Search Results

Dentemp Pro-Comfort is indicated for protection against nighttime teeth grinding (bruxism). It is intended to reduce damage to teeth and prevent the noise associated with teeth grinding and bruxism.

Dentemp Pro-Comfort Dental Guard is an over-the-counter device to be used by lay people for protection against the effects of nighttime teeth grinding. It is manufactured with a two-shot, injection molded process. The first shot is a hard base of Ethylene Methyl Acrylate material (EMA), which contacts the lower tooth surfaces during grinding and prevents grind-through. The second shot is a soft, moldable surface layer of Ethylene Vinyl Acetate material (EVA), which is formed to hug the upper teeth for a comfortable fit. It is a custom fit dental guard, formed to an individual user's mouth by the traditional heat and form fitting technique. It is a full-occlusal guard worn on the upper teeth, providing a barrier to separate the upper and lower teeth and keep them apart while sleeping, thus reducing the damage to teeth caused by bruxism and preventing the noise associated with teeth grinding.

The provided FDA 510(k) Clearance Letter for the Dentemp Pro-Comfort Dental Guard focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria for a novel AI/software medical device.

Therefore, many of the requested details about acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert qualifications, and MRMC studies are not applicable to this type of submission. This document describes a traditional 510(k) for a physical medical device (a dental guard), not an AI/software device.

However, I can extract the information that is present and explain why other details are absent based on the nature of this 510(k) submission.

Analysis based on the Provided Document:

The Dentemp Pro-Comfort Dental Guard is a physical medical device, not an AI/software device. Its approval is based on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against quantitative acceptance criteria typical for AI/software in a clinical trial setting.

Therefore, the study performed is a comparative study and in-home use test to demonstrate equivalence, not a standalone performance study with strict numerical acceptance criteria for AI/software metrics.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The concept of "acceptance criteria" as quantitative metrics (e.g., sensitivity, specificity, F1-score) is not explicitly detailed for this physical device in the manner it would be for an AI/software product. Instead, the "performance" is demonstrated through comparative equivalence and successful real-world use.

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

• Test Set Sample Size:
  • Comparative Study (Fit Technology): The document states "A comparison study... demonstrated the performance of the T-Bars... is equivalent to the performance of the T-Bars...". It does not specify the number of devices or subjects included in this comparative study.
  • In-Home Use Test: "An In-Home Use Test was conducted on the subject device..." The specific number of participants or duration is not provided in this summary.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective, though "In-Home Use Test" typically implies a prospective design.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This information is not applicable for this type of medical device and submission. The "ground truth" for a physical dental guard is its physical properties, material composition, and functional performance (e.g., fit, comfort, barrier function) assessed through physical and observational tests rather than expert interpretation of complex data (like radiology images for AI).
• The "validation" of the in-home use test would likely involve user feedback rather than expert-adjudicated ground truth.

4. Adjudication Method for the Test Set:

• This information is not applicable. Given that this is a physical device and not an AI/software requiring human interpretation of outputs against a "ground truth," adjudication methods like 2+1 or 3+1 are not relevant.

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

• No, this was not done. An MRMC study is relevant for AI/software devices that assist human readers (e.g., radiologists, pathologists) in interpreting medical images or data. This submission is for a physical dental guard.

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

• No, this was not done. This concept is only applicable to AI/software algorithms. The "standalone" performance for this device would refer to its physical properties and mechanical function, which are assessed via the comparative study and in-home use test.

7. The Type of Ground Truth Used:

• For Material and Design Equivalence: The ground truth is the specified material composition (EMA, EVA) and design features of both the subject and predicate/reference devices, established through engineering specifications and potentially material analysis.
• For Fit Technology Performance: The ground truth is presumably quantitative measurements of dimensional variation after forming, demonstrating that the subject device achieves a fit comparable to the reference device.
• For In-Home Use Test: The ground truth is user experience and self-reported outcomes regarding ease of forming, fit, comfort, and perceived effectiveness in preventing bruxing. This is based on direct observation of functional performance and patient subjective feedback.

