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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. The GM Easy Pack System is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

• Intended for single use;
• The subject GM Helix Implants are available in diameters of 3.5, 3.75, 4.0 and 4.3 mm and in heights of 8, 10, 11.5 and 13 mm;
• The subject GM Smart Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm. The GM Smart Abutments can be customized respecting a minimum post height of 4 mm. The GM Smart Abutments are being presented for the first time for FDA's evaluation;
• . All digitally designed copings and/or crowns to be used with the GM Smart Abutments are intended to be sent to Straumann for manufacture at a validated milling center;
• . The subject GM Healing Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm;
• . Implant and Cover Screw delivered sterile via Gamma Radiation;
• Sterile Abutments provided sterile via Ethylene Oxide;
• The subject implant is manufactured of unalloyed titanium grade 4, according to ASTM F67;
• . The GM Cover Screw, GM Smart Abutment, GM Healing Abutment and the Removable Screw are manufactured in titanium alloy Ti6Al4V-ELI according to ASTM F136;
• The GM Helix Implants, Acqua and Neoporos, the GM Cover Screw and the Healings subject of this submission are exactly the same devices already cleared to market per K163194;
• . The GM Smart abutments, subject of this submission, are new abutments being introduced in this premarket notification;
• . The implant to abutment interface is a Grand Morse (GM) connection.

The provided document is a 510(k) premarket notification for a dental implant system. It does not describe a study involving an AI/Machine Learning (AI/ML) device, nor does it present acceptance criteria or performance data for such a device.

The document discusses the substantial equivalence of the Neodent Implant System - Easy Pack to previously cleared predicate devices (K163194, K191191, K182620, K193592). The data presented is related to the physical and biological characteristics of the dental implants and abutments.

Therefore, I cannot extract the information required in your request regarding acceptance criteria and performance data for an AI/ML device, as the document does not pertain to such a device. All the acceptance criteria mentioned and the "results" describe testing for traditional medical device characteristics such as sterilization, shelf life, biocompatibility, pyrogenicity, MRI compatibility, and mechanical properties (torsion, insertion) of the implants and abutments.

Specifically, points 2 through 9 of your request are not applicable to the content of this document, as they relate to AI/ML device studies (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance).

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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.

• Intended for single use;
• Provided sterile via gamma irradiation;
• Manufactured of commercially pure titanium (Ti) grade 4 per ASTM F67;
• Morse Taper prosthetic interface with internal hexagonal indexer, exclusively from the Grand Morse (GM) line;
• Body center and apex with conical format;
• Trapezoidal-profile double threads;
• Rounded apex end;
• Available in Neoporos and Acqua surfaces;
• Ø7.0 mm and 8, 10, 11.5, and 13 mm lengths;
• The subject devices are compatible with all the abutments of the Neodent Implant System that present the GM implant to abutment interface, previously cleared per K163194, K173902, K180536, K191191, and K1922229.

This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Neodent Implant System - GM Helix Implants 7.0. It aims to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the provided text, the device is a dental implant. The concept of acceptance criteria and performance related to the AI/ML device is not applicable here. The document describes different types of testing for device safety and effectiveness.

Here's a breakdown of the requested information based on the document:

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

Please note that this document is for a medical device (dental implant), not an AI/ML device. Therefore, the "acceptance criteria" and "device performance" are related to mechanical, biological, and sterilization aspects, not AI performance metrics like accuracy, sensitivity, or specificity.

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 does not specify exact sample sizes for each test mentioned (biocompatibility, mechanical testing, sterilization validation, shelf life validation). It refers to "representative samples" for endotoxin testing and indicates that tests were "performed" (e.g., dynamic fatigue test per ISO 14801). The "data provenance" is not explicitly stated in terms of country of origin or retrospective/prospective studies for these specific tests. However, the sponsor is JJGC Indústria e Comércio de Materiais Dentários S.A. (dba Neodent) located in Curitiba, Parana, Brazil. The regulatory contact is in Andover, Massachusetts, USA.

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 question is not applicable as the document describes a medical device, not an AI/ML diagnostic system requiring expert interpretation for ground truth establishment. The document relies on established international standards (ISO, ASTM, USP) and FDA guidance for evaluating the physical, chemical, and biological properties of the dental implant. Expert roles would be in the design, testing, and regulatory review processes, but not in establishing "ground truth" in the diagnostic sense.

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

Not applicable. This concept is relevant for AI/ML diagnostic studies where multiple readers interpret cases and their discrepancies are resolved. The document focuses on laboratory and material testing of a physical 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 510(k) submission for a physical medical device (dental implant), not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related comparative effectiveness analysis with human readers would have been performed or reported here.

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

Not applicable. This relates to AI/ML device performance. The described device is a physical dental implant.

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

Not applicable. For this type of physical device, "ground truth" is established by adherence to recognized standards and validated test methods (e.g., ISO 10993 for biocompatibility, ISO 14801 for mechanical fatigue, ISO 11137 for sterilization) rather than expert consensus on diagnostic images or pathology. The "truth" is whether the device meets the physical and biological specifications under test conditions.

8. The sample size for the training set

Not applicable. The concept of a "training set" refers to data used to train an AI/ML model. This document describes the validation of a physical medical device.

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

Not applicable (as above).

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