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One-Stop is intended for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation, and cavity preparation.

One-Stop is a paste-type topical pre-impression agent intended to provide gingival retraction and hemostasis. The product contains aluminum chloride, which functions as an astringent. Its paste consistency allows controlled placement in the target area, and it can be removed by rinsing with water after use.

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For the temporary displacement of the marginal gingiva and drying of the gingival sulcus, e.g. for

• conventional or digital impressions,
• cementation of temporary and permanent restorations
• and the creation of Class II and V fillings.

RetraXil belongs to the group of dental retraction material, mainly as cords (threads) with astringent agents. The retraction material is also marketed in form of a paste as alternative to the cords. RetraXil is a retraction paste containing aluminium chloride as astringent agent, which serves as hemostatic agent.

RetraXil is marketed as a gingival retraction paste with no hints of performance or safety issues for patients and users.

Retraxil is a retraction paste stored in a 1g syringe with a cannula and twisting aid.

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STASIS Gel is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. STASIS Gel facilitates the insertion of the cord into the sulcus.

Stasis Gel is a 15.5% Ferric Sulfate in a water-based, viscous gel that facilitates sulcus retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures. Stasis Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.

This document is a 510(k) summary for the STASIS Gel, a dental device intended for sulcus retraction and control of bleeding/gingival oozing. It primarily focuses on demonstrating substantial equivalence to a predicate device (Vista FS) rather than presenting a detailed study with acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI device testing (e.g., sample size for test set, expert qualifications, MRMC study, standalone performance) is not applicable or provided in this document.

However, based on the provided text, I can extract information related to the device's characteristics and the non-clinical testing performed to support its substantial equivalence.

Here's the information that can be extracted, and where the requested information is not applicable, it is noted.

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

Since this is a submission for a medical device (STASIS Gel) and not an AI/software device, the acceptance criteria are based on demonstrating similarity to a predicate device in terms of chemical characteristics, indications for use, and safety. The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense for a software algorithm, but rather compares key attributes.

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

Not applicable. This document describes the non-clinical testing of a physical medical device (STASIS Gel), not an AI/software device. There is no "test set" in the context of clinical images or patient data for AI performance evaluation. The "testing" refers to bench testing and biocompatibility studies.

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. This is for a physical medical device, not an AI/software device requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. There is no test set or human adjudication process as this is not an AI/software device.

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 for a physical medical device, not an AI/software device, so an MRMC study is not relevant.

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

Not applicable. This is not an AI/software device.

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

For the physical characteristics and safety:

• Biocompatibility: In-vitro and in-vivo testing according to ISO 10993-1 standards, which serve as objective ground truth for safety assessments.
• Chemical Characteristics (Ferric Sulfate content, pH): Laboratory analytical methods that provide objective measurements.
• Viscosity: Laboratory rheometry methods that provide objective measurements.
• Shelf-Life: Accelerated aging studies and ongoing real-time aging studies, which provide objective data on product stability over time.

8. The sample size for the training set

Not applicable. This is not an AI/software device that uses "training sets."

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

Not applicable. This is not an AI/software device.

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GINGI-AID Gel is intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry when used with gingival retraction cords. The gel facilitates the insertion of the cord into the sulcus.

Gingi-Aid Gel is a 25% Aluminum Chloride in a water-based, viscous gel that facilitates gingival retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures. Gingi-Aid Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.

This document is a 510(k) Premarket Notification from the FDA regarding the Gingi-Aid Gel. It focuses on demonstrating the substantial equivalence of the Gingi-Aid Gel to an existing predicate device, rather than providing details on acceptance criteria and performance data for a new, AI-based device that would typically involve the comprehensive testing requested.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/CADe device, specifically:

