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Ready-Fit Disposable Dental Guard is indicated for protection for nighttime teeth grinding or bruxism. It is intended to reduce damage to teeth by cushioning them and keeping them apart during grinding.

Ready-Fit Disposable Dental Guard is a ready-to-wear, posterior-only occlusive mouthquard, with two molar bite surfaces each consisting of three cylinders (bite tubes) connected by a buccal retention band.

The provided document is a 510(k) summary for the DenTek Ready-Fit Disposable Dental Guard. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner typically seen for novel medical devices, especially those involving AI or complex performance metrics.

Based on the document, here's what can be extracted and what cannot:

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

The document does not explicitly state acceptance criteria in a quantitative, measurable format with specific thresholds that the device performance is then measured against. Instead, the "Substantial Equivalence Chart" acts as a comparison against a predicate device across various attributes. The 'Conclusion' column in this chart implicitly serves as a form of acceptance, indicating whether the subject device is considered "Equivalent" or "Substantially Equivalent" to the predicate.

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 mentions an "in-home use test (IHUT)" but does not specify the sample size for this test.
• Data Provenance: The IHUT was conducted in April 2015. No country of origin is specified, but given the company's address is in Maryville, Tennessee, USA, it's highly likely the test was conducted in the USA. It appears to be a prospective test, as it was conducted specifically to validate the device's design.

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)

This section is not applicable as the device is a dental guard, not an AI or diagnostic imaging device that typically requires expert-established ground truth for its performance evaluation. The "in-home use test" would likely involve user feedback on fit, comfort, and perceived effectiveness in protecting against grinding, rather than expert interpretation of data.

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

This is not applicable. The device's evaluation is not based on expert interpretation or medical imaging, so adjudication methods commonly used in those contexts are not relevant here.

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

This is not applicable. The device is a physical dental guard, not an AI or diagnostic assistance tool.

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

This is not applicable. The device is a physical dental guard, not an algorithm.

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

For the physical properties and mechanical properties tests, the "ground truth" would be established by the standardized testing procedures (e.g., ASTM D792 for density, ASTM D1238 for melt flow, etc.) and their inherent methodologies for measuring material characteristics.

For the "in-home use test (IHUT)," the "ground truth" or validation would likely be based on user feedback and self-reported outcomes regarding the device's fit, comfort, and efficacy in protecting against teeth grinding, aligning with the stated "intended use and performance."

8. The sample size for the training set

This is not applicable. This document describes a physical medical device (dental guard), not a machine learning or AI model that requires a training set.

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

This is not applicable. No training set is mentioned or implied for this physical device.

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The Easy Brush with fluoride is intended to mechanically remove plaque and food particles from between teeth to reduce tooth decay. It is to be used with an in and out motion to clean between interdental space as it is done with floss, and other interdental cleaners such as tooth picks.

The Easy Brush with fluoride is an interdental brush designed to clean between teeth. It is composed of 4 parts (a handle, a wire, bristles, and a cap). The wire is twisted around the nylon filaments to create the brush, and then is molded onto a plastic handle. It is then coated with a solution containing flavor and sodium fluoride and then capped off.

This document describes DenTek Oral Care Inc.'s Easy Brush with fluoride. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device (an interdental brush with fluoride) and focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. It covers:

• Device Identification: Name, classification, predicate devices.
• Intended Use: Mechanically remove plaque and food particles, reduce tooth decay.
• Technological Characteristics: Components (handle, wire, bristles, cap), coating with flavor and sodium fluoride.
• Substantial Equivalence: Comparison to existing FDA-cleared devices (Oral-B Woodsticks with Fluoride and Johnson & Johnson Fluoride Dental Floss, Mint Waxed).
• Biocompatibility: Justified by reference to existing approved devices and safe levels of sodium fluoride in public water.
• FDA Clearance Letter: Formal letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide a table of acceptance criteria or details about a study to prove the device meets them because this information is not present in the provided text.

To answer your request, the input text would need to include sections detailing performance specifications, study design, results, and expert involvement.

