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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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SDF Pro is intended to be used by dental professionals to treat tooth hypersensitivity. For use in adults over the age of 21.

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This FDA 510(k) clearance letter for the SDF Pro device does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

The letter's primary purpose is to confirm substantial equivalence of the SDF Pro to a legally marketed predicate device, allowing it to be marketed. It details:

• Device Name: SDF Pro
• Applicant: Belport Company, Inc., Gingi-Pak
• Regulation Number and Name: 21 CFR 872.3260, Cavity Varnish
• Regulatory Class: Class II
• Product Code: PHR
• Indications for Use: Intended to be used by dental professionals to treat tooth hypersensitivity in adults over the age of 21.

Therefore, it is impossible to provide the requested information based on the provided text.

The document is a clearance letter, not a summary of the technical or clinical performance data submitted for the clearance. Clinical study data, including acceptance criteria, performance metrics, sample sizes, ground truth establishment, and expert qualifications, would typically be found in the original 510(k) submission document itself, which is not provided here.

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Rodin Titan 3D Resin is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable denture teeth to be used in a denture. It is indicated as a permanent restorative for both anterior restorations, including occlusal surfaces. It is used for fabricating permanent restorations such as inlays, veneers and full crown restorations.

RODIN Titan 3D Resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need. Fabrication of dental prosthetics with RODIN Titan 3D Resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment. The material is an alternative to traditional dental prostheses material Rodin Titan 3D Resin is intended exclusively for professional dental work. RODIN Titan 3D Resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

The provided text describes a medical device, RODIN Titan 3D Resin, and its acceptance criteria, along with performance data to demonstrate substantial equivalence to predicate devices. The study conducted is primarily a set of performance tests against established standards and comparisons to existing products, rather than a clinical trial with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with international standards (ISO, ASTM) and performance comparable to predicate devices. The "Specification" column in Table 1 represents the acceptance criteria for most physical properties, usually a minimum or maximum value. For some parameters, "N/A" is listed, indicating that there is no specific quantitative acceptance criterion listed in the table, but the result is provided.

Note: For properties listed as N/A under "Specification", their acceptance is often implied by demonstrating comparable performance to predicate devices or simply reporting the value without a specific threshold stated within the document. The comparability to predicate devices is shown in Table 2.

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

The document does not explicitly state the numerical sample size (e.g., number of specimens tested for flexural strength). It refers to the tests being conducted according to specific ISO and ASTM standards, which would define the required sample sizes for each test method.

• Data Provenance: The data appears to be from laboratory testing performed by the manufacturer, or a contracted lab, to characterize the material properties. There is no information provided regarding the country of origin of the data or whether it is retrospective or prospective, but it is characteristic of premarket submission data based on physical and chemical testing.

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

This type of study does not involve expert readers establishing ground truth in the way a diagnostic imaging AI would. The "ground truth" for the performance tests outlined here is defined by:

• Established physical and chemical test methods: The performance data (e.g., flexural strength, water sorption) are objective measurements derived from standardized laboratory tests (ISO, ASTM protocols).
• Predicate device data: The "ground truth" for substantial equivalence comparison is the performance of legally marketed predicate devices, which have already been deemed safe and effective.

Therefore, there were no human experts (e.g., radiologists) establishing ground truth for the test set in this context. The "experts" would be the scientists and engineers who conducted the material characterization tests and those who established the ISO/ASTM standards.

4. Adjudication Method for the Test Set

Not applicable for this type of material characterization study. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly for diagnostic accuracy, where there is subjective interpretation of findings (e.g., by multiple radiologists) requiring a consensus mechanism.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers' Improvement with AI vs. without AI Assistance

Not applicable. This device is a dental resin material, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assisted human reader improvement analysis was performed or described.

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

Not applicable. This is a physical material, not an algorithm. The performance data presented are "standalone" in the sense that they are intrinsic properties of the material itself, measured in laboratory settings.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for this device's performance is based on:

• Standardized Physical and Chemical Characterization: Data derived from established and validated laboratory test methods (ISO, ASTM standards). This is the primary ground truth for material properties.
• Predicate Device Performance: Performance data from already cleared predicate devices serve as a comparative ground truth to establish substantial equivalence.
• Biocompatibility Standards: Compliance with ISO 10993 provides the ground truth for biological safety.

8. The Sample Size for the Training Set

Not applicable. This device is a material, not an AI model requiring a training set.

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

Not applicable, as there is no training set for a material or a traditional AI model discussed.

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RODIN Splint is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, splints and repositioners.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental resin material, RODIN 3D Resin SPLINT, Hard/Flex. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML powered device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.

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Characterization of provisionals.

Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth.
Characterization of C&B composite resin restorations or acrylic resin.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the "RODIN Palette Naturalizing Kit" (K223365) does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily focuses on the regulatory clearance of the device, confirming its substantial equivalence to predicate devices and outlining general regulatory requirements. It specifies the "Indications for Use" but does not delve into the technical study details that would typically be found in a submission's performance section.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided document.

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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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EtchPro® Etching Gel is intended to be used by dental professionals to etch the dentin and enamel before tooth restoration treatments.

EtchPro® Etching Gel is a 38% phosphoric acid etching gel in a soft gel form that is used by dental professionals for etching dentin and enamel before tooth restoration.

This document describes the FDA's clearance of the EtchPro® Etching Gel (K200462) as substantially equivalent to a predicate device. The information provided outlines the non-clinical performance data used to demonstrate this equivalence.

Here's an analysis of the provided text in the context of your questions:

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

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format in the way one might expect for a quantitative medical device study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance data presented shows a direct comparison of key attributes between the subject device (EtchPro® Etching Gel) and a predicate/reference device (Acid Etch Gel (Etch-Rite), with Etch-Rite Royale as an additional predicate).

Study Proving Acceptance Criteria:

The study that proves the device meets the "acceptance criteria" (defined as substantial equivalence to predicate devices) is a non-clinical performance study involving side-by-side comparative testing.

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 used for the non-clinical performance tests (phosphoric acid concentration, pH, and viscosity). It only states that "side-by-side performance tests... were conducted."
• Data Provenance: The document does not specify the country of origin of the data. It also does not specify whether the data was retrospective or prospective. Given the nature of bench testing, it would generally be considered prospective data collected for the purpose of the 510(k) submission.

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

This question is not applicable to the provided document. The ground truth for this type of non-clinical device (etching gel) is established by objective laboratory measurements of its physical and chemical properties, not by expert consensus or interpretation of images.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical or imaging studies where expert interpretation or consensus is required. For non-clinical bench testing, results are typically determined by direct measurement and analysis according to established laboratory protocols.

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 not an AI-powered diagnostic device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithmic device. The device itself (etching gel) is a standalone product.

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

The ground truth for the non-clinical performance tests (phosphoric acid concentration, pH, viscosity, biocompatibility) is established by objective, measurable laboratory standards and comparative data against legally marketed predicate devices. For biocompatibility, this would involve standardized in-vitro or in-vivo tests with defined endpoints, where the "truth" is whether the material elicits a harmful biological response.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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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