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The Inventus Implant System is a series of titanium endosseous dental implants and accessories for surgical implantation in the upper and/or lower jaw. It is intended to artificially provide a root structure to support prosthetic devices, such as artificial teeth, in order to restore the chewing function of the patient.

The Inventus Implant System consists of a series of root-form endosseous dental fixtures (implant) and accessories designed to support single or multiple restorations. The implants and abutments are manufactured from titanium, conforming to ASTM F67, and the screws are manufactured from titanium alloy, conforming to ASTM F136. The implants are available in @3.3mm, @3.75mm, Φ4.0mm, Φ5.5mm and Φ6.0mm diameters and vary in length from 9.0mm to 18.3mm. For optimal osseointegration, the implant surfaces are treated with resorbable blast media (RBM) incorporating hydroxylapatite (HA) powder.

The provided document is a 510(k) summary for the Inventus Implant System, which is a dental implant system. This type of regulatory submission in the medical device industry focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as would be seen for novel high-risk devices.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies that would typically be found in a submission for a diagnostic or AI-driven device.

Here's why the requested information is absent and what the document does provide in lieu of a performance study:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable. This document is a 510(k) submission for a physical medical device (dental implant system). It does not present performance metrics, sensitivity, specificity, accuracy, or other statistical measures typically associated with diagnostic software or AI-driven devices. The "performance" in this context refers to the design and material properties being substantially equivalent to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. No test sets or data provenance are mentioned, as the submission relies on demonstrating equivalence in design, materials, and intended use.

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. Ground truth establishment is not relevant for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. Adjudication methods are not discussed.

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:

• No. This is not an AI-driven device, and therefore, no MRMC study or AI-assistance evaluation was conducted or is relevant.

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

• No. This is a physical dental implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. Ground truth is not established for this device as it's not a diagnostic or AI-driven system.

8. The sample size for the training set:

• Not Applicable. No training sets are mentioned, as this is not a learning algorithm.

9. How the ground truth for the training set was established:

• Not Applicable. No ground truth for training is relevant.

Summary of the Study/Basis for Approval (from the document):

Instead of a clinical study, the submission relies on demonstrating Substantial Equivalence to legally marketed predicate devices.

• The "study" in this context is a comparison of the Inventus Implant System with two predicate devices:

  • The Maestro™ System, BioHorizons Implant Systems, Inc., K010458
  • US System, Osstem Implant Co., Ltd., K062030

• The "criteria for acceptance" is that the Inventus Implant System is "substantially equivalent in terms of safety and effectiveness to the predicate devices identified above" based on:

  • Intended use
  • Design
  • Technology
  • Material composition (titanium conforming to ASTM F67 and F136)
  • Performance (implied to be equivalent due to similar design and materials, including RBM with HA surface treatment for osseointegration)

• Evidence presented: This document provides details about the Inventus Implant System's materials, dimensions, and surface treatment, and explicitly states that it is "similar to other legally marketed devices based on the intended use, design, technology, material composition and performance."

In a 510(k) for a device like a dental implant, the "study" demonstrating performance typically involves:

• Bench testing: Mechanical strength, fatigue, connection integrity, etc. (though specific results are not detailed in this summary).
• Biocompatibility testing: To ensure the materials are safe for human implantation.
• Comparison to predicate devices: Demonstrating that the new device shares fundamental scientific technology with a cleared predicate, and any differences do not raise new questions of safety or effectiveness.

The document concludes that based on this comparison, the Inventus Implant System is substantially equivalent.

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