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RC SwiftPrep™ Gel is a root canal cleanser designed to etch, cleanse, and debride root canal walls, while removing smear layers prior to obturation. It facilitates efficient instrumentation and promotes optimal sealing of the canal.

RC-SwiftPrep is a root canal cleanser in gel form.

Unfortunately, the provided FDA 510(k) clearance letter for RC-SwiftPrep does not contain any information about the acceptance criteria or the study that proves the device meets those criteria.

FDA 510(k) clearance letters primarily focus on:

• Substantial Equivalence Determination: Stating that the device is substantially equivalent to a legally marketed predicate device.
• Regulatory Information: Details about regulatory classification, product codes, and general controls.
• Administrative Information: Submission numbers, dates, contact information, and disclaimers.
• Indications for Use: A brief description of what the device is intended for.

The letter explicitly mentions that the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. It does not delve into the specific performance studies, acceptance criteria, or statistical analyses that would have been submitted by the manufacturer as part of their 510(k) application. This kind of detailed study information is typically found in the full 510(k) submission, which is generally not publicly released in its entirety.

Therefore, I cannot provide the information requested in your prompt based solely on the provided FDA clearance letter. To answer your questions, one would need access to the actual 510(k) submission data provided by Belport Company, Inc. to the FDA, which is not included here.

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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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EPIEN DENTAL CLEANSER is indicated for the following uses:

1. Caries Restoration Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of exposed dentin surfaces in cavity preparations to assist in the removal of contaminated debris and smear-layer.

2. Chronic Periodontitis Treatment Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of tooth root surfaces during periodontal debridement procedures (scaling and root planing) to help with the removal of contaminated debris from the sulcus.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria.

The document is a 510(k) clearance letter from the FDA to EPIEN Medical, Inc. for their device, the "EPIEN Dental Cleanser." It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory obligations for the manufacturer. It specifies the "Indications for Use" for the dental cleanser.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, ground truth methods, or MRMC study details, as these are not present in the provided text.

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Triton is used for debridement, removing the smear layer, and cleansing the root canal system.

Triton is a two-part, dual-action root canal cleanser. Triton Part A is an aqueous solution that contains carboxylic acid chelating agents and surfactants. Triton Part B is an aqueous solution that contains sodium hypochlorite. Once the two solutions are mixed solution cleanses and debrides the root canal system by removing the organic debris during and after endodontic instrumentation.

This document is an FDA 510(k) clearance letter for a dental device called Triton. It primarily addresses the substantial equivalence of Triton to a previously cleared predicate device, V-Mix. It is not a study report detailing clinical performance or acceptance criteria for a new AI/medical imaging device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, especially in the context of an AI-powered or medical imaging device. The device in question, Triton, is a root canal cleanser, and the clearance is based on its chemical composition being identical to a predicate device, with only changes in packaging and shelf-life, which were supported by non-clinical testing.

There is no information in this document to populate the requested table or answer the specific questions about AI/imaging device study methodologies.

To answer your request, I would need a different type of document, such as a clinical study report for an AI/imaging device submission.

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V-Mix is used for debridement, removing the smear layer, and cleansing the root canal system.

V-Mix is a two-part, dual-action root canal cleanser. V-Mix A is an aqueous solution that contains carboxylic acid chelating agents and surfactants. V-Mix B is an aqueous solution that contains sodium hypochlorite. Once the two solutions are mixed, the mixed solution cleanses and debrides the root canal system by removing the organic and inorganic debris during and after endodontic instrumentation.

The provided document is a 510(k) K193357 Premarket Notification for the V-Mix device. It includes a general statement that "Clinical performance is not deemed necessary" and states that non-clinical tests were conducted to evaluate functionality, performance, safety, and substantial equivalence.

Therefore, the document does not report on acceptance criteria or a study proving the device meets acceptance criteria in a clinical setting.

It lists several non-clinical tests that were performed, but no details of these tests (such as specific methods, results, or acceptance criteria) are provided.

Hence, I cannot extract the requested information as it is not present in the provided text.

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Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation.

Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation. Both medical devices are packaged in bottles. Clinical use of the medical devices requires the irrigant to be expelled from syringes through irrigation tips, which are class I medical devices per EIC product code (syringe, periodontic, endodontic, irrigating) and CFR regulation number 872.4565 and are 510(k) exempt.

The provided document is a 510(k) summary for the Vista Rinse and Vista Rinse Plus endodontic irrigating solutions. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria as one might find for a novel medical device. Therefore, much of the requested information regarding a study proving acceptance criteria and specific performance metrics in a clinical context is not explicitly available in this document.

