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The FLOW FLEXTEND Wand, used with a 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/Debridement: 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/Debridement: ACL/PCL, Notchplasty.
Excision/Resection: Capsular release, Cartilage Flaps, Discoid Meniscus, Lateral release, Meniscal Cystectomy, Meniscectomy, Villisectomy.

Shoulder
Ablation/Debridement: Subacromial Decompression.
Excision/Resection: Frozen Shoulder Release, Glenoid Labrum.

Wrist
Excision/Resection: Triangular Fibrocartilage.

The FLOW FLEXTEND Wand is a single use, bipolar, radiofrequency (RF) electrosurgical device designed for specific indications in orthopedic and arthroscopic procedures. The wand is designed for compatibility with the existing hardware and software of the WEREWOLF Controllers (WEREWOLF COBLATION System (K162074), WEREWOLF COBLATION System (K192027), WEREWOLF+ COBLATION System (K210423), and the INTELLIO SHIFT System (P/N 72290150). No design changes have been made to the WEREWOLF COBLATION System or INTELLIO SHIFT System to support the use of the FLOW FLEXTEND Wand.

The FLOW FLEXTEND Wand consists of a handle with integrated finger switches, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached at the proximal end of the handle/handpiece and connect to the WEREWOLF Controller (part of the WEREWOLF Coblation System) and the Fluid Outflow Regulator of the Controller, respectively.

• The integrated cable is compatible with WEREWOLF and INTELLIO SHIFT Systems (Controllers); the cable connector is specific and proprietary to the compatible systems and is designed so the Wand cannot be plugged into any other commercial system.

• The integrated suction tubing is compatible with Integrated Fluid Control Module (FLOW-IQ Pump) of WEREWOLF and INTELLIO SHIFT Controllers and allows connection with saline source. The suction tubing has color-coded and keyed inserts that correspond to matching receptacles on the FLOW-IQ Pump so the tubing cannot be connected incorrectly.

The Wand may be activated using integrated finger switches directly on the handle or by using the compatible Foot Control system accessory for each Controller. The Wand is provided sterile (via ethylene oxide) and is single use only. When used with both the WEREWOLF and INTELLIO SHIFT systems the wand is designed to work in ablation mode for tissue removal, resection, and in coagulation mode to create hemostasis of blood vessels encountered during arthroscopic and orthopedic surgery. The effect is dependent on the selected Controller settings.

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The VantageTM Lumbar Decompression Kit by Allevion Medical is a specialized set of surgical instruments intended to be used to perform lumbar decompression procedures used in the treatment of various spinal conditions.

The VantageTM Lumbar Decompression Kit is a sterile, single-use device designed to facilitate lumbar spine decompression procedures. It includes a variety of specialized instruments intended to be used together to access and remove bone and soft tissue during decompression. The kit supports multiple procedural approaches by utilizing different components of the kit. The physician can utilize VantageTM Lumbar Decompression Kit in open, direct visualization or indirect visualization approaches. All kits contain a disposable light source to assist with visualization if desired.

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MiiS Horus Arthroscope:
The MiiS Horus Arthroscope is a sterile and single-use device designed for operation with its compatible display system.
It is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization of an interior cavity of the body through a surgical opening.
The device is intended for use in a hospital or medical office environment and is designed for use in adults.

MiiS Horus Endoscope Display System -Tablet:
The MiiS Horus Endoscope Display System -Tablet is intend for use with compatible endoscopes to provide visualization for endoscopic diagnosis, treatment, and video observation.

MiiS Horus Endoscope Display System -Video Box:
The MiiS Horus Endoscope Display System -Video Box is intend for use with compatible endoscopes to provide visualization for endoscopic diagnosis, treatment, and video observation.

MiiS Horus Arthroscope is a sterile and single-use device designed to be operated with its compatible display system. The device provides visualization for endoscopic procedures of an interior cavity of the body through a surgical opening.

The Arthroscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet or MiiS Horus Endoscope Display System -Video Box and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.

MiiS Horus Endoscope Display System –Tablet is a tablet which showing live image or snapshot from Arthroscope.

MiiS Horus Endoscope Display System -Video Box is a standalone imaging transfer system; it can be connected to computer to project live imaging. If needed, the pictures or videos can be storage to Tablet or computer.

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The PUREVUE™ FMS is a dual arthroscopic pump system intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

The PUREVUE™ FMS is an arthroscopy pump with irrigation and suction function. The device is equipped with two independent peristaltic pump systems and can be used both as an irrigation pump and as a suction pump. This provides two options for operating the unit: the Single roller mode and the Dual roller mode.

Single roller mode (Inflow): In this mode, the Inflow Cassette Tube transmits fluid from saline bags to the inflow cannula or sheath at the surgical site.

