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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 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.

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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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Subject Device(s) Indications of Use ENT Wands ENT Plasma Wands

Indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction of hypertrophic nasal turbinates, nasopharyngeal/ laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring.

Turbinator Wands

Indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) sinus surgery involving nasal airway obstruction of hypertrophic nasal turbinates and submucosal tissue shrinkage. The Wand is designed to be used exclusively with the COBLATOR II (CII) controller and Irrigation pump or the WEREWOLF COBLATION System (in conjunction with the ENT Adapter and Irrigation Tube Set). Other controllers/pumps must not be used.

WEREWOLF ENT Adapter

The WEREWOLF ENT Adapter, in conjunction with the Smith & Nephew COBLATOR II Compatible ENT Wands, the Smith & Nephew WEREWOLF COBLATION System and the WEREWOLF Irrigation Tube Set (as needed) are indicated for the ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in ENT/otorhinolaryngology procedures.

WEREWOLF Irrigation Tube Set

The WEREWOLF Irrigation Tube Set, in conjunction with the Smith & Nephew COBLATOR II Compatible ENT Wands, the Smith & Nephew WEREWOLF COBLATION System and the WEREWOLF ENT Adapter are indicated for the ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in ENT/otorhinolaryngology procedures.

The ENT Plasma Wands (K070374 and K142999) and Turbinator Wand (K122652) are currently cleared to be used with the ArthroCare ENT Coblator Surgery System (COBLATOR II) (K030108). This 510(k) is to obtain clearance for the use of ENT Wands, in conjunction with two accessories, with the recently cleared WEREWOLF COBLATION System (K192027 - Dec 20, 2019). The accessories are the WEREWOLF ENT Adapter and the WEREWOLF Irrigation Tube Set The extended compatibility does not result in any changes to the overall design or to the indications of use for the ENT Wands nor the WEREWOLF COBLATION System.

ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for use in ablation, resection and coagulation of soft tissue, and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.

Turbinator Wand is a bipolar, single use, high frequency electrosurgical device designed for use for specific turbinate indications in otorhinolaryngology (ENT) procedures.

The WEREWOLF ENT Adapter is a reusable, electrically-activated adapter with an 8pin connector at the distal end an 18-pin connector at the proximal end. The reusable WEREWOLF ENT Adapter is designed to be used with the COBLATOR II Compatible ENT Wands (8-pin connector) and WEREWOLF COBLATION System (18-pin connector), along with the WEREWOLF Irrigation Tube Set, as needed.

The WEREWOLF Irrigation Tube Set is a single use, disposable, sterile device. The Irrigation Tube Set is designed to be used with COBLATOR II compatible ENT Wands and WEREWOLF COBLATION System, along with the reusable WEREWOLF ENT Adapter. The spike of the Irrigation Tube Set is connected to an irrigation source for select ENT Wands; that is, the ENT wands that use a conductive media, such as normal saline intraoperatively.

The provided text does not contain detailed acceptance criteria and a study proving the device meets these criteria in the format requested. The document describes a 510(k) submission for ENT Plasma Wands, Turbinator Wands, and accessories for use with the WEREWOLF COBLATION System. This submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to meet specific, quantitatively defined acceptance criteria through a dedicated study.

However, based on the non-clinical performance testing section, we can infer some aspects of what would typically be considered "acceptance criteria" through design verification.

Here's an attempt to extract and describe the information, inferring where necessary based on the context of a 510(k) submission for substantial equivalence:

Inferred Acceptance Criteria and Reported Device Performance

1. Sample sized used for the test set and the data provenance:

• Test Sample Size: Not explicitly stated as a numerical sample size. The testing involved "ex-vivo bench testing" on "bovine myocardial tissue" for thermal effects. Other tests (electrical, mechanical/functional) likely involved multiple units or measurements but specific numbers are not provided.
• Data Provenance: The ex-vivo bench testing used bovine myocardial tissue. This implies laboratory-controlled experiments rather than human patient data. The country of origin is not specified but implicitly within the ArthroCare Corporation's testing facilities (likely in the US, given the FDA submission). This was a retrospective evaluation in the sense that it was conducted for the 510(k) submission, confirming design aspects before market release for this specific compatibility.

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

• This information is not provided. The testing described is primarily engineering and bench testing, demonstrating technical equivalence and safety rather than diagnostic accuracy requiring expert interpretation.

3. Adjudication method for the test set:

• Not applicable. The testing described does not involve expert adjudication as it's not a diagnostic study requiring human interpretation of output.

4. 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:

• Not applicable. This device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a surgical instrument. Performance is inherently tied to its physical and energetic effects, not an algorithm's output in isolation from human use. While the device does have "Software controlled" and a "Graphical User Interface," the "standalone" performance notion as used in AI/diagnostic studies does not apply here.

6. The type of ground truth used:

• For electrical and mechanical performance: Engineering specifications and standards.
• For biocompatibility: ISO 10993-1:2018 standards; leverage from previously cleared device (K192027).
• For sterilization: Validated sterilization cycles achieving specific Sterility Assurance Levels (SAL).
• For thermal effects: Direct measurement of ablation and coagulation thermal effects on ex-vivo bovine tissue, likely compared against established performance metrics or the predicate devices.

7. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable, as there is no training set for this device.

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