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The Avant handpiece will be used by dentists to remove decayed tooth structure, and to cut or alter the shape of teeth so they may be restored to form and function.

The Avant is a high speed dental handpiece, 132 millimeters long, with a lightly textured finish for enhanced grip. It is a hand-held, channeled instrument that is powered by compressed air that is delivered through a hose to an air channel in the handpiece at 32-40 psi. This impels the turbine in the head of the handpiece to revolve at approximately 375.000 rpm. Other internal channels deliver air and water to the head for cleaning and cooling. The handpiece may contain, as an accessory, an optics device to light the area of operation. Any common dental bur for cutting (not supplied by Ora Innovations) is held in place in the handpiece head by a push-button chuck.

The Avant handpiece housing is constructed of a high temperature, medical grade liquid crystal polymer (Vectra A530 by Ticona, Summit, NJ). There are three major parts which are made from metal: a standard turbine (supplied by a manufacturer of dental handpiece turbines), the threaded connector at the back end which attaches to the standard air/water hose in the dental unit, and the internal tubes that carry the chip air and water. These three parts are substantially equivalent to those in the predicate device.

Similar to the predicate device, the Avant handpiece must be cleaned and lubricated with a quality commercial dental handpiece cleaner/lubricant. It is supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single unit or in multiples.

The provided document is a 510(k) summary for a dental handpiece, focusing on establishing substantial equivalence to a predicate device. It is a regulatory submission, not a study report designed to present detailed acceptance criteria and performance data for a device.

Therefore, the document does not contain the detailed information required to fill out the requested table and answer many of the questions. Specifically, it lacks:

• A table of explicit acceptance criteria with numerical targets.
• Reported device performance against specific metrics.
• Details on sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study results, standalone performance, ground truth types for test/training sets, and training set sample size or ground truth establishment.

Based on the information available:

Acceptance Criteria and Reported Device Performance

The document states that "The following tests were derived from the American Dental Association guideline, ISO 7785-1 and G95-1/ISO-10993." and lists the tests:

• Air pressure
• Biocompatibility
• Polymer material
• Color
• Extraction force
• Rotational speed
• Sterility validation

It then broadly claims, "The test reports, located in the Appendix of the 510(k) application, show that the Avant handpiece is safe and effective." However, it does not provide a specific table of acceptance criteria or the reported device performance values against these criteria.

Study Details

1. A table of acceptance criteria and the reported device performance:

   • Not provided in the document. The document lists types of tests performed but does not specify the quantitative acceptance criteria or the numerical results of these tests.

2. Sample size used for the test set and the data provenance:

   • Not provided. The document states "Performance testing: Comparative performance testing and clinical evaluations are not submitted as part of this 510(k)." This indicates that no separate clinical or comparative performance test set, as might be understood for AI/diagnostic devices, was used or submitted. The "tests" mentioned (air pressure, biocompatibility, etc.) would likely refer to engineering or material verification tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not provided. This type of information is typically relevant for diagnostic devices where expert review establishes ground truth. For this mechanical dental handpiece, the "ground truth" would be objective measurements against technical specifications.

4. Adjudication method for the test set:

   • Not applicable/Not provided.

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:

   • No, not done. The device (a dental handpiece) is a mechanical tool, not an AI or diagnostic tool that would involve human readers or AI assistance in interpretation. The document explicitly states "Comparative performance testing and clinical evaluations are not submitted as part of this 510(k)."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. The device is a mechanical handpiece; there is no "algorithm" in the context of diagnostic or AI performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not explicitly stated in detail. For mechanical devices like this, the "ground truth" for the listed tests (air pressure, rotational speed, etc.) would be established by objective engineering measurements and adherence to specified test standards (e.g., ISO 7785-1, G95-1/ISO-10993). Biocompatibility would be assessed against specific material standards and biological reactivity tests.

8. The sample size for the training set:

   • Not applicable/Not provided. This concept is relevant for AI models, not for a mechanical dental handpiece.

9. How the ground truth for the training set was established:

   • Not applicable/Not provided.

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