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The Remi Night Guard is indicated for protection of teeth and restorations against grinding and clenching.

The Remi Custom Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).

This document is a 510(k) Premarket Notification from the FDA regarding a dental device called the "Remi Custom Night Guard." It states that the device is substantially equivalent to a legally marketed predicate device (LIJIA Night Guard), meaning a full clinical study with acceptance criteria and a detailed study report is not required.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document explicitly states:

• "no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device." (page 6)

Instead, the submission relies on:

• Comparison to a Predicate Device: The Remi Custom Night Guard is shown to have the same indications for use, product code, classification, anatomical sites, sterility, patient removability, and general technological features as the predicate LIJIA Night Guard (K241369).
• Non-Clinical Performance Testing:
  • Durability testing: Completed, but no details on specific acceptance criteria or results are provided.
  • Internal manufacturing validation: Performed to test the dimensional accuracy of the manufacturing process, but no specific acceptance criteria or results are provided.
  • Biocompatibility testing: Performed in accordance with ISO 10993, with cytotoxicity testing completed. No specific acceptance criteria or results are provided beyond the statement that it was completed.

In summary, because this is a 510(k) submission based on substantial equivalence to a predicate device and explicitly states that no clinical studies were deemed necessary, the detailed information about acceptance criteria and a study to prove device performance (as requested in the prompt) is not present in this document.

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The LIJIA Night Guard is indicated for protection of teeth and restorations against grinding and clenching.

The LIJIA Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).

This document is a 510(k) Premarket Notification from the FDA regarding the LIJIA Night Guard. It states that no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the device due to similarities in indications for use, technological characteristics, and non-clinical performance testing validated against a predicate device.

Therefore, there is no information available in the provided text about acceptance criteria for device performance, the study that would prove the device meets these criteria, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or sample sizes for training sets.

The document focuses on the substantial equivalence determination for the LIJIA Night Guard based on non-clinical performance testing and comparison to predicate devices, rather than a clinical study demonstrating performance against specific acceptance criteria.

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LuxCreo Dental Night Guard Resin is a liquid light-curing resin product indicated for the creation of orthodontic and dental appliances such as mouthguards, splints, and repositioners.

LuxCreo Dental Night Guard Resin is a liquid light-curing resin product.

The provided text focuses on the FDA's 510(k) clearance for the "LuxCreo Dental Night Guard Resin" and does not contain information about acceptance criteria or a study proving device performance against those criteria. The document is an FDA clearance letter, which confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample size used, data provenance for the test set
• Number of experts and their qualifications for ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This information would typically be found in a separate clinical or non-clinical study report submitted as part of the 510(k) application, but it is not detailed in this FDA clearance letter.

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The Serena Sleep Night Guard/Occlusal Appliance is a removable medical device that is fitted to the patient's mouth and is intended to protect teeth and restorations against the forces of bruxism and alleviate temporomandibular joint, jaw, and muscle and tension headache pains.

The Serena Sleep Night Guard/Occlusal Appliance is a custom-made intraoral device used for protecting teeth and restorations against the forces of bruxism and alleviating temporomandibular joint, jaw, and muscle and tension headache pains.

The provided text is an FDA 510(k) summary for the Serena Sleep Night Guard, a medical device. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based diagnostic or prognostic system.

The submission is for a physical medical device (a night guard), and the "performance testing" section refers to bench testing for physical properties like flexural strength, water sorption, and durability, and states that no clinical testing was deemed necessary due to the similarity to the predicate device.

Therefore, I cannot extract the information required to answer your prompt from the provided text, as it specifically asks for details related to AI/algorithm performance and clinical validation studies common in the context of AI-driven medical devices.

Here's why and what's missing:

• Acceptance Criteria for AI Performance: The document does not mention any AI, algorithms, or software intended for diagnostic or prognostic purposes. Thus, there are no acceptance criteria related to sensitivity, specificity, AUC, or other metrics typically used for assessing AI performance in a clinical setting.
• Study Proving Device Meets Criteria: Since there's no AI component, there's no study described that evaluates AI performance against clinical outcomes or expert labels. The document explicitly states "no Clinical Testing were deemed necessary."
• Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size/Ground Truth: All these points are relevant to the validation of AI/ML models in medical devices. As the Serena Sleep Night Guard is a physical device analogous to a 3D-printed appliance, these concepts do not apply to its regulatory submission as described.

In summary, the provided document is a 510(k) for a physical medical device and does not contain the information required to address your prompt about AI/algorithm acceptance criteria and validation studies.

