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The Zygomatic implant is intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in patients with fully or partially edentulous maxillae.

The Zygomatic implant is intended to be implanted in the upper jay arch to provide support for fixed or removable dental prostheses in patients with fully or partially edentulous maxillae.

The provided document details a 510(k) premarket notification for a Zygomatic Implant System, focusing on demonstrating substantial equivalence to predicate devices rather than proving new efficacy. Therefore, much of the information typically found in acceptance criteria for AI/ML devices or clinical trials (e.g., performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert qualifications, MRMC studies) is not present in this medical device submission.

This document describes a traditional medical device (dental implant), not an AI/ML device. The "acceptance criteria" here relate to engineering performance and biocompatibility standards rather than diagnostic accuracy.

Here's a breakdown of the available information, noting the absence of AI/ML-specific criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on meeting established international standards for material, manufacturing, sterilization, packaging, and mechanical performance (fatigue). The 'reported device performance' is that the device meets these standards and is technologically comparable to predicate devices.

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • For Fatigue Studies: "Fatigue studies were conducted... Testing revealed a stable screw joint at the highest forces tested." The exact number of devices tested is not specified in this summary.
  • For SEM Testing: "a sample implant is sent for SEM testing four times a year." This implies a very small, ongoing sample, not a large test set for a single study.
  • For Visual Inspection: "Each and every implant is visually inspected under a microscope after surface enhancement." This is 100% inspection during manufacturing, not a formal test set for a study.
  • For Packaging Validation: The standards referenced (e.g., ASTM D 4169-08) outline specific testing protocols which would involve a sample of packaged products, but the sample size itself is not stated in this document.
• Data Provenance: All studies described (fatigue, surface modification checks, packaging validation) appear to be prospective tests conducted by Southern Implants, Inc. as part of their device development and manufacturing quality control. There is no indication of country of origin for the data beyond being generated by the submitter (Southern Implants, Inc., Irvine, CA, USA).

3. Number of Experts and Qualifications for Ground Truth

• This submission does not involve establishing ground truth from expert interpretation in the way an AI/ML diagnostic device would. There are no radiologists or other clinicians involved in creating a "ground truth" for diagnostic performance.
• The 'ground truth' here is essentially objective compliance with engineering standards and material specifications, verified through laboratory testing and manufacturing protocols by technical personnel.

4. Adjudication Method for the Test Set

• Not applicable. There is no expert adjudication process described, as this is a physical medical device proven through engineering tests and comparison to existing devices, not by diagnostic interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation, often with AI assistance), which this implant is not.
• The study performed was a comparison of technological characteristics and engineering performance (e.g., fatigue) against established standards and predicate devices.

6. Standalone (Algorithm Only) Performance Study

• No, this is not applicable. This device is a physical dental implant, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on:
  • Objective Engineering Standards & Specifications: Compliance of materials (ASTM Grade IV Titanium), sterilization parameters (Co60 dose, SAL), packaging integrity (numerous ASTM, EN, ISO standards), and mechanical performance (ISO 14801: 2007(E) for fatigue).
  • Manufacturing Quality Control: Visual inspection, SEM testing for surface modification.
  • Benchmarking/Comparison: Demonstration of comparable technological characteristics to legally marketed predicate devices.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set. The "training" in a manufacturing context would relate to process validation and operator training, not data used to develop an algorithm.

9. How Ground Truth for the Training Set was Established

• Not applicable, as there is no training set for an algorithm.

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The 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. This implant is not intended, nor should it be used, in conjunction with an angled abutment.

The 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. This implant is not intended, nor should it be used, in conjunction with an angled abutment. The physical properties and designs of the additional implants and accessories in the NSI Hexed and Non-Hexed Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable.

The provided text is a 510(k) Premarket Notification Summary for a dental implant system. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data with specific acceptance criteria as you might see for a novel drug or a high-risk device.

Based on the document, here's an analysis of the requested information:

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

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 primarily discusses engineering studies (fatigue testing). It does not specify a "test set" in the context of human subjects or clinical data.

• Sample Size: Not specified for engineering studies, but typically these involve a defined number of devices tested to destruction or specific load cycles.
• Data Provenance: Not applicable in the context of clinical data for this submission. The engineering studies were conducted under ISO standards, implying a controlled laboratory environment.

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. This 510(k) submission did not involve clinical studies or expert-driven ground truth establishment in the way you'd expect for an AI diagnostic device. The evaluation relied on engineering testing and comparison to predicate devices, which is typically overseen by engineers and regulatory specialists.

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

Not applicable. No clinical test set or expert adjudication process was performed for this 510(k) submission.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "Brief Discussion of Clinical Studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." This device is a physical implant, not an AI-assisted diagnostic tool.

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

No, a standalone performance study was not done. This device is a physical implant, not an algorithm.

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

The concept of "ground truth" as it relates to expert consensus or pathology is not applicable here. The primary "truth" established for this device was:

• Material properties: Measured against ASTM standards.
• Mechanical performance: Measured against ISO 14801:2003 (E) for fatigue, demonstrating physical stability.
• Technological characteristics and intended use: Established by comparison to existing legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device (dental implant) and does not involve AI or machine learning models that require a training set.