• A table of acceptance criteria and the reported device performance: Not applicable. This document is for a dental gel, not an AI/CADe device. The "performance" is based on chemical and physical properties and intended use.
• Sample sized used for the test set and the data provenance: Not applicable in the context of AI/CADe. The "testing" here involves biocompatibility, bench testing for aluminum chloride content, and shelf-life testing, not a clinical study on a large test set of images or patient data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/CADe device is usually established by medical experts (e.g., radiologists, pathologists). This is a chemical product.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/CADe sense. The "ground truth" for this device would be established by chemical analysis and standard biocompatibility testing.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

However, I can extract the following information relevant to the submission:

1. Device Description and Characteristics (replacing "Acceptance Criteria" with "Key Characteristics" and "Performance" with "Reported Data"):

The document primarily focuses on demonstrating substantial equivalence to predicate devices (Vista Clear, K193389, and ViscoStat Clear, K123215). The "acceptance criteria" are implicitly met by demonstrating that the Gingi-Aid Gel is chemically and functionally similar and safe.

2. Study Design and Data Provenance (for this specific device which is NOT AI/CADe):

• Sample size and Data Provenance: Not applicable in the context of a clinical study for AI/CADe. The "study" here involves lab testing.
  • Bench Testing: Gingi-Aid Gel's aluminum chloride content was compared to the predicate device.
  • Biocompatibility Testing: Performed according to ISO 10993-1. (Specific sample sizes for these tests are not provided but are standard for material testing).
  • Shelf-Life Testing: Accelerated testing supported 24 months, with real-time aging ongoing.
  • The "data provenance" is from in-house lab testing by the manufacturer (Belport Company, Inc. / Gingi-Pak). The document does not specify country of origin for the data, but the submission is to the US FDA. The nature of these tests is not "retrospective" or "prospective" in a clinical trial sense, but rather lab-based validation.

3-9. Information Not Applicable to this Type of Device (Gingi-Aid Gel is not an AI/CADe device):

As explained above, questions concerning experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, direct patient ground truth, and training set details are entirely irrelevant to this submission, which is for a dental chemical product. The substantial equivalence is based on comparing its physical, chemical, and functional properties to similar, already-cleared predicate devices.

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For temporary retraction of the marginal gingiva to provide a dry gingival sulcus when the periodontium is healthy prior to, e.g - analogue or digital impressions - cementation of temporary and permanent restorations - preparation of class II and V fillings

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The provided text is a 510(k) clearance letter from the FDA for a dental product called "VOCO Retraction Paste". This document does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria. Instead, it outlines the regulatory status of the device, its indications for use, and general regulatory requirements.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the provided input. The details you are asking for, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set information, and ground truth establishment, are not present in this regulatory clearance letter.

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StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures.

StatStix is designed incorporating a hand-held polypropylene handle with a nylon polyamide applicator tip coated with a dried solution of 25% Aluminum Sulfate Hydrate Solution with Mint Flavor. The device is configured in two sizes to help control minor gingival bleeding intended for transient use by a dentist during dental restorative procedures.

The provided FDA document describes the premarket notification (510(k)) for the StatStix device (K200764). It details the device's intended use and compares its characteristics to a predicate device for substantial equivalence. However, it explicitly states that clinical testing has not been performed on this product. Therefore, a study proving the device meets acceptance criteria based on clinical performance in humans is not present in this document.

The document does, however, discuss non-clinical performance data and establishes acceptance criteria for those tests.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

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

• Clinical Test Set: Not applicable, as no clinical testing was performed for StatStix.
• Non-Clinical Test Set: Not specified for biocompatibility, physical properties, or shelf-life testing. The document states "standard laboratory benchtop practices" for physical properties and "consistent with ASTM F1980" for shelf-life, implying standard sample sizes for these types of tests would have been used, but specific numbers are not detailed.
• Data Provenance: Not explicitly stated, but assumed to be from Centrix Incorporated or their contracted laboratories given they are the submitter.

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

• Clinical Test Set: Not applicable.
• Non-Clinical Test Set: Not specified. For non-clinical lab tests, "ground truth" is established by the methodologies and reference standards themselves, as opposed to expert human interpretation.

