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Low-speed (vane motor) handpiece is used for drilling of teeth in a variety of dental procedures.

The Midwest Rhino XE and Air Motor M are low speed air motors. The motors are reusable and can be sterilized in an autoclave. Air Motor M includes an external spray port whereas the Midwest Rhino XE does not have the external sprayport.

This document is a 510(k) premarket notification for the Dentsply Sirona Midwest Rhino XE and Air Motor M dental handpieces. As such, it focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove them.

The information provided confirms that no clinical performance data from human studies was included to support substantial equivalence. The substantial equivalence is based on:

• Identical Indications for Use with the predicate device (LS-100, K792302).
• Same fundamental technology and intended uses as the predicate and a reference device (W&H Air-Powered Handpieces and Handpiece Attachments (Air Motor AM-25 E RM), K162926).
• Non-clinical performance testing to verify conformity with various ISO standards and FDA guidance documents.

Therefore, many of the requested sections related to acceptance criteria and a primary study are not applicable to this 510(k) submission. However, I can extract the relevant information regarding the performance comparison and the non-clinical testing conducted to support substantial equivalence.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, "acceptance criteria" in the context of a primary study proving efficacy are not explicitly stated as they would be for a novel device. Instead, the "acceptance criteria" can be inferred as demonstration of meeting relevant standards and having comparable technical specifications to predicates. The "reported device performance" are the specifications of the proposed devices.

Note: The document primarily highlights differences and how they are addressed (e.g., conformity testing to ISO 14457). The "Acceptance Criteria" for proposed devices are framed as demonstrating substantial equivalence to the predicate, often meaning being within a cleared range or addressing differences through standard conformity.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as it pertains to non-clinical performance testing. The document states "Testing to verify the performance requirements of the proposed devices... was conducted." It specifies the standards to which this testing conformed but not the sample size, data provenance, or whether it was retrospective/prospective.

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)

This is not applicable as no human clinical studies were performed, and thus no expert-established ground truth for a test set was necessary for this type of 510(k) submission.

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

This is not applicable as no human clinical studies were performed.

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

This is not applicable. This device is a dental handpiece, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

This is not applicable, as the device is a physical dental handpiece and not an algorithm.

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

For the non-clinical performance data, the "ground truth" can be considered the established requirements and parameters defined by the various ISO standards and FDA guidance documents listed (e.g., ISO 14457 for dentistry handpieces and motors, ISO 17665-1 for moist heat sterilization, ANSI/AAMI ST79 for steam sterilization, AAMI TIR 30 and ISO 15883-5 for cleaning validation, ISO 10993-1 and ISO 7405 for biocompatibility). The devices' performance was "verified" against these technical and safety standards.

8. The sample size for the training set

This is not applicable as no algorithm or AI component is involved requiring a training set.

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

This is not applicable as no algorithm or AI component is involved.

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