8. The Sample Size for the Training Set:

• This information is not applicable. "Training set" refers to data used to train machine learning models. This is a physical device.

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

• This information is not applicable for the same reason as point 8.

Ask a specific question about this device

The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching.

The Anti Grinding Guard is an over-the-counter (OTC), flexible and moldable one-piece dental mouth guard, which is used as a barrier between teeth for individual s who grind their teeth. The anti Grinding Guard is intended to be worn while sleeping. The guard is constructed of 100% thermoplastic ethylene-vinyl acetate copolymer. When heated it forms to the individual's teeth. It is non-flavored and has no color additives. The mouth guard Is one model/size, is reusable by a single individual at least eighteen (18) years of age and is supplied as non-sterile.

The provided text is a 510(k) Pre-market Notification for a medical device called "Anti Grinding Guard." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new, independent set of clinical efficacy studies. Therefore, much of the requested information about acceptance criteria, detailed study designs, sample sizes, and expert adjudication for proving efficacy is not typically found in these documents.

However, I can extract information related to the non-clinical testing performed to support the substantial equivalence claim.

Here's a breakdown of the available information:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative table with specific target values and reported performance for each criterion in the way a clinical trial might. Instead, it states that "The non-clinical testing of Anti Grinding Guard demonstrates the device's performance in providing including hardness, water absorption and solubility testing, boiling/cooling water testing, impression test, separation test, and comparative wear test, which supports its substantial equivalence to the predicate device."

It implies that the "acceptance criteria" for these tests were met if the results demonstrated performance comparable to the predicate device and compliance with "pertinent standards and specifications."

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

The document does not provide specific sample sizes for the non-clinical tests. It doesn't specify the country of origin of the data or whether the tests were retrospective or prospective; these details are typically not included in a 510(k) summary for non-clinical testing unless directly relevant to a specific regulatory standard.

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 information is not applicable to the non-clinical bench testing described. "Ground truth" and "experts" are concepts usually associated with clinical studies or performance evaluation where human interpretation of data is involved (e.g., image analysis, diagnosis). The non-clinical tests focus on material properties and physical performance.

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

This is not applicable to the non-clinical bench testing. Adjudication methods are typically used in clinical studies where multiple human evaluators assess outcomes that may be subjective.

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 "Anti Grinding Guard," not an AI diagnostic or assistance tool that would involve human readers.

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

This is not applicable, as the device is a physical product, not an algorithm.

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

For the non-clinical tests, the "ground truth" would be established by objective measurements and standardized testing procedures to determine material properties and performance characteristics according to relevant international standards (e.g., ISO 10993 for biocompatibility) and engineering principles. The document states that the testing demonstrated compliance with "pertinent standards and specifications" and met "the requirements of the study protocols."

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.

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

This is not applicable for the same reason as point 8.

Ask a specific question about this device

The Goyo Mouthpiece S is indicated for use as a protection against bruxism or nighttime teeth grinding. The device is designed to reduce tooth damage and reduce the noise associated with bruxism or teeth grinding.

The mouthguard is an over-the-counter, flexible and moldable, one-piece dental mouthguard used as a barrier between the teeth for individuals who wish to prevent teeth grinding during sleep. The Goyo Mouthpiece S is made of ethylene vinyl acetate (EVA). The mouthguard material is conformable to wear and it can be self-fitting by heating the mouthguard in boiling water until it becomes malleable to fit on the upper teeth of the oral cavity. The Goyo Mouthpiece S comes in one model/size, is reusable by a single individual eighteen (18) years of age or older, and is supplied non-sterile. The wearing period of the mouse guard is generally not more than twelve (12) hours a day and it is recommended to replace it with the new mouthguard in the one (1) month.

This document is an FDA 510(k) Premarket Notification for the "Goyo Mouthpiece S", a device indicated for protection against bruxism or nighttime teeth grinding. The submission aims to demonstrate substantial equivalence to a predicate device (K133423, Rest Assured® Extra Comfort Nite Protector / Ranir, LLC).

