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or clinical effectiveness, particularly in the way one would describe an AI/ML medical device.
The document is a 510(k) Premarket Notification for an electrosurgical cutting and coagulation device. The "performance testing" sections refer to:
- Non-clinical performance testing: Bench testing for coagulation, ablation, active life, suction, tip clearing, mechanical, EMC, and functional tests. These tests are about the physical and electrical performance of the device, not its diagnostic accuracy or clinical outcomes based on patient data.
- Pre-clinical (ex vivo) testing: Testing on bovine myocardial tissue to compare insertion channel diameters, thermal zone areas, and thermal zone volumes between the new device and a predicate device. This is a bench/lab test, not a clinical study involving human patients.
- No animal testing was performed.
- No clinical data (human study) was included in the submission.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them in the context of diagnostic performance or comparative effectiveness with human readers supported by AI. The device described is a physical electrosurgical tool, not an AI/ML-driven diagnostic or assistive system for which such studies would be conducted and reported in this format.
The acceptance criteria mentioned are general performance specifications for an electrosurgical device (e.g., meeting established electrical safety standards, functional specifications, sterilization efficacy, shelf life, biocompatibility) rather than statistical performance metrics (like accuracy, sensitivity, specificity, or reader agreement) derived from a test set of labeled patient data for an AI/ML device.
§ 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.