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To relieve dental hypersensitivity caused by bleaching procedures, cold, heat, acids, or sweets.

ReminGel is a convenient, premixed, ready-to-use, opaque aqueous-based gel. ReminGel consists of suspended hydroxyapatite and calcium and phosphate salts that help restore a tooth's hydroxyapatite structure through remineralization. This remineralization results in tubule occlusion and blocks fluid flow in dentinal tubules, thereby relieving dentinal sensitivity. ReminGel blocks nerve excitability through potassium release. ReminGel is packaged in a 3oz (90mL) tube. ReminGel is for prescription use (Rx) and over-the-counter (OTC) use. ReminGel can be applied to teeth using dental appliances (e.g. fluoride tray, whitening tray, periotray, etc.) or via a toothbrush.

Here's a breakdown of the acceptance criteria and study information for ReminGel, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size used for the test set and data provenance:

   • Tubule Occlusion Testing: Resected human teeth were used. The exact sample size ("N") is not specified.
   • Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization): Not specified in terms of human subjects or teeth. These are in vitro and in vivo tests, typically performed on cell cultures or animal models for initial screening (as per ISO 10993 standards listed). The document does not provide details on the specific samples used for these tests.
   • Shelf-Life Testing: Not specified.
   • Transit Testing: Not specified.
   • Data Provenance: Not explicitly stated, but based on the in vitro nature of the tubule occlusion study on "resected human teeth," it implies laboratory testing rather than a clinical trial in patients. The biocompatibility tests are also laboratory-based. It is retrospective in the sense that the results were gathered and submitted as part of the 510(k) submission, not a prospective clinical trial.

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

   • Not applicable/Not specified. The studies cited are non-clinical (laboratory/bench testing). For tubule occlusion, the "ground truth" would be the visible occlusion as observed through microscopy, which doesn't directly involve multiple expert adjudicators for "truth" establishment in the way clinical images would.

3. Adjudication method for the test set:

   • Not applicable. As the studies are non-clinical, there is no expert adjudication method like 2+1 or 3+1 typically used for clinical image interpretation.

4. 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 MRMC study was conducted. This device (ReminGel) is a medical product (cavity varnish) and not an AI/software-as-a-medical-device that would typically involve human readers and AI assistance for interpretation.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • Tubule Occlusion: Visual observation of dentinal tubule occlusion (likely microscopic evaluation).
   • Shelf-Life: Measured physical and chemical properties over time.
   • Transit, Cytotoxicity, Irritation, Sensitization: Results from standardized laboratory test methods (e.g., ISO 10993 series).

7. The sample size for the training set:

   • Not applicable. This is a medical product, not a machine learning/AI model that requires a training set.

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

   • Not applicable, as there is no training set for this type of device.

Overall Context: The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Super Seal) and a reference device (Senzzzz Away) through non-clinical performance and biocompatibility testing, rather than extensive clinical efficacy trials. Clinical performance was explicitly "not deemed necessary" for this submission, likely due to the established mechanism of action and similarity to legally marketed devices.

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• Repair of Root Perforation
• Repair of Root Resorption
• Root End Filling
• Apexification
• Pulp Capping

Vista BC Putty is a hydraulic, ready-to-use injectable bioceramic, bioactive root repair paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. Vista BC Putty is an insoluble, radiopaque material based on a calcium sodium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Putty does not appreciable shrink during setting and demonstrates excellent physical properties.
1.0g of Vista BC Putty is packaged in a 1.2mL syringe. Vista BC Putty is for prescription use (Rx) only.

The provided text describes the regulatory clearance of a dental root canal filling material, Vista BC Putty. It references non-clinical performance testing but does not include information about clinical studies, expert-based ground truth, or MRMC studies that are typically associated with AI/ML-based medical devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ISO 6876 standards for dental root canal sealing materials. The reported performance indicates compliance with these standards and comparability to predicate devices.

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Sealer Solvent, a root canal cleanser, is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy.

The Sealer Solvent presents a clinically effective way to aid in removal of bioceramic root canal sealers during endodontic retreatment procedures. Sealer Solvent is an aqueous-based irrigant that is delivered via syringe and needle tip while instrumenting the canal after any gutta percha is removed. Sealer solvent works to soften and dissolve the sealer to be flushed out or removed with files. Although Sealer Solvent has been designed for use as a retreatment irrigant, it may be used during traditional endodontic non-retreatment procedures as an endodontic irrigant (i.e. root canal cleanser) to help remove inorganic solids from canal walls, such as smear layer and calcium hydroxide, prior to obturation.

Analysis of provided document for Acceptance Criteria and Device Performance Study Details:

Based on the provided FDA 510(k) summary for "Sealer Solvent" (K241354), the document extensively details the device's characteristics, comparison to predicate devices, and non-clinical performance testing. However, it explicitly states:

• "Clinical performance testing has not been performed for Sealer Solvent."

