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510(k) Data Aggregation
(115 days)
The Procera Implant Bridge Overdenture is indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially edentulous jaws for the purpose of restoring chewing function.
Nobel Biocare's Procera® Implant Bridge Overdenture is an overdenture bar that attaches to implants or abutments. The Procera® Implant Bridge Overdenture provides retention and support for a removable denture made of standard laboratory dental materials such as resin composite or porcelain veneer.
Procera® Implant Bridge Overdentures are made individually following instructions and models specific to each patient. The Procera® Implant Bridge is made entirely of titanium, titanium/vanadium alloy, or chromium/cobalt alloy.
The Procera® Implant Bridge Overdenture implant interfaces are the predicate Procera Implant Bridges.
This looks like a 510(k) summary for a medical device (Procera Implant Bridge Overdenture) which is typically about demonstrating substantial equivalence to a predicate device, not necessarily extensive clinical studies with acceptance criteria, ground truth, and reader studies in the way an AI/ML device would be evaluated. As such, most of the requested information regarding AI/ML device evaluation is not present in the provided document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain explicit acceptance criteria or detailed performance metrics in the way an AI/ML diagnostic device would. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through descriptive device characteristics and intended use, rather than quantifiable performance data against predefined criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes a physical medical device (dental implant overdenture bar), not a software or AI/ML diagnostic tool that would typically use a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment with experts is a concept for evaluating diagnostic accuracy, which is not the focus of this 510(k) for a physical implantable device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not part of this device's submission.
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. An MRMC study with AI assistance is specifically for evaluating diagnostic AI systems, not a physical dental implant component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a physical device like this, "ground truth" would relate to its structural integrity, biocompatibility, and mechanical properties, not diagnostic accuracy based on expert consensus or pathology in the context of an AI/ML device. The "ground truth" for demonstrating substantial equivalence would be that its materials and design are comparable to already marketed devices.
8. The sample size for the training set
Not applicable. This document does not describe an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of what is available from the provided text:
The document is a 510(k) Summary of Safety and Effectiveness for the "Procera Implant Bridge Overdenture."
- Device Description: It's an overdenture bar that attaches to implants or abutments to support a removable denture. It's made of titanium, titanium/vanadium alloy, or chromium/cobalt alloy.
- Indications for Use: Indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially edentulous jaws for restoring chewing function.
- Predicate Devices:
- Substantial Equivalence: The FDA's letter (K090069) confirms that the device is deemed "substantially equivalent" to legally marketed predicate devices. This means the FDA found that the device is as safe and effective as a legally marketed device that does not require premarket approval. The basis for this substantial equivalence would have been a comparison of technological characteristics, materials, and intended use to the predicate devices, likely supported by non-clinical bench testing for mechanical properties and biocompatibility, rather than clinical studies with human subjects or AI performance evaluations as requested.
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