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The Atlas Implant System - Wide Plus is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Also, there are no angled abutments intended to be used with this system. Smaller (e 4.5, e 5.5) implants are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger (o 6.0 to o 8.0) implants are dedicated for the molar region and not indicated for immediate loading.

The Atlas Implant System - Wide Plus is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

This is a 510(k) premarket notification for a medical device called the "Atlas Implant System - Wide Plus," which is an endosseous dental implant. The document states that the device is "substantially equivalent" to predicate devices already on the market, meaning no new clinical studies are typically required to demonstrate safety and effectiveness for substantial equivalence.

Therefore, the provided document does not contain any information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way you've described (e.g., performance metrics like sensitivity, specificity, or clinical outcomes from a trial).

Here's why and what information can be extracted/inferred:

Reason for lack of information:

• Substantial Equivalence (510(k)): The 510(k) pathway for medical device clearance in the US primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing design, materials, indications for use, and performance characteristics (often mechanical or biocompatibility testing), but does not typically require prospective clinical trials with performance metrics like those seen in software or diagnostic device submissions.
• Device Type: Endosseous dental implants are mechanical devices. Their "performance" is generally assessed through mechanical properties (strength, fatigue), biocompatibility, and integration with bone, rather than diagnostic accuracy or predictive power that would have metrics like sensitivity/specificity.

Based on the provided text, the following points apply:

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

   • Not available. The document does not specify quantitative acceptance criteria or detailed performance results in the context of comparative effectiveness or diagnostic accuracy. The "performance characteristics" mentioned are likely related to mechanical and material properties compared to predicates, but these are not disclosed in detail.

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

   • Not applicable/Not available. Since no clinical study or test set for performance evaluation (e.g., diagnostic accuracy) is mentioned, this information is not provided.

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/Not available. No ground truth establishment related to a test set is discussed.

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

   • Not applicable/Not available. No test set or adjudication method is described.

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:

   • No. This is a hardware device (dental implant), not an AI/software device. Therefore, an MRMC study with human readers and AI assistance is not relevant or reported.

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

   • No. This is a hardware device, not an algorithm.

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

   • Not applicable/Not available. No ground truth definition for a performance study is provided. For this type of device, "ground truth" might refer to successful osseointegration or long-term clinical success, but no study is detailed.

8. The sample size for the training set:

   • Not applicable/Not available. As this is not an AI/machine learning device, there is no training set in that context.

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

   • Not applicable/Not available. No training set is described.

In summary: The provided 510(k) summary for the "Atlas Implant System - Wide Plus" demonstrates its substantial equivalence to predicate devices based on design, materials (TI6A1-4V ELI alloy), indications for use, and performance characteristics (which are not detailed but are assumed to be mechanical and biocompatibility data typical for such devices). It does not present a clinical study with acceptance criteria and results in the manner typically expected for diagnostic or AI-powered devices.

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