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Papacarie Duo is a gel cleanser intended to clean the interior of a prepared cavity of a tooth prior to self-etch bonding procedures.

Papacarie Duo is a light blue colored gel cleanser dispensed from a prefilled, multi-use syringe storage system to a mixing pad, then applied to the interior of a prepared tooth cavity by dental professionals using a flocked tip brush or micro brush (not included). The tooth cavity is rinsed with water 60 seconds after application and prior to application of self-etch bonding material. The formula has a light blue color for easier visualization when it is applied on tooth surfaces. For single application prior to self-etch bonding procedure.

The provided text is a 510(k) summary for a medical device called "Papacarie Duo." This document is part of a submission to the FDA to demonstrate its substantial equivalence to previously cleared devices. It describes the device, its intended use, and compares it to predicate devices. However, it does not contain specific acceptance criteria, study details, or performance data in the structured format requested.

The summary mentions that "Non-clinical performance tests were conducted according to ISO 29022:2013 using Papacarie DUO to demonstrate substantial equivalence to the predicate device, and cleaning of prepared tooth surfaces prior to bonding of restorations." It also states, "Biocompatibility of Papacarie Duo was demonstrated and the data provided in this submission according to ISO 10993-1:2018."

These statements indicate that studies were performed, but the document does not provide the acceptance criteria or the reported performance data from these studies. Therefore, I cannot complete the requested tables and details based on the provided input.

To answer your request, the following information would be needed from a more detailed study report, not present in this 510(k) summary:

• Specific acceptance criteria: What quantitative or qualitative targets did the device need to meet to be considered effective and safe?
• Reported device performance: The actual results from the tests (e.g., cleaning efficacy measurements, bond strength results, etc.).
• Study design details: Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, details of comparative effectiveness studies (if any), and standalone performance details for the "non-clinical performance tests conducted according to ISO 29022:2013."
• Details about biocompatibility testing according to ISO 10993-1:2018: While mentioned, the specific tests and their outcomes are not described here.

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Black Diamond is intended as Treatment of Dental Hypersensitivity. For use in adults over the age of 21.

Black Diamond is a two-part liquid intended as a treatment for dentin hypersensitivity, for use in adults over the age of 21. The product does not need light cured and will provide occlusion of dentinal tubules preventing or reducing dentin hypersensitivity.

The formula has two liquid steps, each provided in an individual dropper bottle. A drop of each product is placed in a mixing well/dappen dish and applied sequentially to the tooth using a standard flock tip applicator bush such as a microbrush. The mixing pad, and applicator may or may not be included in the product package. These are standard items in dental offices and numerous types of each will work.

This document (K222323) is a 510(k) Premarket Notification from the FDA regarding "Black Diamond," a medical device intended for the treatment of dental hypersensitivity. It primarily focuses on demonstrating the substantial equivalence of Black Diamond to predicate devices based on intended use, technological characteristics, and safety information.

However, this document does NOT contain information about acceptance criteria for a study demonstrating device performance against specific metrics, nor does it detail a clinical study with human or even animal subjects that would typically be used to prove a device meets performance claims through clinical endpoints.

Instead, the document references physical tests and biocompatibility assessments to support the device's technical equivalence and safety.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies are not present in this document.

Here's an analysis of what is and is not available based on the provided text:

Based on the provided document (K222323), here's an attempt to address your request, highlighting the information that is not present as it's a 510(k) submission focused on substantial equivalence rather than a clinical trial report:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance in this 510(k) document. The document's acceptance criteria are implicit in demonstrating "substantial equivalence" to predicate devices based on similar indications for use, technological characteristics, and safety.
• Reported Device Performance:
  • Hydraulic Conductance Test: "A hydraulic conductance test was completed showing the efficacy of Black Diamond in occlusion of dentinal tubules in comparison to the predicate device." However, specific numerical results or the methodology for "efficacy" comparison (e.g., percentage reduction in conductance, statistical significance) are not provided.
  • SEM Images: "Additionally, SEM images were taken of untreated dentin treated with the predicate and subject device to show dentin tubule occlusion, and no other effect on healthy dentin." This indicates qualitative visual evidence but no quantitative performance metric.

2. Sample sizes used for the test set and the data provenance

• Test Set Sample Size: Not specified for the hydraulic conductance test or SEM imaging. These are typically bench-top or in vitro tests, not clinical test sets in the traditional sense of patient data.
• Data Provenance: The tests are described as completed by the company ("A hydraulic conductance test was completed... SEM images were taken..."). The document does not specify the country of origin of this test data or whether it was retrospective or prospective. Given these are bench tests often performed on extracted teeth, the concepts of "retrospective" or "prospective" as applied to clinical data are not relevant here.

