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The AEU-700L-70V is a drive system for instruments and tools used in dentistry for implants / surgical and endodontic procedures. The system includes an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement, or endodontic therapy.

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This document is a 510(k) premarket notification from the FDA for a dental handpiece and accessories, the AEU-7000L-70V Implant/Endodontic Dental System. It primarily addresses the substantial equivalence of this device to previously marketed predicate devices under the 510(k) pathway.

The 510(k) pathway focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This typically involves performance testing to show that the new device meets the same or similar specifications as the predicate. It does not generally involve clinical trials or extensive studies to establish acceptance criteria for novel clinical endpoints in the same way a PMA (Pre-Market Approval) would for high-risk devices.

Therefore, many of the specific questions about acceptance criteria for AI/ML devices, such as sample sizes for test sets, expert adjudication methods, MRMC studies, and detailed ground truth establishment, are not applicable to this type of device and submission.

Here's a breakdown based on the provided document:

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

   • The document does not explicitly state specific quantifiable acceptance criteria (e.g., accuracy, sensitivity, specificity) in the way one would see for an AI/ML diagnostic device.
   • For a device like a dental handpiece, acceptance criteria would typically revolve around engineering specifications, safety standards (e.g., electrical safety, biocompatibility, sterilization efficacy), and performance characteristics (e.g., motor speed, torque, irrigation flow, noise levels, vibration) that are compared to the predicate device.
   • The document states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies that Aseptico, Inc. provided data (likely bench testing, engineering reports, and comparisons to predicate device specifications) to demonstrate this substantial equivalence, and the FDA found that data acceptable. However, the details of these tests and their specific acceptance criteria are not included in this FDA letter.

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 / Not provided in this document. As this is a 510(k) for a dental handpiece, testing would primarily involve bench testing of the device's mechanical and electrical components, not a "test set" of patients or data in the AI/ML context.

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 / Not provided in this document. There is no "ground truth" in the clinical imaging interpretation sense for this device. Ground truth for mechanical devices would be established by validated measurement techniques and engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable / Not provided in this document. This applies to clinical interpretation studies, not mechanical device performance.

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 / Not provided in this document. This is a mechanical device, not an AI/ML diagnostic or assistive tool for human readers.

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

   • Not applicable / Not provided in this document. This device does not have an "algorithm only" component. It is a physical dental system.

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

   • Not applicable / Not provided in this document. For a dental handpiece, "ground truth" for performance would be based on engineering specifications, validated measurement methods, and compliance with recognized standards (e.g., ISO standards for dental equipment).

8. The sample size for the training set:

   • Not applicable. This device does not use machine learning or require a "training set."

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

   • Not applicable. This device does not use machine learning or require a "training set."

In summary: The provided FDA 510(k) letter confirms substantial equivalence for a dental handpiece. It does not contain the detailed performance data, acceptance criteria, or study methodologies that would be typical for an AI/ML device submission because the device itself is a mechanical-electrical system, not a software algorithm. The FDA's determination means they were satisfied with the comparisons made to predicate devices and the data supporting those comparisons, which would primarily be engineering and bench testing data.

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