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The OT-F2 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 OT-F3 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 is suitable for insertion in completely healed jaw bone (late implantation).

The OT-F implants are available in the diameters 3.8, 4.1 and 5.0mm. For the diameter 3.8 and 4.1mm there are 5 lengths: 8, 10, 12, 14 and 16 mm, for the diameter 5.0mm only 4 lengths: 8, 10, 12 and 14 mm. The implants are made from titanium grad 4 acc. to ASTM F-67. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All abutments are made from titanium grad 5 acc. to ASTM F-136.

The OT-F3 implants are available in the diameters 4.1 and 5.0mm. For each diameter there are 3 lengths: 5, 7 and 9 mm. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All implants are made from titanium grad 5 acc. to ASTM F-136.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is a 510(k) premarket notification summary for dental implants, not a clinical study report for an AI device. Therefore, many standard AI study criteria will not be applicable.

The document discusses two distinct dental implant systems: the OT-F2 and the OT-F3, each with its own predicate device comparison. I will treat them separately for clarity, as the provided text presents them as essentially two separate 510(k) submissions consolidated under the same K-number.

OT-F2 Dental Implant System (K113113 - Part 1)

1. Table of Acceptance Criteria and Reported Device Performance

For the OT-F2 system, the acceptance criteria are implicitly defined by substantial equivalence to the predicate device (Pitt-Easy Dental Implant System, K053242). The reported device performance is presented as a comparison of technological characteristics.

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

• Sample Size for Test Set: Not applicable in the context of an "AI device" test set. For the engineering studies, standard test samples were used per ISO 14801:2003, but specific numbers are not provided.
• Data Provenance: The document is from Germany (OT medical GmbH, Bremen/Germany). The non-clinical testing appears to be a mix of internal testing ("SEM Pictures F2") and external lab reports (e.g., MDS, Duddeck, IGMHS). The tests listed are for material properties, sterilization validation, aging, and fatigue.

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

This information is not applicable. The device is a physical dental implant, not an AI diagnostic tool. Ground truth is established through engineering and material testing standards, and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable in the context of expert adjudication for an AI device. Compliance is assessed against established engineering standards and comparison to a predicate device.

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

No. This is not an AI device.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI device.

7. Type of Ground Truth Used

The ground truth for the OT-F2 system is established through:

• Comparison of technological characteristics to a legally marketed predicate device (510(k) pathway).
• Compliance with international standards for dental implants (e.g., ISO 14801:2003 for fatigue testing).
• Results from non-clinical tests on material properties, sterilization efficacy, and aging.

8. Sample Size for the Training Set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

OT-F3 Dental Implant System (K113113 - Part 2)

1. Table of Acceptance Criteria and Reported Device Performance

For the OT-F3 system, the acceptance criteria are implicitly defined by substantial equivalence to the predicate devices (K926354, K971196, K032140 Endopore Dental Implant System). The reported device performance is presented as a comparison of technological characteristics.

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

• Sample Size for Test Set: Not applicable for an "AI device" test set. For the engineering studies, standard test samples were used per ISO 14801:2003, but specific numbers are not provided.
• Data Provenance: The document is from Germany (OT medical GmbH, Bremen/Germany). The non-clinical testing appears to be a mix of internal testing ("SEM Pictures F2", "IfW Report 4451 Metallographie") and external lab reports (e.g., MDS, Duddeck, Endolab, IMA Test Report). The tests listed are for material properties, sterilization validation, aging, and fatigue.

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

This information is not applicable. The device is a physical dental implant, not an AI diagnostic tool. Ground truth is established through engineering and material testing standards, and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable in the context of expert adjudication for an AI device. Compliance is assessed against established engineering standards and comparison to a predicate device.

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

No. This is not an AI device.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI device.

7. Type of Ground Truth Used

The ground truth for the OT-F3 system is established through:

• Comparison of technological characteristics to legally marketed predicate devices (510(k) pathway).
• Compliance with international standards for dental implants (e.g., ISO 14801:2003 for fatigue testing).
• Results from non-clinical tests on material properties, sterilization efficacy, aging, surface analysis, shear bonding strength, tension testing, and biocompatibility.

8. Sample Size for the Training Set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

Overall Note: The provided text is a 510(k) Premarket Notification Summary for dental implants, which are physical medical devices, not AI-powered software or diagnostic tools. As such, the typical "acceptance criteria" and "study types" for AI devices (like sample size for test sets, expert ground truth, adjudication, MRMC studies, standalone performance, training sets) are not relevant to this document. The "study" here refers to non-clinical engineering and materials testing, and the "acceptance criteria" are demonstrating substantial equivalence to predicate physical devices.

