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The FRIALIT® PLUS Dental Implant System is indicated for use in single tooth restorations, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.

The XiVE®S PLUS Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE® dental implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The XiVE® D3.0 PLUS Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.

The XiVE® TG PLUS Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four transgingival implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The FRIALIT®, XiVE® and XiVE® TG dental implants with the new FRIADENT Surface have been cleared for commercial distribution. The purpose of this application is to change the name of the surface to PLUS and obtain clearance for additional marketing claims associated with the PLUS surface.

This 510(k) summary describes a modification to an existing dental implant system, specifically changing the surface name to "PLUS" and seeking clearance for associated marketing claims. As such, the submission focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing de novo performance criteria against acceptance thresholds.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a number of implants or subjects. The studies were preclinical and animal studies.
• Data Provenance:
  • Country of Origin: Germany (University of Tubingen, University of Cologne) and Brazil (University of São Paulo).
  • Retrospective or Prospective: Not explicitly stated, but preclinical and animal studies are typically prospective in their design.

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

Not applicable in the context of this 510(k) summary. The "ground truth" for these types of studies is derived from objective measurements (physiochemical analysis, biomechanical testing, histological evaluation in animal models) performed by researchers at the respective universities, not through expert consensus on interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations (e.g., medical imaging). The studies involved laboratory and animal experiments with quantifiable outcomes.

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 submission is for a dental implant system (hardware), not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" was established through:

• Physiochemical surface analyses: Laboratory measurements of surface properties.
• Histological and biomechanical analyses in animal models: Evaluation of osseointegration, bone-implant contact, and removal torque values in vivo. This is akin to "pathology" or objective biological outcomes in an animal setting.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a training set. The studies described are traditional preclinical and animal investigations.

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

Not applicable. As above, this is not an AI/ML device.

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An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

The ANKYLOS® Dental Implant System consists of threaded dental implants in 3.5 - 7.0 mm diameters with 8 - 17 mm lengths. The implants are coated with the FRIADENT Surface. The ANKYLOS® Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. In the edentulous mandible, the ANKYLOS® dental implants are indicated for immediate loading procedures using the standard protocol.

The provided text is a 510(k) summary for the FRIADENT GmbH ANKYLOS® Dental Implant System. It outlines the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving device performance in the context of typical AI/ML device evaluations (e.g., sensitivity, specificity, F1-score, etc.).

Medical devices, especially hardware like dental implants, are regulated differently from AI/ML software. For devices like dental implants, "performance evaluation" typically refers to:

• Mechanical Strength and Durability Testing: Ensuring the implant can withstand masticatory forces over time.
• Biocompatibility Testing: Confirming the materials are safe for implantation in the human body.
• Sterilization Validation: Ensuring the device can be properly sterilized.
• Clinical Studies (if required): For novel designs or indications, clinical trials might be conducted to demonstrate safety and effectiveness in human subjects, often focusing on outcomes like integration success rates, survival rates, and complication rates.
• Comparison to Predicate Devices: Demonstrating that the new device performs "as well as" or "substantially equivalent" to a legally marketed predicate device, often through a combination of the above testing and analysis of existing literature on the predicate.

The document states: "Performance evaluations of the ANKYLOS® dental implant system show that the device performs as intended. Comparison of the ANKYLOS® dental implant system to the predicate devices shows that the device is substantially equivalent." This suggests that the "study" referred to is likely a compilation of engineering tests and comparative analysis rather than a human-in-the-loop AI performance study.

Therefore, I cannot provide the requested information for an AI/ML device performance study using this document. The questions you've asked are specific to AI/ML device validation, which is not covered in this 510(k) submission for a dental implant system.

To answer your request based solely on the provided text, I must state that the information is not present in the document.

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An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healling or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

The ANKYLOS dental implant system has been previously cleared for commercial distribution. The purpose of this application is to present additional instructions for use sheets for the product. The system and methodology of implantation has not changed with the new labeling.

This 510(k) submission (K040946) for the ANKYLOS® Dental Implant System does not contain a study to prove the device meets acceptance criteria related to performance metrics, a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone AI algorithm performance study. This submission is primarily focused on presenting additional instructions for use sheets for a device that has already been cleared (predicate 510(k) K012681).

