(276 days)
Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation.
The drive unit is used for the removal of supragival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.
The Proxeo ULTRA is a drive unit including handpieces with a piezoceramic oscillating system, which moves the tip in a linear oscillation.
The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.
The medical device consists of the following components that are also included in the scope of delivery:
- Control unit (PB-510, PB-520, and PB-530)
- Handpiece (PB-5 L, PB-5 L, S, and PB-5 L Q)
- Foot control (wired, wireless)
- A Power supply, instruction for use and other accessories
The scaler tips are moved with a piezo-scaler handpiece by converting electrical energy into mechanical vibration. The coolant (water) is directed to the treatment site via a solenoid valve and a control unit via the tip. The scaler tips are re-usable [diamond-coated tips are single use only] and delivered non-sterile. Tips for use with Piezo Scaler for the following dental applications:
- Scaling-tips
- Periodontic-tips
- Implant-cleaning-tips
- Endodontic-tips
- Tips for restoration and prosthetics
With the foot control, corresponding device functions can be operated with the foot. These functions include, for example, program selection (button), operation of coolant function (button), motor direction of rotation selection (button), motor speed level (variable with pedal), power piezo handpiece (variable with pedal).
Bluetooth Low Energy technology is used in the wireless foot controls (C-NW) to make this possible wirelessly as well. The foot controls are powered internally by a rechargeable battery (C-NW) or an external power source (C-NF).
This document is a marketing clearance (510(k)) for a dental device, the Proxeo ULTRA. It details the device's characteristics and its equivalence to previously cleared predicate devices. Since this is a 510(k) summary for a physical medical device (ultrasonic scaler), not a diagnostic or AI-powered software, the typical acceptance criteria and study designs that involve metrics like sensitivity, specificity, or reader studies with AI assistance are not applicable in the same way they would be for an AI/ML medical device.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, performance data (bench testing, biocompatibility, electrical safety, reprocessing validation), and adherence to relevant standards. It does not contain information on "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance metrics for diagnostic or AI-based devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are not relevant or reported for this type of device clearance.
Instead, the "acceptance criteria" for a device like the Proxeo ULTRA are primarily met by demonstrating that it performs as intended (as shown by bench testing) and is as safe and effective as existing legally marketed devices.
Here's how the information would typically be presented if it were an AI/ML device, alongside an explanation of why it's not applicable here:
Based on the provided FDA 510(k) summary for the Proxeo ULTRA (an ultrasonic dental scaler), the requested information regarding acceptance criteria and study designs for AI/ML performance metrics is NOT applicable.
This document is for a physical medical device and demonstrates substantial equivalence through:
- Technical Characteristics Comparison: Showing similar design, operating principles, and materials to predicate devices.
- Performance Data: This primarily involves non-clinical testing to ensure the device functions as intended and meets safety standards, rather than diagnostic accuracy or clinical outcome studies in the context of AI.
Therefore, the following specific information cannot be extracted from this document:
- A table of acceptance criteria and the reported device performance (in terms of AI/diagnostic metrics): Not applicable. The "performance" is demonstrated through bench testing, biocompatibility, electrical safety, and reprocessing validation, ensuring the device operates as specified and is safe.
- Sample sizes used for the test set and the data provenance: Not applicable. There isn't a "test set" of clinical data for diagnostic performance. Bench testing is mentioned, but specific sample sizes for its components are not detailed in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic purposes is not established for an ultrasonic scaler.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. There is no AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Instead, for this device, the "acceptance criteria" are implied by the demonstration of substantial equivalence, which includes:
- Manufacturing and Safety Standards Compliance: The device complies with relevant IEC standards (IEC 60601-1, IEC 80601-2-60, IEC 60601-1-2) for electrical safety and EMC.
- Biocompatibility: Evaluation according to ISO 10993 series.
- Reprocessing Validation: Validation per FDA Guidance for Medical Devices.
- Bench Testing: Functional testing (application, settings, features) per device specifications.
- Software Verification: Compliance with IEC 62304 and FDA guidance for software, given its moderate level of concern.
The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing (bench, biocompatibility, electrical safety, reprocessing, software verification) that demonstrates the device performs as intended and is as safe and effective as its predicate devices. The document explicitly states: "Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device... and the reference device..."
§ 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.