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The New Comfort-Fit® Dental Guard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

The New Comfort-Fit® Dental Guard is a posterior-only occlusion dental guard, consisting of two bite pads connected by a buccal retention strap. The New Comfort-Fit® consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to adjust to the individual user needs, with the strap always contained within the walls of the bite pads. There are 5 positions of adjustability for each bite pad. Bumpers on the lingual wall of the bite pads keep the pads from rubbing against the lower gum line. The upper vertical bite pad wall creates a greater surface area for the cheek to rest against, providing enhanced retention for the guard.

The provided text is a 510(k) Summary for a dental guard, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from this document.

This 510(k) submission is for a "Special 510(k)," indicating minor modifications to an already cleared device. The key argument is that "The minor modifications made to the device do not raise any new questions of safety or effectiveness." This type of submission generally relies on comparing technological characteristics and intended use to a predicate device, rather than new clinical performance data.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

• Cannot be provided. The document does not specify quantitative acceptance criteria or report performance data against such criteria. The basis for clearance is "substantial equivalence" to predicate devices, not meeting specific performance benchmarks in a study.

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

• Cannot be provided. No clinical test set data is mentioned.

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

• Cannot be provided. No test set requiring expert ground truth is mentioned.

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

• Cannot be provided. No test set is mentioned.

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

• Cannot be provided. This device is a physical dental guard, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI improvement metrics are not applicable.

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

• Cannot be provided. This device is a physical dental guard, not an algorithm. Standalone performance is not applicable.

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

• Cannot be provided. No ground truth data is discussed. The device's safety and effectiveness are established by demonstrating similarity to predicate devices.

8. The sample size for the training set:

• Cannot be provided. No training set for an algorithm is mentioned as this is a physical device.

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

• Cannot be provided. No training set is mentioned.

Summary of Device Information Available:

• Device Name: New Comfort-Fit® Dental Guard
• Intended Use: Protection against bruxism or nighttime teeth grinding; intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
• Technological Characteristics: Posterior-only occlusion dental guard, two bite pads connected by a buccal retention strap, made of ELVAX (thermoplastic material), adjustable (5 positions), with lingual wall bumpers and an upper vertical bite pad wall for enhanced retention.
• Predicate Devices:
  • DenTek Oral Care Inc.'s Improved Comfort-Fit NightGuard (K081669)
  • Sleepright® Dura-Comfort® Dental Guard (K071404)
• Basis for Clearance: Substantial equivalence to predicate devices, arguing that minor modifications do not raise new questions of safety or effectiveness.

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The Custom Comfort Nightguard Version 2 is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

The Custom Comfort Nightguard Version 2 is a fully occlusive nightguard, consisting of a soft, formable material, and non-formable base, which cushions the teeth. When heated and then briefly cooled, the formable material is molded to fit the user's maxillary dentition for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces.

This document is a 510(k) summary for a medical device (Custom Comfort Nightguard Version 2). It indicates that the device has undergone no new clinical studies and instead relies on substantial equivalence to previously cleared predicate devices.

Therefore, the following information cannot be extracted from the provided text:

• Acceptance criteria and reported device performance (no new performance data presented)
• Sample size for the test set and data provenance
• Number of experts and their qualifications for establishing ground truth
• Adjudication method for the test set
• MRMC comparative effectiveness study results or effect size
• Standalone algorithm performance
• Type of ground truth used (for a new study)
• Sample size for the training set
• How ground truth for the training set was established

Explanation:

The document explicitly states its purpose is a "Special 510(k) notice" for a "modification" to existing devices. It concludes that "The minor modifications made to the device do not raise any new questions of safety or effectiveness. Thus, the Custom Comfort Nightguard Version 2 is substantially equivalent to its predicate devices." This means the FDA did not require new performance data or clinical studies for this submission. The device's safety and effectiveness are assumed based on its similarity to previously cleared devices.

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The Custom Comfort Nightguard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

The Custom Comfort Nightguard is a fully occlusive nightguard, consisting of a soft, formable material, and non-formable base, which cushions the teeth. When heated and then briefly cooled, the formable material is molded to fit the user's maxillary dentition for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces. The Custom Comfort is designed with an anterior area formed from the soft, formable material that allows for expansion and contraction of the device to fit most mouth sizes.

This is a 510(k) premarket notification for a medical device called "Custom Comfort Nightguard." The document explicitly states that it is a modification to a previously cleared device, the "DenTek Nightguard (K063483)," and claims "The minor modification made in the device does not raise any new questions of safety or effectiveness."

