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The Biodenta Customized Abutment - Titanium is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. The Biodenta Customized Abutment - Titanium is compatible with the following dental implant systems:

Biodenta Customized Abutment - Titanium is a one-piece custom abutment made of titanium. It utilizes an Abutment Screw for abutment retention.

The upper portion is designed by a dental technician using CAD software and manufactured at Biodenta milling centers. The final cement retained restoration is constructed in the lab according to the dentist's specifications.

The Abutment and the Abutment Screw are made of biocompatible Ti-6AI-4V ELI conforming to ISO 3852-3 and ASTM F136.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Biodenta Customized Abutment - Titanium:

Based on the provided document, the device in question is a dental abutment, and its acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to predicate devices, primarily through mechanical and biocompatibility testing, rather than clinical performance metrics typically associated with AI-powered diagnostic tools.

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

The document does not explicitly present a table of acceptance criteria with specific numerical targets for performance and reported device performance in the typical sense of a diagnostic or predictive device (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices, and the "performance" is primarily shown through non-clinical testing results.

The critical acceptance criteria for this type of device revolve around:

• Mechanical Strength/Integrity: The device must demonstrate sufficient mechanical strength for its intended clinical application, particularly under fatigue loading.
• Biocompatibility: The materials used must be biocompatible.
• Fit and Compatibility: The customized abutment must fit well with the original manufacturer's implants as intended.
• Sterilization Effectiveness: The recommended sterilization method must be validated.

Here's a summary of the implicit acceptance criteria and the reported device performance:

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

The document does not specify a "test set" in the context of clinical trials with human subjects. The testing described is non-clinical:

• Fatigue Testing: "The worst-case scenario for the Biodenta Customized Abutment - Titanium and implant was tested." The sample size for fatigue testing (number of abutments/implants tested) is not specified.
• Engineering and Compatibility Analysis: This involved measuring "original implant manufacturer's implant analogs, abutments, and abutment screws." The number of samples measured is not specified.
• Sterilization Validation: Conducted according to ISO 17665-1:2006. Sample sizes for sterilization validation are not detailed.

The data provenance is from non-clinical laboratory testing conducted by Biodenta Swiss AG. The country of origin for the testing would presumably be Switzerland, where Biodenta Swiss AG is located. The nature of these tests is not "retrospective" or "prospective" as those terms apply to clinical studies; these are laboratory-based, controlled experiments.

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 question is not applicable to the provided information. The device is a dental abutment, not a diagnostic imaging device or an AI algorithm requiring expert ground truth for a test set. The validation relies on engineering and material science principles, against established FDA guidance documents and international standards, rather than expert interpretation of clinical data in the manner of a diagnostic study.

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

This question is not applicable for the same reason as point 3. There is no "test set" of clinical cases requiring 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

This question is not applicable. The device is a physical dental abutment, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant to this type of device.

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

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

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

The "ground truth" for this device type is established by:

• Industry Standards and Regulatory Guidance: Adherence to FDA Guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments") and international standards (e.g., ISO 17665-1:2006 for sterilization).
• Material Properties: Established biocompatibility and mechanical properties of Ti-6AI-4V ELI as per ISO 3852-3 and ASTM F136.
• Engineering Measurements and Analysis: Ensuring precise fit and compatibility with specified implant systems based on direct measurements and engineering analysis.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of an AI algorithm for this device. The design and manufacturing process for the customized abutment involves CAD software and milling centers, but this is an engineering process, not an AI training process.

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

This question is not applicable as there is no training set for an AI algorithm. The design and manufacturing parameters for the abutment would be based on dental engineering principles, anatomical considerations, and compatibility specifications for various implant systems.

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The Biodenta Customized Abutment - Hybrid is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

The Biodenta Customized Abutment - Hybrid is compatible with the following dental implant systems:

Biodenta, Bone Level and Tapered B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm
Nobel Biocare, Nobel Replace straight and tapered NP: 3.5 mm; RP: 4.3 mm; WP: 5.0 mm; 6.0: 6.0 mm
Nobel Biocare, NobelActive NP: 3.5 mm; RP: 4.3, 5.0 mm
Biomet 3i, Certain Internal 3.4: 3.25, 4.0 mm; 4.1: 4.0, 5.0 mm; 5.0: 5.0, 6.0 mm; 6.0: 6.0 mm
Dentsply, Astra Tech OsseoSpeed 3.5/4.0: 3.5, 4.0 mm; 4.5/5.0: 4.5, 5.0 mm
Straumann, Bone Level NC: 3.3 mm; RC: 4.1, 4.8 mm
Zimmer, Screw Vent and Screw Vent Tapered 3.5: 3.3, 3.7, 4.1 mm; 4.5: 4.7 mm; 5.7: 6.0 mm

The Biodenta Customized Abutment - Hybrid is a two-piece abutment, which contains a premanufactured (stock) Titanium-Base and a Zirconium coping and/or crown that is designed by a dental technician using CAD software and manufactured at Biodenta milling centers.

