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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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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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Pac-Dent Barrier Sleeve and Cover-It Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only.

Pac-Dent Barrier Sleeve and Cover-It™ Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

Device Name: Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film

1. Table of Acceptance Criteria and Reported Device Performance:

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PacEndo™ EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

PacEndo™ EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endodontic procedures to remove the smear layer produced from root canal instrumentation.

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Disclaimer: This document is a 510(k) premarket notification summary. It focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details of a novel device's performance validation. Therefore, many of the requested categories (especially those related to AI/MRMC studies, ground truth establishment for large datasets, and clinical trials) are not applicable or detailed in this type of submission.

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

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

• Sample size for test set: The document does not specify the sample size for the surface tension test.
• Data provenance: Not specified. The tests were "Non-Clinical Tests," implying laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The "ground truth" for non-clinical performance tests like pH and surface tension would be based on standard scientific measurements, not expert human interpretation.

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

• Not applicable for non-clinical laboratory tests.

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 chemical solution (root canal cleanser), not an AI-powered diagnostic or assistive tool. Therefore, 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 device is a chemical solution, not an algorithm.

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

• For the performance characteristics (pH, appearance, composition, surface tension), the "ground truth" is derived from standard analytical chemistry and physical property measurements.

8. The sample size for the training set

• Not applicable. This is not a machine learning device; there is no training set.

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

• Not applicable. There is no training set.

Study Proving Device Meets Acceptance Criteria:

The document describes a Non-Clinical Performance Test to demonstrate that PacEndo™ EDTA is substantially equivalent to its predicate device, EDTA Plus (K072555).

• Name of Study: "Surface tension test using contact angle measurement" was performed in comparison to the predicate device.
• Outcome: "The subject device was found to have similar surface tension compared to the predicate device and can be used as intended."
• Biocompatibility: A biocompatibility assessment and risk analysis were conducted. The results "demonstrated that no biocompatibility testing was needed to demonstrate biocompatibility of the device for the intended use."
• Conclusion: The summary states, "non-clinical performance testing demonstrates that PacEndo™ EDTA is substantially equivalent to the identified predicate product for its intended use."

The entire submission focuses on showing substantial equivalence through direct comparison of technological characteristics (Indications for Use, Composition, Performance properties like pH and appearance) and a targeted non-clinical test (surface tension) rather than a comprehensive, independent validation against specific performance targets. No clinical testing was provided or deemed necessary for this 510(k) submission.

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PacEndo™ Sodium Hypochlorite is intended to irrigate, cleanse, and debride root canal systems. It is also intended to provide irrigation during root canal instrumentation.

PacEndo™ Sodium Hypochlorite is a Sodium Hypochlorite solution in water with surfactant to lower surface tension. The solution is root canal cleanser for use in endodontic procedures.

The provided text describes the 510(k) premarket notification for PacEndo™ Sodium Hypochlorite. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the comparison to the predicate device in terms of performance characteristics. The document indicates that the subject device (PacEndo™ Sodium Hypochlorite) meets these criteria by demonstrating similar properties and, in one aspect, improved performance.

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

The document does not specify a distinct "test set" and its sample size in the context of clinical or large-scale comparative studies. The performance characteristics (Appearance, pH, % Active Chlorine (w/w), Surface Tension) are likely based on laboratory testing of batches of the product. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective.

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 type of device (sodium hypochlorite solution) does not typically involve expert interpretation for its core performance characteristics (pH, active chlorine, etc.).

4. Adjudication method for the test set

This information is not applicable and therefore not provided, as there is no indication of a test set requiring adjudication by multiple experts.

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

There is no mention of an MRMC comparative effectiveness study, nor is AI assistance relevant to this type of device (a chemical solution).

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

This question is not applicable as the device is a chemical solution and does not involve algorithms or human-in-the-loop performance. The performance characteristics listed (appearance, pH, % active chlorine) are standalone measurements of the chemical product.