Therefore, many of the requested elements for describing a study are not applicable to this particular submission. The "acceptance criteria" here refer to the regulatory requirements for showing substantial equivalence to a predicate device, rather than specific performance metrics demonstrated through a new study.

Here's an breakdown based on the provided text, indicating what is present and what is not:

Acceptance Criteria and Device Performance

Summary of the "Study" (or basis for clearance):

This submission is a "Special 510(k)" or a similar type where the changes are minimal and do not impact safety or effectiveness. The "study" here is a comparison to a predicate device (Dentsply Ceramco ANKYLOS® Dental Implant System, K012681) to demonstrate substantial equivalence, particularly because the primary purpose of this specific application is to present "additional instructions for use sheets." The manufacturer asserts that design, materials, coatings, mechanical strength, prosthetic options, indications for use, system and methodology of implantation, and technological characteristics have not changed.

Non-Applicable or Not Provided Information from the Text:

Due to the nature of this 510(k) (updates to labeling for an already cleared device), the following information, which would typically be present for a clinical or performance study, is not provided in the given text:

2. Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
4. Adjudication method for the test set: Not applicable. No test set needing adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-based device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-based device, and no standalone algorithm performance is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There's no performance evaluation generating new data that would require a ground truth. The "ground truth" for this submission is the established safety and effectiveness of the existing predicate device.
8. The sample size for the training set: Not applicable. This is not an AI-based device, and no training set is mentioned.
9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.

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The XiVE® TG Abutment is intended for use to fabricate screw-retained or cementable crowns and bridges.

The XiVE® TG Abutment is part of the XiVE® TG Transgingival Dental Implant System. The XIVE® TG Abutment is intended for the fabrication of screwretained or cementable crowns and bridges. The XiVE® TG Abutment is constructed of CP-2 titanium and is available in a 3.4 - 4.5mm diameter to correspond to the XiVE® transgingival implant bodies. The XiVE® TG Abutment is available with a straight or angled configuration.

The provided text describes a 510(k) premarket notification for a dental device, the XiVE® TG Abutment. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance data.

Therefore, the requested information elements related to specific acceptance criteria, detailed study design, sample sizes for test/training sets, expert involvement, and ground truth establishment are not explicitly available in the provided text.

Based on the information given, here's what can be extracted and inferred:

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

The document does not provide a table of specific, quantifiable acceptance criteria. Instead, it states that "Performance evaluations of the XiVE® TG abutment show that the device performs as intended." The primary "acceptance criteria" for a 510(k) submission are based on demonstrating substantial equivalence to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness.

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

• Sample size for test set: Not mentioned. The document refers to "Performance evaluations," but no details about the studies or sample sizes are provided.
• Data provenance: Not mentioned. It's likely the evaluations were conducted by FRIADENT GmbH in Germany, given the company's location, but this is not explicitly stated for the "performance evaluations."

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 and not mentioned. This type of detail is typically for diagnostic AI/CAD devices where expert interpretation forms the ground truth. For a dental abutment, performance is based on mechanical properties and clinical use, often tested physically or in animal/cadaver models, or by comparison to existing devices.

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

Not applicable and not mentioned.

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 not a diagnostic device involving human readers or AI assistance.

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

Not applicable. This is a physical dental device, not an algorithm.

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

The "ground truth" for this device would likely be established through:

• Mechanical testing: Demonstrating structural integrity, fatigue resistance, and fit according to established standards.
• Material compatibility: Verification of biocompatibility.
• Clinical performance: Although not detailed in this summary, clinical experience with predicate devices and possibly limited in-house testing would inform the "performs as intended" conclusion. However, no specific "ground truth" data of these types are presented.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires training data in the traditional sense.

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

Not applicable.

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The XiVE® Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE® dental implants (≥ 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The XiVE® Dental Implant System consists of subgingival threaded dental imolants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIADENT Surface M2.1. The XiVE® Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures. In the edentulous mandible, the XiVE® dental implants are indicated for immediate loading procedures using the standard protocol.

The provided document is a 510(k) summary for the FRIADENT GmbH XIVE® Dental Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria via a clinical study with an AI component. Therefore, much of the requested information regarding AI device evaluation is not applicable to this document.