Therefore, the document does not contain information about a study that proves the device meets clinical acceptance criteria, nor does it provide details on sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a clinical test set. The focus of the provided information is on non-clinical (laboratory) testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the available information in relation to your request, highlighting what is present and what is absent:

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

The document does not explicitly present a table of acceptance criteria in terms of specific performance metrics for the device (e.g., a specific percentage of material removal, or a target softening time). Instead, it describes various tests performed and implies the device met the requirements for these non-clinical tests to demonstrate substantial equivalence.

Implied Performance and Testing:

Comparison to Predicate Device (Technological Characteristics):

The document emphasizes that the Sealer Solvent's technological characteristics are "very similar" to the predicate device (Ultradent Citric Acid Irrigant 20%):

• Same function: Cleanses root canal.
• Active Ingredients: Both contain Citric Acid at 20%.
• Mechanism of Action: Both aim to dissolve inorganic materials.
• Form of Use: Both filled into syringes and delivered via dental irrigation tip.
• Non-sterile.
• External communicating device with limited (≤24 hour) contact time.
• Prescription device.

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

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory-based non-clinical tests rather than human clinical studies.

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

• Not applicable as no clinical test set with human data requiring expert ground truth establishment was conducted.

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

• Not applicable as no clinical test set with human data requiring adjudication was conducted.

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 is a medical device (a solvent), not an AI-assisted diagnostic tool or imaging device that would involve human readers.

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

• Not applicable. This is a medical device, not an algorithm.

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

• For the non-clinical tests, the "ground truth" would be established by standard laboratory methods and controls for mechanical/chemical dissolution, biocompatibility, and antimicrobial efficacy testing. It would not involve expert consensus, pathology, or outcomes data in the human clinical sense.

8. The sample size for the training set:

• Not applicable. No AI/machine learning model was developed, so there is no training set.

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

• Not applicable. No AI/machine learning model was developed, so there is no training set or associated ground truth establishment.

In summary, the provided document focuses solely on the non-clinical (laboratory) testing and comparison to a predicate device to establish substantial equivalence for a solvent, without any human clinical performance data or studies involving AI or expert readers.

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Permanent obturation of the root canal following vital pulp-extirpation.
Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

Vista BC Sealer is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. Vista BC Sealer is an insoluble, radiopaque material based on a calcium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Sealer does not appreciably shrink during setting and demonstrates excellent physical properties. Vista BC Sealer is packaged in a preloaded syringe and supplied with disposable single use application tips.

The provided text describes the 510(k) submission for the Vista BC Sealer, a root canal filling material. It details non-clinical performance testing but does not include information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML algorithm or a typical clinical study with a test set, ground truth, or expert involvement. The submission focuses on demonstrating substantial equivalence to predicate devices through physical, chemical, and biocompatibility testing.

Therefore, many of the requested fields regarding acceptance criteria, study design for AI/ML, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies cannot be answered from the provided document as they are not relevant to this type of device clearance.

However, I can extract the information related to the performance demonstrated by the non-clinical tests.

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

The document does not explicitly state numerical acceptance criteria for many of the tests in a table format, but it does state compliance with ISO standards and favorable comparison to the predicate device. Where specific values or qualitative outcomes are mentioned, they are included below.

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The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.

The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.

The provided document is a 510(k) summary for the PS System, a dental device used for endodontic irrigation. It describes the device's function, comparison to a predicate device, and non-clinical and clinical performance data.

Based on the document, here's an analysis of the acceptance criteria and study information, addressing your points:

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

The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of performance tests conducted and then concludes based on the results. The key "acceptance criteria" appear to be:

• Ability to deliver and evacuate endodontic irrigation solutions.
• Performance akin to the predicate device (EndoVac System K140685).
• Reduction of apical extrusion risk compared to conventional positive pressure syringe irrigation.
• Safety and effectiveness equivalent to the predicate.

Reported Device Performance (based on the "Non-Clinical Performance Testing and Compliance" section):

The document states that the following performance tests were conducted as part of design verification:

• Suction Flow Rate Performance
• Critical Dimensions for Clinical Performance Analysis
• Corrosion Testing
• Simulated Canal Performance Testing
• Shelf Life Verification
• Biocompatibility Analysis
• Transit Testing
• Additive Manufacturing Summary Document

The conclusion states that based on "extensive comparative analysis and testing," the PS System is substantially equivalent to the predicate, and that differences "do not raise any new questions of safety and effectiveness." This implies the tests successfully demonstrated comparable performance and met the underlying safety and effectiveness expectations for such a device. However, specific quantitative performance metrics or pass/fail thresholds for these tests are NOT provided in this summary document.

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

The document is a 510(k) summary, which typically provides an overview rather than detailed study protocols. As such, the sample sizes for the non-clinical tests are not specified.

Data Provenance: The studies are described as "Non-Clinical Performance Testing." The document is submitted by Inter-Med, Inc. from Racine, WI, USA, suggesting the testing was likely conducted in the US or by a US-affiliated entity. The document doesn't specify if the data is retrospective or prospective, but as it's for design verification, it would inherently be prospective testing.