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

Not applicable. As above, no training set was used.

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The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The NSI MAX Implant System is intended for implantation in the maxilla or mandibular molar region where bone exists and the surgeon has determined a wider implant would increase the probability of placement of a narrow implant, or increased surgical procedures leading to complications. This MAX implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It also adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The provided document is a 510(k) premarket notification for an Endosseous Dental Implant System. It does not describe acceptance criteria for an AI-powered device, nor does it detail a study proving such a device meets acceptance criteria.

Instead, this document focuses on demonstrating substantial equivalence of a dental implant system to previously marketed predicate devices. Key aspects covered are:

• Device Description and Intended Use: The NSI Implant System for supporting dental prostheses in the upper or lower jaw, with an option for immediate loading.
• Performance Standards: There is no FDA performance standard for endosseous implants. The materials used meet applicable voluntary standards (ASTM F67-95 Grade III or IV Titanium).
• Sterilization Methods: Achieved using Co60 irradiation, validated against ISO 11137, ISO 11737-2, and ISO 13409.
• Packaging Method and Validation: Packaging involves plastic tubing, blister packs, and clear plastic boxes, validated against various ASTM, EN, and ISO standards related to performance testing, seal strength, leak detection, accelerated aging, and general requirements for sterile medical device packaging.
• Technological Characteristics: Compared with predicate devices and found to be comparable.
• Surface Modifications: Blasted with 100 micron alumina particles, with visual inspection and SEM testing.
• Clinical Studies: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." This explicitly states that no clinical performance study was performed or considered necessary to establish substantial equivalence for this particular submission.

Therefore, since the request is about an AI-powered device and the provided document describes a physical medical device (dental implant) and explicitly states no clinical studies were conducted, I cannot provide the requested information about acceptance criteria and a study proving an AI device's performance based on this document.

The document does not contain any information about:

• Acceptance criteria for an AI device.
• Reported device performance for an AI device.
• Sample size for a test set or data provenance for an AI device.
• Number of experts or their qualifications for establishing ground truth for an AI device.
• Adjudication methods for an AI device's test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone AI algorithm performance.
• Type of ground truth used for AI.
• Sample size or ground truth establishment for a training set for AI.

Ask a specific question about this device

The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The 4.0 co-axis implant is not intended, nor should it be used, in conjunction with an angled abutment.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Endosseous Dental Implant System (K070841).

It's important to note that this document is a 510(k) Premarket Notification Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than strictly proving performance against pre-defined acceptance criteria through a clinical trial. Therefore, the "acceptance criteria" here are generally related to compliance with standards and demonstration of comparable performance to predicate devices, rather than specific sensitivity/specificity metrics.

Acceptance Criteria and Reported Device Performance

The submission relies on demonstrating substantial equivalence to previously cleared predicate devices and adherence to relevant standards for manufacturing, sterilization, and packaging. There are no explicit performance metrics in the format of sensitivity, specificity, accuracy, etc., as would be found for a diagnostic device.

Study Details

This 510(k) submission states explicitly that clinical studies were not conducted or deemed necessary. The "study" here refers primarily to engineering bench tests and comparisons to predicate devices and standards.

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

   • Test Set (Engineering Studies): The document mentions "sample implant is sent for SEM testing four times a year" for surface evaluation. For fatigue testing, it states "Modification to the testing protocol was discussed with the FDA prior to conducting the test (Enclosure 8 Appendix B). Testing revealed a stable screw joint at the highest forces tested (Enclosure 8)." The exact number of implants tested for fatigue is not specified in the provided text, but it implies a representative sample.
   • Data Provenance: The engineering studies (fatigue, surface analysis) were conducted internally or by a contracted lab as part of the manufacturing and submission process. The submission does not specify a country of origin beyond the submitter's address (Fairfax, VA, USA). The studies are by nature prospective as they are conducted for the specific purpose of this submission or as part of ongoing quality control.

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

   • Not applicable in the typical sense. For engineering tests like fatigue, the "ground truth" is the established pass/fail criteria of the test method itself, which is based on an FDA guidance document. For material composition and sterilization, the ground truth is adherence to the specified ASTM/ISO/EN standards.
   • Visual Inspection/SEM: Manufacturing protocol includes visual inspection by trained personnel, and SEM testing is conducted by qualified lab personnel.

3. Adjudication method for the test set:

   • Not applicable as this is not a study requiring human reader consensus for "ground truth". The "adjudication" is compliance with engineering and quality standards.

4. 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 type of study is not relevant for an endosseous dental implant system, as it is not an imaging or diagnostic AI device.

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

   • No. This is not an algorithm-based device.

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

   • The "ground truth" for this device's evaluation is primarily compliance with established engineering standards (ASTM, ISO, EN), FDA guidance documents for mechanical testing, and material specifications. For surface characteristics, it involves direct physical measurement and visual/SEM verification against internal specifications and biocompatibility principles.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this device, as it is not an AI/machine learning product.

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

   • Not applicable. See above.

Ask a specific question about this device

The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prosteses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The NSI Implant System is intended to the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary for an endosseous dental implant system, and it primarily focuses on describing the device, its intended use, and establishing substantial equivalence to predicate devices. It does not contain details about performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

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