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510(k) Data Aggregation
(196 days)
The Piezo Bone Surgery is intended for use in the following dental applications:
- Bone cutting for use in oral surgery
- Removing supra and subgingival calculus deposits and stains from teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planning
- Retrograde preparation of root canals
The Guilin Woodpecker Medical Instrument Co., Ltd. Piezo Bone Surgery device is a dental device used in oral surgery situations. In this submission, it is intended to be used for bone cutting in oral surgery, removing supra and sub-gingival calculus deposits, stains from teeth, periodontal pocket lavage with simultaneous ultrasonic tip movement, scaling, root planning, and retrograde preparation of root canals.
The device is a hand held ultrasonic surgical device, which is connected via a cord to the control console. The device operates at frequency range of 24 to 29.5 kHz. There are three modes of operation, which are selectable from the control console. The practitioner can select the Bone, Root or Clean modes of operation. Each mode has a different power mode, with the Bone mode giving the most power. Irrigation to the tip is provided and adjustable via the control console. Water flow for the irrigation is provided via a peristaltic pump.
A selection of tips is available for the dental professional to select and use for the specific dental procedure. The available tips are shown in the User's manual and also in the advertisement brochure.
This device is not delivered sterile, but must be sterilized after each use. Instructions for cleaning and sterilization are provided within the User's Manual.
The provided document is a 510(k) summary for the Guilin Woodpecker Medical Instrument Co., Ltd. Piezo Bone Surgery device, model Ultrasurgery. It primarily focuses on demonstrating substantial equivalence to a predicate device (MECTRON, Piezosurgery, K091227) rather than establishing novel acceptance criteria or performing extensive clinical studies to prove performance against those criteria.
Therefore, the document does not contain the level of detail typically found in a study demonstrating device performance against specific acceptance criteria. Instead, it relies on demonstrating that the new device is substantially similar in design, intended use, and technical characteristics to a previously cleared device, which implicitly means it should perform similarly.
Here's an analysis based on the information available in the document:
1. Table of acceptance criteria and reported device performance:
The document doesn't explicitly state quantitative acceptance criteria for performance in the same way a clinical trial would. Instead, it describes "safety and performance data" and concludes that "All test results were satisfactory," implying that the device met internal or regulatory standards primarily focused on safety and technical specifications, drawing equivalence to a predicate device.
| Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (General principle for 510(k) clearance) | Satisfactory, based on comparison to predicate device and compliance with relevant standards. The device is deemed substantially equivalent to the predicate (MECTRON, Piezosurgery, K091227) for the stated indications for use. |
| Compliance with Electrical, Mechanical, Environmental Safety Standards (e.g., EN/IEC 60601-1, IEC60601-1-2) | All test results were satisfactory. This implies that the device met the requirements of these standards for electrical safety, mechanical robustness, and electromagnetic compatibility. |
| Biocompatibility (e.g., ISO10993-1, ISO10993-5, ISO10993-10, ISO 7405:2008) | All test results were satisfactory. The device is described as "Complying with ISO10993-1" for its tip material (stainless steel) and other components in contact with the patient. Specific cytotoxicity testing (ISO10993-5, ISO10993-10) was also performed and found satisfactory. |
| Risk Management (e.g., ISO 13485, ISO 14971) | All test results were satisfactory. This indicates that a risk management process was followed, and identified risks were mitigated to acceptable levels. |
| Performance Testing (effectiveness and accuracy) | All test results were satisfactory. This is a general statement, without specific quantitative metrics or studies detailed in the summary. The performance is compared to the predicate device, which also uses "piezoelectric ultrasonic technology to generate mechanical micro vibrations for bone cutting and ultrasonic scaling, with minimal trauma to soft tissue." Consistency in intended use and operational principles supports the claim of similar performance. |
| Intended Use Equivalence (Bone cutting, calculus removal, periodontal lavage, scaling/root planning, retrograde root canal prep) | The intended uses of the subject device are identical to those of the predicate device, supporting substantial equivalence. |
| Technical Characteristics Equivalence (Operation, Medium, Tip material, Frequency, Voltage, APC, Power modes, Sterilization, etc.) | Comparative tables indicate substantial similarity across numerous technical specifications (e.g., operation principle, tip material, frequency range, voltage supply, APC circuit, power modes, sterilization methods). Key differences like working frequency range (24KHz~29.5 KHz vs 24 KHz to 36 KHz) and intermittent operation cycles (60" ON 10" OFF vs 60" ON 30" OFF) are present but are implicitly considered not to raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance:
The document does not describe specific clinical test sets with sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The performance claims are primarily supported by engineering and laboratory testing against recognized standards (e.g., IEC, ISO) and a comparison to a predicate device. There is no mention of a patient or clinical data set for performance evaluation in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. As no clinical test set is described, there's no mention of experts establishing ground truth or their qualifications.
4. Adjudication method for the test set:
Not applicable. No clinical test set is described.
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 a Piezo Bone Surgery device, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study or AI-assistance effectiveness is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used:
The "ground truth" for the claims of safety and effectiveness appears to be established through:
- Compliance with international standards: (e.g., EN/IEC 60601-1, ISO10993 series, ISO 14971) through laboratory testing.
- Substantial Equivalence to a legally marketed predicate device: The regulatory clearance of the predicate device (MECTRON, Piezosurgery, K091227) serves as the benchmark for safety and effectiveness. The comparison table (pages 3-4) highlights that the subject device shares the same intended use, operational principle, tip material, and similar technical specifications as the predicate.
8. The sample size for the training set:
Not applicable. This is a conventional medical device, not an AI/ML-based device that relies on a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable. (See #8)
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