(21 days)
The Straumann© PrefGel™ is indicated for topical application onto exposed root surfaces during periodontal surgery in order to selectively remove the smear-layer PrefGel has been shown to mod remove the smear-layer. PrefGel has been shown to produce a fibrillar collagenous meshwork on the exposed and conditioned root surface by selective removal of mineral. It does not induce any detectable necrosis in the surrounding periodontal tissues.
PrefGel is an EDTA gel used for topical application prior to periodontal surgery to remove the smear-layer.
The provided text is a 510(k) summary for the Straumann® PrefGel, a root surface conditioning gel. This FDA submission focuses on demonstrating substantial equivalence to a previously marketed predicate device (PrefGel, K940737), rather than proving performance against specific acceptance criteria through a comprehensive clinical study.
Therefore, the information typically requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies (MRMC, standalone AI performance) is largely not applicable or not explicitly detailed in this type of submission.
Here's an breakdown based on the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in terms of quantitative metrics or a priori thresholds. The core "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device. | Demonstrated substantial equivalence to the currently marketed PrefGel (K940737) in terms of: |
- Same intended use
- Same design characteristics
- Same method of application
- Similar performance characteristics
- Biocompatibility |
Explanation: In a 510(k) for a device like PrefGel, the "performance data" section primarily aims to show that the new device functions in a comparable manner to the predicate. It's not about achieving specific numerical targets (e.g., 90% sensitivity or specificity) in a clinical trial. The performance is indirectly "proven" by its similarity to an already approved device.
Study Details
Given the nature of a 510(k) for a device like this, which relies on substantial equivalence to an existing product, a traditional, large-scale clinical study with the elements you requested is not described.
1. Sample sizes used for the test set and the data provenance:
- Not explicitly stated for a dedicated "test set" in the context of a diagnostic or AI device. The submission indicates "performance characteristics tested and biocompatibility," implying some form of testing was done to confirm the product's properties, but no details on sample size, data provenance, or study design are provided for these tests.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Establishing ground truth with experts is typically for diagnostic devices where human interpretation is the benchmark. This submission is for a topical dental gel.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This is relevant for studies involving human readers and interpretation, which is not the focus here.
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. This device is a dental gel, not an AI-powered diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a dental gel, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "performance characteristics" and "biocompatibility" mentioned, the ground truth would likely involve established laboratory tests and standards (e.g., chemical analysis, in vitro cell studies, animal models for biocompatibility). Specific details are not provided.
7. The sample size for the training set:
- Not applicable. This device is a dental gel, not an AI device that requires a "training set."
8. How the ground truth for the training set was established:
- Not applicable. See point 7.
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