The Biodenta Customized Abutment - Hybrid utilizes an Abutment Screw for abutment retention. The final cement retained restoration is constructed in the lab according to the dentist's specifications.

The Biodenta Customized Abutment - Hybrid is compatible with the following dental implant systems: Biomet 3i, Certain Internal; Dentsply, AstraTech OsseoSpeed; Zimmer, Screw Vent; Nobel Biocare, Nobel Biocare, NobelReplace; Straumann, Bone Level; Biodenta, Bone Level and Tapered

The Titanium-Base and the Abutment Screw of the Biodenta Customized Abutment - Hybrid are made of biocompatible Ti-6AI-4V ELI conforming to ISO 3852-3 and ASTM F136.

The Zirconium coping and/or crown of the Biodenta Customized Abutment - Hybrid are made of biocompatible ZrO2 conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

The provided text is a 510(k) premarket notification for a medical device called the "Biodenta Customized Abutment - Hybrid." This document is a regulatory submission to the FDA proving substantial equivalence to existing devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria.

Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the format requested by the user. The information provided focuses on demonstrating substantial equivalence through non-clinical testing (fatigue testing and engineering/compatibility analysis) and comparison to predicate devices, rather than a clinical trial with acceptance criteria for device performance.

However, I can extract the information that is present concerning non-clinical testing:

Device: Biodenta Customized Abutment - Hybrid

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

Since this is a 510(k) submission and not a clinical study with performance acceptance criteria, the document does not present a table of acceptance criteria and reported device performance directly. Instead, it states that "Fatigue testing was conducted according to FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff. The worst case scenario for the Biodenta Customized Abutment - Hybrid and implant was tested. The results show that the Biodenta Customized Abutment - Hybrid has sufficient mechanical strength for the intended clinical application."

This implies that the acceptance criteria for fatigue testing were met, but the specific numerical criteria and comparative results are not detailed in this summary.

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 mentions "Fatigue testing" and "Engineering and Compatibility analysis" as non-clinical testing data.

• Sample Size: Not specified for either fatigue testing or compatibility analysis.
• Data Provenance: Not specified. As the submitting company is "Biodenta Swiss AG" based in Switzerland, it's plausible the testing was conducted in Switzerland or a country with recognized standards. This information is typically found in the full test reports, not the summary.
• Retrospective or Prospective: Not applicable for non-clinical, in-vitro testing.

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

This is not applicable as the testing described is non-clinical (mechanical and compatibility analysis), not a study requiring expert clinical adjudication of ground truth.

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

Not applicable as the testing described is non-clinical.

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 dental abutment, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a dental abutment.

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

For the non-clinical tests:

• Fatigue Testing: "Ground truth" would be established by the industry standard (ISO 14801:2007) indicating acceptable mechanical loads and cycles without failure.
• Compatibility Analysis: "Ground truth" would be established by engineering specifications and physical fit/interaction with specified implant systems.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

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Biodenta dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. They are intended for delayed loading.

The Biodenta Dental Implant System - Bone Level Tapered D3.0 and L6.5 mm is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, prosthetic parts and related surgical instruments. The Bone Level Tapered D3.0 and L6.5 mm implants use the same platforms and abutment connections like the Bone Level D 3.0 to 6.0 (K123512). Therefore the abutments and prosthetic parts which are compatible to the Bone Level D 3.0 to 6.0 (K123512) are also compatible to the predicate device.

The submission includes:

• Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0
• Diameter 4.1, 4.8, and 6,0 mm Implants with Length of: 6.5 mm; Platform B2

The provided text describes a 510(k) summary for the Biodenta Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable in this context, as the submission relies on non-clinical testing and comparison to predicate devices, not on a clinical performance study with acceptance criteria.