Therefore, this submission does not contain a study proving the device meets acceptance criteria. Instead, it relies on the concept of substantial equivalence to a predicate device already on the market. In 510(k) submissions, especially for modifications of existing devices that do not introduce new questions of safety or effectiveness, often no new clinical studies or detailed performance studies with acceptance criteria are required or performed. The FDA determines substantial equivalence based on the comparison of intended use, indications for use, technological characteristics, and safety and effectiveness information.

Given this context, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory submission for a Class I unclassified device (Over-the-Counter Mouthguard), where rigorous performance study data as typically seen for higher-risk devices or novel technologies is generally not required for clearance.

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The DenTek Improved Comfort-Fit NightGuard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

The Improved Comfort-Fit NightGuard is a posterior-only occlusion nightguard, consisting of two bite pads connected by a buccal retention strap. The Improved Comfort-Fit consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to the individual user needs, with the strap always contained within the wings of the bite pads. There are 5 positions of adjustability for each molar pad.

The provided text is a 510(k) summary for the DenTek Oral Care Inc.'s Improved Comfort-Fit NightGuard. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel acceptance criteria and a detailed study proving the device meets those criteria.

Therefore, the information required in the prompt (acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set sizes) is not available within this 510(k) summary.

Here's a breakdown of why this information is missing and what the document does provide:

• Acceptance Criteria and Device Performance: The document does not describe specific performance metrics (e.g., reduction in tooth wear, noise reduction percentage) or a table of acceptance criteria. Its primary claim is that the "minor differences made in the device for patient comfort do not raise any new questions of safety or effectiveness."
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): This 510(k) is a Special 510(k) based on modifications to an already cleared device (K072147). For such submissions, manufacturers typically demonstrate that the changes do not adversely affect safety or effectiveness, often through engineering analysis, biocompatibility testing, and sometimes limited human factors or user preference studies, rather than large-scale clinical trials with extensive ground truth establishment. No such detailed study information is provided in this summary.
• Ground Truth: Since there's no detailed study described, there's no mention of how "ground truth" would have been established for performance metrics. The implicit "ground truth" for substantial equivalence is the safety and effectiveness of the predicate device.
• Training Set: This is not an AI/ML device, so there is no concept of a "training set" like in typical AI performance studies.

What the document does state regarding demonstrating equivalence (which is the goal of a 510(k)):

• Purpose: The Improved Comfort-Fit NightGuard is a modification to DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147).
• Intended Use: Identical to the predicate: protection against bruxism or nighttime teeth grinding, reduction of damage to teeth, and prevention of noise.
• Technological Characteristics: Made entirely of ELVAX (a thermoplastic material), posterior-only occlusion, two bite pads connected by a buccal retention strap, 5 positions of adjustability for each molar pad. The previous version (K072147) would have had very similar characteristics. The "Improved Comfort-Fit" implies minor design changes for user experience rather than fundamental functional differences.
• Substantial Equivalence Argument: "DenTek's Improved Comfort-Fit has the same intended use and similar indications, principles of operation, and technological characteristics as DenTek's Comfort Fit. The minor differences made in the device for patient comfort do not raise any new questions of safety or effectiveness. Thus, the Improved Comfort-Fit is substantially equivalent to its predicate devices."

In summary, this 510(k) notification for a modified physical device does not contain the kind of performance study data and acceptance criteria you would find for an AI/ML diagnostic or treatment device. Its entire premise is that it's so similar to a previously cleared device that extensive new studies are not required to demonstrate safety and effectiveness.

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The DenTek NightGuard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding.

The DenTek NightGuard is composed of a soft, formable material made of a blend of ethylene vinyl acetates, and non-formable occlusal base, which cushions the teeth. The base is composed of a copolymer of ethylene and methyl acrylate. When heated and then briefly cooled, the formable material is molded to fit the user's upper teeth for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces. The DenTek NightGuard is designed with three flex points that allow for expansion and contraction of the device to fit most mouth sizes.

{"box_2_1": "No performance data is required for the DenTek NightGuard in support of this 510(k) notice. The device demonstrated substantial equivalence to a predicate device based on having the same intended uses, indications, principles of operation, and similar technological characteristics, without raising new questions of safety or effectiveness."}

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