Search Results

XD880A Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: - Otolaryngology - Oral/maxillofacial - Hand and foot - Neurosurgery - Spine - Plastic/reconstructive.

XD880A Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch and an irrigation set (liquid-flow tube and liquid-flow sleeve). The console has a color LCD touch screen user interface for the selection/visualization of device functional parameters. The console activates and controls the ultrasound vibration, controls irrigation flow and displays system condition. Inside the console are located the ultrasonic generator, the electrical power supply module and the micro-processor electronic board that controls and supervises the functional parameters of the device. The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece. XD880A Ultrasonic Osteotomy Surgery System uses ultrasonic technology to generate mechanical micro-vibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert. The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude (less than 0.12mm), while keeping the soft tissues with elastic properties and free of damage.

The provided document does not describe a study involving an AI/Machine Learning device or an imaging device. Instead, it is a 510(k) premarket notification for a physical medical device: the XD880A Ultrasonic Osteotomy Surgical System. This system is an ultrasonic surgical tool used for cutting and shaping bone.

Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment for an AI/ML or imaging device is not applicable to this document.

The document focuses on demonstrating the substantial equivalence of the XD880A Ultrasonic Osteotomy Surgical System to existing legally marketed predicate devices. The performance testing described is related to the physical and functional aspects of the surgical tool, not an AI or imaging algorithm.

Here's a breakdown of the performance testing that was conducted, as described in the document:

• Electrical Safety and Electromagnetic Compatibility (EMC): The system complies with IEC 60601-1:2006 for safety and IEC 60601-1-2:2007/2010 for EMC.
• Biocompatibility: Components in contact with patients (handpiece, tips, liquid-flow sleeve/tube) were tested. Materials (Titanium Alloy TC4, Medical Silicone Rubber) met ISO and JISK requirements, and studies showed them to be biocompatible.
• Software Verification and Validation: Conducted in line with FDA guidance for "moderate level of concern" software.
• Mechanical and Acoustic Testing: Bench testing and acoustic testing performed; results "demonstrated that the subject device performs within its specifications." (Specific acceptance criteria and reported performance values are not detailed in this summary).
• Animal Study (GLP):
  • Objective: Evaluate efficiency, convenience, and safety of 15 tips during spine surgery.
  • Subjects: 10 beagles, split into two groups of 5.
  • Procedure: Spinal surgery (cutting vertebral plate) using the device at maximum power settings.
  • Evaluation Metrics:
    • Efficiency: Cutting time of bone, bleeding volume.
    • Safety: Neurophysiological parameters (SEP latent period and fluctuation, MEP) before, during, and after surgery; clinical observation (mental state, behavior) on days 1, 3, 7 post-op; CT scan on day 7; histopathology on day 8.
  • Results: All tips were efficient and safe.
    • Average cutting time: 12min 2sec (Group 1), 10min 24sec (Group 2).
    • Average bleeding volume: 31.4mL (Group 1), 28.6mL (Group 2).
    • No accidental damage to nerves, vessels, or soft tissues.
    • Normal SEP/MEP values (with explanation for minor anomalies attributed to anesthesia).
    • Normal clinical evaluation scores (with minor, resolved anomalies).
    • CT scan showed normal spine, expected absence of vertebral plate, and minor post-op edema.
    • Histopathology showed no spinal cord tissue damage, and inflammatory cells considered normal tissue reaction.

In summary, the provided text describes a submission for a physical surgical device, not an AI/ML or imaging diagnostic device. Therefore, the questions about AI/ML performance metrics, data sets, and expert evaluations are not applicable to this document.

Ask a specific question about this device