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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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The Atlas Implant System - Mini Plus is intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

The Atlas Implant System - Mini 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.

The provided text describes the "Atlas Implant System - Mini Plus" dental implant. The performance data section states:

"All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004, mechanical testing of the implants demonstrated that the Atlas Implant System - Mini Plus possess mechanical strength at least equivalent to the predicate devices."

This sentence indicates that the acceptance criteria for the device's performance are based on mechanical strength at least equivalent to the predicate devices, as determined by mechanical testing consistent with the referenced FDA guidance document. The study proving this involved mechanical testing of the Atlas Implant System - Mini Plus.

However, the provided document does not contain the specific details required for the table or other requested information. It functions as a summary of a 510(k) submission, confirming substantial equivalence, but it does not include the raw data, specific test results, detailed acceptance limits, or methodological specifics of the performance study beyond the type of test (mechanical) and the comparison to predicate devices.

Therefore, many of the requested fields cannot be accurately populated from the provided text.

Here's how much of the information can be extracted or inferred based on common 510(k) practices for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. Mechanical testing for dental implants typically involves a statistically relevant number of samples to ensure robust results, but the exact number is not included in this summary.
• Data Provenance: Not specified, but likely from laboratory testing conducted by or for the manufacturer (Cowellmedi Co., Ltd.). Origin country (South Korea) could be inferred for where the manufacturer is located, but not explicitly for the test data itself. Retrospective or prospective is not applicable for this type of mechanical testing.

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

• This question is not applicable as the "ground truth" for mechanical testing is based on objective physical measurements and engineering standards, not expert clinical assessment.

4. Adjudication method for the test set

• This question is not applicable for mechanical testing. Adjudication is used for subjective assessments, typically in clinical studies or image interpretations.

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

• This question is not applicable. The device is a physical dental implant, not an AI or imaging diagnostic tool.

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

• This question is not applicable. The device is a physical dental implant, not an algorithm.

7. The type of ground truth used

• For mechanical testing, the "ground truth" is established by objective physical measurements against predefined engineering standards and comparison with established performance of predicate devices, following the FDA guidance. It is not based on expert consensus, pathology, or outcomes data in the usual sense for this type of performance evaluation.

8. The sample size for the training set

• This question is not applicable as the device is a physical dental implant, not a machine learning model requiring a training set.

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

• This question is not applicable for the same reason as above.

Summary of what can be definitively stated from the text:

• Acceptance Criteria: Mechanical strength at least equivalent to predicate devices.
• Study Type: Mechanical testing of implants.
• Proof: The mechanical testing demonstrated the device possesses mechanical strength at least equivalent to the predicate devices.
• Predicate Devices: Intermezzo™ Implant System (K051018), IMTEC Sendax MDI and MDI Plus (K031106), Maximus™ OS Implant (K041938).
• Guidance Followed: FDA guidance document "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004."

The document focuses on establishing substantial equivalence to legally marketed predicate devices, which is common for 510(k) submissions. It confirms that the necessary performance data (in this case, mechanical testing) was provided and met the standards for equivalence, but it does not detail the specifics of that data as would be found in a full study report.

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Atlas Implant Systems are designed for use in dental implant surgery. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including, cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. They are not intended for use of immediate loading.

The Atlas Implant System includes a variety of precision-machined fixtures manufactured from titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a replacement for a patient's tooth root providing a stable foundation for restorations.

The provided document, K071148, is a 510(k) Pre-market Notification for the Atlas Implant System. This type of submission focuses on proving substantial equivalence to a predicate device rather than undergoing a de novo clinical trial with comprehensive acceptance criteria and detailed performance studies typical of AI/software medical devices.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in the context of an AI/software medical device.

Specifically, the document states:

• 14-8. Performance: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This refers to mechanical and material testing of a physical implant, not a software algorithm's performance.
• No mention of sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

The document discusses substantial equivalence for a dental implant, comparing its physical and material characteristics (e.g., material, design, dimensions, surface treatment) to a predicate device (ALLFIM IMPLANT SYSTEM K050635). The "acceptance criteria" for a 510(k) for a physical implant like this are primarily about demonstrating that it is as safe and effective as a legally marketed predicate device, typically through bench testing and comparison of technical specifications, not through clinical performance metrics against a defined ground truth.

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