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

No clinical performance data was provided for this device. The submission relies on non-clinical performance data (biocompatibility and mechanical testing) to demonstrate substantial equivalence to the predicate device, stating that the differences do not affect safety and effectiveness. Therefore, the questions related to clinical study design, sample size, expert involvement, and ground truth for a clinical test set are not applicable here.

Device Performance and Acceptance Criteria Breakdown:

The acceptance criteria for this device are implicitly tied to demonstrating that its performance characteristics are comparable to the predicate device and that it is safe and effective for its indicated use. The studies performed are non-clinical (biocompatibility and mechanical testing).

No specific quantitative acceptance criteria targets (e.g., "accuracy > 90%") are stated for the Goyo Mouthpiece S in this document. Instead, the document states that "All test results for appearance, dimensions, Shore A hardness, tensile strength, tear strength, water sorption, and water solubility were similar to that of the predicate device." and that "The performance characteristics of the subject device are comparable to those of the predicate device for this particular indication and raise no new or different questions of safety and effectiveness."

Here's a table summarizing the reported device performance where applicable, compared to the predicate:

Study Details (Non-Clinical Performance Data):

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify the exact number of samples used for each mechanical test (e.g., 'n=' for tensile strength, tear strength, etc.). It only provides average values and standard deviations for tear strength.
   • Data Provenance: The tests were performed to support substantial equivalence to a predicate device. The location of the testing laboratories is not explicitly stated, but the manufacturer (DIMEDIKOREA) is based in South Korea, and the correspondent (SMB Korea) is also in South Korea. The data would be considered retrospective as it was collected to support the premarket notification.

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

   • Not applicable. This submission relies on objective physical and chemical property testing (biocompatibility and mechanical testing) rather than expert-derived ground truth from interpreting medical images or clinical outcomes.

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

   • Not applicable. This concept relates to human assessment and consensus, which is not part of the non-clinical testing performed.

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

   • Not applicable. This device is a physical mouthguard, not an AI-powered diagnostic or assistive tool for human readers.

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

   • Not applicable. This is a physical device, not an algorithm.

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

   • Objective Test Standards: The "ground truth" for the non-clinical tests (biocompatibility, mechanical properties) is adherence to recognized international standards (e.g., ISO 10993-1 for biocompatibility) and comparison to the known characteristics of the legally marketed predicate device.

7. 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 algorithm.

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

   • Not applicable. (See point 7).

Summary of Approach:

The FDA 510(k) submission for the Goyo Mouthpiece S relied on a direct comparison of the device's technical characteristics and non-clinical performance data (biocompatibility and mechanical properties) to a legally marketed predicate device (K133423). The argument for substantial equivalence is based on the premise that any minor differences in material composition or dimensions do not raise new questions of safety or effectiveness, as demonstrated by the comparable performance in standard physical and chemical tests. Clinical performance data was explicitly stated as not having been provided, indicating that the non-clinical data was deemed sufficient to establish substantial equivalence for this type of device.

Ask a specific question about this device

The Mouth Guard is indicated 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 Mouth Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of a thermoplastic ethylene-vinyl acetate copolymer and is fitted by molding the bite pads to the user's teeth after the guard has been heated via submersion in boiled water. The fully occlusive guard is worn on the upper teeth, maintaining separation between the upper and lower teeth, thereby reducing the noise and damage associated with teeth grinding.

This document is a 510(k) summary for a Mouth Guard device, not a typical diagnostic AI or image analysis device that would be evaluated with specific metrics like sensitivity, specificity, or improvement with AI assistance. Therefore, many of the requested points regarding acceptance criteria and study details (e.g., ground truth, MRMC study, sample size for test/training sets, number of experts, adjudication methods) are not applicable to the information provided in this document.

The Mouth Guard is a physical device, and its acceptance criteria and performance are based on bench testing (non-clinical) rather than clinical studies or the analysis of medical images by AI.

Here's an analysis of the provided text based on the questions, highlighting what is (and isn't) present:

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

The document does not provide a formal table of acceptance criteria with specific numerical thresholds and corresponding performance values for the Mouth Guard. Instead, it states that "Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling."

