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The WEREWOLF COBLATION System controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following otorhinolaryngology (ENT) procedures:

Resection/Ablation/Coagulation

Tonsillectomy (Including Palatine Tonsils)
Adenoidectomy
Uvulopalatopharyngoplasty (UPPP)
Traditional Uvulopalatoplasty (RAUP)
Nasal Airway Obstruction
Submucosal Palatal Shrinkage
Submucosal Tissue Shrinkage
Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
Reduction of Turbinates for the Treatment of Nasal Airway Obstruction
Nasopharyngeal/Laryngeal Indications Including Tracheal Procedures
Mastoidectomy
Myringotomy with Effective Hemorrhage Control
Papilloma Keloids
Nasopharyngeal/Laryngeal Procedures
Polypectomy
Laryngeal Polypectomy
Laryngeal Lesion Debulking
Cysts
Tumors
Neck Mass
Head, Neck, Oral, and Sinus Surgery
Tissue in the Uvula/ Soft Palate for the Treatment of Snoring

Indications for use - COBLATION™ HALO™ Wand

The COBLATION HALO Wand, used with the WEREWOLF COBLATION System, is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: tonsillectory, adenoidectomy, and uvulopalaty (UPPP). It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate.

Device Description

The proposed WEREWOLF COBLATION System consists of:

A bipolar, radiofrequency (RF) generator (Controller) with Integrated Fluid . Module and Operational Interface Screen,
. Re-usable, non-sterile Foot Control (wired or wireless)
Sterile, disposable, single-use COBLATION Wand(s)
. Reusable, non-sterile power cord.

The components are designed to be operated as a single unit.

The WEREWOLF COBLATION System utilizes bipolar technology specifically designed for the resection, ablation, and coagulation of tissues and hemostasis of blood vessels in various arthroscopic, orthopedic and otorhinolaryngology (ENT) procedures.

The proposed Controller is designed to deliver radiofrequency energy to the electrodes of the compatible COBLATION Wand. The Controller is an enclosed unit with incorporated software that runs both the delivery of radiofrequency energy as well as a Graphical User Interface with which the user can control various modes, levels, volume, etc. Ports for connecting the compatible Wands and the Foot Control are located on the front panel. An optional wireless Foot Control can be installed.

The Controller also incorporates a peristaltic Integrated Fluid Control Module, which provides dynamic control of saline flow (inflow or outflow) to or from the surgical site.

The proposed Controller operates in 5 modes (Lo, Med, Hi, Coag and Vac mode) for arthroscopic and orthopedic procedures and in 4 modes (Lo, Med, Hi and Coag) for the ENT procedures.

The proposed HALO Wand is designed to be used exclusively with the proposed WEREWOLF™ COBLATION™ System. The HALO Wand is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: tonsillectomy, adenoidectomy, and uvulopalatopharyngoplasty (UPPP). It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate. The Wands are provided sterile (via ethylene oxide) and are single-use only.

AI/ML Overview

The provided text is a 510(k) summary for the WEREWOLF COBLATION System and COBLATION HALO Wand. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, not a report of a study proving a device meets acceptance criteria in the context of clinical efficacy or diagnostic performance. Therefore, detailed information typically found in a clinical study report or performance study for AI/diagnostic devices, such as sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, is not present in this document.

The document primarily focuses on demonstrating substantial equivalence through non-clinical (mechanical, electrical, functional, biocompatibility) and pre-clinical (ex vivo) bench testing, comparing the proposed device against its predicate.

Here's an attempt to extract relevant information given the constraints of the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a formal table of "acceptance criteria" for clinical efficacy as would be seen in a clinical trial. Instead, it describes various tests conducted to demonstrate the device's safety and effectiveness compared to the predicate. The "performance" reported is primarily that the device meets established design criteria and performs substantially equivalently to the predicate.

Category of Test	Acceptance Criteria (Implied)	Reported Device Performance
Non-Clinical Testing	Meets established design criteria for mechanical integrity, electrical safety, and specified functions.	Confirmed device meets established design criteria.
Mechanical Tests	Cable mechanical integrity, tip insertion/removal force, etc. (Specifics not detailed)	Tests conducted for distal tip, accessory insertion/removal, cable plug insertion/extraction, cable/saline tube integrity; results support substantial equivalence.
Electrical Tests	Compliance with IEC 60601-1 and IEC 60601-2-2 (Specifics not detailed)	Tests conducted for continuity, dielectric withstand, impedance, overcurrent, electrical safety; results support substantial equivalence.
Functional Tests	Proper functioning in all modes, clog resistance, saline rate, temperature limits, use-limiting features, software validation (Specifics not detailed)	Tests conducted for transit conditioning, gloved surfaces, dimensions, visual inspection, suction clog resistance/removal, suction/saline rate, pinch clamp occlusion, coagulation effect, ablation function (all settings, 1X/2X life), use-limiting check, software usage info check, shutoff timer check, maximum temperature check, software V&V, biocompatibility; results support substantial equivalence.
Pre-Clinical Bench Testing (Ex Vivo)	Thermal effects in ablation and coagulation modes are substantially equivalent to the predicate device.	Evidence on bovine myocardial tissue demonstrates HALO device performs substantially equivalent to the PROCISE XP predicate device in relevant aspects of Ablation mode and Coagulation mode thermal effects.
Additional Bench Testing	Peak temperature at active electrode within acceptable range and comparable to predicate.	Max temperatures recorded ranged from approximately 61.4 - 74.3°C. (Implicitly acceptable and/or comparable to predicate, though direct comparison values aren't provided here for the predicate).

2. Sample size used for the test set and the data provenance:

Non-Clinical/Pre-Clinical Bench Testing: The document does not specify the sample sizes for the various non-clinical and ex vivo bench tests (e.g., number of wands tested, number of bovine tissue samples).
Data Provenance:
- Non-Clinical/Pre-Clinical: Conducted by ArthroCare Corporation.
- Ex Vivo: Bovine myocardial tissue was used. This is a lab-based study with animal tissue, not human data.
- Retrospective/Prospective: All described testing is of a prospective nature as it was conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as the submission relies on physical and functional testing, not expert-derived ground truth for clinical diagnostic performance.

4. Adjudication method for the test set:

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which are not present here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done, as this is a medical device (electrosurgical system) and not an AI/diagnostic imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is an electrosurgical system, not an algorithm, and intrinsically requires human operation.

7. The type of ground truth used:

For the non-clinical and ex vivo bench testing, the "ground truth" or reference standard would be the established engineering specifications, performance standards (e.g., IEC 60601 series), and the performance characteristics of the predicate device. For ex vivo testing on bovine tissue, the measured thermal effects serve as the observed performance to be compared.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/machine learning model.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no training set.

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