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

This information is not provided in the document. The tests performed are primarily engineering and material performance tests (e.g., suction flow rate, corrosion, biocompatibility, dimensions). These types of tests typically rely on established standards and laboratory measurements rather than expert human interpretation for "ground truth." Therefore, experts in establishing "ground truth" would not be relevant in the same way they would be for, say, an AI-based diagnostic device.

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

Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used in clinical studies or studies involving human readers/interpreters, especially for AI or diagnostic devices where subjective interpretation is involved. Since this document focuses on non-clinical performance testing of a physical medical device, adjudication methods are not applicable and thus not 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. The PS System is a dental handpiece/irrigation system, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

No. This is not an algorithm or AI device. It is a physical medical device for irrigation. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

For the non-clinical performance tests mentioned (Suction Flow Rate, Critical Dimensions, Corrosion, Simulated Canal Performance, Shelf Life, Biocompatibility, Transit), the "ground truth" would be established by:

• Reference standards and measurements: For dimensions, flow rates, and physical properties.
• Standardized testing protocols: For corrosion, shelf life stability, and transit resilience.
• ISO standards and established biological assays: For biocompatibility (e.g., ISO 7405, ISO 10993-1).

There is no mention of expert consensus, pathology, or outcomes data being used for ground truth in this context, as they are not relevant to the types of tests described.

8. The sample size for the training set

The device is a physical medical device, 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

As there is no "training set" (see point 8), this question is not applicable.

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CHX and CHX-Plus™ are used as a final endodontic rinse after instrumentation to irrigate and cleanse the root canal system for long lasting cleansing

CHX and CHX-PlusTM are 2% Chlorhexidine Gluconate Solutions in water. CHX – PlusTM also contains wetting agents to lower surface tension. CHX and CHX-PlusTM are root canal cleansers for use in endodontic procedures. After endodontic instrumentation, these products should be used to cleanse the canal space before placement of the endodontic filling. The material should be delivered into the canal using an irrigating needle

The provided text is a 510(k) summary for a dental device (root canal cleanser) and does not contain information about the acceptance criteria or a study proving that an AI device meets such criteria. The document explicitly states "Non-clinical Performance" for CHX and CHX-Plus™, indicating evaluations were related to the physical properties, efficacy, and biocompatibility of the chemical solution, not an AI algorithm.

Therefore, I cannot provide the requested information based on the given input regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI device.

The document pertains to a chemical product, not an AI-powered medical device.

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Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM are solutions used for debridement and the instrumentation of root canal. Sodium Hypochlorite-3% & 6% and Chlor-XTRATM 6% are Sodium Hypochlorite in water.

Sodium Hypochlorite 3% & 6%: Solutions are 3% & 6% Sodium Hypochlorite in water.
Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM is a Sodium Hypochlorite solution in water with alkalizing salt agents to increase the electrical capacity of the solution.

The provided document is a 510(k) summary for a medical device (Sodium Hypochlorite solutions for root canal cleaning) and a letter from the FDA determining substantial equivalence to predicate devices. This type of regulatory submission does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC comparative effectiveness studies in the way an AI/ML device submission would.

For devices classified as Endodontic Cleansers (Product Code KJJ), the FDA primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, meaning the new device is as safe and effective as existing ones. The "performance" section mentions "Laboratory analyses are provided in this premarket notification" and "Several published articles supporting this statement have been included in this premarket notification," indicating that the "study" proving the device meets acceptance criteria is likely a combination of these laboratory analyses and existing scientific literature on sodium hypochlorite as a root canal irrigant, rather than a novel clinical trial designed to establish specific performance metrics for this particular device.

Therefore, I cannot extract the specific information requested in the prompt's numbered list because it is not present in the provided 510(k) summary. The summary focuses on demonstrating equivalence to predicate devices based on formula and intended use, and the established standard of care for the active ingredient.

To address the prompt as best as possible with the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, specific quantitative acceptance criteria or device performance metrics for the new device (beyond its chemical composition and intended use) are not explicitly stated. The acceptance criteria for this type of device, as per the 510(k) process, revolve around substantial equivalence to predicate devices in terms of:

• Indications for Use: Identical or similar
• Technological Characteristics: Similar (e.g., Sodium Hypochlorite in water)
• Safety and Effectiveness: Demonstrated by similarity to established predicate devices and the known properties of sodium hypochlorite as a root canal irrigant.

Regarding the other points (2-9):

These points are directly related to the design and execution of clinical performance studies, which are typically required for novel devices or those with higher risk classifications where substantial equivalence cannot be adequately demonstrated through existing literature and technological characteristics alone.

For this 510(k) submission (K082470) for an Endodontic Cleanser, the FDA determined substantial equivalence based on the product's formulation (sodium hypochlorite) and its intended use being consistent with predicate devices and the established "standard of care." Therefore, the details requested in points 2-9 about specific clinical study parameters (sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance, training sets) are not provided in this 510(k) summary. These types of studies were not deemed necessary explicitly for this specific device's clearance. The "performance" section mentions "Laboratory analyses" and "published articles," indicating a reliance on existing scientific knowledge and basic quality control, not a dedicated clinical effectiveness trial for this particular submission.

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