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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 Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. In addition to the Branemark implant, the bridge's hexagon connector interface fits the external hexagon of the following endosseous implants:
• 3i® 3.75

• Lifecore® Biomedical Restore 3.75
  · Zimmer® Dental Taper-lock 4.0
  · Sterngold Implamed® 3.75

Nobel Biocare's Procera® Implant Bridge is a bridge framework that attaches to implants or abutments. The Procera® Implant Bridge framework is intended to be finished into a dental prosthesis using standard laboratory dental materials such as resin composite or porcelain veneer.
Procera® Implant Bridges are made individually following instructions and models specific to each patient. The Procera® Implant Bridge is made entirely of titanium.
The Procera® Implant Bridge implant interfaces are modeled after similar interfaces currently available for the predicate devices listed.

This document is a 510(k) premarket notification for a dental device, the Procera® Implant Bridge. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria and device performance in the way a clinical trial or algorithm validation study would.

Therefore, the requested information elements related to sample size, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable as they are not typically part of a 510(k) submission for this type of device. The "study" here is essentially the comparison of the new device to predicate devices based on design, materials, and intended use.

Here's an analysis based on the provided text, focusing on what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This type of acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy) is not elaborated upon in a 510(k) for a physical medical device like a dental implant bridge. The "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence to predicate devices. The performance is assessed by confirming that the new device functions similarly and uses comparable materials and design principles as already approved devices.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable in this context. A 510(k) for a dental device like this typically relies on design verification and validation tests (bench testing), material specifications, and comparison to predicate devices, rather than a "test set" of patient data in the way an AI/software device would have. The data provenance would be internal engineering and materials testing, not patient data in the sense of a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable. Ground truth, in the context of expert consensus, is critical for AI/software validation. For a physical dental device, the "truth" is established by manufacturing specifications, material science, and clinical performance of predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable. No test set requiring expert 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

An MRMC study is not applicable. This type of study is relevant for AI-powered diagnostic tools or decision support systems. The Procera® Implant Bridge is a physical prosthetic device.

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

This is not applicable. The device is a physical implant bridge, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device primarily relies on:

• Engineering specifications and design parameters: Ensuring the bridge meets specific dimensions, strength requirements, and fits existing implant systems.
• Material properties: Verifying the titanium used meets biomedical standards.
• Clinical history of predicate devices: The fact that the predicate devices (e.g., Procera® Implant Bridge K041236, 3i Dental Abutment K032263, etc.) are already legally marketed and have established safety and effectiveness forms a crucial part of the "truth" for substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable. No training set exists for this device.

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