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Inversa Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Inversa Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

Inversa implants are fully threaded, tapered, root-form dental implants with a design feature known as body shift, where the body design of the implant has a narrow, straight coronal portion with an increased maximum diameter midway down the length of the implant tapering toward the apex. The body of the implant includes two thread types (square and V-shaped) that transition in the middle of the implant body. Inversa implants have a platform that is inclined 12° to the long axis of the implants are made of unalloyed titanium and provided in two connection types (External Hex and Deep Conical).

External Hex Inversa implants are provided in three sizes: coronal diameter 3.5 mm with maximum apical diameter 4.5 mm; coronal diameter 3.5 mm with maximum apical diameter 5.0 mm; and coronal diameter 4.2 mm with maximum apical diameter 5.0 mm. Each size of the External Hex Inversa implant is provided in four lengths (11.5, 13, 15, and 18 mm).

Deep Conical Inversa implants are provided in three sizes: coronal diameter 3.6 mm with maximum apical diameter 4.5 mm; coronal diameter 3.6 mm with maximum apical diameter 5.0 mm; and coronal diameter 4.0 mm with maximum apical diameter 5.0 mm. Each size of the Deep Conical Inversa implant is provided in four lengths (11.5, 13, 15, and 18 mm).

Inversa implants are made from unalloyed titanium conforming to ASTM F67.

This document is a 510(k) summary for the "Inversa Implants" dental implant system, submitted to the FDA. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific performance acceptance criteria for a new AI/software device.

Therefore, many of the requested elements (e.g., acceptance criteria for device performance, sample sizes for test sets, expert involvement, MRMC study results, training set details) are not applicable or not found in this type of regulatory submission for a physical medical device like a dental implant.

The "Performance Data" section of this document refers to non-clinical tests for physical characteristics and safety, not for performance of a software/AI device.

Here's an attempt to extract relevant information and explain why other information is absent:

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

This document does not present a table of acceptance criteria and reported device performance in the way one would for a software or AI device. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and intended use.

The "Performance Data" section mentions the following non-clinical tests performed or referenced:

No clinical data were included in this submission. This means no human study was performed to "prove the device meets acceptance criteria" in a clinical setting.

2. Sample sizes used for the test set and the data provenance

• Sample Size for Test Set: Not applicable for this type of submission. The "test set" for a physical device like this refers to the samples of the device used for non-clinical bench testing (e.g., for mechanical strength, sterilization). The specific number of units tested for each non-clinical test (e.g., how many implants were tested for dynamic compression-bending) is not provided in this summary.
• Data Provenance: Not applicable. The data is primarily derived from bench testing (non-clinical) of prototype/production units and references to previously cleared predicate devices (K163634, K163060, K030463, K053478, K070841, K093562). The manufacturer is Southern Implants (Pty) Ltd., based in Irene, Gauteng, South Africa.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a submission for a diagnostic AI/software device that requires ground truth established by medical experts. The "ground truth" for a dental implant's performance would be engineering specifications and physical test results, not expert consensus on images.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert readings/assessments.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. This type of study is typically done for diagnostic imaging devices/software to evaluate human reader performance with and without AI assistance. This submission is for a physical dental implant.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" would be the physical and chemical properties of the materials and the mechanical performance consistent with engineering standards (e.g., ISO 14801 for dynamic compression-bending). For the regulatory submission, the primary "ground truth" is the demonstration of substantial equivalence to existing, legally marketed predicate devices based on design, materials, and intended use.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device submission.

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

Not applicable, as there is no training set for an AI/machine learning model.

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