(64 days)
NEOPLANT Internal Hex Implant system is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
NEOBIOTECH Internal Hex Implant System(NEOPLANT) consists of two-stage, root-form tapered and straight walled threaded dental implant and associated abutment system, which provide the clinical with Screw-Retained(UCLA, Cement-on Crown), and overdenture Snap Abutments. The System also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauge, abutment drivers, ratch-type drivers, open end wrench, and hand-piece adapters. NEOBIOTECH implant system(NEOPLANT) is available with a S.L.A. roughened surface. All implants have an internal hexagon as a connection and as an anti-rotational feature for the prosthetics.
The provided text details a 510(k) summary for the NEOPLANT Implant System. However, it explicitly states that "Laboratory testing was conducted to determine device functionality and conformance to design input requirements" but does not provide any specific quantitative acceptance criteria or reported performance data from these tests.
Furthermore, this 510(k) is a Traditional 510(k) based on substantial equivalence to predicate devices, rather than a De Novo submission or a PMA, which would typically contain detailed clinical study data showcasing device performance against specific criteria. The submission largely focuses on comparing the NEOPLANT system to already approved predicate devices (3i Dental Implants) to demonstrate similar fundamental scientific technology, materials, and intended use.
Therefore, many of the requested details regarding acceptance criteria, study methodologies, and performance data are not available within the provided document.
Here is a summary of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|
| Functionality | "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." (No specific results provided.) |
| Conformance to design input requirements | "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." (No specific results provided.) |
Explanation: The document mentions that laboratory testing was conducted for functionality and conformance to design input requirements, but it does not specify what those design input requirements were, nor does it provide any quantitative results or acceptance thresholds. The primary basis for approval in this 510(k) is substantial equivalence to predicate devices, not meeting specific performance criteria demonstrated by new data.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample size for test set: Not applicable and not provided. This 510(k) relies on substantial equivalence to predicate devices, not on a clinical test set from a new study.
- Data provenance: Not applicable. The document refers to "laboratory testing" but does not specify the details of any data generated or where it originated, as it's not a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. There is no mention of a test set with human-established ground truth. The submission focuses on device characteristics and comparison to predicates.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring expert adjudication is described.
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) and not an AI/Software as a Medical Device (SaMD) that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. There is no mention of ground truth in the context of performance evaluation, as the submission relies on substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/machine learning model.
Conclusion:
The provided 510(k) summary for the NEOPLANT Implant System is a "Substantial Equivalence" submission. This type of submission aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive de novo performance data against specific acceptance criteria from clinical studies. While the document states "Laboratory testing was conducted to determine device functionality and conformance to design input requirements," it does not elaborate on the specific acceptance criteria, methodology, or the results of these tests. Therefore, most of the detailed information requested regarding study design, sample sizes, ground truth, and expert involvement is not present in this document.
§ 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.