Dual roller mode (Inflow/Outflow): This mode uses both the inflow and outflow functions of the pump via the Inflow Cassette Tube and Outflow Cassette Tube.

The device is non-invasive and designed to be placed in non-sterile areas.

The PUREVUE™ FMS is a fluid management system based on the peristaltic principle that provides irrigation and suction functionalities for arthroscopic procedures. Along with its accessories (Tube set for irrigation (single-use), Tube set for suction (2-lines, single-use), Day use tube set for irrigation (pump part, 10 applications), Patient tube for irrigation (single-use), Tube set for suction (1-line, single-use), Tube set inflow 4-spike adaptor, Tube set for vacuum incl. filter (30-day use, reusable), autoclavable remote control and double foot switch), the device delivers medical sterile irrigation fluid from fluid bags to the cavity. This distends the cavity to create space for the procedure. In addition, the device along with its accessories can aspirate fluid from the patient's cavity to improve the visibility.

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The Articulator™ Arthroscopic Bur is indicated for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip, to provide abrasion, resection, debridement, and removal of bone and cartilage.

The Articulator Arthroscopic Bur can be used to abrade, cut and excise tissue and bone in arthroscopic surgeries.

The arthroscopic bur components include a bur attached to a constant velocity joint that is attached to a long rod rotating within a long hollow stainless steel housing. The bur is shielded on one side by its housing, allowing the bur to cut one structure while tissues on the opposite side of the shield are protected. A pushrod stabilizes the burr housing and holds the articulation into one of three preset flexion angles chosen by the user. A trigger mechanism on the proximal end of the bur allows the user to ergonomically flex and release the working angle of the bur with one hand. This system attaches to a motorized handpiece that drives the internal bur inside the outer housing and provides suction to pull the cut tissue away from the surgical site.

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Kyphoplasty Balloon Dilatation Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacrylate (PMMA) bone cements).

The proposed device, Kyphoplasty Balloon Dilatation Catheters are inflatable balloon catheters used in percutaneous kyphoplasty (PKP). It consists of Inner Stylet, Balloon Catheter, and polypropylene (PP) Protection tube. The radiopaque markers located at the balloon catheter tip to reflect the balloon position during positioning.

The proposed device, Kyphoplasty Balloon Dilatation Catheters are inflatable balloon catheters used in percutaneous kyphoplasty (PKP). It consists of Inner Stylet, Balloon Catheter, and polypropylene (PP) Protection tube. The device is made of PC, stainless steel, TPU, PE, Pebax and Pt/Ir.

The inner stylet is made from a stylet attached to a 6% Luer cap. The stylet enhances the stiffness of the balloon catheter to facilitate a smooth insertion of balloon catheter through the established working pathway during the percutaneous procedure. The PP Protection tube protects the balloon from damage during the production and packaging.

The balloon catheter is composed of six sections: Inflation Port, Stylet Port, Inner Tube, Outer Tube, Radiopaque Markers, Inflatable Component. The Stylet Port is used to provide a support for the Stylet. The Inflation Port provide an adapter for a balloon inflation Injector. The Inflatable Component plays a critical role in the procedure. The Inflatable Component is to restore the height of a compression-fractured vertebral body and also leave a cavity in the fractured area after the Inflatable Component deflation. The cavity is therefore to facilitate safer filling of the bone cement. The cavity in the fractured area left by the inflated balloon reduces the filling pressure of bone cement. This technology greatly reduces the risk of uncontrollable bone cement leakage and spread, and thus lowers complications and minimizes the risk of the procedure.

The radiopaque markers located at the balloon catheter tip to reflect the balloon position during positioning.

Kyphoplasty Balloon Dilatation Catheters are supplied sterilized, single-use.

There are generally two types of Kyphoplasty Balloon Dilatation Catheters, one is straight type which has a straight balloon catheter tip, and the other one is curved type which has a curved shape of tip of the balloon catheter. These catheters are available in different effective length. The detailed specifications are listed in Table 1.

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The TunnelVision Endoscopic Soft Tissue Release System is indicated for use in minimally invasive ligament or fascia release:

• Carpal tunnel release in the wrist
• Cubital tunnel release in the elbow

The HBL Blade Assembly is indicated for use with the TunnelVision Endoscopic Soft Tissue Release System, the 3M Agee Inside Job Carpal Tunnel Release System, or the MicroAire SmartRelease Endoscopic Soft Tissue Release System in minimally invasive ligament or fascia release:

• Carpal tunnel release in the wrist
• Cubital tunnel release in the elbow

Hand Biomechanics Lab's TunnelVision Endoscopic Soft Tissue Release System is a surgical system designed for minimally invasive soft tissue release procedures. The system includes the TunnelVision Endoscope, TunnelVision Handpiece, reusable manual surgical instruments (small and medium dilators, synovium elevator, coequal dilator), an instrument sterilization tray, and the HBL Blade Assembly.

