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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Titamax WS implant is indicated for a delayed loading protocol.

The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

The Neodent Implant System implants included in this submission are threaded, self-tapping, root form, endosseous dental implants with a Morse taper abutment interface. They are designed to provide support for prosthetic teeth to restore chewing function. They are made of commercially pure titanium or titanium alloy, with a surface that is grit blasted and acid etched. In addition, multiple abutments made of titanium alloy are provided for each implant for both cement-retained and screw-retained prostheses. The CM Drive implant comes in three diameters (3.5, 4.3 and 5.0 mm), each in five lengths (8.0, 10.0, 11.5, 13.0, and 16.0 mm). The Titamax WS implant design comes in three diameters (4.0, 5.0, and 6.0 mm) with corresponding platform diameters. The 4.0 mm diameter Titamax WS implant comes in one length (6.0 mm). The 5.0 and 6.0 mm diameter Titamax WS implants come in two lengths (5.0 and 6.0 mm). The Facility implant design comes in one diameter (2.9 mm), and in five lengths (8, 10, 12, 14, and 16 mm). All abutments included in this submission are straight and have a Morse taper connection.

The provided 510(k) summary for the Neodent Implant System does not contain information related to acceptance criteria or a study proving device performance against such criteria.

The document is a premarket notification for a medical device (dental implants). It focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving performance against specific acceptance criteria through a clinical study or benchmark performance testing with ground truth.

Therefore, many of the requested elements cannot be extracted from this document, as they are not present in a "substantial equivalence" submission for this type of device.

Here's an breakdown of what can be stated based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance

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. No clinical or performance test data on a "test set" are presented.
• Data Provenance: Not applicable. The submission explicitly states: "Clinical data were not submitted in this premarket notification." The non-clinical data mentioned (engineering analysis, dimensional analysis, comparative surface area analysis) would not typically involve a "test set" in the sense of patient data.

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. As no clinical or performance test data are presented, there is no "ground truth" established by experts for a test set in this submission.

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

• Not applicable. No test set requiring adjudication is mentioned.

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 submission for a physical medical device (dental implants), not an AI diagnostic tool. No MRMC study was done, nor is AI assistance relevant to this device.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable. No performance data requiring ground truth ascertainment is presented. The submission relies on "substantial equivalence" based on design, materials, and non-clinical characteristics (engineering, dimensional analysis) comparing the new device to existing predicate devices.

8. The sample size for the training set

• Not applicable. As no machine learning or AI model is involved, there is no "training set."

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

• Not applicable. No machine learning or AI model is involved, so no training set or ground truth for it was established.

Summary based on the provided document:

The 510(k) summary for the Neodent Implant System explicitly states: "Clinical data were not submitted in this premarket notification." The submission focuses on demonstrating that the new components of the Neodent Implant System are "substantially equivalent" to predicate devices already cleared for market. This equivalence is based on:

• Identical intended use.
• Similar design, identical material, and identical surface to a previously cleared Neodent system (K101945).
• Similar indications, design, and dimensions to other predicate devices for the new Titamax WS and Facility implants.
• Non-clinical data including engineering analysis, dimensional analysis, and comparative surface area analysis.

The conclusion drawn is that "The device is safe and effective for its intended use and performs as well as or better than the predicate devices," based on the comparison of an existing cleared device characteristics rather than new performance data against specific acceptance criteria.

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