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The Neoss Access Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.

Neoss Access Abutments represent a two piece abutment system and are designed to be connected to the Neoss implants, to receive another abutment or framework and intended for use as an aid in multiple-unit prosthetic rehabilitation such as dental bridge restorations.

The internal connection of the Neoss Access Abutment provides a solution with a minimum height of the complete prosthesis of 5 mm and allows an overall implant alignment of up to 60 degrees without restraining the fabrication of a multiple-unit screw-retained restoration.

The angulated 10°, 20° and 30° abutments are intended for multi-unit cases in order to improve the position of the screw access hole.

Restorations can be based on Neolinks being incorporated into gold or ceramic frameworks, or solid titanium and ceramics frameworks. The frameworks are then tightened with prosthetic screws onto the Neoss Access Abutments.

The Neoss Access Abutments are dental abutments.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document mentions "performed testing" but does not detail the number of units tested.
• Data Provenance: Not explicitly stated. Given that the manufacturer is Neoss Ltd (UK) and the submission is to the FDA (USA), the testing was likely conducted in a controlled laboratory environment, but the location of the lab or the origin of any materials used is not specified. It is a prospective test specifically for regulatory submission.

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

• Number of Experts: Not applicable. This device is a physical dental abutment, and its performance is assessed against engineering and material requirements, not against human expert interpretation of data.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. Performance testing of a physical device against engineering standards typically involves direct measurement and comparison to predefined thresholds, not a multi-expert adjudication process.

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:

• MRMC Study: No. This is a physical medical device (dental abutment), not an AI/software device. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Ground Truth: The "ground truth" for this device's performance is established by the "recommended requirements" outlined in the "Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004." These requirements specify the mechanical, material, and biocompatibility properties the abutment must meet.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by engineering principles, material science, and previous product development, but not a data-driven training set.

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

• Ground Truth for Training Set: Not applicable. (See point 8).

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The Neoss ProActive Implant is for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neoss ProActive Implant is intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

The Neoss ProActive is an modified version of the Neoss Bimodal Implant (K043195), Identical to K043195, the ProActive Implant is a threaded, internal abutment connection, root-form titanium dental implant. The ProActive assortment consists of a number of implants with a diameter of Ø3,5 to Ø5,5 mm and lengths between 7,0 - 19.0 mm having the same internal abutment dimension independent of implant diameter. The internal connection being equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. Supplied sterile.

The provided 510(k) summary for the Neoss ProActive Implant does not contain the detailed information requested regarding acceptance criteria and a study proving device performance as typically understood for AI/ML-based medical devices.

This submission is for a dental implant, which is a physical device, not a software or AI/ML diagnostic tool. Therefore, the traditional metrics of sensitivity, specificity, accuracy, and detailed ground truth generation processes that would be relevant for devices making diagnostic claims are not applicable or present in this type of submission.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Neoss Bimodal Implant K043195) due to a modification in the surface finish process. The performance is assessed through comparisons of physical characteristics and biological responses in animal models, rather than a clinical study with a human test set and expert adjudication.

Here's a breakdown of what is and is not available based on the provided text:

1. Table of acceptance criteria and reported device performance:

Note: These are based on biological responses in animal testing and general performance verification, not metrics like sensitivity or specificity.

2. Sample size used for the test set and data provenance:

• The document mentions "animal testing" but does not specify the sample size, type of animals, or country of origin for these tests. This is a pre-clinical, non-human study.
• The study is retrospective in the sense that it's comparing a modified device to a previous one, but the specific animal tests themselves would be prospective experiments.

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

• This is not applicable as the "ground truth" for a physical dental implant's performance would be established through mechanical testing, material characterization, and biological response in animal models, not expert clinical interpretation of images or other data.

4. Adjudication method for the test set:

• Not applicable for this type of device.

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, not an AI/ML diagnostic tool.

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

• Not applicable. This is a physical dental implant.

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

• The closest concept to "ground truth" here would be the biological outcomes observed in animal models (e.g., strength of osseointegration, bone-to-implant contact) and engineering/material properties verified during performance testing.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set. The "development" of the device involves engineering design and pre-clinical testing.

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

• Not applicable.

In summary: The provided 510(k) pertains to a hardware modification (surface finish) of an existing dental implant. The safety and effectiveness data provided are based on pre-clinical animal testing and engineering verification, not clinical studies with human participants or the detailed performance metrics typically associated with AI/ML-based diagnostic devices.

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