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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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The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The P50 and P90 Electrodes when used with Mitek VAPR Electrosurgical Systems are intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The VAPR CP90 Electrodes when used with Mitek VAPR VUE Electrosurgical System is intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The DePuy Mitek VAPR Electrodes for use with all VAPR Electrosurgical Systems are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency System are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

The VAPR VUE Radiofrequency System is DePuy Mitek's next generation of VAPR Radiofrequency Systems. The system consists of a generator, wired or wireless footswitch and electrodes. The VAPR VUE generator was designed to provide comparable RF performance with legacy VAPR electrodes.

As with its predicate devices including the VAPR 3 generator, this electrosurgical system utilizes bipolar technology specifically designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, contouring, cutting and coagulation and temperature control.

The VAPR VUE system offers five output types of operation: Vaporization (ablation), Coagulation, CP Vaporization (ablation), Blended Vaporization (ablation and coagulation) and temperature control coagulation. All types are present in the predicate device (VAPR3 generator) except the CP Vaporization (ablation).

The VAPR P50 and P90 Electrodes are an addition to the family of LPS Electrodes. These Suction Electrodes are soft tissue ablation and coagulation devices intended for use with the VAPR Electrosurgical Systems. They extend the utility of the system by removing bubbles created during activation from the operating site.

The VAPR CP90 Electrodes are identical in technological characteristics as the P90 electrode only it is intended to be run only off the VAPR VUE platform at pre-determined default settings specific for the device. The CP90 with Handcontrols offers the integration of handcontrol capabilities via three buttons molded on the existing one-piece handles. Those buttons control ablation, coagulation and the generator mode functions.

The information provided describes the DePuy Mitek VAPR VUE Radiofrequency System and associated electrodes, which is a medical device for electrosurgical cutting and coagulation. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific quantitative acceptance criteria or detailed reported device performance in terms of clinical metrics (e.g., success rates, complication rates, accuracy). Instead, it relies on demonstrating compliance with recognized electrical safety and software standards and asserting comparable RF performance.

The device's performance is generally stated as:

• RF Performance: "The VAPR VUE generator was designed to provide comparable RF performance with legacy VAPR electrodes."
• Safety and Performance Testing: "In addition safety and performance testing have been done to validate the performance and safety of the device. It has been demonstrated that these device modifications will not affect safety and effectiveness of the subject devices."
• Verification Testing: "Verification of the VAPR VUE System and Electrodes includes electrical, Safety and software and performance tests to show that the device meets its product Performance specifications over a range of operating conditions."

Acceptance Criteria (Implied by Standards & Equivalence):

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify sample sizes for "test sets" in the context of clinical performance or accuracy in a medical imaging or diagnostic sense. The testing mentioned (electrical, safety, software, performance) would typically involve engineering verification and validation on the device itself and its components, rather than patient data test sets.

• Test Set Sample Size: Not applicable/not specified in the provided text for clinical performance. The testing mentioned is for engineering verification and validation.
• Data Provenance: Not applicable, as no clinical/patient data test sets are described. The testing is device-centric.

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 because the submission explicitly states:

• "No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance."
• Therefore, there were no "ground truth" derived from expert review of clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable as there were no clinical test sets requiring adjudication by experts.

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. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device. The concept of "human readers improve with AI vs without AI assistance" is not relevant to this type of device.

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

• Not applicable. This is a hardware-based electrosurgical system, not an algorithm, and does not operate in a standalone diagnostic capacity.

7. The Type of Ground Truth Used

• No clinical grand truth was used. The "ground truth" for the device's performance is its compliance with engineering specifications, electrical safety standards, software standards, and its ability to achieve its intended physical effects (resection, ablation, coagulation) in laboratory or simulated environments, as demonstrated through non-clinical performance and safety testing.

8. The Sample Size for the Training Set

• Not applicable. This device does not employ machine learning or AI that would require a "training set" of data.

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

• Not applicable. As no training set was used, no ground truth needed to be established for it.

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The IRIDEX Wireless Footswitch is intended for use with compatible IRIDEX Laser Systems operated in hospital or outpatient facilities.

The IRIDEX Wireless Footswitch is indicated for use as an accessory to provide input control of laser emission to compatible IRIDEX Laser Systems. This accessory includes a wireless footswitch and a receiver. It is cleared for use for the particular indications of the laser system to which it is attached.

The Wireless Footswitch is an alternate option to the existing cabled footswitch for users of IRIDEX laser consoles. It consists of two discreet parts - a footswitch/transmitter and receiver. The wireless footswitch receiver connects to the laser through the same connector as the current wired footswitch, and operates with the console by directly emulating the functionality of the current wired footswitch.

This document describes the IRIDEX Wireless Footswitch, seeking clearance as an accessory for existing IRIDEX laser systems. As an accessory that emulates the functionality of a wired footswitch, the submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria.

Therefore, the requested information fields related to clinical efficacy studies, expert ground truth, and training data are largely not applicable in the context of this 510(k) submission. The FDA clearance is based on the device's functional similarity to predicate devices and its adherence to general controls for safety and effectiveness.

Here's an attempt to populate the table and answer the questions based on the provided text, indicating "Not Applicable" where the information is not present or relevant to a substantial equivalence submission for an accessory device:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an accessory (wireless footswitch) demonstrating substantial equivalence to wired and other wireless footswitches, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity or specificity. Instead, acceptance is based on functional equivalence and safety to predicate devices. The document implies functional equivalence to existing wired and wireless footswitches as the primary criterion.

Study Details:

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

   • Not Applicable. The submission is for substantial equivalence of an accessory device (wireless footswitch) based on functional emulation and comparison to predicate devices, not requiring a clinical performance study with a test set of patient data. The documentation does not mention such a study.

2. 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)

   • Not Applicable. No clinical test set or ground truth validation by experts is mentioned or required for this type of 510(k) submission.

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

   • Not Applicable. No clinical test set.

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 a hardware accessory (wireless footswitch), not an AI-powered diagnostic tool. MRMC studies are irrelevant.

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

   • Not Applicable. This is a hardware accessory, not an algorithm. Performance is assessed based on its ability to emulate the wired footswitch function and comply with relevant standards (though not explicitly detailed in this summary).

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

   • Not Applicable. Not a clinical diagnostic device requiring ground truth for clinical performance. The "ground truth" for this device's functionality would be the successful and consistent control of the laser system, as performed by the wired equivalent.

7. The sample size for the training set

   • Not Applicable. This is a hardware accessory, not a machine learning algorithm requiring a training set.

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

   • Not Applicable. No training set for an algorithm.

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