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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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Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework.

The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket.

The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.

The SIMPACT Endosseous Dental Implant System, Line Extension

This document is a 510(k) summary for the SIMPACT Implant System, which is a dental implant device. It is a submission to the FDA requesting clearance to market the device.

As such, this document describes the device and asserts its substantial equivalence to a predicate device based on similar indications for use, materials, design, and principles of operation. It does not contain information about acceptance criteria, clinical studies, sample sizes, expert qualifications, or ground truth establishment in the context of device performance evaluation.

Therefore, I cannot provide the requested information from this document. It does not contain the details of a study that proves the device meets specific acceptance criteria as it would for a medical AI/software device.

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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.

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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ENDOPORE Anatomic dental implants may be used as artificial root components to support a prosthesis in an edentulous or partially edentulous mandible or maxilla.

ENDOPORE Anatomic dental implants are provided in three diameters, each intended for surgical placement into specific regions of the mandible and maxilla. Diameters and their corresponding regions are:

3.75 mm provided in lengths of 10, 12, and 15 mm for the anterior mandible

5.0 mm provided in lengths of 8.5, 10, 12, and 15 mm for the anterior maxilla, and

4.5 mm provided in lengths of 8.5, 10, 12, and 15 mm for both the posterior mandible and posterior maxilla.

The appropriate diameter of implant corresponding to the planned placement region should be selected. In addition, as with all dental implants, appropriate preoperative buccolingual width and crestal bone height measurements of the planned site should be made to ensure that adequate alveolar bone volume is available to accommodate the diameter and length of implant selected. If bone volume is not adequate, a press-fit ENDOPORE or threaded ENTEGRA implant of appropriate diameter and length may be considered for placement.

The technological characteristics of the modified Endopore® Anatomic Endosseous Dental Implant System also are identical to those of the predicates, except for the use of customized configurations to fit specific anatomic jaw locations, including the anterior mandible, anterior maxilla, posterior mandible and posterior maxilla, and the addition of concentric "steps" along the length of the implant's body. The dimensions of the Anatomic Implant System include diameters of 3.75 mm, 4.5 mm, and 5 mm and lengths of 8.5 mm, 10 mm, 12 mm, and 15 mm. These dimensions are within the range of those of the previously cleared Endopore® Endosseous Dental Implant System, with the addition of the 3.75 mm diameter and 15 mm length.

The provided text is a 510(k) summary for the Endopore® Anatomic Endosseous Dental Implant System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove device performance against specific acceptance criteria in the typical sense of a clinical or analytical performance study.

Therefore, many of the requested elements (e.g., acceptance criteria table, sample sizes, expert qualifications, MRMC study, standalone performance) are not applicable or not available in this type of regulatory submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)

For 510(k) submissions, the primary "acceptance criterion" is proving substantial equivalence to a legally marketed predicate device. Device performance is typically evaluated by demonstrating that the new device shares similar technological characteristics, intended use, and performs no worse than its predicate.

Explanation: This 510(k) summary explicitly states: "The minor modification to the design of the Scalloped Endopore® Endosseous Dental Implant System and Endopore® Endosseous Dental Implant System does not alter the implant's indications for use or its fundamental scientific technology. Therefore, the modified device is substantially equivalent to the predicate devices." This is the core "study" and "acceptance criterion" for a 510(k) – demonstrating that the new device is as safe and effective as a legally marketed one.

Detailed Information on Studies:

1. 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 provided. This submission is based on demonstrating substantial equivalence through comparison of technological characteristics and intended use, not on a new clinical or analytical performance study with a test set of data.

2. 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 provided. No "ground truth" establishment by experts for a test set is mentioned in this substantial equivalence submission.

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

   • Not applicable/Not provided. No adjudication method is mentioned as there's no disclosed test set or expert review process.

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:

   • Not applicable. This device is a dental implant, not an AI-assisted diagnostic or imaging device, so an MRMC study is irrelevant.

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

   • Not applicable. This is a physical medical device (dental implant), not an algorithm or software. "Standalone performance" in this context would refer to material testing and mechanical performance, which are part of device design and manufacturing but not explicitly detailed as "standalone studies" in this summary for substantial equivalence.

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

   • Not applicable. For this type of 510(k) submission, "ground truth" in the sense of a clinical benchmark for a new diagnostic or prognostic algorithm is not relevant. The "ground truth" for substantial equivalence is the existing, legally marketed predicate devices and their known performance/safety profiles.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

   • Not applicable. As above, no training set.

In summary: The K052951 document is a 510(k) summary demonstrating substantial equivalence for a dental implant system. It explicitly states that the device's design modifications do not alter its fundamental scientific technology or intended use, thereby making it substantially equivalent to predicate devices. This type of submission relies on comparative analysis of specifications and intended use rather than new clinical or performance studies with separate test and training sets.