The HBL Blade Assembly (Model CTR-455) was previously cleared under 510(k) K222490 for use with the 3M® and MicroAire® SmartRelease® systems. This submission expands indications for use to include compatibility with the TunnelVision platform. No changes were made to blade assembly materials, design, or sterilization method.

Reusable components (handpiece, endoscope, surgical instruments, sterilization tray) are supplied non-sterile, to be cleaned and steam sterilized by the end user. The HBL Blade Assembly is a sterile, gamma-irradiated, single-use device.

The subject device is comprised of two components:

1. TunnelVision Endoscopic Soft Tissue Release System – includes the endoscope, handpiece, manual surgical instruments, and sterilization tray. These components are reusable following validated cleaning and sterilization processes.
2. HBL Blade Assembly – a gamma-sterilized, single-use disposable device containing the cutting blade. The blade cuts in a retrograde direction to safely release the targeted soft tissue.

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The UltraGuideCTR® image guided soft tissue release system using real-time ultrasound visualization and guidance with integrated safety-engineered Sharps Injury Prevention is indicated for use in minimally invasive soft tissue release:

• Carpal tunnel release in the wrist

The UltraGuideCTR® image guided soft tissue release system with Sharps Injury Prevention feature is comprised of a disposable Handpiece with inflatable Balloons and a Blade assembly (UltraGuideCTR® device) that is utilized with Ultrasound imaging (continuous real-time Ultrasound visualization and guidance). The device is gamma sterilized and intended for single-use only.

Continuous real-time multi-planar ultrasound imaging throughout the procedure enables the user to visually identify pertinent anatomical structures of the hand and wrist and to visualize and navigate the device throughout the procedure. The device design and components enhance the echogenicity and visualization of the device and ensures the device is compatible with any musculoskeletal (MSK) Ultrasound system. The echogenic features of the device include:

• Inflatable Balloons located along the Shaft on either side of the Blade track, which, once inflated with saline, appear under Ultrasound as two dark circles.
• Metal Shaft/Tip of Blade - the Shaft, which houses the recessed blade at the distal Tip, appears as a bright echogenic line, with a visible notch indicating the point where the recessed Blade will be deployed from the Tip of the Shaft.
• After deployment, the Blade appears on Ultrasound as a bright star-shaped structure moving along the track in the Shaft.

Collectively, these echogenic features facilitate visualization and navigation of the device within the critical anatomy throughout the procedure.

The low-profile of the Tip allows the device to be inserted through a single, percutaneous incision in the proximal wrist flexor crease. The device is operated using an ergonomic Handle with separate controls to activate and inflate the integrated Balloons and actuate the Blade. The two inflatable Balloons are integrated on either side of the Blade track in the Shaft and once inflated, function as both anatomical guards and visual confirmation of desired device placement, as well as a safety mechanism before the Blade can be deployed from the Tip.

The Balloons are inflated in the intracarpal space of the carpal tunnel to create additional space and protect the surrounding anatomy while the Blade is actuated to transect the TCL. The design of the Blade includes a safety-engineered Sharps Injury Prevention feature. The Blade remains recessed in the Tip of the device until the Balloons are inflated using the Activation Lever on the Handle. Once the Balloon inflation/Blade interlock safety mechanism is released, the Blade Slider on the Handle is pulled back in a retrograde motion to actuate the Blade in a distal-to-proximal direction along the Blade track in the Shaft to transect the TCL. The Blade must be retracted into the fully recessed position in the Shaft before the Balloons are deflated, and the device is removed.

This integrated design of the Metal Tip/Shaft/Blade and Balloons serves to protect the surrounding anatomy during the palmar pressure that is applied to the device during the insertion, navigation, TCL transection, and removal of the device, and prevents deployment of the Blade prior to inflation and subsequent to deflation of the Balloons.

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The ELID (Endoscopic Less Invasive Decompression) system intended to provide lumbar decompression of the spine to treat various spinal condition(s) using minimally invasive techniques and instrumentation.

The ELID (Endoscopic Less Invasive Decompression) System consists of instrumentation intended to aid the user in completing steps necessary to perform lumbar decompression. Instruments include a bone needle, flat blade dilator, dilator tubes, and rongeurs. Instruments in the ELID (Endoscopic Less Invasive Decompression) System are supplied non-sterile, reusable, and manufactured from aluminum per ASTM B211, Nitinol per ASTM 2063, or stainless steel per ASTM A564.

