Search Results

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.

Ask a specific question about this device

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.

The Procera Implant Bridge can be used at the implant or abutment level of the following implant systems:

Nobel Biocare Brånemark System Nobel Biocare Replace Select

The Procera Implant Bridge can be used at the implant level of the following implant systems:

Nobel Biocare Replace

Nobel Biocare Steri-Oss HL Nobel Biocare Novum

Nobel Biocare Novum
Straumann Dental Implants

Straumann Dental Implant System Regular neck 4.8 Straumann Dental Implant System Wide neck 6,5

The Procera Implant Bridge can be used at abutment level of the following implant systems: Nobel Biocare ARK abutment for Teeth-in-Hour concept

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 and abutment interfaces are modeled after similar interfaces currently available for the predicate devices listed.

This document describes a 510(k) premarket notification for the Procera® Implant Bridge, a dental bridge framework. However, the provided text does not contain acceptance criteria for device performance, nor does it detail any specific studies (e.g., clinical trials or performance tests with statistical results) that directly prove the device meets such criteria.

The document primarily focuses on:

• Device Description: What the device is and how it's made (titanium, custom-made).
• Intended Use/Indications for Use: What the device is for (restoring chewing function in partially or totally edentulous jaws) and compatible implant systems.
• Substantial Equivalence: Comparing the device to legally marketed predicate devices.
• Regulatory Information: Classification, product code, and relevant regulations.

Here's an analysis based on the provided text for the requested information, highlighting what is not present:

1. Table of acceptance criteria and reported device performance

Not present in the document. The submission is for substantial equivalence to predicates, implying that if it's materially similar to already approved devices, it's considered safe and effective. There are no specific performance metrics or acceptance criteria listed for the Procera® Implant Bridge itself, nor are there reported results of performance tests against such criteria.

2. Sample size used for the test set and the data provenance

Not applicable. No specific test set or study data are mentioned for this device. The submission relies on substantial equivalence.

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 establishment is described as there's no performance study detailed.

4. Adjudication method for the test set

Not applicable. No test set or related adjudication process 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 device is a dental implant component, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies or AI improvement metrics are irrelevant here.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No ground truth data is mentioned for this 510(k) submission.

8. The sample size for the training set

Not applicable. As the device is not an AI/ML algorithm or software, there is no training set in the context of data-driven models.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there's no ground truth establishment for it.

Summary of what the document states about "Performance Standards":

The document mentions in section 1.5 "Performance Standards": "The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDA was identified as applicable to this submission." This indicates that the device operates under a framework of "Special Controls," which are regulatory measures beyond general controls to provide reasonable assurance of safety and effectiveness. However, the document does not elaborate on what specific performance criteria from this guidance the device was tested against or the results of such testing. It merely states that the guidance was identified as applicable.

Ask a specific question about this device