(88 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Compliance to device specifications | Confirmed through performance testing |
| Compliance to recognized standards | Confirmed through performance testing |
| All functions operate as designed | Verified through performance testing |
| Safety and effectiveness comparable to predicate devices | Demonstrated through "Substantial Equivalence Discussion" based on dimensional changes not affecting safety/performance. |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.