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The FBCC Night Guard is indicated for protection of teeth and restorations against grinding and clenching.

The FBCC Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).

This document describes an FDA 510(k) clearance for the FBCC Night Guard. It is a submission that declares the device is "substantially equivalent" to predicate devices, meaning it does not introduce new questions of safety or effectiveness. As such, the information provided focuses on demonstrating this equivalence rather than detailing an extensive clinical study with specific acceptance criteria and performance metrics for a novel AI device.

Therefore, many of the requested elements (e.g., acceptance criteria for AI performance, sample size for test sets, expert-established ground truth, MRMC studies, standalone AI performance, training set details) are not applicable to this type of regulatory submission, as the FBCC Night Guard is a physical medical device (a mouth guard), not an AI-powered diagnostic or therapeutic device.

However, I can extract the relevant information regarding the performance testing that was conducted to support its substantial equivalence:

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

Since this is a physical device and a 510(k) submission based on substantial equivalence, there are no "acceptance criteria" in the traditional sense of a specified performance metric (e.g., accuracy, sensitivity, specificity) for an AI algorithm. Instead, the "acceptance criteria" were implied to be the demonstration of similarity to legally marketed predicate devices and satisfactory non-clinical performance.

• Product Code (OBR)
• Classification Panel (Dental)
• Device Class (Unclassified)
• OTC or Rx (OTC, same as predicate)
• Anatomical Sites (maxillary or mandibular teeth)
• Sterile (Non-Sterile)
• Patient Removable (Yes)
• Mechanism of Action (Disocclusion)
• Indications for Use (protection of teeth and restorations against grinding and clenching). |
  | Material Safety | Material must be suitable for its intended use and not introduce new risks. | The FBCC Night Guard uses Thermoplastic Polyurethane or Ethylene-Vinylacetate. The predicate uses Thermoplastic resin (Propylene Elastomer: ethylene-vinylacetate [Elvax]). The submission states: "While these are not identical polymers, each material is a known dental thermoplastic polymer with similar characteristics. The use of thermoplastic polyurethane does not introduce or reduce any risks when compared to the other." |
  | Manufacturing Process | Manufacturing process must be appropriate and not introduce new risks. | The FBCC Night Guard is Thermoforming. The predicate (Bright Guard) is Injection Molding, and the reference device (JS Dental Lab Mouth Guard) is Thermoforming. The submission states: "While these are not identical processes, both are commonly used to create mouth guards and other dental devices... The use of thermoforming does not increase the risk associated with manufacturing." An internal manufacturing validation demonstrated "dimensional accuracy of the manufacturing process" and "robustness of the process... from 3D printing through thermoforming." |
  | Durability Testing | Must demonstrate suitability for the intended period of use under simulated real-world conditions. | "Durability testing was completed on these night guards. Real world use was simulated to ensure that the Night Guard material and manufacturing process produced Night Guards that were suitable for the intended period of use." (Specific quantitative results or "acceptance criteria" for durability are not provided in this summary document, but the statement indicates it passed this internal testing). |

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

This information is not applicable as there was no AI test set with case data. The testing mentioned (durability, manufacturing validation) would be internal laboratory testing on physical prototypes/products.

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 device is a physical mouth guard, not an AI diagnostic/imaging device requiring expert interpretation for ground truth.

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

Not applicable. No AI test set or clinical image review was performed for this 510(k) submission.

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 a physical device, not an AI-assisted diagnostic tool.

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

Not applicable. There is no algorithm.

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

Not applicable. As a physical device submission focused on substantial equivalence, the "ground truth" for the claims rested on:

• Comparison of specifications to legally marketed predicate devices.
• Results of non-clinical, mechanical, and material testing (e.g., durability, dimensional validation).
• Scientific literature supporting the use of the materials and mechanism of action for night guards.

8. The sample size for the training set

Not applicable. There is no AI model or training set.

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

Not applicable. There is no AI model or training set.