However, I can extract the non-clinical testing data that was used to support the safety and effectiveness for equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The device should have sufficient mechanical strength for the intended clinical application and its surface area/bone to implant contact area should be sufficient compared to predicate devices.
• Reported Device Performance:
  • Dynamic Fatigue Testing: The subject device (Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm) was found to be "identical" to the predicate device (Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm, K123512) and thus has "sufficient mechanical strength for the intended clinical application."
  • Surface Area and Bone to Implant Contact Area: The Biodenta implant's surface area and bone to implant contact area were calculated to be "larger than the predicate device's surface area and bone to implant contact area." Therefore, the surface area and bone to implant contact area are "considered to be sufficient."

2. Sample size used for the test set and the data provenance: Not applicable. The testing described is non-clinical (dynamic fatigue, CT scan modeling).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical tests is based on established engineering standards (e.g., ISO 14801:2007) and calculations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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/medical imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests:
* Dynamic fatigue testing: Conformance with ISO 14801:2007 standard.
* Surface area and bone to implant contact area: Calculated from 3D models generated from CT scans, compared against predicate devices.

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

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

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Biodenta Dental Implant System Multi Use Abutments are intended for terminal or intermediate abutment support for fixed or removable crown, bridgework and to retain overdentures.

The Biodenta Dental Implant System - Multi-Use Abutment is an extension to the Biodenta Dental Implant System Bone Level (K111003), which is an integrated system of endosseous dental implants, abutments and prosthetic parts and related surgical instruments.

The Biodenta Dental Implant System - Multi-Use Abutment includes 0°, 18°, and 30° abutments for screw retained restorations. Each angulation is available with 2, 3, 4, and 5 mm cuff height for both Biodenta Bone Level implant platform types (B1 and B2). The angulated abutments include hexed and non-hexed versions for single unit or multi unit restorations respectively. Abutment diameters are from 4.5 - 5.0 mm.

The system includes a ball attachment abutment with a diameter of 4.5 mm and height of 5.5 mm, and temporary abutments with a diameter of 4.0 mm and height of 12.5 mm, which are to be attached onto the Multi-Use Abutment. Burn out cylinders are provided. The system includes 2 diameters of abutment and 1 diameter of prosthetic screws. Short and long impression posts for open and closed tray impression taking, and a protective cap for the Multi-Use Abutment is included.

The provided 510(k) summary does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically seen for AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, this submission is for a dental implant abutment, and its "acceptance" is based on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing and comparison of design features and intended use.

Here's an breakdown based on the information provided, highlighting what is present and what is absent regarding acceptance criteria and study details:

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

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

• Test Set Sample Size: Not explicitly stated. The "worst case scenario" was tested for fatigue, implying a limited number of test units were subjected to mechanical loading.
• Data Provenance: The testing was conducted internally by Biodenta Swiss AG. This is a non-clinical, in-vitro study (mechanical testing), not a study involving human patient data.

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

• This is not applicable as the "ground truth" for a mechanical strength test is the material's failure point under a specific load, determined by engineering standards and equipment, not human experts.

4. Adjudication method for the test set

• Not applicable. The test results are objective measurements from mechanical testing.

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

• No. This is a submission for a physical medical device (dental implant abutment), not an AI/ML diagnostic software. Therefore, an MRMC study is not relevant or performed.

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

• No. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" in this context is the mechanical load and cycle count at which the device fails, compared against established engineering standards and guidelines for dental implant abutments (specifically, the FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments).

8. The sample size for the training set

• Not applicable. There is no "training set" as this is a physical device and not an AI/ML model.

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

• Not applicable. No training set for an AI/ML model is involved.

Summary of the Study:

The primary study mentioned is fatigue testing conducted according to the "FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff." This is a non-clinical, in-vitro mechanical test. The study design focused on a "worst case scenario" for the Biodenta Dental Implant System - Multi Use-Abutment and implant. The purpose of this testing was to demonstrate that the device possesses sufficient mechanical strength for its intended clinical application, thereby supporting its substantial equivalence to predicate devices. The study did not involve human subjects, AI/ML algorithms, or expert adjudication for its results.

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Biodenta Dental Implant System Abutments are intended for terminal or intermediate abutment support for fixed or removable crown or bridgework.

