(79 days)
The Piezosurgery FLEX is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and paalstic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.
Piezosurgery FLEX is a piezoelectric ultrasonic device that uses ultrasonic energy to generate mechanical micro-vibration of tip inserts intended for bone cutting. The device consists of a base control unit with intearated peristaltic pump, a sterilizable handpiece with connecting cord, a range of sterile, single use tip inserts, a torque wrench, a foot-pedal, an irrigation set, and other minor attachments.
The console is equipped with a touch panel that allows the surgeon to control device operation. The control panel also provides monitoring information, by means icons, in case of malfunction of the device. 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 mains power by an electrical cord, and includes connectors for the handpiece and for the foot-pedal. 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 foot-pedal. 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.
The touch panel of the console allows the operator to set the treatment parameters, as follows:
- Seven levels of power: .
- Six levels of irrigation: .
- Three ultrasonic output modes; .
- · The pump function.
The Piezosurgery FLEX uses piezoelectric ultrasonic technology to generate mechanical microvibrations 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.
This 510(k) summary describes a traditional submission for the Mectron Spa Piezosurgery FLEX, an ultrasonic surgical system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical Testing) | Reported Device Performance |
|---|---|
| Compliance with safety requirements of standard IEC 60601-1 | Confirmed |
| Compliance with EMC requirements of standard EN 60601-1-2 | Confirmed |
| Similar intended use/indications of use to predicate devices | Confirmed (demonstrated through submission) |
| Similar technology to predicate devices | Confirmed (demonstrated through submission) |
| No significant effect on safety and effectiveness due to technological differences from predicate devices | Confirmed (stated in submission) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing focused on compliance with electrical safety and electromagnetic compatibility (EMC) standards. It does not contain information about a "test set" in the context of clinical performance evaluation (e.g., patient data). The testing performed was related to device characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document describes compliance testing against established engineering standards (IEC 60601-1, EN 60601-1-2), not a study requiring expert-established ground truth for a clinical dataset.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human interpretation or performance, which is not described 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
Not applicable. This device is an ultrasonic surgical system, not an AI-based diagnostic or assistive technology that would involve human "readers" or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a surgical instrument. "Standalone" performance testing would relate to its engineering specifications and functionality, which are covered by the non-clinical testing mentioned (IEC and EMC standards compliance).
7. The Type of Ground Truth Used
For the non-clinical testing: The "ground truth" was defined by the requirements and specifications outlined in the international standards IEC 60601-1 (medical electrical equipment safety) and EN 60601-1-2 (electromagnetic compatibility).
8. The Sample Size for the Training Set
Not applicable. The Piezosurgery FLEX is a hardware surgical device, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this device does not utilize a "training set" in the context of machine learning.
§ 888.4580 Sonic surgical instrument and accessories/attachments.
(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.