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The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The Tapered Screw-Vent Implant, 4.1mm is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with double-lead threads.

I am sorry, but the provided text describes a 510(k) summary for a dental implant (Tapered Screw-Vent Implant, 4.1mmD) and does not contain information about studies related to acceptance criteria or performance of an AI/ML device.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study
6. Standalone performance study
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document focuses on the substantial equivalence of a modified dental implant to a predicate device, as required for a 510(k) submission to the FDA.

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The Tapered Screw-Vent®, Screw-Vent®, AdVent®, and Zimmer® One-Piece 3.7 mm Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Zimmer One-Piece 3.7 mm implants are limited to restorations (immediately loaded or loaded after a conventional healing period) in the premolar, cuspid, and incisor regions of partially edentulous jaws.

The purpose of this submission is to add an immediate loading single tooth indication to the following implants systems previously cleared by FDA: Tapered Screw-Vent, Screw-Vent (K013227), AdVent (K011245) and Zimmer One-Piece 3.7 mm (K052997). These implants are titanium alloy, self-tapping implants that incorporate either the MTX or MP-1 surface. There is no significant difference in design or materials between the implants in this submission and the previously cleared implants from Zimmer Dental.

The provided document describes the 510(k) premarket notification for the Zimmer Dental Implants - Immediate Loading Indication. It is primarily a declaration of substantial equivalence to previously cleared devices, rather than a detailed study demonstrating performance against specific acceptance criteria for a novel device.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be fully extracted from this document, as it focuses on demonstrating equivalence rather than a de novo performance study.

Here's what can be inferred and what cannot:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The basis for clearance is substantial equivalence to predicate devices. The "performance" reported is that the "Zimmer Dental Implants - Immediate Loading Indication have the following similarities to the predicate devices":

• Same intended use
• Same operating principle
• Same basic design
• Same materials
• Packaged and sterilized using the same materials and processes.

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

Not applicable. This is a 510(k) for substantial equivalence based on product design and material similarities to previously cleared devices, not a performance study with a test set of 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. There is no mention of a test set requiring expert ground truth establishment.

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

Not applicable. There is no mention of a test set or 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

Not applicable. This is not an AI/software device, and no MRMC study is mentioned.

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

Not applicable. This is a medical device (dental implants), not an algorithm.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices based on their design, materials, and intended use.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a learning algorithm or a study requiring data collection for training.

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

Not applicable. See point 8.

Summary based on the provided document:

The Zimmer Dental Implants - Immediate Loading Indication received 510(k) clearance by demonstrating substantial equivalence to legally marketed predicate devices (Tapered Screw-Vent, Screw-Vent, AdVent, and Zimmer One-Piece 3.7 mm Implants, and Nobel Biocare TiUnite Dental Implants).

The "acceptance criteria" and "performance" described are qualitative similarities in:

• Intended use
• Operating principle
• Basic design
• Materials
• Packaging and sterilization methods

No specific clinical studies with defined quantitative acceptance criteria, test sets, or expert evaluations are detailed in this 510(k) summary for the immediate loading indication, as the submission relies on the established safety and effectiveness of the predicate devices.

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The ScrewVent and Tapered ScrewVent implants are intended for surgical implantation in edentulous or partially edentulous mandibles or maxillae for attachment of complete In countilious of partially or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.

In patients with an edentulous mandible, ScrewVent and Tapered ScrewVent implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.

ScrewVent and Tapered ScrewVent implants are screw type implants made from titanium alloy. They have the same surfaces as currently available Sulzer Dental implants. The implants are all provided sterile.

This document is a 510(k) Pre-market Notification for a dental implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the new device. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of algorithmic performance metrics (like sensitivity, specificity, etc.) is not applicable or available in this submission.

Here's a breakdown based on the provided text, addressing what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not outline specific performance acceptance criteria for the ScrewVent® and Tapered ScrewVent® implants in the way one would for an AI/ML device (e.g., sensitivity, specificity, F1-score). Instead, the "acceptance criteria" for a 510(k) submission like this are met by demonstrating substantial equivalence to predicate devices.

The "performance" is implicitly demonstrated through the comparison of technological characteristics and intended use, asserting that the new device performs similarly to or no worse than the predicate devices for their stated intended uses.

Note: The "acceptance criteria" here are not numerical thresholds for performance metrics but rather a demonstration of similarity in design and function to legally marketed devices, ensuring safety and effectiveness are maintained.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical "test set" in the context of an AI/ML device. It is a 510(k) submission for a physical medical device (dental implants). Therefore, concepts like "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable.

The "comparison" is based on the technical specifications and intended uses of previously cleared predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable to a 510(k) submission for a dental implant. There is no "ground truth" establishment by experts in the context of a dataset for algorithmic evaluation. The safety and effectiveness are established through material compatibility, mechanical testing (which is not detailed here but implied by substantial equivalence), and historical clinical use of similar devices.

4. Adjudication Method for the Test Set

Not applicable. There is no test set adjudication for a physical dental implant in this type of submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance. This document concerns a physical dental implant and therefore an MRMC study was not conducted or is not relevant to this submission.

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

No. This is not an AI/ML device.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI performance evaluation (e.g., pathology, outcomes data for diagnostic accuracy) is not directly applicable here.

For a physical device like a dental implant, the "ground truth" for its safety and effectiveness is established through:

• Established clinical practice and long-term outcomes of very similar predicate devices.
• Material properties and biocompatibility testing (implied, not detailed).
• Mechanical performance such as strength, fatigue, and interface stability (implied, not detailed).
• Adherence to recognized standards (implied).

The document states, "There have been no modifications to the ScrewVent and Tapered ScrewVent implants. There has been no change to the implant materials or to the implant/abutment interface." This statement and the comparison table are the primary "evidence" presented for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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