The provided text is a U.S. FDA 510(k) Clearance Letter and a 510(k) Summary for the ELID (Endoscopic Less Invasive Decompression) System. While it describes the device, its indications for use, technological characteristics, and a list of performance tests conducted, it does not provide specific acceptance criteria or detailed study results that demonstrate the device meets those criteria.

The "Performance Data" section states that certain tests were conducted and their results "show that the strength of the ELID (Endoscopic Less Invasive Decompression) System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." However, it does not quantify this performance, nor does it specify the acceptance criteria for each test.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance. The document only lists the types of tests performed (Cleaning Validation, Sterilization Validation, Biocompatibility, Usability Testing, Particulate Analysis) but doesn't provide the detailed results or the specific quantitative acceptance thresholds for these tests.
• Sample sizes used for the test set and the data provenance. The document mentions "test modes" but does not detail the sample sizes for these tests or the origin of any data (e.g., human or ex-vivo samples, country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth establishment. This type of information is typically relevant for AI/ML-based devices relying on expert annotations, which is not clearly indicated as a component of the ELID system described. The ELID system seems to be a set of physical surgical instruments.
• Adjudication method. Similar to the point above, this is generally for AI/ML performance evaluation against expert ground truth.
• MRMC comparative effectiveness study. This is typically for AI/ML devices assisting human readers/interpreters, which doesn't seem to be the primary function of the ELID system.
• Standalone performance. This again relates to AI/ML algorithms. The ELID system appears to be a set of manual surgical instruments.
• Type of ground truth used. For an AI/ML device, this could be expert consensus, pathology, or outcomes data. For the ELID system, ground truth would likely refer to engineering specifications and performance evaluations for mechanical properties, biocompatibility, etc. The document does not specify this in detail.
• Sample size for the training set. Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.
• How the ground truth for the training set was established. Not applicable.

In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence based on a set of non-clinical performance tests, but it does not disclose the detailed quantitative acceptance criteria or the specific results of these tests, nor does it describe AI/ML related study methodologies like those you've requested. The "Performance Data" section only states that the results "show that the strength... is sufficient for its intended use and is substantially equivalent."

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The HydroCision SpineSite System is intended to be used as a single-use endoscopic video camera in a variety of endoscopic diagnostic and surgical procedures for spine applications. The device is also intended to be used as an accessory for microscopic surgery.

The HydroCision SpineSite System is comprised of (i) sterile disposable endoscope and (ii) reusable Video Processing Unit (VPU). The HydroCision SpineSite System provides illumination, image processing and digital documentation for endoscopic procedures. The HydroCision SpineSite System is not suitable for use in the MR environment.

The SpineSite Endoscope provides distal LED illumination via LEDs surrounding a high-resolution video sensor. The SpineSite Endoscope contains a working channel for the passage of micro instrumentation to the surgical site. The SpineSite Endoscope is provided sterile, via ethylene oxide sterilization.

The SpineSite Endoscope is designed to be connected to the SpineSite VPU via a proprietary edge card connector which provides power to the endoscope and supports video processing capability. The SpineSite VPU is powered via connection to an external wall outlet via a 12V power adapter.

The provided text is a 510(k) clearance letter and a 510(k) summary for the HydroCision SpineSite System. It details the device's indications for use, its components, and various non-clinical performance tests conducted to meet regulatory requirements. However, this document does not contain any information about a study proving the device meets specific acceptance criteria related to its performance in a clinical or AI-assisted context.

The "Performance Testing" section lists only non-clinical tests:

• Biocompatibility per ISO 10993-1
• Design verification/validation to mechanical and optical specifications
• Electrical, Mechanical and Thermal (EMT) safety testing per IEC 60601-1, IEC 60601-2-18
• Human Factors/ Usability per IEC 60601-1-6
• Electromagnetic compatibility testing per IEC 60601-1-2
• Software validation

The "Substantial Equivalence Summary" focuses on comparing the HydroCision SpineSite System to its predicate device (Arthrex Nanoscope System) on aspects like intended use, technological design, sterilization, electrical safety, materials, and technical features (optical resolution, field of view, depth of field, etc.). It states: "The safety and effectiveness of the HydroCision SpineSite System are adequately supported by the non-clinical performance data, substantial equivalence information, and comparison of design characteristics provided within this premarket notification."

Therefore, based solely on the provided text, I cannot answer the specific questions related to acceptance criteria and a study proving the device meets those criteria, particularly those concerning:

1. A table of acceptance criteria and reported device performance (in a clinical/AI context).
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study (AI vs. human).
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The device described is an endoscopic video camera system, not an AI-powered diagnostic device, which is what the questions regarding "AI assistance," "effect size," "standalone algorithm performance," and "training set" typically refer to. The document suggests a traditional medical device clearance based on substantial equivalence and non-clinical performance testing for a physical device, not an AI/ML algorithm.

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