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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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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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