7. The type of ground truth used

The ground truth for the non-clinical tests (Appearance, pH, % Active Chlorine (w/w), Surface Tension) would be defined by standard chemical and physical measurement methods. For instance, pH meters, titration for active chlorine, and contact angle measurement for surface tension. There's no reliance on expert consensus, pathology, or outcomes data for these specific parameters.

8. The sample size for the training set

This information is not provided and is not applicable in the context of "training set" for an AI/algorithm-based device. If "training set" refers to the development and formulation of the chemical product, such details are not disclosed.

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

As there is no "training set" in the context of AI/algorithm, this question is not applicable. For the development and quality control of the chemical product, the ground truth would be established through documented chemical and physical testing protocols and specifications.

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Elements™ is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.

Elements™ is an addition-reaction base/catalyst polyvinylsiloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.

This document outlines the substantial equivalence of the "Elements™" dental impression material to a predicate device, "Take 1 (K091613)", based on non-clinical performance testing. It does not describe a study involving an AI-powered medical device or human readers. Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving an AI device meets those criteria.

The provided text focuses on the following:

• Device: Elements™ (dental impression material)
• Predicate Device: Take 1 (K091613)
• Purpose: To demonstrate substantial equivalence for FDA 510(k) clearance.
• Study Type: Non-clinical performance testing based on ISO 4823-2000.
• Key Finding: "No clinical testing was performed."

Since the request is about an "AI device" and "how much human readers improve with AI vs without AI assistance," the provided document is irrelevant to answering those specific questions. The document details the physical properties and a comparison of a traditional dental material, not an AI or software as a medical device.

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PacSeal™ Pit & Fissure Sealant is intended for use as:

• Seal the pits and fissures in teeth

PacSeal™ Pit & Fissure Sealant is a fluoride releasing, light-cured acrylate resin designed to fill and seal the pits and fissures of teeth.

Here's a breakdown of the acceptance criteria and study information for the PacSeal™ Pit & Fissure Sealant as derived from the provided document:

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with specific acceptance criteria in the manner of a novel device. Therefore, the "acceptance criteria" are implied by the comparison to the predicate device's performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds. Instead, it compares the subject device's performance to that of predicate devices, implicitly suggesting that performance comparable to or better than the predicate is acceptable.

Note: For "Compressive Strength," the subject device (181 MPa) is lower than the predicate (210 MPa). The document still concludes substantial equivalence, suggesting that this difference was deemed acceptable in the context of overall performance and "equivalent to the predicate" claim for other properties.

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

The document does not specify the sample sizes used for the performance tests (e.g., number of specimens for depth of cure, strength tests).
The data provenance is not explicitly stated beyond being presented in a 510(k) summary by Pac-Dent International, Inc. These types of tests are typically in-vitro laboratory tests, not clinical studies with patient data.

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

This type of information is not applicable to the data provided. The "ground truth" for these physical property tests is based on standardized laboratory measurements (e.g., ISO standards) and not on expert consensus from human readers or clinicians.

4. Adjudication Method for the Test Set

This is not applicable as the tests are for physical properties measured in a lab, not for diagnostic or interpretive tasks requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This document describes the physical and chemical characteristics of a dental sealant, not an AI or imaging device that would typically undergo MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not relevant to the device described. The device is a physical dental sealant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics (e.g., depth of cure, strength, film thickness) is based on standardized laboratory test methods (e.g., ISO 6874-2005, ISO 4049-2009).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an algorithm that requires a training set.

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

This is not applicable for the same reason as above.

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ProFluoro™ Fluoride Varnish is intended for use as:

• Professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film

ProFluoro™ Fluoride Varnish is a resin-based 5% sodium fluoride varnish applied to tooth surfaces with an applicator brush. Moisture from saliva cures the varnish and leaves a film on tooth to treat tooth hypersensitivity.

This document describes a 510(k) premarket notification for "ProFluoro™ Fluoride Varnish" by Pac-Dent International, Inc. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.

