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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 SX-One MicroKnife is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.

The Sonex Health SX-One MicroKnife is a mechanical device that uses a blade to manually transect the transverse carpal ligament. The device is provided sterile and intended for single use.

The SX-One MicroKnife® consists of a thin stainless-steel shaft connected to a handpiece that is designed to be ambidextrous. A lever on the handle is activated to unlock the blade actuator and inflate the two balloons located on the lateral sides of the tip of the device. The blade actuator is used to activate a cutting blade that transects the TCL. The cutting blade is manually moved proximally and distally along a track. The purpose of the blade is to transect the transverse carpal ligament to treat carpal tunnel syndrome.

This document describes the Sonex Health SX-One MicroKnife, a manual surgical instrument for carpal tunnel release. The information provided is primarily related to its regulatory clearance (510(k) submission) and does not contain details about acceptance criteria, clinical study results, or AI/software performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC studies, as the provided text explicitly states "No clinical data was required" and describes a mechanical device with no mention of AI or software.

The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance testing related to sterilization, biocompatibility, and shelf life for a mechanical surgical instrument.

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