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For treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces.

Cervitec®F is a dental varnish for the treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces. The varnish system is characterized by its good moisture tolerance during application. Cervited in either a Tube (4gm, 7gm) or Single Dose (0.26gm) delivery form.

The provided document describes the substantial equivalence of the Cervitec F dental varnish to its predicate devices, primarily Fluor Protector S (K131487), based on non-clinical performance testing and biocompatibility assessments. It does not contain information about a study proving the device meets acceptance criteria related to its clinical efficacy in treating dentinal hypersensitivity or exposed dentin and root cervical surfaces using metrics typically found in medical device studies (e.g., sensitivity, specificity, AUC).

Instead, the acceptance criteria and supporting study are focused on demonstrating that Cervitec F adheres to a relevant standard for fluoride varnishes and is biocompatible.

Here's a breakdown of the information available based on your request:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Non-clinical performance testing (ISO 17730:2014): Not explicitly stated. The document mentions "Specific physical properties have been assessed and verified," but details on the number of samples or methodology are not provided. These are generally laboratory tests on product batches.
• Biocompatibility testing: Not explicitly stated. Biocompatibility tests usually involve in vitro assays and in vivo animal studies, but the number of samples or subjects is not mentioned.

The provenance of this data is internal testing conducted by the manufacturer, Ivoclar Vivadent AG, to demonstrate compliance with international standards. It's retrospective in the sense that these tests were performed to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided. The "ground truth" for the non-clinical performance and biocompatibility refers to the established standards (ISO 17730:2014, EN ISO 10993-1:2009, EN ISO 7405:2008) themselves, and the device's adherence to their requirements as measured through laboratory and biological tests. There are no human "experts" establishing a clinical ground truth for image interpretation or diagnosis in this context.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human reader interpretations are compared. This document describes non-clinical and biocompatibility testing.

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:

No. This type of study (MRMC, AI assistance) is not mentioned and is not relevant for a dental varnish approval for dentinal hypersensitivity. The device is a direct treatment, not a diagnostic or AI-powered assistive technology for human readers.

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

Not applicable. This device is a manual application dental varnish, not an algorithm.

7. The type of ground truth used:

• For non-clinical performance: The ground truth is defined by the specifications set out in the international standard EN ISO 17730:2014 "Dentistry – fluoride varnishes," particularly regarding the total fluoride content.
• For biocompatibility: The ground truth is established by the accepted scientific and regulatory principles for biocompatibility testing as outlined in EN ISO 10993-1:2009 and EN ISO 7405:2008, determining whether the material elicits an adverse biological response.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set."

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

Not applicable, as there is no training set.

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Intended Use: Symptomatic treatment of xerostomia.
Indications for Use: Relieve symptoms of dry mouth, refresh, moisturize, clean and soothe oral irritation, and lubricate oral dryness.

Oral77M products are specially formulated saliva substitutes which contain moisturizers, humectants, proteins and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Oral7™ Moisturizing Gel, Mouthwash, and Mouth Spray:

Important Note: This document is a 510(k) summary, which is a premarket notification for devices that are "substantially equivalent" to legally marketed predicate devices. It primarily focuses on demonstrating equivalence rather than proving the device's efficacy through extensive clinical trials. Therefore, many of the typical acceptance criteria and study details for novel or high-risk devices will not be present.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" in the format typically seen for algorithm performance (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" is demonstrated through non-clinical and bench testing, focusing on safety and technological similarity.

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

• Test Set: The "test set" in this context refers to the samples of the Oral7™ products used for nonclinical (biocompatibility) and bench (stability) testing.
  • Biocompatibility Testing: The number of samples/replicates used for ISO 10993-1, -5, and -10 testing is not specified in the summary document. It's typically done on representative finished devices.
  • Stability Testing: Three (3) batches each of Oral7™ Moisturizing Gel and Oral7™ Moisturizing Mouthwash were tested.
• Data Provenance: Not explicitly stated, meaning a specific country of origin for test specimens or an explicit retrospective/prospective design is not detailed in this summary. Biocompatibility and stability testing are generally prospective tests conducted specifically for the submission.

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

This type of information is not applicable to this submission. The ground truth for biocompatibility is established by standardized laboratory tests (e.g., cell cultures for cytotoxicity, animal models for sensitization) and recognized international standards (ISO 10993). The ground truth for stability is established by analytical chemistry and physical property measurements over time. No human experts establish a "ground truth" in the way they would for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used when multiple human readers independently evaluate data (e.g., medical images) and their interpretations need to be reconciled to form a definitive "ground truth." This submission involves laboratory and bench testing, not subjective human evaluation of product performance in a clinical context.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are used to assess the impact of a diagnostic aid (often AI) on human reader performance. This device is a therapeutic product (saliva substitute) and not a diagnostic tool where human interpretation of cases is involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm performance study was not done. This device is a physical product (gel, mouthwash, spray), not a software algorithm.

7. The Type of Ground Truth Used

• Biocompatibility: The ground truth is based on established international standards (ISO 10993) and their defined criteria for cytotoxicity, sensitization, and irritation.
• Stability: The ground truth is based on analytical chemistry and physical property measurements defined in product specifications and monitored over time. This determines if the product remains within acceptable limits.
• Equivalence: The overarching "ground truth" for the submission is the predicate device's known safety and effectiveness as previously cleared by the FDA. The Oral7™ products' ground truth is its demonstrated similarity in intended use, technological characteristics, and safety profile to these established predicates.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established for it.

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