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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.

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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 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.

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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 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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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 provided text describes a 510(k) premarket notification for the KOG1169 Endosseous Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on establishing performance criteria through clinical studies.

Therefore, many of the requested details about acceptance criteria, specific device performance, clinical study design, and ground truth establishment are not applicable or available in this document.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable (N/A): This submission is for an Endosseous Dental Implant System, and the document explicitly states, "FDA has not established a performance standard applicable to endosseous implants and their accessories." The submission relies on demonstrating substantial equivalence to predicate devices and meeting applicable voluntary standards for materials (ASTM F67-95 Grade III or Grade IV Titanium), sterilization, and packaging. The document does not provide specific quantitative performance metrics beyond these material and process standards.

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

Not Applicable (N/A): No test set, in the context of an AI/algorithm performance study, was used or described. The submission is for a physical medical device (dental implant).

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

Not Applicable (N/A): As no test set for an AI/algorithm was used, no ground truth experts were involved in this context.

4. Adjudication Method for the Test Set

Not Applicable (N/A): No adjudication method was involved as this is not an AI/algorithm performance study.

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

Not Applicable (N/A): No MRMC study was conducted. The device is a physical dental implant, not an AI-assisted diagnostic tool. The document explicitly states: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission."

6. Standalone (Algorithm Only) Performance Study

Not Applicable (N/A): No standalone algorithm performance study was done as the device is a physical dental implant.

7. Type of Ground Truth Used

Not Applicable (N/A): As this is a submission for a physical device, not an AI/algorithm, the concept of "ground truth" in the context of diagnostic accuracy is not directly relevant. The assessment of the device's characteristics relies on compliance with material specifications (ASTM F67-95 Grade III or Grade IV Titanium) and validated sterilization and packaging methods (ISO, ASTM, EN standards).

8. Sample Size for the Training Set

Not Applicable (N/A): No training set was used as this is not an AI/algorithm submission.

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

Not Applicable (N/A): No training set was used or ground truth established in this context.

Summary of Acceptance Criteria and Study:

Instead of typical AI/algorithm acceptance criteria and studies, this 510(k) submission demonstrates compliance by meeting material, sterilization, and packaging standards and demonstrating substantial equivalence to existing predicate devices.

Acceptance Criteria (based on compliance requirements):

Study Proving Acceptance Criteria:

The "study" or justification for meeting acceptance criteria in this 510(k) involves:

• Conformance to Voluntary Standards: Explicitly stating that materials meet ASTM standards and sterilization/packaging processes are validated according to a comprehensive set of ISO, AAMI, ASTM, and EN standards.
• Predicate Device Comparison: A direct comparison of the technological characteristics and intended use of the new implants and accessories with a list of previously cleared predicate devices (K003620, K020617, K033171, K052490, K053478 NSI systems, and several Straumann Implant Systems K894595, K955281, K012757, K013798, K990342, K962023). The conclusion drawn is that the new components are substantially equivalent.
• Declaration of No Clinical Studies Needed: The submission explicitly states, "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission," indicating that the justification for safety and effectiveness is based on the substantial equivalence argument and adherence to recognized standards, rather than new clinical data.

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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 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.

This 510(k) submission (K053478) for the NSI Hexed and Non-Hexed Endosseous Implant System did not include a study or defined acceptance criteria related to device performance in an AI/software context. This submission is for an endosseous dental implant system, which is a physical medical device, not an AI or software-based device.

The "acceptance criteria" and "device performance" in this context refer to the physical and manufacturing properties of the dental implants, as well as their sterilization and packaging. There are no performance metrics like sensitivity, specificity, or accuracy that would be associated with AI/software devices.

Here's a breakdown of the information provided in the context of a physical device submission:

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

The submission details specific standards that the device and its manufacturing processes meet, rather than specific numerical performance metrics in the way one would describe AI.

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. This submission explicitly states: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." Therefore, there is no "test set" in the context of clinical performance data or AI evaluation. The "data" refers to the results of testing against the physical/manufacturing standards mentioned in point 1. These tests are typically performed in a laboratory setting by the manufacturer.

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. As no clinical studies or AI evaluations were conducted, there was no need for experts to establish ground truth in this context. The "ground truth" for the physical device relates to its adherence to material, manufacturing, sterilization, and packaging standards, which are verified through established engineering and quality control procedures.

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

• Not Applicable. No clinical studies or AI evaluations were performed.

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 physical dental implant, not an AI or imaging device that would involve human readers.

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

• Not Applicable. This device is an implant, not an algorithm.