The Biodenta Dental Implant System Abutments is an extension and compatible to the Biodenta Dental Implant System Bone Level (K111003) which is an integrated system of endosseous dental implants, abutments and prosthetic parts and related surgical instruments.

The Biodenta Dental Implant System Abutments includes 3 abutment types:

Temporary PEEK abutments are manufactured of biocompatible PEEK plastic and used for temporary restorations for 180 days or less. They are attached to the dental implant using an abutment screw made of titanium alloy.

Swift Abutments are manufactured of biocompatible Titanium Alloy. The Abutments are attached to the implant by screwing them directly to the implant with the integrated screw thread. The Swift Abutments are designed in order that crowns and bridges can be attached by cement retention.

Sleeve Abutments are manufactured of biocompatible Titanium Alloy. The Abutments are attached to the implant by screwing them directly to the implant with the integrated screw thread. The Sleeve abutments are designed in order that bridges can be attached by screw retention.

All Abutments are straight abutments.

The provided document is a 510(k) Summary for the Biodenta Dental Implant System Abutments. This type of document is for regulatory clearance of medical devices and focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria and statistical analysis as is common for AI/ML-based medical devices or more complex devices requiring clinical trials.

Therefore, the input document does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, or MRMC studies, standalone performance, or training/test set specifics.

The document primarily states:

• Non-clinical Testing Data:

  • No further fatigue testing was performed, referencing a guidance document for "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseus Dental Implant Abutment." (This implies the device is presumed to meet performance standards if it meets the guidance's conditions, rather than requiring specific new fatigue tests).
  • A sterilization validation was carried out according to ISO 14937:2009.
  • Biocompatible raw materials were used, and chemical cleanness by XPS analysis and leachable cytotoxic substances (ISO 10993-5:2009) were investigated.
  • A risk analysis was carried out, referencing the same guidance document.

• Equivalence to marketed device: The report claims "substantial equivalence... in intended use, material composition, fundamental scientific technology, principles of operation, and basic design" to predicate devices. This is the core of a 510(k) submission, where direct performance metrics against acceptance criteria are often replaced by comparisons to devices already on the market.

Based on the provided text, I cannot complete the requested tables and information as it is not present in the document. The document describes a regulatory submission for a dental implant abutment, which relies on demonstrating equivalence to predicate devices and adherence to established standards for materials and sterilization, rather than performance studies with quantified acceptance criteria as typically seen for novel diagnostic or AI-driven devices.

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Biodenta dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

The Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, prosthetic parts and related surgical instruments. The Bone Level D 3.0 to 6.0 mm implants use the same platforms and abutment connections like the Bone Level implants (K111003) for the diameter 4.1. 4.8. and 6.0 mm implants, and therefore the abutments and prosthetic parts of the Bone Level implants are used. The diameter 3.0 mm implants use the same connection concept in a narrower version. The submission includes:

• Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0
• Diameter 4.1 and 4.8 mm Implants with Length of: 6.5 mm; Platform B2
• Diameter 6.0 mm Implants with Length of: 6.5, 8, 10, and 12 mm; Platform B2
• Straight abutments (Straight, Temporary, Ball, Locator); B0 platform, Length 10.4 14.9 mm, Diameter 3.6 - 4.0 mm
• Healing abutments, closure screws; B0 platform, Height 0.5 7.1 mm, Diameter 2.8 3.9bmm

The provided text describes a 510(k) Pre-market Notification for the Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. Therefore, it does not involve a study with acceptance criteria and reported device performance in the typical sense of a diagnostic or AI-driven device.

Here's an analysis of the provided information based on your requested criteria, highlighting what is present and what is not:

Acceptance Criteria and Study for Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm

This 510(k) submission primarily relies on non-clinical testing to demonstrate the substantial equivalence of the Biodenta Dental Implant System to previously marketed predicate devices. The "acceptance criteria" here are defined by the performance in these non-clinical tests, ensuring the device meets safety and effectiveness standards comparable to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information (primarily relevant for AI/diagnostic studies):

• 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented. The testing pertains to physical device properties.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established for this type of device submission. Performance is based on engineering tests.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 medical device (dental implant), not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/diagnostic device. The "truth" for this device is its adherence to mechanical performance standards and material specifications, demonstrated through laboratory testing.
• 8. The sample size for the training set: Not applicable. There is no "training set" for a physical dental implant.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of Approach:

The Biodenta Dental Implant System's 510(k) submission demonstrates substantial equivalence primarily through non-clinical test data. This involved:

• Fatigue testing: Conducted according to FDA guidance for root-form endosseous dental implants and abutments. This test assessed the mechanical strength under worst-case scenarios, proving it is sufficient for the intended clinical application.
• Surface area analysis: Compared the implant surface area of the new device to predicate devices, finding it to be almost identical or higher, which is deemed sufficient.