4. Adjudication Method for the Test Set:

• Clinical Test Set: Not applicable.
• Non-Clinical Test Set: Not applicable. Adjudication methods are typically relevant for subjective assessments or when multiple human readers/experts are involved in ground truth establishment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states, "Clinical testing has not been performed on this product." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance. The StatStix device is a physical product (applicator with astringent), not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No, a standalone performance study in the context of an algorithm or AI was not done. StatStix is a physical device, not an algorithm.

7. Type of Ground Truth Used:

• Clinical Ground Truth: Not applicable, as no clinical testing was performed.
• Non-Clinical Ground Truth: Established through standardized laboratory testing methodologies (e.g., ISO, ASTM, FTIR/pH/dosage weight analysis) where the outcomes are measurable and objective.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical product, not an AI/machine learning algorithm requiring a "training set" of data.

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

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

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Vista Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Vista Clear facilitates the insertion of the cord into the sulcus.

Vista Clear is used to facilitate sulcus retraction prior to taking a dental impression of a tooth. This entails placement of the device into the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject device facilitates the insertion of the cord into the sulcus while also creating a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.

The provided text describes a 510(k) premarket notification for a medical device called "Vista Clear." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials or performance testing against specific acceptance criteria for efficacy in the same way a novel device might.

Therefore, the document does not contain information on "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance or diagnostic accuracy. Instead, the "device performance" described relates to non-clinical testing demonstrating equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your questions to the extent possible, and highlighting what's not present:

Key Takeaway: This 510(k) summary is for a device with a clear physical/chemical function (sulcus retraction, bleeding control) and claims substantial equivalence based on technological characteristics and non-clinical testing, not clinical performance or diagnostic accuracy with human interpretation.

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

The concept of "acceptance criteria" in this 510(k) largely revolves around demonstrating substantial equivalence to the predicate device and meeting relevant non-clinical performance standards. There are no explicit quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, AUC) stated in the document, as it's not a diagnostic device.

Reported Device Performance (from "Non-Clinical Performance Testing and Compliance"):

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

• Test Set (for non-clinical performance): The document does not specify a "test set" in the context of clinical or diagnostic performance data (e.g., number of patient cases, images). The testing refers to laboratory-based evaluations of the device's material properties, packaging, and stability.
  • Data Provenance: N/A. This is a submission for a new device, and the data provenance refers to materials/engineering tests, not patient data. No country of origin for patient data (as there isn't any provided in text) or retrospective/prospective study type is mentioned as no clinical studies were performed.

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

• N/A. This information is relevant for studies involving human interpretation or diagnostic accuracy. For this type of device and 510(k) submission, ground truth relates to the results of objective laboratory tests (e.g., is it cytotoxic?), not expert consensus on clinical findings.

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

• N/A. As no expert consensus or human interpretation of clinical cases was performed, no adjudication method is relevant or described.

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

• N/A. This device is a dental material, not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted or is applicable.

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

• N/A. This is not an algorithm-based device.

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

• The "ground truth" for this device is based on objective laboratory test results (e.g., analytical chemistry, toxicology, microbiology, stability) that confirm the material properties, safety, and functionality of the device compared to established scientific principles and the predicate device's known characteristics. It's not clinical outcomes or expert labels.

8. The sample size for the training set

• N/A. This term is relevant for machine learning models. No training set is applicable for this type of medical device submission.

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

• N/A. As there is no training set, this question is not applicable.

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Vista FS and Vista FS Liquid are intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Vista FS Liguid facilitate the insertion of the cord into the sulcus.

Vista FS and Vista FS Liquid are medical devices used to facilitate sulcus retraction prior to taking a dental impressions of a tooth. This entails placement of the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject devices facilitate the insertion of the cord into the sulcus while also facilitating the creating of a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.

The provided text does not contain specific acceptance criteria for performance metrics (such as sensitivity, specificity, or F1 score) or detailed results from a clinical study that would allow a direct comparison to such criteria. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, intended use, and non-clinical performance testing.