It lists the types of performance tests conducted:

• Hardness
• Tear strength
• Impact and rebound
• Water absorption
• Impression test
• Separation test
• Stability test

It also lists biocompatibility tests:

• Cytotoxicity
• Oral Mucosa Irritation
• Skin Sensitization
• Acute systemic toxicity
• Sub chronic systemic toxicity
• Genotoxicity

The reported performance is a qualitative statement: "The non-clinical testing of Mouth Guard demonstrates the device's performance in providing including hardness, tear strength, impact and rebound, and water absorption, which supports its substantial equivalence to the predicate device." And for biocompatibility: "The results of the testing met the requirements of the study protocols and the material is considered non-toxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence to the predicate."

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

This information is not provided because the submission did not include a clinical study or a "test set" in the context of AI/ML evaluation. The testing was non-clinical (bench testing) and biocompatibility testing. No mention of data provenance like country of origin or retrospective/prospective nature is made for these types of tests in this document.

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. As this is a physical device measured through bench tests and biocompatibility, there are no "experts" establishing ground truth in the sense of medical image interpretation. Performance is measured against physical standards and parameters.

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

Not applicable. There is no "test set" or adjudication process described for the evaluation of this physical 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 not an AI/ML 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 AI/ML device.

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

For the non-clinical tests, the "ground truth" would be established physical standards, material specifications, and validated test methods for properties like hardness, tear strength, and biocompatibility. It's not "expert consensus" or pathology outcomes as would be seen in diagnostic claim evaluations.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this kind of physical device submission.

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

Not applicable. There is no concept of a "training set" for this kind of physical device submission.

In summary, the provided document is a 510(k) clearance letter for a non-AI/ML medical device (a mouth guard). The substantial equivalence determination is based on a comparison to predicate devices and non-clinical bench testing. The nature of the device and the submission means that most of the questions relating to AI/ML device evaluation criteria are not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

Protect-It Custom Fit Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding.

Protect-It Custom Fit Dental Guard is an over-the-counter device to be used by lay people for protection against the effects of nighttime teeth grinding. It is made of a single thermoplastic resin, ethylene vinyl acetate copolymer, EVA, which is easily molded to the teeth when heated. It is a full-occlusal guard worn on the upper teeth, providing a cushion to separate the upper and lower teeth and keep them apart while sleeping, thus reducing the damage to teeth associated with bruxism.

The provided text is a 510(k) premarket notification for a medical device: DOC Brands, Inc.'s Protect-It Custom Fit Dental Guard. This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study as would typically be done for a new or high-risk device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a test set, expert adjudication, MRMC studies, standalone performance, or training set details for an AI/ML device.

The relevant sections of the document describe:

• Substantial Equivalence Discussion: This is the core of the submission, comparing the subject device to a predicate (DenTek Oral Care, Inc.'s Ready-Fit Disposable Dental Guard - K151149) and a reference device (DenTek Oral Care, Inc.'s Custom Comfort Nightguard Version 2 - K091660) across various characteristics like manufacturer, 510(k) #, device classification, regulation #, product code, regulatory class, description, packaging, design, indications for use, OTC/Rx status, user population, technological characteristics, duration of use, materials, physical properties (tensile strength, elongation, hardness, melt index, density), fit, dimensions, weight, sterilization, and cleaning method.
• Non-Clinical Performance Testing: This section details "bench testing" and "biocompatibility testing."
  • Bench Testing: An "in-home use test (IHUT)" was conducted to validate the design and performance expectations, specifically verifying reusability. The document references "Section 18: Bench Testing, Attachment 4A: Bench Test Protocol, 4B: Bench Test Engineering Study, and Attachment 4C: Bench Test Data" which are not provided in the given text.
  • Biocompatibility Testing: Four tests were performed according to ISO standards: In-vitro Cytotoxicity (ISO 10993-5:2009(E)), Skin Sensitization (ISO 10993-10:2021(E)), Intracutaneous Reactivity (ISO 10993-23:2021(E)), and Oral Mucosa Irritation (ISO 10993-23:2021(E)). The results indicated the device was non-cytotoxic, non-sensitizer, non-reactive, and non-irritant, respectively.

