(79 days)
To be used by Dental Professionals during dental cleaning and periodontal (gum) therapy to remove calculus, plaque and staining of the tecth by application of an ultrasonic vibrating tip to the teeth.
The Hu-Friedy® brand Symmetry S-Series Piezo Scaling Tip is similar to the Piezo Scaling Tips used with the predicate devices listed above. This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth. The Symmetry S-Series ultrasonic insert has essentially the same design as the predicate device's ultrasonic inserts. Laboratory tests performed to make this determination include cleaning, sterilization, and mechanical life testing. The key elements of piezoelectric ultrasonic tip compatibility include: correspondence of tip thread to hand-piece specification, tip vibration at resonant frequency established by equipment specification, (27-32 kHz) and a linear tip displacement in a range consistent with the power output setting on the generator.
The provided 510(k) summary focuses on the substantial equivalence of the Symmetry S-Series Piezo Scaling Tips to predicate devices. The "study" mentioned is a field evaluation rather than a rigorous clinical trial with quantified acceptance criteria in the typical sense for a medical device with objective performance metrics.
Here's an attempt to extract and format the information based on the provided text, while acknowledging its limitations for certain categories:
Acceptance Criteria and Device Performance Study
The primary study mentioned is a field evaluation comparing the Symmetry S-Series Piezo Scaling Tips to a predicate device's competitive tip.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Compatibility: | |
| Tip thread correspondence | Compatible with hand-piece specification |
| Tip vibration (resonant) | Consistent with equipment specification (27-32 kHz) |
| Linear tip displacement | In a range consistent with the power output setting on the generator |
| Clinical Performance: | |
| Scaling efficiency | Perceived to be equal to, or slightly better than the predicate device's competitive tip |
| Adaptability to tooth surface | Perceived to be equal to, or slightly better than the predicate device's competitive tip |
| Water delivery | Perceived to be equal to, or slightly better than the predicate device's competitive tip |
| Patient comfort during use | Perceived to be equal to, or slightly better than the predicate device's competitive tip |
| Overall preference | Overall conclusion: perceived to be equal to, or slightly better than the predicate device's competitive tip (This is the overarching "acceptance" for clinical use) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text only mentions "clinicians were asked to evaluate."
- Data Provenance: Not explicitly stated. Likely refers to a prospective evaluation conducted by dental professionals. Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated. The text refers to "clinicians" in the plural, but
the exact number is not provided. - Qualifications of Experts: The experts are described as "clinicians," implying dental professionals (e.g., dentists, dental hygienists). No specific years of experience or board certifications are mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The evaluation seems to be based on individual clinician perceptions, summarized as an "overall conclusion." There is no indication of a formal adjudication process (e.g., 2+1 or 3+1 consensus).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The evaluation was a field study assessing subjective perceptions from clinicians, not a formal MRMC study evaluating diagnostic or therapeutic accuracy with quantifiable endpoints.
- Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as this device is a physical dental scaling tip and not an AI-assisted diagnostic or therapeutic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable, as this device is a physical dental scaling tip and not an algorithm. The "mechanical compatibility" tests (resonant frequency, tip displacement) can be considered standalone performance for the physical device characteristics, confirming it operates within specified parameters before human use.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the mechanical aspects, the ground truth was engineering specifications and measurements (e.g., resonant frequency range, consistent linear tip displacement). For the clinical performance, the "ground truth" was essentially expert subjective opinion/perception (clinician evaluations of scaling efficiency, adaptability, water delivery, patient comfort, and overall preference) in comparison to a predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI. The design and validation of the device were based on engineering principles and compatibility with existing equipment.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device. The design was established based on existing knowledge of piezoelectric ultrasonic technology and the characteristics of predicate devices, with lab tests verifying mechanical characteristics.
§ 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.