Here's an analysis of the provided text in relation to your request:

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

The document does not specify quantitative acceptance criteria or report specific performance metrics against such criteria in the way a clinical study for an AI device would. The core of this 510(k) is to demonstrate "substantial equivalence." The "performance evaluations" mentioned are general and refer to the device performing "as intended," not against specific numerical thresholds.

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 510(k) submission does not describe a clinical study with a "test set" in the context of an AI device. The comparison is primarily based on technological characteristics and intended use relative to predicate devices. The "performance evaluations" mentioned are not detailed as a specific study with a quantifiable sample size.

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 submission does not involve AI model development or ground truth establishment by experts in the context of a "test set."

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

Not applicable. There is no mention of a test set or adjudication for an AI device.

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 not an AI device, and no MRMC study is described.

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

Not applicable. This is not an AI device.

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

Not applicable. There is no AI model requiring ground truth. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set.

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

Not applicable. There is no AI device or training set.

Summary based on the provided document:

The K032158 submission for the XiVE® Dental Implant System focuses on demonstrating substantial equivalence to previously cleared predicate devices (K013867 and K021318). The primary argument for equivalence is that the device has the same design, materials (CP-2 titanium), mechanical strength, prosthetic options, instructions for use, and intended use as the predicate devices. The only stated difference is a change in the surface morphology to the "FRIADENT Surface M2.1." The submission asserts that "Performance evaluations of the XiVE® dental implant system show that the device performs as intended." This implies that internal testing or existing knowledge about the materials and design support its function, but no detailed study or specific quantitative acceptance criteria are provided in this summary. The FDA's clearance letter confirms their agreement that the device is substantially equivalent to the predicate.

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The FRIALIT®-2 Dental Implant System is indicated for use in single tooth restoration, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.

The FRIALIT®-2 Dental Implant System consists of subgingival threaded dental implants in 3.4 - 6.5mm diameters with 8 - 15mm lengths. The implants are coated with the FRIADENT Surface M2.1. The FRIALIT®-2 Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures.

The provided document is a 510(k) premarket notification for the FRIALIT®-2 Dental Implant System. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving device performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the way envisioned for a novel AI/software device. Instead, it demonstrates equivalence to previously cleared dental implants.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study, or effect size for human readers with/without AI assistance.
6. A standalone algorithm-only performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How ground truth for a training set was established.

Summary of what the document does provide regarding "performance evaluation":

The document states under "17.9 CONCLUSIONS": "Performance evaluations of the FRIALIT®-2 dental implant system show that the device performs as intended. Comparison the FRIALIT®-2 dental implant system to the predicate devices show that the device is substantially equivalent. The complete surface characterization of the new FRIADENT Surface M2.1 has been detailed in Device Master File MAF-1235."

This "performance evaluation" likely refers to non-clinical tests (e.g., mechanical strength, material characterization as mentioned for the FRIADENT Surface M2.1), and a comparison to the predicate devices to establish substantial equivalence. It is not a clinical study with a test set, ground truth, or an AI component as your questions imply.

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The XiVE® TG Dental Implant System is indicated for singlestage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular spinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants.

In the edentulous maxilla, a minimu of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together.

In the edentulous mandible, a minimum of four transgingival implants (> 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The XiVE® TG Dental Implant System consists of transgingival threaded dental implants in 3.4 -4.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIADENT Surface M2.1. The XiVE® TG Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for splinted crowns, bridges and complete dentures. In the edentulous mandible, the XiVE® TG transgingival dental implants are indicated for immediate loading procedures using the standard protocol.

The provided document is a 510(k) summary for the XiVE® TG Dental Implant System. It presents information regarding substantial equivalence to a predicate device, rather than detailed studies demonstrating performance against pre-defined acceptance criteria for a new device.

Therefore, the requested information, specifically acceptance criteria, device performance from a new study, sample sizes for test sets, ground truth establishment details, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document.

The document primarily focuses on establishing substantial equivalence to a previously cleared device (K024004) due to a change in the surface morphology of the implant.

Here's an explanation of why the requested items are not present:

1. Table of acceptance criteria and reported device performance: This document asserts substantial equivalence, stating that "Performance evaluations of the XiVE® TG dental implant system show that the device performs as intended." However, it does not provide specific acceptance criteria or quantitative performance data from these evaluations. The focus is on demonstrating that the new device is functionally identical to the predicate.