Summary of the Study Proving the Device Meets Criteria (Based on Provided Document):

The "study" proving the device met the criteria for 510(k) clearance was primarily a demonstration of substantial equivalence to existing predicate devices already on the market. This involved:

• Comparison of Technical Characteristics: A detailed comparison table (Table 1) was presented, highlighting similarities in product code, classification, device class, OTC status, anatomical sites, sterility, patient removability, indications for use, and mechanism of action with the Bright Guard (K181099) and JS Dental Lab Mouth Guard (K210011).
• Material Equivalence: Although different specific polymers (thermoplastic polyurethane vs. thermoplastic resin), the submission argued both are "known dental thermoplastic polymer with similar characteristics" and introduce no new risks.
• Manufacturing Process Equivalence: While the subject device uses thermoforming and the primary predicate uses injection molding, the submission highlighted that thermoforming is also used by the reference device and is a "commonly used" method that "does not increase the risk."
• Non-Clinical Performance Testing:
  • Durability Testing: Simulated real-world use was conducted to ensure the night guards were suitable for the intended period of use. (Specific quantitative results were not detailed in this summary).
  • Manufacturing Validation: An internal validation was performed to check the dimensional accuracy and robustness of the manufacturing process (3D printing through thermoforming).
• Conclusion: Based on these comparisons and non-clinical tests, the FDA determined the FBCC Night Guard to be "substantially equivalent" to the predicate devices, and therefore, no clinical studies were deemed necessary to demonstrate its safety and effectiveness.

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Night Guard is indicated for protection against bruxism or nighttime teeth grinding. It creates a barrier between upper and lower dentition to protect the patient's overall occlusion.

Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or facial muscle pains are common side effects of bruxing or clenching the teeth. These patients specific devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching, while protecting teeth from daily wear and tear. Night Guard is shipped non-sterile.

The provided text describes the acceptance criteria and the study that proves the "Night Guard" device meets these criteria. The study focuses on non-clinical performance tests to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Additionally, Biocompatibility testing per ISO 10993-1 was passed for cytotoxicity, sensitization, acute systemic toxicity, subacute/subchronic toxicity, genotoxicity, and implantation.
Process Flow validation was performed to ensure that the finished device matches the software output specifications, and the Night Guard met these specifications.

2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size for each test. However, for the "Toughness" test, the acceptance criteria mention "180 times of flexing cycles," and for "Wear Resistance," it mentions "10,000 cycles of abrasion," indicating the number of iterations or repetitions for these specific tests on material samples. The data provenance is not specified in terms of country of origin or whether it's retrospective or prospective; it appears to be internal testing conducted by 3D Diagnostix Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts or their qualifications for establishing ground truth for the performance tests. The "Rigidity" and "Fit" tests rely on visual examination and manual assessment, but the "expert" status is not defined.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
No adjudication method is mentioned for the test set.

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. This document describes the testing of a physical medical device (night guard), not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the subject device is a physical night guard, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance tests (Rigidity, Toughness, Fit, Wear Resistance) is based on compliance with predefined acceptance criteria derived from internal requirements and/or relevant standards (ASTM D695, ISO 14569). It's a combination of objective measurements (e.g., compressive stress for toughness) and subjective assessment against established criteria (e.g., "feels sufficiently rigid," "stays on metal dentition when turned upside down" for fit). For biocompatibility, the ground truth is established by adherence to ISO 10993-1.

8. The sample size for the training set:
This section is not applicable. The Night Guard is a physical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:
This question is not applicable, as there is no training set for a physical device.

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The Brux Night Guard 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 grinding.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted for the Brux Night Guard. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory information and indications for use, but no performance data or study details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this text.

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OTC:

• Protection against bruxism or night time teeth grinding
• Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding.

Rx:

• Protection of teeth grinding, bruxism, and jaw clenching.
• Protection of restorations from injury due to bruxism or clenching.
• Relief of bruxism related headaches and pains.
• Short-term pain relief from muscle spasm due to occlusal interference; for the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.
• Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.

The SmartGuard® is a dental night guard composed of Elvax and once this thermoplastic material is submerged in hot water (see molding instructions) it softens and conforms to the individual's anterior maxillary teeth from first bicuspid. SmartGuard® is designed to be worn on the anterior, upper 6 to 8 teeth, preventing the posterior teeth from coming into occlusion, which relaxes the jaw muscles and helps to reduce jaw clenching and grinding and reduces the associated symptoms. The lower bottom anterior teeth bite against the bottom of the substrate with the ability to slide around freely as the device reduces posterior teeth cuspal interferences. The design features of SmartGuard® allow patients to easily mold this device at home or in a prescribing office, to fit their teeth properly. The SmartGuard® is designed to be worn at night and not longer than 12 consecutive hours in a 24 hour period.

SmartGuard® Original and SmartGuard Elite® differ slightly in design, with the primary difference being in the width of the palatal ex-tension, (Original 21mm and Elite 30 mm) as well as the distance between the outer rim and mesial/occlusal surface of the palatal extension (Original 10 mm and Elite 9 mm). The SmartGuard Elite® was designed to fit the majority of individuals mouths. However, if the patient has a small mouth or has a sensitive gag reflex, the SmartGuard® Original might be a better fit.

