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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 INTELLIO SHIFT System is indicated for:

• Resection of soft and osseous tissues .
• . Resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during the following arthroscopic and orthopedic procedures:
  | Arthroscopic | | |
  |----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
  | Location | Ablation/Debridement | Excision/Resection |
  | All Joints (Hip,
  Knee, Shoulder,
  Wrist, Ankle,
  Elbow) | Articular Cartilage Bursectomy Chondroplasty Fascia Ligament Scar Tissue Soft Tissue Synovectomy Tendon | Articular Labrum Capsule Cysts Ligament Loose Bodies Plica Removal Scar Tissue Soft Tissue Synovial Membrane Tendon |
  | Hip | N/A | Acetabular Labrum |
  | Knee | ACL/PCL Notchplasty | Capsular Release Cartilage Flaps Discoid Meniscus Lateral Release Meniscal Cystectomy Meniscectomy Villusectomy |
  | Shoulder | Subacromial Decompression Acromioplasty | Frozen Shoulder Release Glenoid Labrum |
  | Wrist | N/A | Triangular Fibrocartilage (TFCC) |
  | Orthopedic | | |
  | Hemostasis (via coagulation) of soft tissue and bone | | |

The INTELLIO SHIFT System combines two previously cleared technologies into one system. The INTELLIO SHIFT System is composed of (1) a controller that combines the radio frequency coblation/coagulation technology of the previously cleared (K210423) WEREWOLF+ COBLATION System with the mechanical resection technology of the previously cleared (K062849) DYONICS POWER II Control System and (2) a wired foot pedal that controls these two technologies. The INTELLIO SHIFT System utilizes the same technologies as the predicates and matches the performance requirements of the WEREWOLF+ and DYONICS POWER II controllers. The INTELLIO SHIFT System allows the user to select and operate two established resection technologies using the same device: Mechanical Resection (MR) for cutting and tissue removal, and Bipolar Radio Frequency (RF) for coblation/coagulation. The INTELLIO SHIFT System is compatible with various accessories including RF coblation/coagulation Wands, a Mechanical Resection Motor Drive Unit Handpiece, and a wired foot pedal. The INTELLIO SHIFT System interfaces with a handpiece Motor Drive Unit (MDU) shaver, to provide mechanical cutting and tissue removal. The INTELLIO SHIFT System interfaces with RF Wands to utilize bipolar RF technology for the resection, ablation, and coagulation of tissues and hemostasis of blood vessels in various arthroscopic, and orthopedic procedures. Additionally, the INTELLIO SHIFT System can be interfaced directly with 510K cleared fluid management systems. INTELLIO SHIFT provides an optional interface for the INTELLIO Connected Tower, which is composed of Smith and Nephew equipment typically used in arthroscopic or orthopedic surgical procedures and stored near each other on a single cart. While the INTELLIO SHIFT System provides options to healthcare professionals to use both Mechanical Resection and Coblation/Coagulation through the same device and within the same surgery, these technologies cannot be used at the exact same time.

The INTELLIO SHIFT System is an electrosurgical cutting and coagulation device. The provided text, however, is a 510(k) summary for FDA clearance and does not include a clinical study with acceptance criteria and reported device performance directly comparable to the format requested.

The summary focuses on demonstrating substantial equivalence to existing predicate devices (WEREWOLF+ COBLATION System and DYONICS POWER II Control System) through a comparison of intended use, indications for use, and general/technical characteristics, along with non-clinical performance data.

Here's an attempt to extract and present the information based on the provided text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) summary predicated on substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined target performance metrics for a novel clinical study. Instead, the "acceptance criteria" for clearance are that the new device's characteristics and performance are "at least as safe and effective as the predicates" and that any differences do "not raise any new questions of safety and efficacy." The "reported device performance" is essentially the device demonstrating it meets these equivalence criteria through non-clinical testing.

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

The provided text does not describe a clinical study with human subjects that would have a "test set" in the context of AI performance evaluation. The "tests" mentioned are non-clinical bench tests. Therefore, information on sample size for a human-data test set or its provenance (country of origin, retrospective/prospective) is not applicable or available in this document.

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

As there is no clinical study involving human data or expert review mentioned, this information is not applicable to this 510(k) summary.

4. Adjudication Method

This is not applicable as no expert review or adjudication of a test set is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or described in this 510(k) summary. The device discussed is a surgical tool, not an AI-assisted diagnostic or interpretation system for human readers.

