Search Results

The ANKYLOS® Dental Implant System 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 endosseus implant.

The ANKYLOS® Dental Implant System has been cleared for commercial distribution. The purpose of this application is to obtain clearance for additional marketing claims associated with the special features of the ANKYLOS® Dental Implant System.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for the ANKYLOS® Dental Implant System. It primarily focuses on:

• Device Description and Intended Use: Explaining what the device is and what it's used for.
• Predicate Device Information: Stating that the current device is substantially equivalent to a previously cleared one.
• Technological Characteristics: Asserting that no changes have been made to the device itself, implying that previous safety and effectiveness data still apply.
• Regulatory Communication: Correspondence from the FDA affirming the substantial equivalence and permitting marketing.

There is no mention of:

• Specific performance metrics or acceptance criteria for the device (e.g., success rates, torque values, osseointegration rates).
• Any clinical or non-clinical study that was conducted to demonstrate performance against such criteria.
• Details about test sets, data provenance, expert panels, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

Therefore, I cannot provide the requested table or detailed information about a study based on the given text.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device