Therefore, many of the requested fields cannot be directly extracted from the provided text. However, based on the information available, here's what can be provided:

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

The document does not explicitly state quantitative acceptance criteria in terms of clinical performance metrics. The evaluation is based on demonstrating substantial equivalence to predicate devices. The "reported device performance" in this context refers to the results of non-clinical testing confirming manufacturing, cytotoxicity, shelf-life, microbiological properties, and transit resilience.

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

The document describes non-clinical laboratory testing. It does not refer to a "test set" in the context of clinical data or a patient population. The samples for testing were likely materials from the manufactured devices themselves (e.g., aliquots for analytical testing, cell cultures for cytotoxicity). No information on the country of origin of data or whether it was retrospective or prospective is provided, as these are not relevant to the described non-clinical tests.

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

Not applicable. This information is relevant for studies relying on expert-derived ground truth, typically in image analysis or diagnostic scenarios. The provided document concerns non-clinical testing of a dental product.

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

Not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, which are not described in this document for the evaluation of this dental product.

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 dental product (sulcus retraction material) and not an AI-assisted diagnostic tool.

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

Not applicable. This device is a dental product and not an algorithm.

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

The "ground truth" for the non-clinical tests described would be the established scientific standards and methods for analytical chemistry, cytotoxicity assessment, stability testing, and microbiological evaluation. For example, for cytotoxicity, the "ground truth" is typically determined by observing cell viability and growth inhibition according to standardized protocols (e.g., ISO 10993).

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this document describes non-clinical testing of a physical medical device, not a machine learning model.

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 is not relevant to the provided document.

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Smartcord is knitted retraction cord made from 100% cotton for the temporary gingival retraction.

Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride for the temporary gingival retraction and hemostasis of the gingival margin.

Smartcord is non-impregnated knitted retraction cord made from 100% cotton. Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate.

The provided document is a 510(k) summary for the medical devices Smartcord and Smartcord X. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving the device meets those criteria.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance results are not available in this type of document.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define specific performance acceptance criteria (e.g., minimum tensile strength, specific retraction efficacy metrics) or report quantitative results for the device against such criteria. Instead, it relies on demonstrating equivalence in material composition, intended use, and general properties to the predicate device.

The "performance" described is in the context of biocompatibility testing, which confirmed the device is biocompatible as directed.

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

• Sample Size for Test Set: Not specified. The biocompatibility tests would have involved samples of the Smartcord X device, but the number of samples is not stated.
• Data Provenance: Not specified, but generally, non-clinical performance testing for 510(k) submissions is conducted as part of the device development and validation process by the manufacturer or accredited labs on behalf of the manufacturer. It's prospective in the sense that the tests are planned and executed to evaluate the device. The country of origin of the data is not specified beyond "EASTDENT CO., LTD." being from Korea.

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

• Number of Experts: Not applicable. For biocompatibility testing, the "ground truth" is established by the standardized methods outlined in ISO 10993, and the results are interpreted by trained laboratory personnel. There isn't a concept of "expert ground truth" in the way it would be applied to diagnostic imaging interpretation.
• Qualifications of Experts: Not specified, but implied to be qualified laboratory personnel experienced in conducting and interpreting biocompatibility tests according to ISO standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Biocompatibility testing involves objective laboratory measurements and observations against pre-defined criteria in the ISO standards, rather than subjective judgments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess performance improvement. Smartcord and Smartcord X are physical dental retraction cords, not diagnostic algorithms.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Standalone Performance Study: No, this is not applicable. There is no algorithm involved in the Smartcord or Smartcord X product. The assessment is of the physical device's properties and biological safety.

7. The Type of Ground Truth Used:

• Ground Truth: For biocompatibility, the "ground truth" is defined by the established biological responses and thresholds outlined in the ISO 10993 series of standards. This involves measuring cytotoxicity, irritation, and sensitization responses in laboratory models (e.g., cell cultures, animal models) and comparing them to acceptable limits defined by the standards.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. There is no AI or machine learning algorithm in these devices, so there is no training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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