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

• Not Applicable. For a device for hypersensitivity, clinical studies would involve patient reported outcomes or objective measurements by dental professionals. The tests described (hydraulic conductance, SEM) are physical/material characterization tests that do not typically involve human "experts" establishing a "ground truth" through consensus on images or clinical assessments in the way an AI-driven diagnostic device would.

4. Adjudication method for the test set

• Not Applicable. This concept is relevant for clinical studies involving human interpretation or multi-reader reviews, not for the physical/bench tests mentioned.

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 document does not describe any MRMC study. Black Diamond is a physical dental product (cavity varnish), not an AI-assisted diagnostic or treatment planning software.

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

• Not Applicable. Black Diamond is not an algorithm or software. It is a physical dental varnish applied by a human.

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

• Proxy Ground Truth for Equivalence: For this 510(k), the "ground truth" for performance is effectively demonstrated through physical property testing (hydraulic conductance, SEM imaging) and comparison to the known performance/composition of legally marketed predicate devices. The ground truth for safety is based on biocompatibility testing (ISO 10993-1) and risk assessment (ISO 14971), as well as the long-standing safety history of its components.
• For a device like this, clinical outcomes data (e.g., reduction in patient-reported hypersensitivity scores) would be the ultimate ground truth for clinical efficacy, but such clinical trial data is typically not required for a 510(k) submission seeking substantial equivalence based on established predicate devices and bench performance. The document only mentions "a significant safe history of use as well as a published body of literature" for the components.

8. The sample size for the training set

• Not Applicable. This device is not an AI/ML product requiring a "training set."

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

• Not Applicable. This device is not an AI/ML product.

Summary of Device Performance Proof in this 510(k) Context:

For Black Diamond, demonstrating "substantial equivalence" is the primary means of "proving" it meets regulatory requirements for marketing. This is achieved by:

• Similar Indications for Use: Directly compared and shown to be identical to the predicate and reference devices.
• Similar Technological Characteristics: Contains silver and fluoride, similar two-part liquid application, and similar mechanism of action (silver deposition for tubule occlusion).
• Bench Testing:
  • Hydraulic Conductance Test: Used to show ability to occlude dentinal tubules, implying efficacy for hypersensitivity. (Details lacking on specific quantitative results).
  • SEM Images: Visual confirmation of tubule occlusion.
• Safety Assessments: Biocompatibility testing (ISO 10993-1), risk assessments (ISO 14971), and ion elution tests.
• Long History of Use: Mention of commercial availability in other countries with a safe history for its components.

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• Elevate Moisturizing Spray is indicated to provide comfort for individuals suffering from dry mouth. It is recommended to be used by people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.
• Elevate Moisturizing Spray is indicated for rapid relief of dry mouth symptoms, to provide a protective coating inside the mouth and to help control bad breath.
• A mouth spray that quickly reduces mouth discomfort, oral malodor and other symptoms of dry mouth.

Elevate Moisturizing Spray is a viscous liquid dispensed from a spray bottle into the mouth. The spray will coat the inside of the mouth for a period of time and create relief from dry mouth symptoms in those who suffer oral malodor, discomfort, difficulties eating or speaking from dry mouth complications.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Elevate Moisturizing Spray, formatted to answer your questions:

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

The document does not explicitly state formal "acceptance criteria" for clinical performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through a comparison of physical properties and general indications for use. The closest we can get to performance data is the desorption testing.

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

• Sample Size for Test Set: The "test set" in this context refers to the samples used in the "Summary of Physical Tests," specifically the Desorption Testing. For this test, it states that "0.4g of each product was placed on a weighing dish." This implies a small, laboratory-scale sample size for each product, likely a single measurement or a very small number of replicates per product. The exact number of replicates is not specified.
• Data Provenance: Not explicitly stated. This appears to be laboratory testing conducted by the manufacturer or a contracted lab. There is no information regarding the country of origin or whether it's retrospective or prospective, though lab tests are generally considered prospective in their execution.

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. The "test set" for the physical desorption testing does not involve human expert ground truth. It's a laboratory measurement of a physical property.

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

Not applicable. The physical desorption testing does not involve human readers or adjudication.

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 an artificial saliva spray, not an AI software or diagnostic imaging device. No MRMC study was performed.