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

The device is a physical electrosurgical system with software control. It is designed to be used with a human operator (surgeon). Therefore, the concept of a "standalone algorithm only" performance test is not applicable in the AI sense. The software's performance is verified through automated verification, electrical safety, and other non-clinical tests as part of the overall system's safety and effectiveness.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established by engineering specifications, safety standards (e.g., IEC 60601), and the expected performance parameters derived from the predicate devices. For instance, for electrical safety, the ground truth is adherence to the specified voltage, current, and power limits as defined by the standards. For mechanical resection performance, it would be the ability to cut specific tissue analogs within predefined parameters. No pathology or outcomes data is mentioned in relation to testing for this 510(k).

8. The Sample Size for the Training Set

This is not applicable as the document does not describe an AI/machine learning model that undergoes a "training set." The software is designed and verified, not "trained" in the typical ML sense.

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

This is not applicable because there is no mention of a training set for an AI/machine learning model.

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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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Indications for Use - WEREWOLF™COBLATION™ SYSTEM

The WEREWOLF COBLATION System controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following otorhinolaryngology (ENT) procedures:

Resection/Ablation/Coagulation

• Tonsillectomy (Including Palatine Tonsils)
• Adenoidectomy
• Uvulopalatopharyngoplasty (UPPP)
• Traditional Uvulopalatoplasty (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 Control
• 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

Indications for use - COBLATION™ HALO™ Wand

The COBLATION HALO Wand, used with the WEREWOLF COBLATION System, is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: tonsillectory, adenoidectomy, and uvulopalaty (UPPP). It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate.

The proposed WEREWOLF COBLATION System consists of:

• A bipolar, radiofrequency (RF) generator (Controller) with Integrated Fluid . Module and Operational Interface Screen,
• . Re-usable, non-sterile Foot Control (wired or wireless)
• Sterile, disposable, single-use COBLATION Wand(s)
• . Reusable, non-sterile power cord.

The components are designed to be operated as a single unit.

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 proposed Controller is designed to deliver radiofrequency energy to the electrodes of the compatible COBLATION 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 compatible Wands and the Foot Control are located on the front panel. An optional wireless Foot Control can be installed.

The Controller also incorporates a peristaltic Integrated Fluid Control Module, which provides dynamic control of saline flow (inflow or outflow) to or from the surgical site.

The proposed Controller operates in 5 modes (Lo, Med, Hi, Coag and Vac mode) for arthroscopic and orthopedic procedures and in 4 modes (Lo, Med, Hi and Coag) for the ENT procedures.

The proposed HALO Wand is designed to be used exclusively with the proposed WEREWOLF™ COBLATION™ System. The HALO Wand is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: tonsillectomy, adenoidectomy, and uvulopalatopharyngoplasty (UPPP). It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate. The Wands are provided sterile (via ethylene oxide) and are single-use only.

The provided text is a 510(k) summary for the WEREWOLF COBLATION System and COBLATION HALO Wand. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, not a report of a study proving a device meets acceptance criteria in the context of clinical efficacy or diagnostic performance. Therefore, detailed information typically found in a clinical study report or performance study for AI/diagnostic devices, such as sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, is not present in this document.

The document primarily focuses on demonstrating substantial equivalence through non-clinical (mechanical, electrical, functional, biocompatibility) and pre-clinical (ex vivo) bench testing, comparing the proposed device against its predicate.

Here's an attempt to extract relevant information given the constraints of the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a formal table of "acceptance criteria" for clinical efficacy as would be seen in a clinical trial. Instead, it describes various tests conducted to demonstrate the device's safety and effectiveness compared to the predicate. The "performance" reported is primarily that the device meets established design criteria and performs substantially equivalently to the predicate.

2. Sample size used for the test set and the data provenance:

• Non-Clinical/Pre-Clinical Bench Testing: The document does not specify the sample sizes for the various non-clinical and ex vivo bench tests (e.g., number of wands tested, number of bovine tissue samples).
• Data Provenance:
  • Non-Clinical/Pre-Clinical: Conducted by ArthroCare Corporation.
  • Ex Vivo: Bovine myocardial tissue was used. This is a lab-based study with animal tissue, not human data.
  • Retrospective/Prospective: All described testing is of a prospective nature as it was conducted specifically for this submission.

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 as the submission relies on physical and functional testing, not expert-derived ground truth for clinical diagnostic performance.

4. Adjudication method for the test set:

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which are not present here.

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, as this is a medical device (electrosurgical system) and not an AI/diagnostic imaging device that would involve human readers.

