(171 days)
The Compact Piezo P2K and Powercare devices are ultrasonic scalers intended for use, with the appropriate associated insert tips, in the following dental applications:
Scaling: All general procedures for removal of supragingival and interdental calculus/plaque deposits.
Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning.
Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation.
Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
The Compact Piezo P2K and Powercare are multipurpose piezoelectric ultrasonic scaler sub-assembly devices intended to be incorporated into a dental unit/table-top device and used for ultrasonic treatment in scaling. periodontics, endodontics and prosthetics dental applications.
The Compact Piezo P2K and Powercare devices are intended to be supplied as modular sub-assemblies devices to OEM manufacturers of dental units.
The subject devices consist of an ultrasonic generator, a handpiece with cord, a range of insert tips, a torque wrench and a wiring connections kit.
The subject devices are intended to be assembled inside a dental unit and connected to the unit's electrical supply by the wiring connections kit provided.
The handpiece cord is connected directly to the ultrasonic generator from which it receives the functional drive signals, including those for water supply from the dental unit for water irrigation. The ultrasonic power and water flow are simultaneously activated by pressing the footswitch of the dental unit. The power output and water flow are adjusted by the dental unit's controls.
The Compact Piezo P2K and the Power Care devices use a piezoelectric transducer inside the handpiece to generate the insert tip oscillation. The ultrasonic transducer uses four piezoceramic disks to convert the generator's electrical signal to ultrasonic mechanical vibration of the insert tip.
A key function of the ultrasonic generator is to locate the optimal frequency of the transducer/insert tip and then to drive the output at this resonant frequency.
The provided text describes the "Compact Piezo P2K" and "Powercare" ultrasonic scalers and their "510(k) Summary," which is an submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This type of submission relies on comparing a new device to an existing one, rather than presenting novel clinical studies with specific acceptance criteria and performance metrics for the new device itself.
Therefore, the text does not contain the information requested for a detailed description of acceptance criteria and a study proving the device meets those criteria, as typically found in clinical trial reports or performance validation studies for devices demonstrating new functionalities or efficacy claims.
Instead, the document focuses on demonstrating that the Compact Piezo P2K and Powercare devices are substantially equivalent to predicate devices (Piezosurgery 3 and SP Newtron Module). This means the acceptance criteria are implicitly related to meeting the standards and characteristics of the predicate devices and relevant industry standards.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
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A table of acceptance criteria and the reported device performance:
- The document does not outline specific, quantitative acceptance criteria for the Compact Piezo P2K and Powercare's clinical performance (e.g., successful calculus removal rate, time to complete a procedure, patient discomfort levels).
- It lists non-clinical testing for compliance with standards (IEC 60601-1 for safety, IEC 60601-1-2 for EMC, and tip vibrational mode testing). While these are criteria, they are not presented with specific performance values or a table format in the document. The implicit "performance" is compliance with these standards.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No clinical test set is mentioned because this is a 510(k) submission based on substantial equivalence, not a standalone clinical efficacy study for the new device.
- The non-clinical testing for compliance would have involved specific test setups, but the document doesn't provide details on sample sizes for these internal engineering tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as there is no mention of a human-read clinical test set requiring ground truth establishment by experts. The "ground truth" for non-clinical compliance testing would be established by reference to the specified standard requirements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as there is no mention of a clinical test set requiring adjudication.
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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 an ultrasonic scaler, not an AI-powered diagnostic tool, and no MRMC studies are mentioned.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests mentioned (safety, EMC, tip vibration), the "ground truth" is defined by the technical specifications and requirements of the referenced standards (IEC 60601-1, IEC 60601-1-2, and internal tip design specifications).
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The sample size for the training set:
- Not applicable. This is not an AI or machine learning device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
Summary of available information related to acceptance criteria and "study" (non-clinical testing):
1. Table of implicit Acceptance Criteria and Reported "Performance" (Compliance):
| Acceptance Criterion Type | Specific Standard/Requirement | Reported Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | "Testing to confirm compliance with the safety requirements of standard IEC 60601-1" (i.e., met) |
| EMC (Electromagnetic Compatibility) | Compliance with IEC 60601-1-2 | "Testing to confirm compliance with the EMC requirements of standard IEC 60601-1-2" (i.e., met) |
| Tip Vibrational Mode | Ensure desired vibrational mode occurs at a frequency within the specified range for the device (for each tip design) | "Each tip design is tested to ensure that the desired vibrational mode occurs at a frequency within the specified range for the device" (i.e., met) |
| Intended Use | Substantial equivalence to predicate devices for scaling, periodontics, endodontics, restorative/prosthetics applications | Argued to be substantially equivalent to Piezosurgery 3 (K091227) and SP Newtron Module (K033764). |
| Technology | Uses piezoelectric ultrasonic technology similar to predicate devices. | Confirmed: "The subject devices and the predicate devices use same piezoelectric ultrasonic technology." |
2. Sample size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Training Set, Training Ground Truth:
As explained above, these sections are not applicable to the information provided in this 510(k) summary, which focuses on substantial equivalence rather than original clinical efficacy studies or AI performance validation. The document states "Non-clinical testing of the device components covered by this 510(k) submission includes" the tests listed above, indicating these were internal verification tests against established standards.
§ 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.