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

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

• Sample Size: Not explicitly stated for each specific physical test (appearance, total fluoride, pH, film thickness). The document refers to "bench testing" without providing specific sample numbers for each measurement.
• Data Provenance: The study was conducted as "bench testing," meaning it was performed in a laboratory setting. The country of origin for the data is not specified, but the applicant (Pac-Dent International, Inc.) is based in Walnut, CA, USA, suggesting the testing was likely conducted in the USA or supervised by the US-based company. The study is retrospective in the sense that it evaluates the performance of the new device against an existing predicate.

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 to this type of submission. The "ground truth" for the physical and chemical properties of a fluoride varnish is based on established scientific and engineering principles and objective measurements, not expert consensus in the diagnostic sense. The comparison is against quantifiable properties of a predicate device.

4. Adjudication method for the test set:

Not applicable. This study focuses on objective physical and chemical property comparisons rather than subjective human assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This submission concerns a fluoride varnish, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-assistance evaluation was performed.

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

Not applicable. This submission concerns a fluoride varnish, not an algorithm or AI device.

7. The type of ground truth used:

The ground truth for the physical tests (appearance, total fluoride, pH, film thickness) was the measured performance of the legally marketed predicate device, Enamelast™ Fluoride Varnish, combined with established scientific standards for such dental materials. For biocompatibility, the ground truth was the established safety record of the chemical components when used in predicate devices and the results of a risk analysis.

8. The sample size for the training set:

Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."

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

Not applicable. See point 8.

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OptiFlow II Flowable Composite, LC is intended for use as:

• Repair of minimally invasive cavity (including non-stress bearing areas)
• Pit and fissure sealant
• Class III-V restorations
• Repair of porcelain restorations
• Repair of ceramic/composite veneers

OptiFlow II Flowable Composite, LC is a light cure resin-based flowable restorative dental composites. The restorative is packaged in capsules and syringes. The fillers are a combination of radiopaque inorganic fillers and advanced nano-silicas with an average particle size of 0.7 microns to produce a loading approximately 57% by weight (40% by volume). All shades have a radiopacity of 200%.

The available text describes the 510(k) summary for OptiFlow II Flowable Composite, LC, a dental material. The submission focuses on demonstrating substantial equivalence to a predicate device through physical tests.

Here is the information structured according to your request, with a note where the information is not provided in the text:

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

The document states that the device was evaluated for Flexural Strength, Young's Modulus, Compressive Strength, Diametral Tensile Strength, and Rockwell Hardness and compared to the predicate device. However, the specific acceptance criteria (e.g., minimum values or range for each test) and the reported device performance (the actual numerical results for OptiFlow II and the predicate) are not included in this summary. It only states that the device is "substantially equivalent."

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

The document mentions "data from bench testing" but does not specify the sample size used for these tests. It also does not indicate the provenance (e.g., country of origin, retrospective or prospective) of this test data. Bench testing is typically conducted in a laboratory setting.

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

This document describes physical, bench-top testing of a dental material. It does not involve human interpretation or subjective assessment by experts for establishing ground truth in the way an AI diagnostic device would. Therefore, this question is not applicable to the provided context.

4. Adjudication method for the test set

Since this is bench testing of physical properties and not an expert-driven assessment, no adjudication method (like 2+1 or 3+1) was used.

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 MRMC comparative effectiveness study was done, as this submission is for a dental material and not an AI-assisted diagnostic device involving human readers.

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

This question is not applicable as the device is a dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the measured physical properties (Flexural Strength, Young's Modulus, Compressive Strength, Diametral Tensile Strength, and Rockwell Hardness) of the materials being tested. These are quantitative measurements derived from standardized laboratory tests.

8. The sample size for the training set

This is a physical material, not an AI model, so there is no training set in the typical sense. Physical properties are inherent to the material formulation and manufacturing process, not "trained" on data.

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

As there is no training set for a physical material, this question is not applicable.

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