This document is a 510(k) premarket notification for the SmartGuard® Night Guard, SmartGuard® Original, SmartGuard® Night Guard Original and SmartGuard Elite™ dental guards. The document outlines the device description, intended use, and a comparison to predicate devices, ultimately demonstrating substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific numerical targets. Instead, the entire submission is based on demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" is therefore implied to meet the same level of safety and effectiveness as the predicate devices.

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

The document does not describe a specific test set or clinical study with a sample size for the SmartGuard® device itself. The claim of substantial equivalence is based on a comparison of technical characteristics, design, materials (Elvax), and intended uses to already cleared predicate devices. There is no mention of a clinical trial or performance study on human subjects with the SmartGuard® device to establish its performance.

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

As there is no described test set or clinical study for the SmartGuard® device itself, there were no experts used to establish ground truth in this context. The "ground truth" for the predicate devices' safety and effectiveness would have been established during their respective clearance processes, which are not detailed here.

4. Adjudication Method for the Test Set

Since no specific test set or clinical study is described for the SmartGuard® device, no adjudication method is mentioned or applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study was done as part of this 510(k) submission. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and an AI's impact on their performance is being evaluated. This submission pertains to a physical dental device.

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

This is not applicable. The SmartGuard® is a physical dental device, not an algorithm or AI system. Its performance is inherent in its design and material properties, intended for direct use by the patient or under doctor's guidance, not as a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The SmartGuard® is deemed substantially equivalent because it shares the same intended uses, similar technological characteristics, and material composition with these cleared predicate devices, asserting that it raises "no new questions of safety or effectiveness."

8. The Sample Size for the Training Set

There is no training set described as this is not an AI/machine learning device. The design and materials are based on existing dental guard technologies.

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

This is not applicable as there is no training set mentioned in the document for an AI/machine learning device.

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The Night Guard is intended for protection against bruxism and nighttime teeth grinding. It is intended to reduce damage to teeth and to prevent the noise associated with bruxing and grinding.

NightGuard is a soft, comfortable, mouth guard intended to provide a barrier between the teeth for those patients who grind their teeth at night (bruxism). The product is shaped like a dental arch and is available in three sizes, but can be trimmed to fit more comfortably. NightGuard is a full coverage device which covers the occlusal surfaces of all the upper teeth.

The provided text describes a 510(k) submission for a non-diagnostic medical device (a mouth guard), not an AI/ML-enabled diagnostic device. Therefore, the typical acceptance criteria and study design elements requested in the prompt, which are relevant to AI/ML device performance evaluation, are largely not present in this document.

However, I will extract the information that is present concerning the device's "performance" in the context of this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (NightGuard mouth guard), the "acceptance criteria" and "performance" are framed around substantial equivalence to predicate devices, rather than quantitative performance metrics like sensitivity or specificity. The primary "performance" characteristic is its ability to serve the intended use.

Study That Proves the Device Meets the Acceptance Criteria:

Based on the provided document, no specific study was performed to "prove" the device meets acceptance criteria in the context of performance metrics. For this 510(k) submission, the "proof" is established through a comparison to legally marketed predicate devices to demonstrate substantial equivalence.

Here's why and what was reported:

• Non-Clinical Tests Performed: "No non-clinical tests were preformed for the determination of substantial equivalence."
• Clinical Tests Performed: "No clinical tests were preformed for the determination of substantial equivalence."
• Conclusions Drawn From Non-Clinical and Clinical Tests: "No conclusions were drawn from Non-clinical and Clinical Test."
• Overall Conclusion: "NightGuard is as safe, as effective, and performs as well as or better than the predicated device." This conclusion is drawn purely from the narrative and tabular comparison of features with the predicate devices, not from direct testing of the NightGuard itself.

Given that this is a 510(k) for a non-diagnostic, non-AI device, the subsequent questions are not applicable. I will explicitly state why for each:

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. No test set or data was used as no clinical or non-clinical studies were performed for this 510(k). The determination was based on comparison to predicate devices.

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. No test set was used, and therefore no ground truth was established by experts for performance evaluation.

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

• Not applicable. No test set 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

• Not applicable. This device is not an AI/ML diagnostic. No MRMC study was performed.

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

• Not applicable. This device is not an AI/ML algorithm.

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

• Not applicable. No ground truth was established as no performance studies were conducted. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device and does not have a training set.

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

• Not applicable. This is not an AI/ML device and does not have a training set.

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