(111 days)
The Compact Piezo Led is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications:
· Scaling: Procedures for removal of supragingival and interdental calculus/plaque deposits:
· Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning:
· Endodontics: Treatments for root canal reaming irrigation, filling, gutta-percha condensation and retrograde preparation;
· Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.
The Compact Piezo Led is a multipurpose piezoelectric ultrasonic scaler sub-assembly device intended to be supplied to manufacturers of dental unit devices and incorporated within such devices, to be used for ultrasonic treatment in scaling, periodontics and prosthetics dental applications.
The Compact Piezo Led uses ultrasonic energy to generate mechanical micro-vibration of the available tip inserts to perform the dental procedures defined in its intended use.
The Compact Piezo Led consists of an ultrasonic generator, a handpiece/cord incorporating a range of insert tips, a torque wrench, different wiring connection kits, and other minor accessories.
The range of tip inserts, handpiece and torque wrench are autoclavable.
The subject device is intended to be assembled inside a dental unit and connected to the dental unit's electrical supply by the wiring connection kit provided.
The handpiece/cord is connected directly to the device's ultrasonic generator, from which it receives the functional drive signals, including those for irrigation supply, from the dental unit. 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 through the dental unit's controls.
The ultrasonic generator of the Compact Piezo Led is microprocessor-based and uses electronics to generate and control the appropriate drive signal (power and frequency) for the ultrasonic transducer, which is housed inside the handpiece.
The ultrasonic generator electronics search and locate the resonant frequency of the transducer/insert tip combination, which varies according to the geometry/morphology of the tip insert in use.
The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The Compact Piezo Led handpiece transducer and family of inserts are designed to resonate within this frequency range.
The Compact Piezo Led device complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.
This document describes the Mectron Compact Piezo LED, an ultrasonic scaler device. However, it does not contain a study that establishes acceptance criteria and proves the device meets them in the context of clinical performance or diagnostic efficacy.
The document is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to legally marketed predicate devices. This type of submission primarily focuses on comparing the new device's technological characteristics and safety with existing, cleared devices, rather than conducting new clinical performance studies with acceptance criteria for diagnostic accuracy or effectiveness.
Here's a breakdown of the information provided, specifically addressing the points in your request:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in terms of diagnostic or clinical efficacy (e.g., sensitivity, specificity, accuracy for a disease detection task). The device is an ultrasonic scaler, a therapeutic and dental hygiene tool, not a diagnostic imaging or AI-driven diagnostic device.
The "performance" discussed relates to technical specifications and compliance with safety and electromagnetic compatibility standards, which are:
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (Electrical Safety) | Complies |
| Compliance with IEC 60601-1-2 (EMC Requirements) | Complies |
| Compliance with IEC 80601-2-60 (Safety Requirements) | Complies |
| Software Verification and Validation | Validated in accordance with FDA Guidelines |
| Functional testing (current, working frequency, leakage, ultrasonic transducer power) | Confirmed |
| Photobiological safety of LED illumination (IEC 62471:2006) | Found to be in compliance |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is not a study evaluating a diagnostic device with a test set of patient data. The "testing" mentioned is non-clinical, focusing on engineering, electrical safety, and regulatory compliance.
3. 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. There is no concept of "ground truth" as typically understood in diagnostic AI/imaging studies, as this is a dental scaling device undergoing technical and safety evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication for a test set is mentioned.
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 an ultrasonic scaler, a physical tool used by dentists. It is not an AI diagnostic tool and does not involve "human readers" or AI assistance in the interpretation of information.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no standalone algorithm performance as this is a hardware device. The device has software that controls its functions, and this software was verified and validated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As explained, the device is not being evaluated against a diagnostic "ground truth." The "truth" in this context refers to compliance with established engineering standards and functional specifications.
8. The sample size for the training set
Not applicable. This refers to a manufactured device and its components, not a machine learning model that undergoes training on a dataset.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.