The submission explicitly states: "Non-clinical test data was used to support the decision of safety and effectiveness." No clinical testing was presented in this summary to support the substantial equivalence. The "acceptance criteria" were met by successfully passing these specified non-clinical performance benchmarks.

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Biodenta bone level tapered dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

The Biodenta Dental Implant System - Bone Level Tapered is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants and related surgical instruments. The Bone Level Tapered implants use the same platforms and abutment connections like the Bone Level implants (K111003), and therefore the abutments and prosthetic parts of the Bone Level implants are used with the Bone Level Tapered implants.

The System includes dental implants with the following dimensions:

• Diameter 3.5 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B1
• Diameter 4.1 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B2
• Diameter 4.8 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B2
• Diameter 6.0 mm Implants with Length of: 8, 10, and 12 mm; Platform B2

The provided document is a 510(k) summary for the Biodenta Dental Implant System - Bone Level Tapered. It details the device's indications for use, description, and a comparison to predicate devices, focusing on demonstrating substantial equivalence.

However, the document does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML algorithm or a human-in-the-loop study. The "Non-clinical Testing Data" section only mentions fatigue testing according to FDA guidance and ISO 14801 for mechanical strength. This is a physical device (dental implant), not a software or AI/ML device that would typically have acceptance criteria presented in the requested format.

Therefore, I cannot provide the requested table and study details. The information requested (sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth) is only relevant for studies validating AI/ML-based medical devices, which is not the subject of this 510(k) submission.

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Biodenta bone level dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

The Biodenta Dental Implant System - Bone Level is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and prosthetic parts and related surgical instruments.

The provided text describes a 510(k) premarket notification for the Biodenta Dental Implant System - Bone Level. This document primarily focuses on demonstrating substantial equivalence to predicate devices and includes non-clinical testing data (fatigue testing). It does NOT describe an AI/ML powered medical device, nor does it contain information regarding acceptance criteria or a study that typically involves these concepts for AI/ML devices.

Therefore, the requested information cannot be extracted from the provided text as it pertains to a traditional medical device (dental implant) that does not utilize AI/ML.

Here's why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses "sufficient mechanical strength" based on fatigue testing, but there are no specific numerical acceptance criteria or performance metrics in a table format that would typically be associated with AI/ML device evaluations (e.g., sensitivity, specificity thresholds).
2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical dental implants used in fatigue testing, not a dataset for an AI model. The document mentions "worst case scenario" for the implants but no sample size for a test set in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts on a dataset. This is irrelevant for a physical dental implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve disagreements among experts on ground truth for AI datasets. This is not mentioned as the device is not AI-powered.
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. MRMC studies are specific to evaluating AI's impact on human performance in diagnostic tasks. This device is an implant, not a diagnostic tool assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to the performance of an AI algorithm on its own. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for AI is not relevant here. The "proof" for this device lies in its physical properties and mechanical strength demonstrated through non-clinical testing.
8. The sample size for the training set: Not applicable. This device does not involve a training set for an AI model.
9. How the ground truth for the training set was established: Not applicable. This device does not involve a training set for an AI model.

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The Biodenta Customized Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

The Biodenta Customized Abutment is compatible with the following implant systems:

-Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Friadent: FRIALIT Implant. XiVA Implant. 3i:Certain Internal Connect Type: Astra: Osseospeed Implant. Osseospeed TX implant; Biohorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System.

-Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered, Replace Select Straight; for the NP, RP, WP and 6.0 implants. -External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.

Biodenta Customized Abutments are titanium abutments designed to be used in coniunction with specific dental implants utilizing the Biodenta customized abutment screws to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch.

The abutment is milled using computer-assisted technology that enables the creation of final abutments that are manufactured with specific geometry. The abutment is made from titanium grade Ti-6AL-4V ELI (meets ASTM standard F-136). The abutment screw and interface is made from titanium grade Ti-6AL-4V ELI (meets ASTM standard F-136).

