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The FLOW 90 Wand, used with Qualified Controller is indicated for the 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/ Debrideement - (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/ Debrideement - (ACL/PCL, Notchplasty)
• Excision/Resection - (Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release, Meniscal Cystectomy, Meniscectomy, Villusectomy)

Shoulder

• Ablation/ Debrideement - (Subacromial Decompression)
• Excision/Resection - (Frozen Shoulder Release, Glenoid Labrum)

Wrist

• Excision/Resection - (Triangular Fibrocartilage)

The FLOW 90 Wand is a bipolar, RF electrosurgical device designed for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. The FLOW 90° Wand is compatible with Qualified controllers (WEREWOLF® COBLATION® Systems (includes WEREWOLF® (K162074), WEREWOLF® ENT, (K192027) and WEREWOLF® + (K210423)) and INTELLIO® SHIFT ® System (K232290)).

The FLOW 90 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 Qualified Controller and the Fluid Outflow Regulator of the Controller, respectively. No design changes have been made to the Qualified Controllers to support the use of the modified FLOW 90 Wand.

The provided text is a summary of a 510(k) premarket notification for a medical device called the FLOW 90° Wand. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

The relevant section, "NON-CLINICAL Testing," mentions electrical safety and bench testing (flow rate, fluid ingress, suction tube kinking, finger switch testing, and packaging validation), but these are for a physical electrosurgical device, not an AI/ML system.

Therefore, I cannot provide the requested information as it is not present in the given document.

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The Ambient Hip Vac 50 Wand with Integrated Finger Switches is indicated for the resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthopedic procedures:

The Ambient HipVac 50 Wand is a bipolar, high frequency (HF) electrosurgical device designed for resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the indicated arthroscopic and orthopedic procedures (K161481).

The Ambient HipVac 50 Wand consist of a handle, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached to the proximal end of the handle and connect to the Controller and hospital wall suction, respectively. The plastic molded handle includes three integrated finger switches (IFS) used to activate and adjust the Coblation (ablation) and Coagulation modes: CUT (ablation), COAG (coagulation), and set point adjustment. The Ambient feature provides accurate (± 3° C) real-time temperature monitoring of the circulating irrigating fluid between 20°C and includes a user adjustable alarm set point. The Wand is designed for use up to 15 minutes of cumulative active ablation and is currently cleared to be used with ArthroCare System 12000 (QUANTUM II). Alternately, the surgeon can control these functions with the optional foot pedal.

The WEREWOLF COBLATION Systems (RF20000, WEREWOLF, WEREWOLF+) consist of a bipolar, radiofrequency (RF) generator (COBLATION System) 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), and Reusable, non-sterile power cord. The systems utilize bipolar technology specifically designed for the resection, ablation, and coagulation of blood vessels in various arthroscopic, orthopedic, and otorhinolaryngology (ENT) procedures. The controllers are enclosed units with incorporated software that runs both the delivery of radiofrequency energy as well as a Graphical User Interface which the user can control various modes, levels, volume, etc.

The provided text describes a 510(k) premarket notification for a medical device, the Ambient HipVac 50 Wand, to be used with newer COBLATION Systems (RF20000, WEREWOLF, WEREWOLF+). This is not a submission for an AI/ML medical device, but rather for an electrosurgical cutting and coagulation device.

Therefore, the requested information regarding acceptance criteria and study proving device meets acceptance criteria related to AI/ML device performance (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

However, I can extract the information relevant to this medical device's performance testing for substantial equivalence:

Device Under Review: Ambient HipVac 50 Wand with Integrated Finger Switches, to be used with RF20000 COBLATION System, WEREWOLF COBLATION System, and WEREWOLF+ COBLATION System.

Predicate Device: Ambient HipVac 50 Wand with ArthroCare System 12000 (QUANTUM II).

