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The InnerView System is intended 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 by producing two distinct outputs. InnerView's Mobility quantifies the external tooth and/or implant mobility. InnerView's NFE quantifies the internal mobility within the tooth and/or implant structure.

The InnerView System is an electromagnetically driven percussion system designed for dental professionals to collect percussion data of intraoral sites such as teeth and/or dental implants. The device utilizes non-destructive quantitative percussion diagnostics (QPD), a mechanics-based methodology to measure the damping capacity of a tooth and implant by applying light percussion to its buccal surface.

The InnerView System consists of a wireless handheld handpiece, a base station, single-use disposable tips, and software. A USB cable connects the base station to the user's PC. The handpiece and base station are automatically paired when the handpiece is placed in the base station. The base station also functions as a charger for the handpiece when docked. A fresh disposable tip must be attached to the handpiece before each new procedure and replaced after each patient use.

The percussion response captured by the handpiece is wirelessly transmitted to the base station, then forwarded to the PC via USB, and subsequently to the Cloud-based software for analysis and calculations. The percussion data is captured in an energy response graph (ERG), which depicts the mechanical response of the intraoral site as a function of time. InnerView proprietary software algorithms analyze the ERG data and, through the user interface, display two independent outputs: Mobility, which quantifies external mobility of the tooth or implant, and NFE, which quantifies internal mobility within the tooth or implant structure.

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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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The Periometer is a unit that precisely measures the damping characteristics of the periodonium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

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I'm sorry, but without access to the full 510(k) submission document for K072213, I cannot provide details on the acceptance criteria, device performance, or study specifics for the Periometer device. The provided text is only the FDA's decision letter and the Indications for Use statement, which does not contain the detailed technical data and study information required to answer your questions.

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