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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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For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.

The principles of operation of the modified device are identical to the previously cleared Endopore Implant System except for the attachment of abutments via an internal connection.

The provided text is a 510(k) summary for a dental implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and device performance results in the way commonly associated with AI/ML device evaluations.

Therefore, many of the requested categories for AI/ML study reporting cannot be directly extracted from this document, as they are not applicable to the type of information presented in a 510(k) for a physical medical device like a dental implant.

Here's an attempt to address the applicable points or explain why certain points cannot be answered based on the provided text:

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

This information is not provided in the document. For a physical device like a dental implant, acceptance criteria would typically relate to mechanical strength, biocompatibility, design specifications, and manufacturing quality. The document states that the "minor modification to the surface of the Endopore Implant does not alter its indications for use or its fundamental scientific technology," suggesting that the previous performance and acceptance criteria of the predicate devices apply.

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

This information is not provided as this document does not describe a clinical study in the context of assessing algorithms or AI performance. The evaluation is based on technological characteristics and comparison to predicate devices, not on a test set of 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)

This information is not applicable/provided. There is no "ground truth" establishment in the context of expert review for a test set as described for an AI/ML device. The evaluation is a regulatory review for substantial equivalence.

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

This information is not applicable/provided.

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 information is not applicable/provided. This is a physical medical device, not an AI/ML diagnostic or assistive device.

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

This information is not applicable/provided.

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

This information is not applicable/provided. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

This information is not applicable/provided. There is no training set mentioned, as this is not an AI/ML device.

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

This information is not applicable/provided.

Summary of Device Information Found in the Document (relevant to the 510(k) process):

• Device Name: Scalloped Endopore® Endosseous Dental Implant System
• Intended Use: For use in the upper or lower jaw arches to provide support for a dental prosthesis.
• Predicate Devices: Endopore® Endosseous Dental Implant System (K926354, K971196, K032140).
• Summary Basis for Substantial Equivalence: "The minor modification to the surface of the Endopore Implant does not alter its indications for use or its fundamental scientific technology. Therefore, the modified device is substantially equivalent to the predicates."
• Technological Characteristics of Modified Device:
  • Identical to predicates except for:
    • Addition of a 1.5 mm lightly-acid etched region immediately apical to the smooth coronal region.
    • A scalloped coronal margin.
  • Dimensions: 10.5 mm in length x 4.8 mm diameter (within range of previously cleared Endopore implants).
  • Principles of operation are identical to previously cleared Endopore Implant System except for attachment of abutments via an internal connection.

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For use as an endosseous dental implant in the upper or lower jaw arches to provide support for a dental prosthesis.

The device consists of the implant (root component), collar, collar retaining screw, coping, coping retaining screw, healing cap, and healing cap retaining screw. Alternatively, the overdenture abutment (with an overdenture abutment retaining screw) is available; this assembly incorporates the coping retaining screw, collar, and collar retaining screw into a combined component for attachment to the root component. All of the component parts of the Endopore Implant are fabricated from a surgical grade (ASTM F 136-9) titanium-aluminum-vanadium (TicAl;V) alloy. The bone-contacting portion of the implant component has a powder-sintered porous coating of a surgical grade titanium-aluminum-vanadium alloy. The bonccontacting portion of the implant component is a truncated conical design with tapered sides.

The provided text describes a 510(k) summary for the Innova LifeSciences Corporation Endopore® Endosseous Dental Implant System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria or detailing a clinical study with performance metrics in the way a diagnostic algorithm or AI device submission would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details, ground truth for training set) are not applicable to this type of device submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission is for a medical device (dental implant), not a diagnostic algorithm or AI device that would typically involve a "test set" in the computational sense. The "performance data" mentioned likely refers to mechanical testing or a summary of existing clinical data related to the predicate devices or the modified device. The document does not specify human subject data for this particular submission's performance evaluation.

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

• Not Applicable. See explanation above.

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

• Not Applicable. See explanation above.

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 hardware medical device; it does not involve AI or human readers in an MRMC study context.

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

• Not Applicable. This is a hardware medical device; it does not involve algorithms.

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

• The "ground truth" in this context is implicitly the established safety and effectiveness of the predicate dental implants through their long-standing use and prior FDA clearances, supported by material characterization and mechanical testing to demonstrate that the new, shorter length of the implant does not compromise these established performance parameters. The "performance data" mentioned would likely consist of engineering and bench test results.

8. The sample size for the training set

• Not Applicable. This is a hardware medical device and does not use a "training set" in the machine learning sense.

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

• Not Applicable. See explanation above.

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