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CAMLOG® Vario SR components for crown and bridge restorations:

• Occlusal screw-retained crown, bridge and bar constructions on CAMLOG® implants (with J and K article numbers) in the anterior and posterior region of the maxilla and mandible
  CAMLOG® Vario SR components for bar restorations:
• Anchorage of implant-supported full dentures for the edentulous maxilla and mandible in combination with 2, 4 or more CAMLOG® implants (with J and K article numbers)

CAMLOG® Vario SR Abutments are titanium dental implant abutments for use with the CAMLOG® Dental Implant System. They have an internal connection to the implant, a conical interface with the prosthetic attachment, and are used for single and multi-unit screw-retained, prefabricated restorations. They are appropriate for supporting laboratory cast frameworks as well as laser-welded bar constructions and have dedicated prosthetic components.

The provided text describes the 510(k) summary for Altatec GmbH CAMLOG® Vario SR Abutments. This is a medical device submission, and the information requested pertains to the evaluation of AI/ML-driven medical devices. Unfortunately, the provided document does not contain any information about an AI/ML-driven device or its performance evaluation.

Instead, the document details a traditional medical device (dental implant abutments) and its substantial equivalence to other legally marketed predicate devices. The "testing" mentioned refers to mechanical testing according to ISO 14801 for static and dynamic fatigue properties of the physical device.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about studies involving sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these concepts are not applicable to the content provided.

I can, however, extract the relevant "testing" information for this specific device from the provided text, which focuses on mechanical performance:

Acceptance Criteria and Device Performance (for mechanical properties of the physical device):

Regarding the other requested information (AI/ML specific details):

1. Sample size used for the test set and the data provenance: Not applicable as the device is not AI/ML-driven.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be its physical strength and material properties.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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The NobelProcera Zi Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Nobel Biocare's NobelProcera Zi Abutment is an endosseous dental implant abutment. The Nobel Biocare's NobelProcera Zi Abutment attaches directly to endosseous dental implants and provides a platform for restoration.

Nobel Biccare's NobelProcera ZI Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Zi Abutments are made entirely of zirconium oxide.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study designs (such as sample sizes, data provenance, expert qualifications, or adjudication methods), or any details regarding a comparative effectiveness study or standalone algorithm performance. The document appears to be a 510(k) summary for a dental implant abutment, primarily focusing on its regulatory classification and indications for use, rather than a performance study report. Therefore, I cannot fulfill your request based on the given input.

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Nobel Biocare's Procera Zirconia Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Zirconia Abutments fit the following endosseous implants: Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm

Nobel Biocare's Procera Zirconia Abutment for Camlog Implant System is fabricated to the exact shape, size, and specifications determined in the design process in order to achieve a personalized device that fits precisely, and properly functions, according to each patient's individual needs.

Nobel Biocare's Procera Zirconia Abutment for Camlog Implant System is similar in design, intended use, and operation to the abutments cleared in predicate devices.

The provided text describes a 510(k) summary for the Procera Zirconia Abutment for Camlog Implant System. It focuses on device description, intended use, and substantial equivalence to predicate devices, but does not contain any information about acceptance criteria, study data, sample sizes, ground truth establishment, or expert involvement for assessing device performance.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, and performance metrics as this information is not present in the provided document.

This particular document is a regulatory submission summary, indicating the device has been deemed substantially equivalent to existing devices, which means it meets the regulatory requirements for marketing, but it does not detail the specific performance testing data that might be associated with such a determination.

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