(283 days)
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.
Ultrasonic Osteotomy Surgical System uses 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 cutting tip insert. The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude.
Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of cutting tips, wrench and torque wrench, a foot switch and 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.
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.
The provided text describes an Ultrasonic Osteotomy Surgical System and its 510(k) summary for FDA clearance. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" as typically understood for AI/ML performance (e.g., accuracy, sensitivity, specificity, or human reader improvement) does not apply directly in this context.
Instead, for this type of device (an ultrasonic surgical system), "acceptance criteria" relates to demonstrating that the new device is as safe and effective as its predicate device. This is primarily done through non-clinical performance data (bench testing) and demonstrating substantial equivalence in design, materials, and intended use. Clinical studies for performance improvements relative to human readers or AI algorithms are not relevant to this device type or regulatory pathway.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the AI/ML sense, nor information on sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the information provided in the document for this specific medical device.
However, I can extract what the document presents as evidence for "meeting acceptance criteria" in the context of a medical device 510(k) submission, focusing on Non-Clinical Performance Data and Substantial Equivalence.
1. "Acceptance Criteria" (in the context of a 510(k) for this device) and Reported Device "Performance":
For this device, "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device and showing that differences do not raise new questions of safety and effectiveness, supported by non-clinical testing. The "reported device performance" is the successful outcome of these non-clinical tests, showing the device operates within expected parameters and safely.
| Acceptance Criteria Category (Implied for 510(k)) | Method of Proof / Reported "Performance" |
|---|---|
| Substantial Equivalence to Predicate Device (K172464) | Demonstrated through detailed comparison (Table 1) showing: |
- Same manufacturer, composition, indications for use, user interface, ultrasonic vibration activation, tip material, frequency, maximum flow, ultrasound output mode, electrical safety classification, power supply, power cord length, and operating/shipping/storage conditions.
- Minor differences (irrigation system pump placement, wrench type, sterilization method) are discussed and deemed to not impact safety or effectiveness. |
| Sterilization Efficacy and Shelf Life | Single Use Disposable Components: EO sterilization validation tests for sterile package, sterile barrier testing, device performance testing on sterilized components, simulated shipment testing, accelerated and natural aged testing to support claimed shelf life.
Reusable Components: Cleaning and sterilization testing performed for each reusable component (moist heat). |
| Functional / Bench Performance | Successful completion of: - Ultrasound Performance Testing
- Irrigation Performance Testing
- Cutting Efficiency and Thermal Testing
- Mechanical Testing for Torque Wrench |
| Safety and Effectiveness | "Safety and performance testing have demonstrated the Ultrasonic Osteotomy Surgical System is as safe and effective as the predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in terms of patient data. The testing is primarily bench testing and validation studies for sterilization, shelf-life, and functional performance. It would involve specific numbers of device units or components tested to statistical significance, but these specifics are not detailed in this summary.
- Data Provenance: Not applicable in the context of clinical data. For non-clinical validation, the testing was performed by SMTP Technology Co., Ltd. in China. The data would be prospective in the sense that the tests were specifically conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/ML study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device revolves around objective engineering and performance specifications (e.g., frequency output, flow rate, sterilization efficacy, cutting efficiency) which are measured against established physical standards and predicate device performance characteristics, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human reader interpretation or clinical adjudication.
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:
- No, a MRMC comparative effectiveness study was not done. This device is an ultrasonic surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this device is not an algorithm. It is a physical surgical system. "Standalone performance" in this context refers to the device's functional performance metrics (e.g., frequency output, flow rate, cutting ability) which are detailed as "Non-Clinical Performance Data."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance validation is based on engineering specifications, international standards (e.g., for sterilization), and direct comparison to the physical and functional characteristics of the predicate device. It relies on objective quantitative measurements (e.g., 39 kHz±4kHz frequency, 120ml/min±20% flow rate) and validated processes (e.g., EO sterilization efficacy). It does not involve medical "ground truth" in the diagnostic sense.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.
§ 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.