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The InnerView LC is intended to precisely measure the damping characteristic of the periodontium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

The InnerView LC is an electromagnetically driven percussion system used to collect the percussion data of teeth and/or implants by the dental professional. The system is indicated to precisely measure the damping characteristics of the periodontium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

The InnerView LC consists of a wireless hand-held handpiece, base station, disposable film tip, and software. A USB cable provides a connection from the base station to a PC.

The device utilizes non-invasive quantitative percussion diagnostics (QPD), a mechanics-based methodology that tests the damping capability, and consequently mobility of teeth and dental implants by lightly percussing their buccal surface. The percussion data generated by the handpiece is wirelessly transferred to the base station and forwarded to the USB connection. In addition, the base station acts as a handpiece battery charger when the handpiece is docked. The device requires a fresh single use disposable film tip to be attached to the handpiece prior to each new procedure.

This document does not contain the specific acceptance criteria, reported device performance, or details of a study that proves the device meets acceptance criteria for the "InnerView LC". Instead, it is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study against specific acceptance criteria.

The document states that:

• Performance data (Bench Testing): "Performance testing of the InnerView LC was conducted to support substantial equivalence determination. The results demonstrate that the InnerView LC performs as well as the predicate, Periometer."
• Clinical Studies: "Clinical studies were not performed since the intended use and indications for use are the same and performance characteristics are equivalent."

Therefore, I cannot provide the requested information. The document implies that the "acceptance criteria" are effectively the performance characteristics of the predicate device, and the "study" is the bench testing demonstrating equivalence. However, the specific metrics, methodologies, and quantitative results of this bench testing are not detailed.

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