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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 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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