(71 days)
The Neoss ProActive Implant is for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neoss ProActive Implant is intended for immediate placement and function 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 ProActive is an modified version of the Neoss Bimodal Implant (K043195), Identical to K043195, the ProActive Implant is a threaded, internal abutment connection, root-form titanium dental implant. The ProActive assortment consists of a number of implants with a diameter of Ø3,5 to Ø5,5 mm and lengths between 7,0 - 19.0 mm having the same internal abutment dimension independent of implant diameter. The internal connection being equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. Supplied sterile.
The provided 510(k) summary for the Neoss ProActive Implant does not contain the detailed information requested regarding acceptance criteria and a study proving device performance as typically understood for AI/ML-based medical devices.
This submission is for a dental implant, which is a physical device, not a software or AI/ML diagnostic tool. Therefore, the traditional metrics of sensitivity, specificity, accuracy, and detailed ground truth generation processes that would be relevant for devices making diagnostic claims are not applicable or present in this type of submission.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Neoss Bimodal Implant K043195) due to a modification in the surface finish process. The performance is assessed through comparisons of physical characteristics and biological responses in animal models, rather than a clinical study with a human test set and expert adjudication.
Here's a breakdown of what is and is not available based on the provided text:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implied/General: | |
| Compliance to device specifications | All functions verified to operate as designed. |
| Safety and Effectiveness equivalent to predicate device (K043195) | Demonstrated through similar intended use, operating principle, basic device design, physical properties, and materials. |
| Increased strength of osseointegration when compared to machined surfaces (animal testing) | Exhibit an increase in the strength of osseointegration |
| Increased bone to implant contact when compared to grit-blasted surfaces (animal testing) | Exhibit an increased bone to implant contact |
Note: These are based on biological responses in animal testing and general performance verification, not metrics like sensitivity or specificity.
2. Sample size used for the test set and data provenance:
- The document mentions "animal testing" but does not specify the sample size, type of animals, or country of origin for these tests. This is a pre-clinical, non-human study.
- The study is retrospective in the sense that it's comparing a modified device to a previous one, but the specific animal tests themselves would be prospective experiments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for a physical dental implant's performance would be established through mechanical testing, material characterization, and biological response in animal models, not expert clinical interpretation of images or other data.
4. Adjudication method for the test set:
- Not applicable for this type of device.
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 physical dental implant, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical dental implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The closest concept to "ground truth" here would be the biological outcomes observed in animal models (e.g., strength of osseointegration, bone-to-implant contact) and engineering/material properties verified during performance testing.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The "development" of the device involves engineering design and pre-clinical testing.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided 510(k) pertains to a hardware modification (surface finish) of an existing dental implant. The safety and effectiveness data provided are based on pre-clinical animal testing and engineering verification, not clinical studies with human participants or the detailed performance metrics typically associated with AI/ML-based diagnostic devices.
§ 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.