2. Sample size for test set and data provenance: No specific test set or study with corresponding sample size and data provenance information is described. The clearance relies on equivalence to a previously cleared device.

3. Number of experts used to establish ground truth and their qualifications: Not applicable, as there's no diagnostic or interpretative test set described needing expert ground truth.

4. Adjudication method: Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This device is a dental implant, not an imaging or diagnostic AI tool that would typically involve human readers.

6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This is a physical medical device (dental implant), not an AI algorithm.

7. Type of ground truth used: Not applicable, as no ground truth for a diagnostic or interpretative task is required.

8. Sample size for the training set: Not applicable, as there is no mention of a machine learning or AI model being trained.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does state regarding performance (without specific data):

• "Performance evaluations of the XiVE® TG dental implant system show that the device performs as intended." (Section 17.9, "CONCLUSIONS")
• The device is "substantially equivalent to the current XiVE® TG Dental Implant Systems in terms of design, materials, mechanical strength, prosthetic and laboratory options and intended use." (Section 17.5, "SUBSTANTIAL EQUIVALENCE")
• "The only difference is the change in the surface morphology of the dental implant to the FRIADENT Surface M2.1." (Section 17.7, "TECHNOLOGICAL CHARACTERISTICS")
• "The complete surface characterization of the new FRIADENT Surface M2.1 has been detailed in a Device Master File." (Section 17.9, "CONCLUSIONS") This implies that the properties of the new surface were characterized, but the details are not in this summary.

In essence, this 510(k) summary is a declaration of substantial equivalence based on the device's similarity to an already cleared product, with the only change being a surface modification that is presumed not to raise new questions of safety or effectiveness. It does not provide the detailed study results that would typically be found for a novel device or a device making new performance claims.

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The XiVE® Transgingival Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns. bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants.

In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together.

In the edentulous mandible, a minimum of four transgingival implants ≥ 9.5mm are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.

The XiVE® Transgingival Dental Implant System consists of transgingival threaded dental implants in 3.4 - 5.5mm diameters with 8 -- 18mm lengths. The implants are coated with the FRIOS Deep Profile Surface. The XiVE® Transgingival Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures and for immediate loading indications in the edentulous mandible.

This document is a 510(k) premarket notification for a dental implant system. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Based on the provided text, the dental implant system is being cleared through the 510(k) pathway by demonstrating substantial equivalence to predicate devices, rather than through a study demonstrating direct performance against specific acceptance criteria.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria or Reported Device Performance: The document does not specify any quantitative acceptance criteria for device performance (e.g., success rates, failure rates, stability measurements) or report any performance data from a study.
• No Study Described: The submission relies on substantial equivalence to predicate devices (FRIALOC® Dental Implant System K013067 and XiVE® Dental Implant System K013867) rather than a new study to prove specific performance metrics. The information provided does not describe a clinical or non-clinical study designed to test the device's performance against acceptance criteria.
• No Information on Sample Sizes, Experts, Adjudication, MRMC, or Standalone Performance: Since no performance study is described, there is no mention of these elements.
• No Ground Truth Information: Without a study to establish performance, there is no discussion of how ground truth would be established for such a study.

The core of this 510(k) submission is the claim of substantial equivalence in "design, materials, coatings, mechanical strength, and intended use" to previously cleared devices (for FRIALOC®) and "materials, coatings, prosthetic options, and intended use" (for the existing XiVE® system). The FDA's clearance letter confirms this substantial equivalence determination, allowing the device to be marketed.

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FRIOS® ALGIPORE® is indicated for:

• Treatment of intrabony defects .
• Augmentation of bony defects of alveolar ridge .
• Filling of extraction sites ●
• Sinus elevation grafting .

FRIOS® ALGIPORE® is a bone filling and augmentation material indicated for use in dental applications. FRIOS® ALGIPORE® is an inorganic, biocompatible calcium phosphate material derived from calcium-encrusted sea algae. The algae are processed in order to develop an apatite material that is analogous to bone apatite. FRIOS® ALGIPORE® is provided sterile in pre-filled vials and has a granular size range from 300 - 2000 microns.

The provided text describes a 510(k) submission for a medical device called FRIOS® ALGIPORE®, a bone filling and augmentation material. The submission aims to demonstrate substantial equivalence to predicate devices, not to meet specific performance acceptance criteria through a clinical study with defined endpoints. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them cannot be directly extracted from this document, as it's not a performance study report in the typical sense.