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

Not applicable. This device is an electrosurgical system, not an algorithm, and intrinsically requires human operation.

7. The type of ground truth used:

• For the non-clinical and ex vivo bench testing, the "ground truth" or reference standard would be the established engineering specifications, performance standards (e.g., IEC 60601 series), and the performance characteristics of the predicate device. For ex vivo testing on bovine tissue, the measured thermal effects serve as the observed performance to be compared.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/machine learning model.

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

Not applicable. As above, there is no training set.

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The FLOW 90° Wand, used with the WEREWOLF COBLATION System, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:

The FLOW 90 Wand (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. Similar to the predicate device FLOW 50 Wand (K162074), FLOW 90 Wand is designed to be exclusively used with WEREWOLF® COBLATION® System (K162074). 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 WEREWOLF Controller (part of the WEREWOLF Coblation System) and the Fluid Outflow Regulator of the Controller, respectively. No design changes have been made to the WEREWOLF Controller to support the use of the Flow 90 Wand.

This document describes a 510(k) premarket notification for the "FLOW 90º Wand", an electrosurgical device. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the "FLOW® 50 Wand" (K162074).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing as establishing that the device meets "established design criteria and supports substantial equivalence with the predicate device." However, specific numerical acceptance criteria (e.g., pass/fail thresholds for ablation rate, thermal effects) are not explicitly stated in a table format. Instead, the document mentions the types of tests performed and the general conclusion that the device "meets all design and performance specifications."

Reported Device Performance (Qualitative):

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

The document states:

• "Pre-clinical bench testing (ex vivo testing) was performed across multiple tissue models (muscle, tendon, cartilage and meniscus) to verify substantial equivalence to the predicate device in terms of thermal effects."

Sample Size: Not explicitly stated. The phrase "multiple tissue models" implies more than one instance of each tissue type but does not give a specific number.
Data Provenance: Ex vivo testing. This means the testing was performed on biological tissue outside of a living organism, typically in a laboratory setting. The country of origin for the data is not specified. It is retrospective in the sense that the device design was complete before these tests were conducted to demonstrate performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. This device is an electrosurgical wand, and the performance testing described is hardware-based (e.g., ablation rate, thermal effects, electrical safety). There is no mention of human expert evaluation being used to establish ground truth for the device's functional performance in the way it might be for an AI diagnostic device.

4. Adjudication Method for the Test Set:

Not applicable. As stated above, this is for hardware performance testing, not for subjective interpretation or diagnostic evaluation requiring adjudication between multiple human readers.

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. The document explicitly states: "No clinical data are included in this submission." and "No animal data are included in this submission." This indicates that a human-in-the-loop study, such as an MRMC study, was not performed or included. This device is a surgical instrument, not an AI diagnostic tool that assists human readers.

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

Partially yes (for the device's functional performance). The performance testing described (software verification and validation, non-clinical, and preclinical bench testing) assesses the device's functional characteristics and safety without human-in-the-loop evaluation for diagnostic purposes. This is characteristic of standalone performance evaluation for a medical device. However, it's critical to note this is not an AI algorithm being evaluated in a standalone manner, but rather the electrosurgical wand itself.

7. The Type of Ground Truth Used:

The ground truth for the functional performance tests was established by objective measurements and comparisons to the predicate device. For example:

• Ablation testing: Likely involved measuring the amount or rate of tissue removal.
• Thermal effects: Involved measuring temperature changes in and around the tissue.
• Electrical safety: Compliance with electrical safety standards.
• Biocompatibility: Testing materials for biological compatibility.

The ground truth is based on objective physical and biological measurements in a controlled laboratory setting, not on expert consensus, pathology, or outcomes data in a clinical context.

8. The Sample Size for the Training Set:

Not applicable. This device is an electrosurgical wand with no mention of machine learning or AI algorithms requiring a training set in the conventional sense.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.

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The AMBIENT Super MULTIVAC® 50 Wand with Integrated Finger Switches is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures.
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow): Articular Cartilage Bursectomy Chondroplasty Fascia Ligament Scar Tissue Soft Tissue Synovectomy Tendon
Knee: ACL/PCL Notchplasty
Shoulder: Acromioplasty Subacromial Decompression
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow): Articular Labrum Capsule Cysts Ligament Loose Bodies Plica Removal Scar Tissue Soft Tissue Synovial Membrane Tendon
Hip: Acetabular Labrum
Knee: Capsular Release Cartilage Flaps Discoid Meniscus Lateral Release Meniscal Cystectomy Meniscectomy Villusectomy
Shoulder: Frozen Shoulder Release Glenoidale Labrum
Wrist: Triangular Fibrocartilage (TFCC)
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow): Articular Cartilage Ligament Tendon
Knee: ACL/PCL Medial Retinaculum
Shoulder: Glenohumeral Capsule Rotator Cuff
Wrist: Carpal Ligaments Wrist Tendons

