(63 days)
The Piezosurgery® device is intended for use in the following dental applications:
- Bone cutting for use in oral surgery (K043408) -
- Removing supra and subgingival calculus deposits and stains from teeth -
- Periodontal pocket lavage with simultaneous ultrasonic tip movement -
- Scaling and root planing -
- Retrograde preparation of root canals
The Piezosurgery® device uses piezoelectric ultrasonic technology to generate mechanical microvibrations for bone cutting and ultrasonic scaling, with minimal trauma to soft tissue. The device is supplied with sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics.
The provided text is a 510(k) summary for the Piezosurgery® device. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than providing a detailed study report with specific acceptance criteria and performance data as one might find for a novel AI/ML medical device.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission, as it describes a traditional medical device (an ultrasonic scaler) and its performance evaluation for established indications.
Here's an analysis based on the provided text, addressing the points where information is available and indicating where it's not applicable:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| For Ultrasonic Scaling: Substantial equivalence to predicate device (EMS Piezon® Master 600) for indications including: |
- Removing supra and subgingival calculus deposits and stains
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planing
- Retrograde preparation of root canals | Technical, clinical, and histologic comparisons supported a finding of substantial equivalence to the predicate device. |
| For Bone Cutting: Substantial equivalence to a predicate device (K043408, though the specific predicate for bone cutting is only referenced by K-number, not name) for bone cutting in oral surgery. | Performance and safety evaluations demonstrated: - Precisely delineated tissue cutting
- Reduced risk of adjacent tissue damage
- Needed limited pressure on the handpiece to achieve desired cutting action
- Improved surgical control
- Reduced possibility of trauma to soft tissue |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The submission mentions "clinical data," but no numbers are given for patient or case count.
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not specified. The summary refers to "clinical data" and "histologic comparisons" but does not detail how these assessments were conducted or by whom.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: Not applicable. This is a traditional medical device, not an AI/ML diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a traditional medical device that requires human operation; it is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The performance evaluations were based on "clinical data on the characteristics of the inserts in vibration, cutting precision, and on the risk of adjacent tissue damage." It also mentions "histologic comparisons." These suggest a combination of clinical observation, physical measurements of device performance (vibration, cutting), tissue damage assessment, and potentially histopathological analysis to confirm tissue effects.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a traditional medical device, not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. (See #8)
Summary of Key Findings from the Document:
The Piezosurgery® device achieved 510(k) clearance by demonstrating "substantial equivalence" to existing predicate devices (EMS Piezon® Master 600 for ultrasonic scaling and K043408 for bone cutting). This equivalence was supported by "technical, clinical and histologic comparisons." The performance evaluations specifically highlighted precise cutting, reduced risk of adjacent tissue damage, and improved surgical control with limited pressure. The document, being a 510(k) summary, does not provide detailed study methodologies, sample sizes, or expert qualifications as typically found in comprehensive clinical trial reports.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.