However, I can extract information related to the demonstration of equivalence, which is the basis of this 510(k) submission.

Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence:

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

This document does not present specific acceptance criteria in numerical values for performance endpoints that would typically be found in a clinical study report (e.g., success rates, complication rates). Instead, the acceptance criterion for a 510(k) is substantial equivalence to legally marketed predicate devices.

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

• Sample Size for Test Set: Not applicable in the context of this document. The "test set" here refers to the comparative analytical testing conducted on the material itself, not a clinical study on patients. The document does not specify the number of samples of the material used for ICP-AES and X-Ray Diffraction tests.
• Data Provenance: The analytical comparison testing was performed for the purpose of this submission by FRIADENT GmbH, whose address is in Mannheim D-68229, Germany. The type of data is laboratory comparison testing of material properties, not clinical patient data. Therefore, terms like retrospective or prospective do not apply.

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. The "ground truth" for material equivalence was established through objective analytical methods (ICP-AES and X-Ray Diffraction) and comparison to established ASTM standards for Hydroxylapatite, not through expert consensus on clinical outcomes or images.

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

• Not applicable. Adjudication methods are relevant for clinical studies or image interpretation by multiple experts. The evaluation of material properties (chemical and mineralogical composition) is determined by analytical instruments and standard comparisons, not expert adjudication.

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 device is a bone filling and augmentation material, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed or is relevant here.

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

• Not applicable. This is a material device, not an algorithm.

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

• The "ground truth" for establishing equivalence was based on analytical laboratory measurements (Inductively Coupled Argon Plasma Atomic Emission Spectroscopy (ICP-AES) and X-Ray Diffraction) compared against ASTM standard specifications for the composition of Hydroxylapatite for surgical implants, and comparison to the known composition and intended use of legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. There is no AI algorithm being trained. The reference to "training set" is irrelevant in this context.

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

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

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The XiVE Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE dental implants (≥ 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.

The XiVE Dental Implant System consists of subgingival threaded dental implants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIOS Deep Profile Surface. The XiVE Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for two stage procedures for single tooth replacement, fixation of bridges and complete dentures and for immediate loading procedures using four implants in the anterior mandible.

The provided text describes a 510(k) premarket notification for the FRIADENT GmbH XiVE® Dental Implant System. This type of submission is for medical devices, not AI/ML algorithms, and therefore the information requested about acceptance criteria and study design for AI/ML performance metrics is not applicable to this document.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device already legally marketed, rather than establishing de novo performance criteria through extensive clinical trials as would be required for a novel AI/ML device.

Here's an analysis based on the provided text, highlighting why the requested AI/ML specific information cannot be found:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify "acceptance criteria" in the sense of performance thresholds for an AI/ML algorithm (e.g., specific sensitivity, specificity, or AUC targets). Instead, the "performance" demonstrated is that the XiVE Dental Implant System is substantially equivalent to legally marketed predicate devices.

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

Not applicable for AI/ML performance. The submission relies on mechanical testing (compressive and static strength, finite element analysis) of the physical implant, which does not involve a "test set" of data in the AI/ML sense. No patient data provenance information is provided for these mechanical tests, as they are likely conducted in a lab setting.

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

Not applicable for AI/ML performance. No ground truth determination by experts for AI/ML performance is described.

4. Adjudication method for the test set

Not applicable for AI/ML performance. No adjudication method for AI/ML data is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical dental implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical dental implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for a physical medical device typically relates to its material properties, biocompatibility, and mechanical performance. The document only mentions:

• Mechanical Testing: Compressive and static strength, and finite element analysis. These tests likely follow established industry standards to ensure the implant's durability and structural integrity.
• Substantial Equivalence: The primary "ground truth" from a regulatory perspective for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.

8. The sample size for the training set

Not applicable for AI/ML performance. No training set for an AI/ML algorithm is mentioned.

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

Not applicable for AI/ML performance. No ground truth for an AI/ML training set is mentioned.

In summary, the provided document pertains to a traditional physical medical device (dental implant) seeking 510(k) clearance based on substantial equivalence to existing devices, not an AI/ML powered device. Therefore, the specific criteria for evaluating AI/ML algorithm performance are entirely absent and not relevant to this submission.

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