However, I can extract information related to the non-clinical performance testing which served as the basis for demonstrating substantial equivalence.

Here's the breakdown based on the provided text:

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

The document does not define explicit "acceptance criteria" in a quantitative sense as might be found in a clinical trial protocol. Instead, it relies on demonstrating comparable performance to predicate devices through non-clinical testing. The reported device performance is presented as being "commensurate with" or "identical to or better than" the predicate devices.

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

The document does not specify the sample sizes (e.g., number of test specimens, number of wells for cytotoxicity) used for the non-clinical tests.

• Cytotoxicity Testing: No specific sample size is mentioned.
• SEM Evaluation & Calcium Chelation Testing: No specific sample size is mentioned for the SEM evaluations or calcium chelation.
• Data Provenance: The testing was conducted by Inter-Med/Vista Dental Products, the submitter, as part of their 510(k) submission. The exact country of origin or whether the data was retrospective or prospective (for non-clinical lab studies) is not detailed.

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. For non-clinical performance testing like cytotoxicity and smear layer removal, the "ground truth" is established by scientific methodologies and laboratory measurements, not by expert consensus. There were no human experts adjudicating test results in this context.

4. Adjudication method for the test set

Not applicable, as there was no human expert adjudication of test results for these laboratory studies.

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 endodontic irrigating solution, not an AI-assisted diagnostic or therapeutic device that would involve human readers or MRMC studies.

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

Not applicable. This device is a medical solution, not a software algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical performance testing was based on:

• Laboratory measurements and analytical chemistry: For composition verification (analytical testing), pH, and chelation characteristics.
• Standardized biological assays: For cytotoxicity testing (ISO 10993-5:2009).
• Microscopic imaging and qualitative assessment: For smear layer removal (SEM evaluation). The effectiveness was compared to the known performance of predicate devices, which utilize 17% EDTA, considered the "gold standard."

8. The sample size for the training set

Not applicable. This document describes a traditional medical device (chemical solution), not a machine learning or AI-driven device that requires a training set.

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

Not applicable, as no training set was used.

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RC-Prime Root Canal Preparation Cream is intended to be used by dental practitioners to cleanse and debride root canals for more efficient instrumentation during endodontic therapy.

RC-Prime Root Canal Preparation Cream

I am sorry, but the provided text does not contain the acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a dental product called "RC-Prime Root Canal Preparation Cream." It primarily discusses the regulatory classification, equivalence to predicate devices, and general controls provisions of the Act for marketing the device.

There is no information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used, data provenance, or ground truth establishment for a test set.
• Number or qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case comparative effectiveness studies.
• Standalone algorithm performance.
• Ground truth type.
• Training set sample size or how its ground truth was established.

Therefore, I cannot fulfill your request based on the provided input.

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ChlorCid, ChlorCid V and ChlorCid Surf are used for irrigating, instrumentation and debriding of root canal preparations.

The ChlorCid family of products are aqueous solutions of 3% sodium hypochlorite used for endodontic procedures. When desired, ChlorCid V is a more viscous solution for enhanced flow control and lubrication, and ChlorCid Surf includes a surfactant which assists in the product's ability to penetrate in tight canal spaces.

This document is a 510(k) premarket notification for dental devices (ChlorCid, ChlorCid V, ChlorCid Surf), which are root canal cleansers. It asserts substantial equivalence to predicate devices, and therefore, does not contain details of an AI/ML-based device or a comparative effectiveness study involving AI assistance.

The document describes material properties, such as concentration, pH, viscosity, and wettability, and "simulated root canal" and "extracted molars" tests to demonstrate performance of the device. It focuses on chemical and physical properties and their functional relevance, rather than diagnostic accuracy or human-AI interaction.

Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device acceptance criteria and study designs (e.g., sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.). The provided document is for a traditional medical device (chemical solution) and its substantial equivalence filing, not a software as a medical device (SaMD) or an AI-enabled device.

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Straumann PrefGel is intended for topical application onto exposed root surfaces during periodontal surgery in order to remove the smear layer.

Straumann PrefGel is a neutral EDTA formulation intended for topical application onto exposed root surfaces during periodontal surgery in order to remove the smear-layer. Mechanical debridement of a root surface inevitably produces a smear-layer, which in turn may prevent or retard periodontal healing. Exposure of collagen fibers may be important for linking fibrin in the blood clot to the root surface. Clinical studies with PrefGel have demonstrated the ability to remove the smear-layer and to expose the collagenous matrix of dentin surfaces.