In summary, the provided document is a regulatory submission for substantial equivalence of a physical dental guard, not a study proving an AI/ML device meets acceptance criteria through a rigorous test set and expert review. Therefore, I cannot extract the specific information requested in your prompt.

Ask a specific question about this device

Protection against bruxism or nighttime teeth grinding
Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding
Protection against teeth grinding, bruxism, and jaw clenching
Short-term pain relief from muscle spasm due to occlusal interference
Prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle

The subject devices, the SleepRight® ProRx® + Custom Dental Guard (K212706) and the SleepRight® ProRx® Custom Dental Guard (K212706) are the second-generation quard to the SleepRight® ProRx™ Custom Dental Guard (K172223). Both subject devices (K212706) are completely identical to each other, except for the material that makes up the internal core of each guard. The subject devices (K212706) are both a full occlusal custom formable protector that acts as a barrier between the upper and lower teeth to protect the teeth against bruxism or nighttime teeth grinding. The subject devices (K212706) both contain the exact same horizontal core design with a vertical sectional lattice structure, primarily wrapping around the labial and buccal side of the teeth, as well as around the lingual posterior side of the teeth. The core and lattice are fully encapsulated by a moldable thermoplastic material in both guards. The guards are designed to be fit using the exact same method to heat the guard in hot (not boiling) water until it becomes malleable and can be formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls/lattice are gently pushed to surround the teeth. The lattice retains the malleable material up against the teeth until the device hardens in approximately four minutes.

The provided text describes performance testing for the SleepRight® ProRx® + Custom Dental Guard and SleepRight® ProRx® Custom Dental Guard.

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

Acceptance Criteria and Reported Device Performance

Study Details

The provided text describes several types of studies performed, primarily comparative evaluations.

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

   • Material Properties (Tensile Strength, Flexural Strength, Flexural Modulus, Elongation, Shore D Hardness): The document reports that these tests were performed on "the subject devices" and "predicate devices." No specific sample sizes for these tests are mentioned. The provenance of the data is not specified (e.g., country of origin, retrospective/prospective).
   • Biocompatibility (Cytotoxicity, Sensitization, Irritation): No specific sample sizes (e.g., number of cell lines, animal subjects) are given. The provenance of the data is not specified.
   • Wear and Abrasion Resistance: The "longevity of the guards was evaluated by comparing the number of 'bruxing' cycles that the guards could withstand before failure." No specific sample size (i.e., number of guards tested) is provided. The provenance of the data is not specified.

2. 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 involvement of experts for establishing ground truth in any of the described tests. The tests appear to be laboratory-based evaluations against established standards (ASTM, ISO) or comparative performance evaluations, where the "ground truth" is defined by the test procedure itself (e.g., cytotoxicity grade, skin reaction score, number of bruxing cycles to failure).

3. Adjudication method:

   • Not applicable as no human assessment or consensus-based ground truth establishment is described.

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

   • An MRMC study is not relevant here as the device is a dental guard, not an AI-assisted diagnostic or decision support system for human readers.

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

   • Not applicable. This is a physical medical device, not an algorithm. The reported performance refers to the device itself.

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

   • For material properties and biocompatibility, the "ground truth" is defined by the validated testing methodologies and acceptance criteria specified in international standards (ASTM, ISO).
   • For wear and abrasion resistance, the "ground truth" is defined by the number of "bruxing" cycles to failure observed during the test, with comparative analysis against other devices.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

   • Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

1. As an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing;

2. Protection against bruxism or nighttime teeth grinding and reduce damage and the noise associated with bruxing and/or grinding.

Not Found

I apologize, but the provided text only contains an FDA 510(k) clearance letter for the NTI ClenchGuard device. It does not include information about acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA reviewed how the NTI ClenchGuard compares to existing devices for the same intended use. The letter does not detail any novel studies conducted to prove the device meets specific acceptance criteria in the way you've described for an AI/algorithm-based device.

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

Ask a specific question about this device

The DenTek™ Fresh Protect™ Dental Guard is indicated 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 DenTek™ Fresh Protect™ Dental Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of an ethylene/vinyl acetate copolymer and utilizes a ready-to-wear, one-size-fits-all design. The fully occlusive guard is worn on the lower teeth, maintaining separation between the upper and lower teeth, thereby preventing the noise and damage associated with teeth grinding.

