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G+U•M® HYDRAL™ Dry Mouth Oral Gel helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

G•U•M® HYDRAL™ Dry Mouth Oral Rinse helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

G.U.M® HYDRAL™ Dry Mouth Oral Spray helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

G+U•M® HYDRAL™ Dry Mouth Oral Gel, G•U•M® HYDRAL™ Dry Mouth Oral Rinse and G•U•M® HYDRAL™ Dry Mouth Oral Spray are specifically formulated artificial saliva with a pH between 5.00 to 7.00. The proposed device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, soothing, and humectant, sweeteners and flavors that collectively have lubricating, moisturizing, and refreshing properties to help relieve and manage the symptoms of dry mouth.

The device is provided in a realy to use at home. G-U-M- HYDRAL" " Dry Mouth Oral Gel is supplied in a 1.5-oune Polyethylene Laminate tube. G-U-M " Hrise is spay i.69 fluid ounce bottle. Both rinse and spray are packaged in Polyethylene Terephthalate (PET) bottles with white polypropylene caps.

This document describes the 510(k) premarket notification for three dry mouth products: G•U•M® HYDRAL™ Dry Mouth Oral Gel, Oral Rinse, and Oral Spray. The main focus is on establishing substantial equivalence to a predicate device (Biotene® Oral Balance® Dry Mouth Moisturizing Gel and associated rinse/spray, K123731).

Here's an analysis of the acceptance criteria and supporting study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the goal of demonstrating substantial equivalence to the predicate device, particularly in terms of technological characteristics and intended use. The performance reported is primarily a comparison against the predicate device's characteristics.

Study Proving Acceptance Criteria:

The document states that "Bench testing comparing predicate and proposed devices' technological characteristics was performed. It was demonstrated that predicate and proposed devices are not significantly different from each other in terms of technological characteristics."

This bench testing, along with a shelf-life stability report and biocompatibility testing, forms the basis for the substantial equivalence determination. The variations in formulation and characteristics like color, odor, and viscosity were assessed and deemed not to "affect the functions or equivalency of the proposed products," being primarily related to viscosity control and flavor. New components were identified as GRAS ingredients, food additives, or having a significant history of use.

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

The document does not explicitly state the sample size used for the bench testing. It only mentions "Bench testing comparing predicate and proposed devices' technological characteristics was performed." There is no information regarding data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided in the document. For these types of devices (artificial saliva), "ground truth" typically relates to chemical and physical property measurements rather than expert clinical assessment of individual cases for the purpose of demonstrating substantial equivalence based on technological characteristics.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the bench testing described (measurement of physical and chemical parameters), an adjudication method in the typical sense (e.g., for clinical diagnoses) would not be applicable.

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

There was no MRMC comparative effectiveness study done. This document concerns a medical device that is a topical oral product (artificial saliva), not an AI-powered diagnostic or imaging device used by human readers.

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

There was no standalone (algorithm-only) performance study done. This product is not an algorithm or AI.

7. The Type of Ground Truth Used

For the technological characteristics, the "ground truth" implicitly refers to standardized physical and chemical measurement methods and specifications. For ingredients, it refers to chemical composition and regulatory status (e.g., GRAS, food additive, history of use). For biocompatibility, the ground truth is conformance with ISO 10993-1 standards.

8. The Sample Size for the Training Set

There is no training set in the context of this device. A training set is typically relevant for machine learning or AI models, which this device is not. The "study" here is a set of bench tests and validations of the product's physical, chemical, and biological properties.

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

As there is no training set for this type of device, this question is not applicable.

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GBR Configurations: To aid in bone regeneration and augmentation in oral surgery for: Extraction socket site preservation; Immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desire; Ridge augmentation; Sinus elevation; Stable barrier for the containment of bone grafting materials. GTR Configurations: To aid in the regeneration and integration of periodontal tissue components. For use as an adjunct in periodontal surgical treatment to supplement the reparative process following scaling and root planning for: Class II furcations; intrabony defects; recession type defects.

The GUIDOR® Bioresorbable Matrix Barrier is a two-layered (sandwich) structure with spacers between the layers that provide stability to the matrix and maintain an adequate space to aid in tissue regeneration and prevention of epithelial downgrowth. The GUIDOR® Matrix is bioresorbable to allow for singlestep surgery, eliminating the need for a second surgery to remove the matrix.