The Biodenta Customized Abutment is compatible with the following implant systems:

-Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Friadent: FRIALIT Implant, XiVA Implant, 3i:Certain Internal Connect Type; Astra: Osseospeed Implant. Osseospeed TX implant: Biohorizons: Internal Implant System. Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System.

-Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered. Replace Select Straight; for the NP, RP, WP and 6.0 implants. -External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.

Here's a breakdown of the acceptance criteria and the study information for the Biodenta Customized Abutment, based on the provided 510(k) summary:

This device is a physical medical device (dental implant abutment) and therefore does not involve AI/ML technology. The questions regarding AI/ML-specific study design (such as MRMC studies, standalone algorithm performance, training/test set details, expert ground truth establishment for AI/ML models) are not applicable to this submission.

The study described is a non-clinical fatigue testing study to demonstrate mechanical strength and compatibility, and a substantial equivalence comparison to predicate devices, both standard for this type of physical device.

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)

• Sample Size: Not explicitly stated as "test set" in the context of clinical data. For the fatigue testing, it's typically understood that a sufficient number of samples (representing the "worst case scenario" for each connection platform) would have been used to meet ISO 14801 requirements. The specific number of abutments tested is not provided.
• Data Provenance: The fatigue testing is non-clinical laboratory testing, not human data. The testing was conducted to ISO 14801 standards. The manufacturer is Biodenta Swiss AG, located in Switzerland. The testing was likely conducted in a lab in Switzerland or another accredited facility.

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 is a physical medical device. Ground truth in this context refers to established engineering standards (ISO 14801) and regulatory definitions of "substantial equivalence," not expert interpretation of clinical data or images.

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

• Not Applicable. This is a physical medical device; there is no "test set" requiring adjudication in the context of reader studies. The evaluation is based on meeting engineering standards and regulatory equivalence.

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

• No. This is a physical medical device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant.

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

• Not Applicable. This device does not involve an algorithm.

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

• Engineering Standards: For the fatigue testing, the ground truth is defined by the performance requirements outlined in the ISO 14801 standard.
• Regulatory Framework: For substantial equivalence, the ground truth is adherence to the criteria of "intended use, material composition, fundamental scientific technology, principles of operation, and basic design" as compared to legally marketed predicate devices, as assessed by the FDA.

8. The sample size for the training set

• Not Applicable. This is a physical medical device; there is no "training set."

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

• Not Applicable. This is a physical medical device; there is no "training set."

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Biodenta dental implants intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

Specific indications for small diameter (Ø 3.5 mm) implants: It is recommended not to place small implants with "NP" platform in the molar or premolar region.

The BIODENTA Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the BIODENTA Dental Implant System:

Summary: The provided document is a 510(k) submission for the BIODENTA Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and materials. It does not contain information about formal acceptance criteria, a clinical study with performance metrics for the device itself, sample sizes, expert ground truth, or adjudication methods for this specific device's performance.

The document states: "The clinical data and the test results demonstrate that the BIODENTA Dental Implant System is as safe and effective as the legally marketed device Straumann AG, Implant System Standard Plus." and "Based on the risk analysis, performance testing was conducted to confirm compliance to device specifications; all functions were verified to operate as designed." However, it does not explicitly detail these "clinical data and test results" or the specific performance metrics and acceptance criteria used.

Therefore, the following sections will indicate where the requested information is Not Provided (N/P) in the supplied text.

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)

• Sample Size for Test Set: N/P
• Data Provenance: N/P (No specific study details are provided, so provenance cannot be determined.)

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)

• Number of Experts: N/P
• Qualifications of Experts: N/P

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

• Adjudication Method: N/P

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

• MRMC Study: No. This device is a dental implant system, not a diagnostic AI system, so an MRMC study comparing human readers with and without AI assistance is not applicable.
• Effect Size of Human Improvement with AI: N/A

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

• Standalone Study: No. This device is a dental implant system, not an algorithm.

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

• Type of Ground Truth: N/P (No specific studies with explicit ground truth methodologies are detailed for the BIODENTA system itself. The claim of "safe and effective" relies on equivalence to predicate devices, which would have had their own clinical data and outcomes.)

8. The sample size for the training set

• Sample Size for Training Set: N/P (This device is not an AI/ML algorithm requiring a training set.)

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

• Ground Truth Establishment for Training Set: N/A (This device is not an AI/ML algorithm requiring a training set and ground truth establishment in that context.)

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