This document is a 510(k) Premarket Notification from the FDA for a dental guard, not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present.

The document discusses the substantial equivalence of the DenTek™ Fresh Protect™ Dental Guard to a predicate device based on non-clinical performance data and biocompatibility tests.

Here is a summary of the non-clinical performance data presented for the DenTek™ Fresh Protect™ Dental Guard:

Acceptance Criteria and Device Performance (Non-Clinical)

Regarding the other requested points (sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type, training set size, training set GT):

• Sample sized used for the test set and the data provenance: Not explicitly stated as this is a non-clinical bench testing and biocompatibility assessment, not a clinical study with a patient test set. The tests involved "finished guards" or specific materials.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for bench tests would be the measured physical properties or biochemical reactions. For biocompatibility, established ISO standards define the endpoints.
• Adjudication method for the test set: Not applicable for non-clinical bench testing.
• 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 document is not about an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI/ML device.
• The type of ground truth used: For the non-clinical tests, the ground truth is derived from the established physical and chemical measurements as per the referenced ISO standards and simulation studies.
• The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
• How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document is a 510(k) premarket notification for a physical medical device (dental guard) and thus does not contain the information relevant to an AI/ML device's acceptance criteria, study design, or ground truth establishment.

Ask a specific question about this device

· Protection against bruxism or nighttime teeth grinding
· Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding
· Protection against teeth grinding, bruxism, and jaw clenching
· Short-term pain relief from muscle spasm due to occlusal interference
· Prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle

The SleepRight® ProRx® Custom Dental Guard (K193577) is the second-generation guard to the predicate SleepRight® ProRx™ Custom Dental Guard (K172223). The SleepRight® ProRx® Custom Dental Guard (K193577) is a full occlusal custom formable protector that acts as a barrier between the upper and lower teeth to protect the teeth against bruxism or nighttime teeth grinding. The guard contains a horizontal core with a vertical sectional lattice structure, primarily wrapping around the labial and buccal side of the teeth, as well as around the lingual posterior side of the teeth. The core and lattice are fully encapsulated by a moldable thermoplastic material. The guard is heated in hot (not boiling) water until it becomes malleable and can be formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls/lattice are gently pushed to surround the teeth. The lattice retains the malleable material up against the teeth until the device hardens in approximately four minutes.

The provided text describes the SleepRight® ProRx® Custom Dental Guard (K193577) and its performance testing for FDA 510(k) clearance. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

The document mentions "biocompatibility testing" and "comparative wear and abrasion resistance testing."

• Biocompatibility Testing: The specific sample sizes for in vitro cytotoxicity, in vivo sensitization, and in vivo irritation are not explicitly stated in the provided text. The provenance is also not specified (e.g., country of origin, retrospective/prospective), but these are typically lab-based tests.
• Comparative Wear and Abrasion Resistance Testing: The sample size for this test is not explicitly stated. The data provenance is also not specified.

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

This information is not provided in the document. The tests performed are laboratory-based and do not involve expert consensus on subjective interpretations like image analysis.

4. Adjudication Method for the Test Set:

This information is not provided in the document, as the tests are primarily objective laboratory assessments rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study and the effect size of human improvement with AI assistance are not applicable to this device. The SleepRight® ProRx® Custom Dental Guard is a physical dental guard, not an AI-powered diagnostic or assistive tool.

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

Standalone algorithm performance is not applicable to this device, as it is a physical dental guard.

7. The Type of Ground Truth Used:

• Biocompatibility Testing: The ground truth for these tests is established through standardized laboratory procedures and measurements as defined by ISO 10993. This involves observing cell morphology, skin reactions, and irritation scores, which are objective biological responses.
• Comparative Wear and Abrasion Resistance Testing: The ground truth is established through mechanical testing measuring the number of "bruxing" cycles until failure and abrasion results.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable to this device. This is a physical medical device, not an AI or machine learning algorithm that requires training data.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device