1. Acceptance Criteria and Reported Device Performance:

Study Information:

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 explicitly state a specific "test set" sample size or its country of origin.
   • The clinical evidence provided is based on "retrospective clinical data and human studies reported in the literature." This suggests the data is retrospective, but the origin country is not specified.

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

   • Not applicable. The study relies on "retrospective clinical data and human studies reported in the literature" rather than a specific expert-adjudicated test set for this 510(k) submission. No information is provided about the number or qualifications of experts involved in the original studies forming the literature review.

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

   • Not applicable. No explicit adjudication method is mentioned for a test set. The submission relies on a literature review.

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 bioresorbable matrix barrier, not an AI or imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

   • Not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

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

   • The "ground truth" is implicitly derived from the established clinical outcomes and efficacy reported in the existing "retrospective clinical data and human studies reported in the literature" for both synthetic resorbable membranes and resorbable collagen membranes. This effectively means outcomes data from previously conducted clinical studies.

8. The sample size for the training set:

   • Not applicable. This submission does not describe an AI/machine learning model with a distinct "training set." The evidence for substantial equivalence is based on existing published clinical literature.

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

   • Not applicable, as there is no described training set for an algorithm in this submission.

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Butler® Calci-Flor Prophylaxis Paste is designed to clean and polish teeth during professionally administered dental hygiene prophylaxis treatments.
Butler® Calci-Flor Prophylaxis Paste is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

Butler® Calci-Flor Prophylaxis Paste is an oral cavity abrasive polishing agent that contains calcium and fluoride. This device is regulated by FDA as a Class I device.
Butler® Calci-Flor Prophylaxis Paste is an abrasive oral prophylaxis paste (available in one of several levels of grit coarseness), which contains fluoride, calcium, humectants, bulking agents for proper paste formation, a sweetener, flavor, color, and preservatives. This device is intended for use by dental professionals, during professionally administered dental prophylaxis treatment (tooth-cleaning), to remove stain from and polish the teeth. Paste application is designed for use with a prophy angle with suitable cup. The device is to be limited to individuals who are professionally trained to perform dental prophylaxis.

The provided document is a 510(k) premarket notification for a dental prophylaxis paste, Butler® Calci-Flor Prophylaxis Paste. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding clinical studies, ground truth, and expert adjudication is not present in this type of submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This type of data is not typically presented in a 510(k) submission for a Class I device seeking substantial equivalence based on material composition and intended use. The submission focuses on demonstrating that the new device is "at least as safe and effective as the legally marketed predicate device" through bench testing and comparison of characteristics.

• Acceptance Criteria (Implicit): The implicit acceptance criteria are that the device's characteristics (material composition, intended use, duration of patient contact) are substantially equivalent to predicate devices, and that any new testing (fluoride release) does not raise new questions of safety and effectiveness.
• Reported Device Performance:
  • Material Composition: "Butler® Calci-Flor Prophylaxis Paste is made of the same ingredient component materials that are used in lawfully marketed predicate devices..."
  • Intended Use/Indications: "...has the same indications for use and intended use as lawfully marketed predicate devices."
  • Patient Contact: "...with the same type and durations of patient contact."
  • Fluoride Release Data: "Bench testing was performed on the Butler® Calci-Flor Prophylaxis Paste to ascertain fluoride release data." The results "do not raise new questions of safety and effectiveness."

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

This information is not provided because a clinical test set, in the sense of a patient cohort or a large dataset, was not used. The testing described is "bench testing" for fluoride release. Details of this bench testing, including any sample sizes for the laboratory tests, are not elaborated upon in this summary document.

• Data Provenance: Not applicable as no clinical test set was described.

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

Not applicable. Ground truth, in the context of clinical studies with expert adjudication, is not relevant to this 510(k) submission, which relies on demonstrating substantial equivalence through material comparison and bench testing.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring clinical adjudication is described.

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

No, an MRMC comparative effectiveness study was not done.

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

This is not applicable, as the device is a prophylaxis paste, not an algorithm or AI system.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable here. The "truth" in this submission relies on:

• The known characteristics and regulatory history of predicate devices.
• The chemical composition of the new device.
• The results of basic bench testing (fluoride release).

8. The Sample Size for the Training Set

Not applicable. The 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, for the same reason as point 8.

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