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

Not applicable. This device is an artificial saliva spray, not an algorithm.

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

For the Desorption Testing, the "ground truth" is the objective physical measurement of weight loss after incubation. There is no biological or clinical "ground truth" in the typical sense for this specific test.

For the overall substantial equivalence determination, the "ground truth" is

• Chemical Composition: Comparison of ingredients and their classification (GRAS, approved food additives).
• Intended Use & Indications: Direct comparison to the stated indications of legally marketed predicate devices.
• Mode of Action: Comparison to the known physiological effects of artificial saliva products.

8. The sample size for the training set

Not applicable. This is a medical device (artificial saliva spray), not a machine learning algorithm that requires a "training set."

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

Not applicable. There is no training set for this type of device.

Summary of Device Performance and Equivalence Claim:

The submission for the Elevate Moisturizing Spray primarily relies on demonstrating substantial equivalence to predicate devices (Biotene Moisturizing Mouth Spray and GC Moisturizing Gel) rather than establishing novel clinical performance against strict acceptance criteria.

The key arguments for substantial equivalence are:

• Similar Indications for Use: The stated indications for providing comfort, rapid relief of dry mouth symptoms, protective coating, and controlling bad breath are presented as similar to the predicate devices.
• Similar Technological Characteristics: The chemical composition and mode of action are claimed to be similar to the predicate devices, despite some variations in specific ingredients (solvents, mucoadhesive agents, rheology modifiers, preservatives).
• Physical Testing (Desorption): The device's moisture loss (21.96%) is within the range observed for the predicate devices (Biotene at 36.8%, GC Mint at 17.15%), supporting its ability to retain moisture.
• Biocompatibility and Risk Assessment: Information was provided to confirm safety based on ISO 10993 and ISO 14971, though no details of these assessments are given in the provided text.
• Ingredient Classification: Ingredients are either used in predicate devices, listed as GRAS, or approved food additives.

The FDA's letter states that they "have determined the device is substantially equivalent... to legally marketed predicate devices," affirming that the provided data (including the physical tests and comparisons) met their requirements for equivalence.

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SmartCoat 2.5% NaF Varnish is intended for use on sensitive teeth, over exposed dentin . and root surface sensitivity, and under temporary restorations or cements where post operative sensitivity is of concern.
. Rapid Desensitizer
. Provides rapid relief from sensitive teeth due hypersensitivity

SmartCoat 2.5% NaF Varnish is classified as a Cavity Varnish (21 CFR 872.3260) because it is a device that provides relief from tooth surface hypersensitivity when applied to dentin surfaces by forming a film that facilitates occlusion of compromised surfaces including open dentinal tubules.

SmartCoat is a topically applied, flavored cavity varnish containing sodium fluoride in a shellac resin based preparation. The varnish is an insoluble viscous liquid that dries once applied to the teeth to form a surface film. The packaging provides an accurate dosing and uniform dispensing mechanism for consistent product mixing and delivery.

The provided document describes the acceptance criteria and a study to demonstrate the performance of the SmartCoat™ 2.5% NaF Varnish.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: "Human dentin slabs" were prepared and used. The exact number of slabs (sample size) is not specified in the document.
• Data Provenance: The study was a bench performance test conducted in a lab setting, not involving human subjects. The provenance of the human dentin slabs (e.g., country of origin) is not mentioned.

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

• The document states that the testing involved "subjective light microscopy analysis." It does not specify the number of experts or their qualifications for establishing the ground truth (i.e., rating the occlusion).

4. Adjudication Method for the Test Set:

• The document implies a subjective analysis but does not specify any formal adjudication method (like 2+1, 3+1, or none) for the assessment of dentin tubule occlusion. Ratings were assigned, but the process of how these ratings were finalized is not detailed.

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

• No, an MRMC comparative effectiveness study was not done. The described study is a bench performance test focused on the physical occlusion property of the varnish, not on human reader performance, with or without AI assistance.

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

• Not applicable. This device is a dental varnish, not an algorithm or AI system. The performance study evaluates the physical properties of the varnish itself.

7. The Type of Ground Truth Used:

• The ground truth for this bench test was established by subjective light microscopy analysis at 500x magnification to observe dentin tubule occlusion. This involved visual assessment and ranking on a defined scale.

8. The Sample Size for the Training Set:

• Not applicable. This device is a dental varnish, not a machine learning model. Therefore, there is no "training set."

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

• Not applicable. As there is no training set for a machine learning model, this question does not apply.

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