Search Results

• Reduction or even elimination of pain in exposed cervical areas that do not . require restoration.
• Alleviation or reduction of dentine sensitivity after preparation of teeth to receive . fixed prosthesis or restorations.

GLUMA Desensitizer PowerGel is used for treatment of hypersensitive dentine. The product should be applied only on dentin with a sufficient remaining pulpal wall. It achieves its effects by precipitation of plasma proteins, which reduces dentinal permeability and occludes the peripheral dentinal tubules. This inhibits the flow of fluid through the tubules which is the cause of sensitivity. Gluma® Desensitizer PowerGel is a product for a simple and safe application. It's viscous gel like consistency leads to an easy and save application. Uncontrolled flowing from the tooth is avoided and subsequent irritation of soft tissue should be reduced. The opaque, green colour has a good visible contrast to the tooth and the mucosa so that the operator could easily see where he has applied the product.

Here's an analysis of the provided text regarding the acceptance criteria and study for Gluma® Desensitizer PowerGel, structured as requested:

Acceptance Criteria and Device Performance Study for Gluma® Desensitizer PowerGel (K093575)

This device is a desensitizing agent for dental use. The acceptance criteria primarily revolve around its physical properties, biocompatibility, and clinical effectiveness in reducing dentin sensitivity.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" with a specific sample size in the context of a prospective clinical trial. The evaluation relies on:

• Nonclinical tests: Internal specifications for physical properties.
• Biocompatibility evaluation: Based on compliance with EN ISO 10993-1, which likely involves in vitro and/or in vivo testing but no sample size for a human test set is provided.
• Clinical Evaluation: This is described as a critical evaluation of existing scientific data (literature review) and technical results, rather than a new prospective clinical study with a defined patient sample size.
• Data Provenance: The biocompatibility evaluation and clinical evaluation were performed "In accordance with the Medical Device Directive 93/42/EWG and national European medical device legislation." This indicates the data, where available, would likely be from European sources or follow European regulatory standards. The clinical evaluation primarily relies on retrospective literature review and internal technical results.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: The document refers to "the expert" (singular) and "the experts" (plural) in various instances related to assessing the benefit/risk ratio and clinical evaluation. It doesn't specify a fixed number for establishing a ground truth for a discrete test set.
• Qualifications of Experts: No specific qualifications (e.g., years of experience, specialty like "radiologist") are explicitly stated for these experts. They are referred to generally as "the expert" or "experts" involved in the clinical evaluation and risk assessment process.

4. Adjudication Method for the Test Set

Since a distinct "test set" with individually adjudicated cases for human performance evaluation (e.g., in a clinical trial) is not described, there is no adjudication method (e.g., 2+1, 3+1, none) mentioned for such a set. The clinical evaluation was a review of existing scientific data and technical results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or reported in this summary. The document does not describe human readers improving with or without AI assistance, as AI is not mentioned as part of this device or its evaluation.

6. Standalone Performance Study (Algorithm Only)

This device is a desensitizing gel, not an algorithm. Therefore, no standalone (algorithm only) performance study was conducted or is applicable. The evaluation focused on the physical, biological, and clinical performance of the chemical product itself.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established through a combination of:

• Internal specifications for physical properties (e.g., viscosity, composition).
• Biocompatibility standards (EN ISO 10993-1, DIN EN ISO 10993), which involve established protocols for testing material interactions with biological systems.
• Clinical evaluation based on existing scientific data and comparator products (literature review), which likely references studies where clinical outcomes (e.g., pain reduction) are measured, potentially against a placebo or other desensitizing agents. This could be considered outcomes data from previous studies.

8. Sample Size for the Training Set

Not applicable. This device is a chemical product, not an AI algorithm. Therefore, there is no training set in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As the device is not an AI algorithm, there is no training set or ground truth establishment method for a training set.

Ask a specific question about this device