(201 days)
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.
| Acceptance Criteria/Test | Reported Device Performance |
|---|---|
| Clean room qualification (per ISO14644-1) | Qualified |
| Secondary packaging equipment qualification (consistent with ISO 11607 series) | Qualified |
| Syringe filling, labeling, and assembly process validation | Validated |
| Transport validation (per ISTA 2A) | Adequately protects the product |
| Biocompatibility assessment (per ISO 10993-1, ISO 10993-5, and ISO 10993-18) | Assessed (The therapeutic material is unchanged, implying continued biocompatibility.) |
| Ethylene oxide sterilization validation (per ISO 11135 and ISO 11737-2) | Validated to a Sterility Assurance Level (SAL) of 10-6 |
| Ethylene oxide residuals testing (per ISO 10993-7) | Tested |
| Simulated use validation (to assure proper use of the proposed Tip Cap) | Validated (Clinicians will be able to properly use the proposed Tip Cap) |
| Primary Package (Syringe) | Equivalent to predicate (glass syringe with compatible plunger components, back stop added for glass syringe functionality) |
| Secondary Package (Blister) | Equivalent to predicate (same material blister tray, Tyvek 1073B lid stock with additional durability) |
| Tertiary Package (Shelf box) | Equivalent to predicate (same material cardboard, changed configuration to accept larger secondary blister) |
| Sterility - Primary (In syringe) | Identical to predicate (produced in same clean rooms, sterilizers, and aseptic conditions) |
| Sterility - Secondary (After blister packaging) | Identical to predicate (adopted into same EtO sterilization cycle as predicate, validated to SAL of 10-6, new clean room facilities for internal packaging) |
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.
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