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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:

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.

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