(149 days)
The Piezosurgery® Plus is an ultrasonic surgical system consisting of handpieces and associated tips for 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, and
- Orthopedic surgery.
The device may also be used with endoscopic visual assistance to perform the above listed procedures.
The Piezosurgery Plus device is a surgical system that uses ultrasonic energy to generate mechanical micro-vibration of associated inserts, to perform cutting of bony structures in the procedures defined by its intended use.
The Piezosurgery Plus system consists of a control unit which provides control and power functions, two different detachable surgical handpieces which provide the ultrasonic mechanical energy, two peristaltic irrigation pumps, two irrigation tubing systems, a range of single use insert tips, torque wrenches, and a foot-pedal.
The control unit has a color LCD touch screen user interface for the selection/visualization of device functional parameters. Inside the control unit are located two ultrasonic generators which drive the two handpieces, the electrical power supply modules and the microprocessor electronic board that controls and supervises the functional parameters of the device.
The two piezoelectric ultrasonic handpieces available for the Piezosurgery Plus are identified as 'Piezosurgery Medical' and 'Piezosurgery Medical +'. The handpieces are reusable and capable of being reprocessed by autoclaving.
The handpiece labeled 'Piezosurgery Medical +', uses identical technology to the 'Piezosurgery Medica' handpiece but differs from it as it contains larger piezoceramic rings in its transducer, allowing more efficient cutting of thick bony structures, and also use with extended reach for minimally invasive bone surgery in long narrow access path, in small cavities and other hard to reach areas.
The two peristaltic pumps, which provide, through the two single-use irrigation tubing sets, sterile fluid to the surgical site, are mounted on the two lateral panels of the control unit.
The control unit includes connectors for the handpieces and for the foot-pedal. Each handpiece receives the functional drive signals from the control unit.
Each irrigation tubing set connects each handpiece irrigation connector to a sterile fluid bag (not supplied with the device) via the associated peristaltic pump.
The user may select either of the two handpieces for activation from the LCD touch-screen. Ultrasonic power and irrigation flow are simultaneously activated for the selected handpiece by pressing the foot-pedal.
The ultrasonic generator(s) provides electrical energy at a specific range of frequency. The generator must drive the transducer at or near its anti-resonance frequency for optimal operation. A key function of the generator is to locate the anti-resonant frequency and drive the output at this frequency.
In particular, the generator conducts an automatic frequency sweep across a frequency interval of 36 kHz - 24 kHz to locate and lock the electrical resonance frequency of the transducer/insert system. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The Piezosurgery Plus handpieces transducers and family of inserts are designed to resonate in this range of frequencies.
The ultrasonic signal can be modulated in amplitude, generating a sinusoidal signal with alternative amplitudes of high and low value that creates a hammer effect that enhances cutting and minimizes insert stalling.
The Piezosurgery Plus complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.
The provided text describes the Mectron Piezosurgery Plus device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device numerically meets specific criteria as typically seen in AI/ML device submissions.
This document is a 510(k) summary for a traditional surgical instrument, not an AI/ML powered device. The "performance testing" section focuses on demonstrating the device's functionality, safety, and equivalence to predicate devices based on well-established non-AI engineering principles and physical testing.
Therefore, many of the requested items (e.g., sample size for test sets, data provenance, number of experts, MRMC studies, standalone performance, ground truth types for training/test sets, training set size) are not applicable to this type of device and submission.
Here's a breakdown of the information that can be extracted from the document, acknowledging the non-AI nature:
Acceptance Criteria and Device Performance (Non-AI Device)
Since this is a traditional surgical instrument, the "acceptance criteria" are generally framed around demonstrating functional equivalence to predicate devices and compliance with relevant safety standards, rather than numerical performance against a specific metric (like sensitivity/specificity for AI). The "reported device performance" refers to the results of engineering tests confirming these aspects.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):
| Acceptance Criterion (Inferred) | Reported Device Performance (Summary from Text) |
|---|---|
| Electrical Safety Compliance | Complies with IEC 60601-1:2005 + AMD1:2012 |
| Electromagnetic Compatibility (EMC) Compliance | Complies with IEC 60601-1-2:2007 |
| Software Verification & Validation | Conducted and documentation provided per FDA Guidance for Medical Device Software (May 11, 2005). Software classified as 'major' level of concern. |
| Biocompatibility of Patient-Contacting Components | Tip inserts (single-use) classified as 'external communicating devices' in contact with 'tissue/bone/dentin' with 'limited' contact duration. Materials (stainless steel, titanium alloy, PEEK) are identical to or in accordance with predicate device/standards, with PEEK data provided. |
| Osteotomy/Osteoplasty Efficiency (Comparative) | Able to efficiently carry out osteoplasty and osteotomy with results at least equivalent to the identified predicate device with equivalent inserts. (Evaluated by measuring cutting speed for osteotomy and bone volume removed for osteoplasty). |
| Bone Safety (Prevention of Necrosis) | No evidence of bone necrosis recorded on any bone sample obtained using 'worst case' tip inserts during comparative testing. (Evaluated by microscopic inspection at 40x magnification on cow femur/rib samples). |
| Device Safety (Prevention of Insert Breakage) | No insert breakages noted during stress tests. ('Worst case' inserts subjected to 600 mechanical stress cycles, 5 samples per insert type, simulating clinical usage). |
| Sterility Assurance Level (SAL) | Components supplied sterile (irrigation tube set, insert tips) meet SAL = 10-6. Recommended steam sterilization for reusable parts (handpieces, torque wrenches) at 132°C (270°F) for 4 min achieves SAL = 10-6. |
| Substantial Equivalence to Predicate Devices | The device's technological characteristics, intended use, and performance testing demonstrate substantial equivalence to the Piezosurgery Flex (K132848) and/or Alliger Ultrasonic Surgical System Model AUSS-7 (K070313), with differences evaluated and determined not to raise new questions of safety or effectiveness. |
Information Regarding the Study (or lack thereof for AI/ML specific aspects):
-
Sample size used for the test set and the data provenance:
- Test Type 1 (Osteotomy/Osteoplasty Efficiency): "cow femur or rib samples" were used. No specific number of samples is provided.
- Test Type 2 (Bone Safety): Performed on "bone surfaces derived from the above test type 1." Same samples, no specific count.
- Test Type 3 (Device Safety - Insert Breakage): "Five samples were tested for each investigated insert type."
- Data Provenance: In vitro testing (cow bone), not human data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this engineering performance testing. "Ground truth" was established by direct measurement (cutting speed, volume removed) or visual inspection (microscope for necrosis). The document does not mention external experts for ground truth establishment.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML diagnostic or prognostic study requiring multi-reader adjudication.
-
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:
- No MRMC comparative effectiveness study was done. This is a traditional surgical instrument, not an AI-assisted device for diagnostic or prognostic purposes.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a console and handpiece system, always used with a human operator. The performance testing describes the device's physical capabilities.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For mechanical testing, the "ground truth" was direct physical measurement and observation:
- Cutting speed measurement.
- Volume of bone removed measurement.
- Microscopic visual inspection for bone necrosis.
- Observation of insert integrity after stress cycles.
- For safety and software, it was compliance with recognized standards and guidance.
- For mechanical testing, the "ground truth" was direct physical measurement and observation:
-
The sample size for the training set:
- Not applicable; this is not an AI/ML device that requires a training set. The software mentioned is for device control and functionality, validated through traditional software V&V.
-
How the ground truth for the training set was established:
- Not applicable as there is no training set mentioned for an AI/ML algorithm.
§ 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.