Search Results

The Neoss Implant System Ø3,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neoss Implant System Ø3,25 are intended for immediate loading on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar. The Neoss Implant Ø3,25 abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.

The Neoss Implant System Ø3,25 assortment consists of a number of implants with a diameter of Ø3,25 mm and lengths between 9,0 - 17.0 mm having the same internal abutment designs as previously cleared per K083561 & K043195 & K071838, but a smaller diameter and includes a selection of abutments. Identical to K043195 & K083561, the Neoss Implant System Ø3,25 remains a threaded, internal abutment connection, root-form titanium dental implant. The internal connection being equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. Smaller associated bone cutting instruments are also available. The Neoss Implant System Ø3,25 available surface treatment will be identical to either the Neoss Bimodal or Neoss ProActive Implant. Supplied sterile.

The provided text describes a 510(k) premarket notification for a dental implant system (Neoss Implant System Ø3,25). This submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a study proving a device meets specific performance acceptance criteria through clinical trials or detailed non-clinical performance benchmarks. Therefore, most of the requested information regarding acceptance criteria, specific study details, ground truth establishment, expert adjudication, MRMC studies, or training sets is not applicable or not available in the provided document.

However, I can extract information related to the device's technological characteristics and the general approach to demonstrating safety and effectiveness based on the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for performance metrics. Instead, "compliance to device specifications and recognized standards" and "all functions were verified to operate as designed" are mentioned in the context of performance and fatigue testing. The performance is then discussed in terms of "substantial equivalence" to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This document describes a 510(k) submission for a modified dental implant, which primarily relies on demonstrating substantial equivalence to existing predicate devices through engineering analysis and limited non-clinical testing rather than new clinical trials with patient test sets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The substantial equivalence argument does not involve establishing ground truth from expert consensus on a test set in the way a diagnostic AI device would.

4. Adjudication Method for the Test Set

Not applicable.

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. This is a medical device (dental implant), not an AI diagnostic tool that would involve human readers.

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

Not applicable. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" for the device's performance is implicitly defined by its ability to function safely and effectively as a dental implant, comparable to its predicate devices, based on engineering tests and intended use.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Ask a specific question about this device