Summary of Device Performance and Equivalence Justification:

The submission argues for substantial equivalence based on the following:

• Identical Intended Use, Indications for Use, Fundamental Technology, and Principle of Operation: The subject devices and the primary predicate share these core characteristics.
• Minor Technological Differences in Controllers: The newer COBLATION systems (RF20000, WEREWOLF, WEREWOLF+) incorporate a Graphical User Interface (GUI), an Integrated Fluid Outflow Regulator, and updated software versions. However, the manufacturer states that no changes were made to the 18-pin wand functionality used by the HipVac 50 Wand, and all required system-level testing for these controllers was previously conducted (K162074, K192027, K210423).
• No Changes to the Ambient HipVac 50 Wand Accessory: The wand itself (materials, specifications, electrical safety, sterilization, etc.) remains unchanged from the predicate accessory.

Details on Performance Testing (Non-Clinical):

The RF20000 COBLATION system was selected as the representative model for all WEREWOLF COBLATION Systems for non-clinical testing due to identical hardware and 18-pin software functionality across RF20000, WEREWOLF, and WEREWOLF+ controllers.

1. Acceptance Criteria and Reported Device Performance:

The document does not provide a quantitative table of "Acceptance Criteria" for specific metrics, as it is a substantial equivalence submission based on comparative performance and unchanged characteristics rather than a de novo approval requiring novel performance targets. However, the functional tests performed and the conclusion implicitly refer to meeting existing performance expectations for the device type.

Functional Tests Included:

• Coagulation testing
• Ablation life (at 1X, 2X, 3X life)
• Ambient accuracy
• Finger switch functionality
• Shaft temperature
• Suction tube temperature

Pre-clinical Bench Testing (Ex Vivo):

• Measurements: Thermal effect width, ablation depth (amount of tissue removed), and thermal effect depth.
• Tissue Models: Bovine myocardium (muscle), cartilage, meniscus, and tendon.
• Test Conditions: Minimum, default, and maximum ablation set points.
• Reported Performance: Demonstrated that the Ambient HipVac 50 with RF20000 COBLATION System performs substantially equivalent to the predicate (Ambient HipVac 50 with QUANTUM 2) in these ex vivo tests.

Additional Performance Testing:

• Test: Comparison of the peak temperature of the electrode during ablation at the maximum set point.
• Methodology: Tested with both the predicate QUANTUM II and the representative subject RF20000 COBLATION system. Used a Neoptix T1 fiber optic temperature probe (model T1S-02-W05-PT05).
• Tissue Model: Beef heart tissue.
• Activation: Devices activated directly over the temperature probe for 10 seconds at maximum ablation setpoint (9) with auxiliary suction.
• Reported Performance: Maximum temperatures recorded using both controllers were similar, supporting evidence of substantial equivalence.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly stated as a number of "samples" in the context of a dataset. The testing refers to functional tests, ex-vivo bench testing, and comparative temperature measurements on tissue models. No patient data is involved.
• Data Provenance: This is non-clinical, bench testing data, likely performed in a lab setting by the manufacturer (ArthroCare Corporation, Austin, Texas). Details on the country of origin for the data are not provided beyond the company's location. The data is implicitly "prospective" in the sense of being generated specifically for this submission.

3. Number of Experts to Establish Ground Truth and Qualifications:

• Not Applicable: This is an electrosurgical device, not an AI/ML medical device requiring expert consensus for image or signal interpretation. The ground truth for performance is established through direct physical measurements on tissue models and functional tests, not through expert annotation.

4. Adjudication Method for the Test Set:

• Not Applicable: No human interpretation/adjudication is described in the performance tests. The results are objective measurements.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• Not Applicable: This type of study is relevant for AI-assisted diagnostic or interpretative devices, not an electrosurgical cutting device.

6. Standalone Performance (Algorithm Only):

• Not Applicable: There is no "algorithm only" performance to evaluate. The device is a physical electrosurgical system.

7. Type of Ground Truth Used:

• Objective Measurements/Physical Properties: The "ground truth" for this device's performance is established by direct measurement of physical parameters (e.g., ablation depth, thermal effect width, temperature, functional activation) in controlled ex vivo environments, rather than human expert labels, pathology, or outcomes data.

8. Sample Size for the Training Set:

• Not Applicable: This device is not an AI/ML device that requires a "training set" in the computational learning sense.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable: See point 8.

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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:

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