Search Results

The device is intended to be utilized during Functional Endoscopic Sinus Surgery (FESS) for the excision of soft and osseous tissues in the sinus cavities. The device may also be utilized for endoscopic or open plastic, reconstructive, and aesthetic surgery of the head and neck. Additionally, the device may be used in conjunction with Visualization Technologies, Inc. (VTI) InstaTrak (K960330) image guided system.

The Hummer Trak System can be sub-divided into two systems, the handpiece and the power unit. The power unit is placed in a secure position, permitting the handpiece to access the surgical site. The power unit contains a motor that drives the handpiece via a flexible drive shaft. Slots are cut in the body of the power unit, permitting lashing straps to secure the unit. The power unit is connected to the TPS Console (K942956 and K943563/S2). The handpiece is mechanically driven from the power unit via the flexible drive shaft. The handpiece effectively transmits the motor energy of the power unit to the shaver blade or bur attachment. A slot is cut longitudinally along the circumference of the handpiece body, securing irrigation tubing. A ball-type valve is provided to regulate suction from the shaver blade or bur attachment. Suction tubing is connected to the handpiece utilizing a suction fitting. A quick release trinkle-type mechanism is used to secure shaver blade and bur attachments. A receiver mount is located on the upper portion of the handpiece body, allowing an image guided sensor to be secured. The InstaTrak image guided sensor is secured to the handpiece by means of a receiver mount. The mount holds the sensor in place by engaging a notch within the sensor and a Delrin latch. The sensor provides three dimensional visualization of the shaver blade or bur attachment's precise location. Small magnets embedded within the receiver mount identify the handpiece as a probe type to the image guided surgery system. Two physical interlocks ensure that calibration is performed when required. Removal of the image guided sensor triggers recalibration when the magnets are no longer detected. Additionally, a mechanical arm connected to the locking mechanism shifts the magnets, creating an intermittent signal loss, forcing recalibration.

The provided text is a 510(k) summary for the Stryker Hummer Trak System, a medical device. It does not describe acceptance criteria for a study, nor does it present any study data demonstrating the device meets performance criteria.

Instead, the document details:

• Device identification: Proprietary name (Hummer Trak), common name (Electrical surgical shaver with irrigation), and classification.
• Equivalence claim: States the Hummer Trak System is equivalent to the Hummer II Microdebrider System (K952681 and K972584).
• Description: Explains the components (handpiece, power unit), how they work, and the integration of an image-guided sensor.
• Intended Use: Specifies its application in Functional Endoscopic Sinus Surgery (FESS) for tissue excision, endoscopic/open plastic, reconstructive, and aesthetic surgery of the head and neck, and its use with the VTI InstaTrak image-guided system.
• Technological Comparison: Highlights differences from the predicate device (Hummer II Microdebrider System), primarily concerning integration with image-guided surgery sensors (minimizing electromagnetic materials, flexible drive shaft) and minor design changes to the suction mechanism.
• Standards: Mentions that both devices will be tested to IEC 601-1, CSA 601.1, UL 2601, IEC 601-1-2, and MDD 93/42/EEC for safety and compliance.
• FDA Clearance Letter: A letter from the FDA confirming substantial equivalence and allowing the device to be marketed.

Therefore, I cannot provide the requested information (acceptance criteria table, study details, sample sizes, ground truth information, MRMC study details) because it is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than presenting a performance study with specific acceptance criteria and results.

Ask a specific question about this device