This document ([K162311](https://www.accessdata.fda.gov/cdrh_docs/pdf16/[K162311](https://510k.innolitics.com/search/K162311).pdf)) describes the Straumann PrefGel, a neutral EDTA formulation for topical application on exposed root surfaces during periodontal surgery to remove the smear layer. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, primarily by detailing changes to the packaging system while asserting that the therapeutic material and indications for use remain unchanged. Therefore, the "acceptance criteria" and "device performance" in this context refer to the performance of the packaging and manufacturing processes to ensure the safety and effectiveness of the unchanged therapeutic material.

Here's an analysis of the provided information, framed as a response to your request, but with the understanding that this device is a chemical product and not an AI/ML powered device. Therefore, no AI/ML specific sections can be filled.

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

Since this is not an AI/ML enabled device, typical metrics like sensitivity, specificity, or AUC are not applicable. The acceptance criteria and performance are based on maintaining the safety and efficacy of the original product through changes in packaging and manufacturing processes.

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 specify a "test set" in the context of clinical or diagnostic performance for the device itself, as the therapeutic material remains unchanged. The studies described are engineering and manufacturing validations. Therefore, sample sizes would be implicit in standard validation protocols for each specific test (e.g., a certain number of syringes for filling validation, a certain number of packages for transport validation). The provenance is from Institut Straumann AG (Switzerland) and Straumann USA, LLC (USA), as the submitter and manufacturer are based there. The studies are prospective in nature, as they are validations of new or modified manufacturing processes and packaging.

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, as this is not a diagnostic device and no clinical or diagnostic "ground truth" was established for a test set in the conventional sense. The "ground truth" here is adherence to engineering and quality standards, established by qualified personnel in the respective fields (e.g., sterilization experts, packaging engineers, biocompatibility specialists).

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

Not applicable. This is not a diagnostic device that requires expert adjudication of results.

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 chemical product for topical application and does not involve human readers or AI.

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

Not applicable. This is not an algorithm or an AI system.

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

The "ground truth" in this context is based on:

• Engineering and Manufacturing Standards: Adherence to international standards (e.g., ISO 14644-1 for clean rooms, ISO 11607 series for packaging, ISO 11135 for sterilization, ISO 10993 series for biocompatibility).
• Functional Equivalence: Demonstration that the new packaging components and processes perform equivalently to or better than the predicate device's components and processes, ensuring the therapeutic material's integrity and safe delivery.
• Simulated Use: Validation that the device can be properly used by clinicians.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not have a "training set."

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

Not applicable.

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PacEndo™ Chlorhexidine is intended to irrigate and cleanse root canal systems after endodontic instrumentation.

PacEndo™ Chlorhexidine is a 2% Chlorhexidine Gluconate solution in water with surfactant to lower surface tension. The solution is root canal cleanser for use in endodontic procedures.

This document is a 510(k) premarket notification for a medical device, specifically PacEndo™ Chlorhexidine, an endodontic cleanser. The document focuses on establishing substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be directly extracted from this document as it pertains to a different type of evaluation.

Here's a breakdown of what can be inferred or is missing based on the document:

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

The document does not define explicit "acceptance criteria" in the sense of predefined thresholds for clinical efficacy or safety that might be found in a clinical trial protocol. Instead, it relies on comparison to a predicate device.

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: Not applicable in the context of this 510(k) submission. No human or clinical "test set" for performance evaluation is described. The "test set" essentially refers to laboratory samples used for non-clinical comparative testing. The document does not specify the number of samples (e.g., number of pH measurements, number of contact angle measurements) used for these non-clinical tests.
• Data Provenance: Not applicable for a non-clinical comparison study. No information on country of origin for non-clinical lab data.
• Retrospective or Prospective: Not applicable as this is not a clinical study involving patients. The non-clinical tests would have been performed prospectively as part of the device development and submission process.

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. "Ground truth" in the context of clinical expert consensus is not relevant to this type of non-clinical, comparative device evaluation. The "ground truth" for the non-clinical tests (pH, contact angle) would be the physical measurements themselves.

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

Not applicable. This is not a clinical study involving human readers or interpretation of medical images/data that would require an adjudication method.

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 is not mentioned as this device is a chemical solution (root canal cleanser), not an AI diagnostic or assistive tool.

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

No. This question applies to AI-driven devices, which this is not. The "performance" here is intrinsic to the chemical properties of the solution.

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

The "ground truth" for the non-clinical tests (pH and surface contact angle) would be the results of the physical and chemical measurements obtained in a laboratory setting. There is no expert consensus, pathology, or outcomes data used for this type of submission.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.

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

Not applicable. There is no training set mentioned or implied.

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