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

• Not Applicable (in the AI/clinical sense). The "ground truth" for this device's acceptance is its compliance with established engineering, material, sterilization, and packaging standards (e.g., ASTM, ISO standards) and its substantial equivalence to predicate devices. This is verified through laboratory testing and documentation, not clinical outcomes or expert consensus on interpretations of data.

8. The sample size for the training set

• Not Applicable. No AI or machine learning model was developed or trained for this device.

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

• Not Applicable. As no AI training occurred, no ground truth for a training set was established.

Summary:

This 510(k) submission is for a physical medical device (dental implants). The "acceptance criteria" and "study" described in the document relate to the manufacturing process, materials, sterilization, and packaging of the implants, rather than clinical performance studies or AI/software validation. The claim for substantial equivalence is based on the device's similar technological characteristics and intended use to legally marketed predicate devices, and its compliance with relevant voluntary industry standards for materials, sterilization validation, and packaging. No clinical studies were conducted or deemed necessary for this particular submission.

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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 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 NSI Implant System is intended 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 provided text is a 510(k) Premarket Notification Summary for an Endosseous Dental Implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel devices.

Therefore, many of the requested sections (e.g., acceptance criteria, detailed study design with sample sizes, expert ground truth, MRMC studies) are not applicable in this context. The document explicitly states that "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission."

However, I can extract information related to what was conducted and what the overall conclusion implies regarding its "acceptance."

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:

1. Table of Acceptance Criteria and 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)

• N/A: Clinical studies were not conducted. The "test set" for this submission primarily consisted of the engineering tests (fatigue and torsion) performed on the new device iterations. The sample size for these engineering tests is not specified in this summary. Data provenance is not applicable as there are no human subject 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)

• N/A: Clinical studies were not conducted, so there was no "ground truth" derived from expert review of patient data in the context of this 510(k) submission. For the engineering tests, the "ground truth" is established by the accepted standards and protocols for mechanical testing.

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

• N/A: No clinical studies were performed requiring adjudication of results from human subjects.

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

• N/A: This is for an endosseous dental implant, not an AI-powered diagnostic device. No comparative effectiveness studies involving human readers or AI assistance were conducted.

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

• N/A: This is not an algorithm or AI device.

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

• For the substantive equivalence claim: The "ground truth" is the established safety and effectiveness of the predicate devices and the accepted engineering standards (ASTM F67-95, FDA Class II Special Controls Guidance Document) for material and mechanical performance.
• For engineering studies: The "ground truth" is defined by the passing criteria of the specific fatigue and torsion tests, derived from the FDA guidance and discussions with the FDA.

8. The sample size for the training set

• N/A: No clinical studies were conducted, and this is not a machine learning device that requires a "training set."

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

• N/A: No clinical studies were conducted, and this is not a machine learning device.

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The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments for 3i Certain™ Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with 3i Certain Standard Implants with 4.1mm, 5.0mm, 6.0mm diameters; the OSSEOTITE® XP Certain Implants with 5.0mm and 6.0mm diameters; and the OSSEOTITE® NT® Certain™ Implants with 4.0mm, 5.0mm and 6.0mm diameters.

The provided text describes a 510(k) premarket notification for a medical device called the Atlantis™ Abutment for 3i Certain™ Implant. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

Therefore, the document does not contain information regarding:

• Acceptance criteria and reported device performance in a table. The summary focuses on equivalence to a predicate device rather than specific performance metrics against pre-defined acceptance criteria.
• A study that proves the device meets acceptance criteria. No specific study design, methodology, or results are presented that would demonstrate the device meeting particular performance targets.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document focuses on:

• Device Identification: Trade Name, Common Name, Classification Name, Regulation Number, Product Code.
• Predicate Device: Identification of the legally marketed device to which equivalence is claimed.
• Description of the Device: Material used (Titanium grade Ti-6A1-4V ELI), compatibility with various implant diameters, and its function as an abutment and abutment screw.
• Intended Use: As an accessory to an endosseous implant to support a prosthetic reconstruction in partially or completely edentulous patients, supporting single and multiple tooth prostheses in the mandible or maxilla, with cement-retained prostheses.
• Basis for Substantial Equivalence: Stating that the device is substantially equivalent in intended use, material, design, and performance to the predicate device cleared under K981858.
• Regulatory Outcome: FDA's determination of substantial equivalence, allowing the device to be marketed.

In summary, this document is a regulatory submission demonstrating equivalence, not a clinical or performance study report with specific acceptance criteria and detailed study results. Therefore, it does not provide the information requested in the prompt regarding acceptance criteria, study details, and ground truth establishment.

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