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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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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.

GingiDent gingival retraction paste is an astringent formulated to provide gingival retraction and hemostasis. GingiDent gingival retraction paste contains Aluminum Chloride and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. This product is a blue-green paste developed exclusively for transient surgically invasive use in the oral cavity. The paste contains Aluminum Chloride in a water-based clay inert carrier.

This document describes the premarket notification (510(k)) for the GingiDent Gingival Retraction Paste. The submission primarily relies on non-clinical bench testing and comparison to predicate devices, rather than a clinical study involving human subjects. Therefore, many of the requested categories related to clinical study design and outcomes (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (Bench Test Results) and Reported Device Performance:

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

• Sample Size: Not applicable. The testing described is bench testing of the product itself, not a clinical test set with human subjects.
• Data Provenance: Not applicable for a clinical test set. The data originates from laboratory bench testing conducted by the manufacturer, Pac-dent International, Inc.

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

• Not applicable. This was bench testing, not a clinical study requiring expert ground truth for patient data.

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

• Not applicable. This was bench testing.

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 device is a gingival retraction paste, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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

• No. This is a physical dental paste, not an algorithm.

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

• Not applicable to a clinical test set. For the bench tests, the "ground truth" was established by standard laboratory measurement techniques for pH, viscosity, and chemical concentration.

8. The sample size for the training set:

• Not applicable. This is not a machine learning device; therefore, there is no training set in the context of AI/ML.

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

• Not applicable.

Additional Information from the Document:

• Biocompatibility Tests: Performed in accordance with ISO 10993, including skin sensitivity and oral mucosa irritation tests in hamsters. Results showed no evidence of causing skin sensitization or oral mucosa irritation.
• Stability Tests: Accelerated stability testing was conducted at 50 °C and 60 °C, evaluating AlCl3-6H2O concentration, pH value, extrusion force, and weight loss. Estimated shelf life for room temperature storage is 2.8 years.
• Clinical Performance Test: "No clinical testing was provided." The submission relies solely on non-clinical (bench) testing and comparison to legally marketed predicate devices to establish substantial equivalence.
• Conclusion: The manufacturer concluded that GingiDent Gingival Retraction Paste is substantially equivalent to the identified predicate devices based on non-clinical performance testing. The FDA concurred with this determination for the purpose of market authorization.

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For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.

The Retraction Paste is a medium viscosity substance that contains aluminium chloride hexahydrate in a water-based kaolin (clay) inert carrier. The kaolin/water paste provides physical displacement of the gingiva as the material is placed into the sulcus via a manual dispensing syringe. The aluminium chloride hexahydrate component has hygroscopic and astringent properties, which produce a hemostatic/drying effect, and assist in temporarily shrinking the gingival tissue and holding it slightly away (retracted) from the tooth surface, thereby allowing complete access of the impression material.

This device, called "Retraction Paste," is a medical product used in dentistry for temporary retraction and hemostasis of the gingival margin. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way one might see for a novel AI or diagnostic device.

Therefore, many of the requested fields regarding detailed study design, sample sizes, expert qualifications, and AI-specific metrics (like MRMC studies) are not applicable to this type of submission. The "acceptance criteria" here are primarily about demonstrating that the new device shares fundamental characteristics and performance with an already legally marketed device.

Here's the breakdown based on the provided text, with explanations for why certain information is not present:

Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The "study" proving the device meets its (implied) acceptance criteria is the 510(k) Substantial Equivalence comparison provided in the document. This is a non-clinical comparison, not a human clinical trial or a performance study with a test set in the traditional sense for AI.

Detailed Study Information:

1. 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 is a 510(k) premarket notification for a dental retraction paste, not a diagnostic device involving a "test set" of data or patient cases in the context of AI or imaging. The "test" here is a comparison of product specifications and characteristics to a predicate device.

2. 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. No "ground truth" was established by experts for a test set in the context of this 510(k) submission. The comparison is based on the chemical, physical, and functional properties of the device itself and its predicate.

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

   • Not Applicable. No test set or expert adjudication was performed for this 510(k) submission.

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:

   • Not Applicable. This device is a manual dental paste, not an AI-assisted diagnostic tool.

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

   • Not Applicable. This device is a manual dental paste, not an algorithm.

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

   • Not Applicable. For this 510(k) submission, "ground truth" is established by the known characteristics and performance of the legally marketed predicate device, as well as the intrinsic properties (pH, viscosity, chemical composition) of the submitted device. There is no biological or diagnostic "ground truth" in the AI sense.

7. The sample size for the training set:

   • Not Applicable. No training set was used, as this is not an AI or machine learning device.

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

   • Not Applicable. No training set was used.

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Re/Stasis™ is a paste containing kaolin clay and aluminum chloride, and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. These procedures include dental impressions, restorations, seating of temporary and permanent restorations, placement of rubber dam, and other procedures.

Re/Stasis™ is a paste containing kaolin clay and aluminum chloride

This K111348 document is a 510(k) clearance letter from the FDA for a device named Re/Stasis™. This type of document primarily confirms that the device is "substantially equivalent" to a legally marketed predicate device and grants permission to market it. It does not contain acceptance criteria, details of a clinical study, or performance data.

The sections you've asked for (acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are typically found in the submission itself, which is not publicly released in this format, or in a Summary of Safety and Effectiveness Data (SSED) if one were available (which is more common for PMA devices).

Therefore, based solely on the provided text, I cannot answer the specific questions about acceptance criteria and study details. The document states that the device is intended for "temporary retraction and hemostasis of the gingival margin during dental procedures." The FDA's determination is based on substantial equivalence, implying that the safety and effectiveness are considered comparable to an existing device without necessarily requiring new clinical trials to demonstrate specific performance metrics for this particular 510(k) submission.

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Korlex-GRTM is intended for the temporary retraction and hemostasis of the gingival margin during dental procedures when sulcus widening is needed.

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The provided text is a 510(k) premarket notification letter from the FDA to Biotech One, Incorporated, regarding their device Korlex-GR™. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for the detailed table and study information based on this input. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It also outlines general regulatory compliance requirements.

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