The AMBIENT Super MULTIVAC° 50 Wand with Integrated Finger Switches ("Wand") is a bipolar, high frequency electrosurgical device used for specific indications in orthopedic and arthroscopic surgeries. 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 five minutes of cumulative active ablation time at the default set point of 7 and is to be used only with the QUANTUM® 2 Controller ("Controller").

This document describes the premarket notification (510(k)) for the AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

Based on the provided text, the device in question is an electrosurgical cutting and coagulation device, not an AI/ML-driven medical device for which the requested information would typically apply (like a diagnostic imaging algorithm). Therefore, many of the requested criteria regarding AI/ML model acceptance (sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not relevant to this submission type and are not present in the provided text.

This 510(k) summary focuses on demonstrating substantial equivalence through performance bench testing and technological characteristics comparison, not through clinical or AI/ML performance metrics.

Here's the information that can be extracted from the provided text, in relation to the closest applicable sections of your request:

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

The document does not explicitly present "acceptance criteria" in a quantitative table format that would typically be found for AI/ML performance. Instead, it lists the types of performance bench testing conducted and states that the device "continues to meet the design requirements and supports substantial equivalence with the predicate device."

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

• Sample Size: Not explicitly stated for each bench test. The wording "All devices used for verification testing were sent to an ArthroCare approved supplier for sterilization" implies multiple units were tested, but the exact number is not provided.
• Data Provenance: Not applicable as this is bench testing of a physical device, not an AI/ML system using patient data. The tests were performed in-house by ArthroCare or an approved supplier.

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)

• Not applicable. Ground truth for electrosurgical device performance is established through engineering and biophysical measurements (e.g., precise temperature, ablation rate, coagulation effectiveness), not expert human interpretation of medical images.

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

• Not applicable. This is not a study assessing observer performance.

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, as this is not an AI-assisted diagnostic device. The submission explicitly states: "No clinical data are included in this submission."

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

• Not applicable. This is a physical electrosurgical device, not an algorithm. Bench tests evaluate the device's functional performance directly.

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

• The "ground truth" for this type of device is established through quantitative engineering and biophysical measurements in controlled laboratory settings (e.g., temperature sensors, material removal rates, impedance measurements, and visual inspection of tissue effects).

8. The sample size for the training set

• Not applicable, as this is not an AI/ML device that requires a training set.

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

• Not applicable, as this is not an AI/ML device that requires a training set.

Summary of Device and Evidence:

The AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches is an electrosurgical device. The 510(k) submission (K180848) establishes substantial equivalence to a predicate device (K083306) primarily through bench testing. The key change from the predicate appears to be related to the integrated cable and potentially a change in the use-limiting scheme (7 minutes of active ablation time vs. 40 minutes for the predicate, though the overall connection time remains 8 hours). The submission relies on engineering and functional performance data, not clinical data or data from AI/ML model validation studies.

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The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:

Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis

Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair

Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon reattachment

Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure

Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in phalanx; Volar plate reconstruction

Hip: Acetabular labral repair

The Q-Fix Suture Anchor (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. This family of suture anchors previously was available in two sizes, 1.8mm and 2.8mm. This submission proposes an additional size of Q-Fix Suture Anchor, the 1.8mm Q-Fix MINI Suture Anchor.

The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.

The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.

The Q-Fix Suture Anchor consists of the bone anchor and associated instruments for implanting the bone anchor.

The provided text describes a 510(k) premarket notification for a medical device (Q-Fix Suture Anchor) and does not contain information related to software or AI device performance studies. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical bench testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving a device meets those criteria, as there is no mention of a software or AI-driven device, nor are there any clinical studies involving human readers or ground truth establishment in the context of AI performance.

The document states:

• "No clinical or animal data are included in this submission." (Page 4, under "Clinical Data")
• "Bench testing was performed on both the proposed and predicate devices in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996. This in vitro testing involved insertion of the anchors into a simulated human bone substrate followed by both static and cyclic fatigue testing." (Page 4, under "Non-Clinical Data")

This submission is for a physical medical device (a suture anchor), and the testing described is mechanical, not related to diagnostic accuracy or AI performance.

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