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WEREWOLF™ FASTSEAL 6.0 Hemostasis Wand:
The FASTSEAL 6.0 Wand, used with the WEREWOLF™ + COBLATION System, is indicated for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures.

WEREWOLF™ + COBLATION™ SYSTEM - See Page 2

The WEREWOLF"+ COBLATION System controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic, orthopedic and otorhinolaryngology [ENT] procedures:
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow): Ablation/Debridement (Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, 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))
ENT: Resection/Ablation/Coagulation (Tonsillectomy (including Palatine Tonsils) Tracheal, Adenoidectomy, Uvulopalatopharyngoplasty (UPPP), Traditional Uvulopalatoplasty Control (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, 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)
Orthopedic: Hemostasis (via coagulation) of soft tissue and bone.

The subject devices include the WEREWOLF ° + (RF20000) COBLATION System, which includes the WEREWOLF®+Controller and the WEREWOLF® FASTSEAL 6.0 Hemostasis Wand.
The subject WEREWOLF + COBLATION System (System) is an iteration of the WEREWOLF Controllers previously cleared via 510(k)s K143235, K162074, K 192027 and K202006 which utilizes bipolar technology specifically designed for the resection, ablation, and coagulation of tissues and hemostasis of blood vessels in various arthroscopic, orthopedic (cleared via K143235 and K162074), and otorhinolaryngology (ENT) procedures (K192027 and K202006).
The subject WEREWOLF + COBLATION System consists of:

• A bipolar, radiofrequency (RF) generator (WEREWOLF + Controller, subject . Controller) with Integrated Fluid Module (FLOW~IQ Pump), and Operational Interface Screen,
• Re-usable, non-sterile Foot Control (wired or wireless) .
• . Sterile, disposable, single-use COBLATION Wand(s)/FASTSEAL 6.0 Hemostasis Wand (subject Wand)
• Reusable, non-sterile power cord.
  The components are designed to be operated as a single unit and are for prescription use only.
  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 WEREWOLF + Controller is designed to deliver radiofrequency energy to the electrodes of the compatible 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 (setpoints), volume, etc. Ports for connecting the compatible Wands and the Foot Control are located on the front panel.
  The subject WEREWOLF FASTSEAL 6.0 Hemostasis Wand is a bipolar, RF electrosurgical device used for specific indications in orthopedic surgeries. The Wand is indicated for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures. It is intended for procedures using normal saline (0.9% NaCl) as the irrigation fluid for the Wand.

The provided document is a 510(k) premarket notification for the WEREWOLF+ Coblation System, WEREWOLF+Controller, and Werewolf FASTSEAL 6.0 Hemostasis Wand. It seeks to demonstrate substantial equivalence to a predicate device, the Aquamantys Pump Generator System and Aquamantys 6.0 Bipolar Sealer. The focus of the new submission is "hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures."

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" against which the device performance is measured in a quantitative manner for clinical efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device through various non-clinical tests. The performance assessments are comparative to the predicate device.

However, based on the performance testing descriptions, we can infer some criteria and reported performance:

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 mentions preclinical bench testing using "multiple tissue models (bovine myocardium, porcine skeletal muscle, and porcine bone)" for functional equivalence and "beef heart tissue model" for temperature testing. However, specific sample sizes for these preclinical tests are not provided.

The data provenance is from preclinical bench testing (ex vivo). There is no mention of country of origin for the data as it's not human subject data. The studies performed are experimental bench tests, not retrospective or prospective human studies.

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 applicable as the studies are preclinical bench testing and do not involve human subject data or expert assessment of diagnostic outcomes. Ground truth in this context typically refers to the physical measurements and observations made during the bench tests, rather than expert interpretation.

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

This information is not applicable as the studies are preclinical bench testing and do not involve human subject data or diagnostic interpretations requiring adjudication.

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 comparative effectiveness study was done. The document explicitly states: "No clinical data are included in this submission." and "No in vivo animal testing data are included in this submission." This submission is focused on demonstrating substantial equivalence through non-clinical (bench) testing.

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

This concept is not directly applicable in the sense of a diagnostic algorithm. However, the performance testing described for the device (e.g., peak temperature, thermal damage) assesses the device's inherent functional characteristics in a standalone manner through bench testing, rather than its performance in conjunction with human interpretation of an output. The device itself is an electrosurgical tool, where its "performance" is its ability to perform hemostasis, not to provide an interpretive output for a human.

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

For the preclinical bench testing, the "ground truth" is derived from direct physical measurements and observations made during the experiments. For example:

• Temperature measurements (using Neoptix fiber optic temperature probe).
• Thermal damage assessment (e.g., total thermal effect width or maximum thermal depth in myocardium tissue).
• Functional performance (comparative coagulation efficacy, albeit not quantitatively defined in the provided text beyond "substantially equivalent").

8. The sample size for the training set

Not applicable. This submission describes a hardware device (electrosurgical system and wand) with integrated software, not a machine learning or AI algorithm that requires a distinct "training set" for predictive model development. The software verification and validation are for control and operational aspects, not for learning from data.

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

Not applicable. As the device does not involve a machine learning "training set," the concept of establishing ground truth for it does not apply.

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