Search Results

Straumann PrefGel is intended for topical application onto exposed root surfaces during periodontal surgery in order to remove the smear layer.

Straumann PrefGel is a neutral EDTA formulation intended for topical application onto exposed root surfaces during periodontal surgery in order to remove the smear-layer. Mechanical debridement of a root surface inevitably produces a smear-layer, which in turn may prevent or retard periodontal healing. Exposure of collagen fibers may be important for linking fibrin in the blood clot to the root surface. Clinical studies with PrefGel have demonstrated the ability to remove the smear-layer and to expose the collagenous matrix of dentin surfaces.

This document ([K162311](https://www.accessdata.fda.gov/cdrh_docs/pdf16/[K162311](https://510k.innolitics.com/search/K162311).pdf)) describes the Straumann PrefGel, a neutral EDTA formulation for topical application on exposed root surfaces during periodontal surgery to remove the smear layer. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, primarily by detailing changes to the packaging system while asserting that the therapeutic material and indications for use remain unchanged. Therefore, the "acceptance criteria" and "device performance" in this context refer to the performance of the packaging and manufacturing processes to ensure the safety and effectiveness of the unchanged therapeutic material.

Here's an analysis of the provided information, framed as a response to your request, but with the understanding that this device is a chemical product and not an AI/ML powered device. Therefore, no AI/ML specific sections can be filled.

1. A table of acceptance criteria and the reported device performance

Since this is not an AI/ML enabled device, typical metrics like sensitivity, specificity, or AUC are not applicable. The acceptance criteria and performance are based on maintaining the safety and efficacy of the original product through changes in packaging and manufacturing processes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of clinical or diagnostic performance for the device itself, as the therapeutic material remains unchanged. The studies described are engineering and manufacturing validations. Therefore, sample sizes would be implicit in standard validation protocols for each specific test (e.g., a certain number of syringes for filling validation, a certain number of packages for transport validation). The provenance is from Institut Straumann AG (Switzerland) and Straumann USA, LLC (USA), as the submitter and manufacturer are based there. The studies are prospective in nature, as they are validations of new or modified manufacturing processes and packaging.

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, as this is not a diagnostic device and no clinical or diagnostic "ground truth" was established for a test set in the conventional sense. The "ground truth" here is adherence to engineering and quality standards, established by qualified personnel in the respective fields (e.g., sterilization experts, packaging engineers, biocompatibility specialists).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a diagnostic device that requires expert adjudication of results.

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 chemical product for topical application and does not involve human readers or AI.

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

Not applicable. This is not an algorithm or an AI system.

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

The "ground truth" in this context is based on:

• Engineering and Manufacturing Standards: Adherence to international standards (e.g., ISO 14644-1 for clean rooms, ISO 11607 series for packaging, ISO 11135 for sterilization, ISO 10993 series for biocompatibility).
• Functional Equivalence: Demonstration that the new packaging components and processes perform equivalently to or better than the predicate device's components and processes, ensuring the therapeutic material's integrity and safe delivery.
• Simulated Use: Validation that the device can be properly used by clinicians.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not have a "training set."

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

Not applicable.

Ask a specific question about this device

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

• 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.

Ask a specific question about this device