Search Results

The Werewolf Coblation System, comprised of the FLOW 50 Wand and the RF20000 Controller, is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:

All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow)
Ablation/Debridement: Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Scar Tissue, Soft Tissue, Synovectomy, Tendon
Excision/Resection: Articular Labrum, Capsule, Cysts, Ligament, Loose Bodies, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon

Hip
Excision/Resection: Acetabular Labrum

Knee
Ablation/Debridement: ACL/PCL, Notchplasty
Excision/Resection: Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release, Meniscal, Cystectomy, Meniscectomy, Villusectomy

Shoulder
Ablation/Debridement: Acromioplasty, Subacromial Decompression
Excision/Resection: Frozen Shoulder Release, Glenoid Labrum

Wrist
Excision/Resection: Triangular Fibrocartilage (TFCC)

The RF20000 Coblation System is an electrosurgical system consisting of a bipolar radiofrequency Controller with Integrated Fluid Outflow Regulator; a sterile, disposable, single-use FLOW 50 Wand; Black Connector Quantum Wands, and a non-sterile, reusable wired Foot Control or wireless Foot Control. This System utilizes bipolar technology specifically designed for the resection, and ablation of soft tissue and hemostasis of blood vessels in various arthroscopic and orthopedic procedures. The System offers five distinct Modes of operation: Hi (Ablation), Med (Ablation), Lo (Ablation), Vac (Vacuum), and COAG (Hemostasis), Each Ablation (Coblation) mode allows for precise ablation with minimal damage to surrounding healthy tissue. The COAG mode allows for consistent and precise hemostasis of blood vessels.

The FLOW 50 Wand consists of a handle, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached at the proximal end of the handle and connect to the RF20000a Controller and the Fluid Outflow Regulator, respectively. The handle has finger switches that enable Ablation Mode switching (Lo. Med. Hi) as well as activation of the Wand (Vac. Coag, or Ablate). The Foot Control provides an alternate means of controlling these same functions. The Wand is provided sterile and is single-use only.

The RF20000 Controller is designed to deliver radiofrequency energy to the electrodes of the FLOW 50 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 FLOW 50 Wand, Black Connector Quantum Compatible Wands and the Foot Control are located on the front panel. An optional wireless Foot Control can be installed. The Controller incorporates a peristaltic integrated Fluid Outflow Regulator, which provides dynamic control of the rate of removal of conductive irrigating solution and/or fine, less dense, free-floating debris.

The provided text describes a 510(k) premarket notification for the "Werewolf Coblation System (RF20000) with FLOW IQ Technology," which is an electrosurgical device. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (RF20000a Coblation System, K143235).

The document does not contain acceptance criteria for device performance or a study demonstrating the device meets those criteria in a way that involves the detailed points requested in your prompt (e.g., sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training sets).

Instead, the submission focuses on demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical bench testing.

Here's a breakdown based on the information available and what is not present:

1. Table of acceptance criteria and the reported device performance:

The document provides a comparative table of technological characteristics between the subject device (Werewolf Coblation System) and predicate devices (RF20000a Coblation System, K143235, and Quantum 2, K082666). It does not explicitly state "acceptance criteria" as performance metrics with thresholds that the device was evaluated against, but rather notes where characteristics are "Same" or identifies specific values.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document states: "Bench testing was performed on both the proposed and predicate devices." It does not provide details on:

• The sample size of devices tested.
• The specific tests performed to demonstrate performance equivalence beyond "design, performance, and safety specifications."
• Data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided as the submission relies on non-clinical bench testing for substantial equivalence, not human expert evaluations of clinical outcomes or images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/provided as the submission is based on bench testing of physical characteristics and performance, not expert consensus on diagnostic or clinical outcomes.

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:

This is not applicable. The device is an electrosurgical system, not an AI-assisted diagnostic or clinical decision support tool that would typically involve human readers. No MRMC study was mentioned or would be relevant for this type of device.

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

This is not applicable in the context of the requested AI-related performance. The "algorithm" here refers to the embedded software controlling the electrosurgical device's functions (RF energy delivery, fluid outflow, safety features). While software validation was performed, it's not a "standalone performance" in the sense of an AI model's diagnostic accuracy. The device always functions with a human operator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this submission, the "ground truth" for demonstrating substantial equivalence is the performance and safety specifications of the legally marketed predicate device (K143235 and K082666) and established engineering/performance standards. This is evaluated through non-clinical bench testing, not through clinical outcomes, pathology, or expert consensus in an AI context.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device that involves training data sets. The software changes concern control algorithms for electrode wear detection and low voltage impedance, not a learning model.

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

This is not applicable for the same reasons as point 8.

Ask a specific question about this device