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The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAM software, ceramic material, milling machine and associated tooling and accessories.

The intended use for the TiB narrow abutments used with the Ø3.0 mm External hex and Ø3.0 mm Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular lateral and central incisors.

The Narrow TIB Abutment bases are standard premanufactured titanium allov abutments for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The DC Ø3.0mm Narrow TiB abutments are only to be placed straight in the patient. Occlusal loading forces are only to be applied through the central longitudinal axis of the implant body.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of Zirconia, which is designed to fit the abutment base in order to restore chewing for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.

The subject Narrow TIB Abutments are compatible with the Southern Implants' Deep Conical and External Hex implants and screws. The subject TIB abutment bases are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by gold anodizing. The anodization process is the same as used for previously cleared anodized titanium alloy devices in K193084. The mesostructured restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K130991.

The digital workflow includes the following products (not subject devices to this submission):

• Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991)
• . Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• Intra-oral scanner ●
• . Lab scanner: 3Shape E3 Desktop Scanner (3Shape A/S)
• Abutment design software: 3Shape Abutment Designer Software (K151455) ●
• Milling machine: Roland DXW51D ●

This is a summary of the provided text regarding the TIB Abutments.

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

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding reported performance for the subject device. Instead, it demonstrates substantial equivalence by comparing the technological characteristics of the subject device (TIB Abutments) with primary and reference predicate devices. The implicit acceptance criterion is that the subject device's performance, as demonstrated by the listed tests and comparisons, is equivalent to the predicate devices.

Here's a table comparing the subject device's characteristics to the primary predicate, which serves as the basis for demonstrating equivalence:

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

The document primarily relies on non-clinical performance data for mechanical fatigue testing (ISO 14801).

• Sample size: The specific sample size for the dynamic fatigue testing is not provided in the summary. It states "Dynamic testing was performed on worst-case subject device constructs." This typically implies multiple samples were tested to statistical confidence.
• Data provenance: The document does not explicitly state the country of origin of the data for the performance tests, nor whether it was retrospective or prospective. Given that this is a 510(k) submission for a South African company, it is likely the testing was conducted at a certified lab, possibly in South Africa or internationally, to ISO standards. The type of testing (mechanical fatigue) is inherently prospective in its execution (i.e., new tests are run on new devices).

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)

This device is a physical dental implant component, not a diagnostic AI system or image analysis tool. Therefore, the concept of "ground truth" established by experts in the context of diagnostic accuracy or clinical interpretation is not applicable here. The "ground truth" for this device's performance is established by engineering tests and material science standards, such as ISO 14801 for mechanical fatigue.

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

Not applicable. This is not a diagnostic device involving human interpretation that would require an adjudication method.

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 physical dental implant component, not a diagnostic or AI-assisted device. No MRMC study was conducted or is relevant.

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-only device in the context of a diagnostic or interpretive tool. The "digital dentistry workflow" involves software (3Shape Abutment Designer Software) but it's for design and manufacturing, not standalone diagnostic performance. Software validation was referenced from K193084.

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

The "ground truth" for the TIB Abutments is based on:

• Compliance with material specifications (e.g., Titanium Grade 5 Alloy (ASTM F136), Zirconia - Sage Maxx NexxZr).
• Performance against international engineering standards (e.g., ISO 14801 for dynamic fatigue testing).
• Biocompatibility established through material equivalence to a predicate device with established biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

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

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