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The Rest Assured® Extra Comfort Nite Protector is indicated for use for protection against bruxism or night time teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

The Rest Assured Extra Comfort Nite Protector is indicated for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding.
The Rest Assured® Extra Comfort Nite Guard is an occlusive nightguard. fitted to the consumer by the "boil and bite" method.

Here's an analysis of the acceptance criteria and study information for the Ranir, LLC's Rest Assured® Extra Comfort Nite Protector based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for the various tests (e.g., number of devices tested for biocompatibility, simulated wear, or boil and bite testing).

Regarding data provenance, the testing was conducted by:

• North American Science Associates, Inc. ("NAMSA") for comprehensive biocompatibility testing.
• A "third party testing" firm for evaluation of physical characteristics, workmanship, performance, and hazards against a predicate device.

The country of origin for the data is not specified beyond "North American Science Associates, Inc." or "third party testing," though the submitter (Ranir, LLC) is based in the U.S. and the submission is to the FDA. The studies appear to be prospective as they were conducted specifically for this device modification and submission.

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

This type of information is not applicable to this submission. The device is a physical dental protector, and the performance testing focuses on material properties, physical characteristics, and simulated use rather than diagnostic accuracy or human interpretation. Therefore, there's no "ground truth" derived from experts in the same way there would be for an AI-powered diagnostic device analyzing medical images. The "ground truth" here is established by the results of standardized tests and evaluations against predicate devices.

4. Adjudication Method for the Test Set

This is not applicable. As explained above, the tests are objective measurements and comparisons, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human interpretation is involved. The Rest Assured® Extra Comfort Nite Protector is a physical dental device.

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

No, a standalone algorithm-only performance study was not conducted. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing in this submission is established through:

• Compliance with recognized consensus standards (ISO standards) for biocompatibility and risk management.
• Objective laboratory testing results for cytotoxicity, irritation, toxicity, sensitization, pyrogenicity, and leachables/extractables.
• Direct comparison to a legally marketed predicate device ("Doctor's Advance Comfort Night Guard") for physical characteristics, workmanship, performance, and hazards.
• Simulated wear and boil-and-bite testing to confirm structural integrity after modifications.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical device submission, not a machine learning model.

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

This information is not applicable as there is no training set.

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The Rest Assured Generation III Dental Protector is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

The Rest Assured III is a fully occlusive nightguard, fitted to the patient by the "boil and bite" method. The Rest Assured III is the same device as Ranir's Rest Assured Generation II with the following minor differences: a reduction in the overall mass of the device, slight increase in arc width, additional impression material and base material, removal of sidewall material, addition of a small triangle fitting notch, and limited labeling changes.

The provided text describes a 510(k) summary for the Ranir, LLC's Rest Assured Generation III Dental Protector. It details the device's purpose, technological characteristics, intended use, and performance testing to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• User study: The text states "Ninety percent (90%) of the participants." While a percentage is given, the exact number of participants (sample size) in the user study is not specified.
• Data Provenance: The text does not explicitly state the country of origin or if the user study was retrospective or prospective.

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

The document describes a user study for fitting process satisfaction, not a study requiring expert-established ground truth for a diagnostic or evaluative purpose. Therefore, this information is not applicable or not provided in the context of expert ground truth. The "ground truth" for the user study would likely be the self-reported satisfaction and correct fitting as assessed by the users themselves.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method as would be typical for a study involving expert review for accuracy or consensus. The user study evaluated user satisfaction and correct fitting, which is typically a subjective, self-reported assessment by the participants or direct observation by the study administrators rather than an adjudicated expert review. Therefore, an adjudication method is not applicable or not provided for the type of study conducted.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a user study focused on the fitting process and satisfaction with a new device modification, not a comparative effectiveness study involving human readers with and without AI assistance.

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

This device is a physical dental protector, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not applicable. The performance testing focused on material biocompatibility, comparability to predicate devices, and user fitting experience.

7. The Type of Ground Truth Used

• For Biocompatibility and Comparability Testing: The ground truth would be established through laboratory testing standards (ISO 7405) and direct comparison against a legally marketed predicate device using objective physical/material properties.
• For the User Study: The "ground truth" for the user study's success metric (90% pleased with fitting process and fit correctly) would be self-reported satisfaction from the participants and potentially observational assessment by the study administrators regarding correct fitting. It is not expert consensus, pathology, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

This device is a physical dental protector, not a machine learning model. Therefore, there is no training set for an algorithm. The concept of a "training set" is not applicable to this type of device and study.

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

As there is no training set (see point 8), the ground truth for a training set is not applicable.

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The Rest Assured Ready to Wear Nite Protector is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

The Rest Assured Ready to Wear Nite Protector is a posterior-occlusive nightguard, comprised of two molar bite pads connected by a buccal retaining strap. The device is fit to the user's mouth by adjusting the bite plates along the retaining strap.

Here's a breakdown of the acceptance criteria and study information for the Ranir, LLC's Rest Assured Ready to Wear Nite Protector, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 20 subjects were used for the user study.
• Data Provenance: The document does not specify the country of origin. It is a prospective user study conducted to verify labeling effectiveness.

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

There were no external experts used to establish ground truth in the user study. The "ground truth" for the user study was based on the subjects' own successful fitting of the device and their agreement/approval of the product features and fitting process.

4. Adjudication Method for the Test Set

No formal adjudication method (like 2+1, 3+1) was used as the "ground truth" was derived directly from the subjects' experience and their self-assessment of successful fitting and satisfaction with the bite pads and fitting process.

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

No, an MRMC comparative effectiveness study was not done. The studies described are bench tests and a user study focusing on device fit and labeling comprehension.

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

This question is not applicable. The device is a physical night guard, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

• Biocompatibility: Compliance with ISO 7405 (a standard).
• Wear Resistance: Comparison to predicate devices, presumably against established wear characteristics of those devices.
• Comparability: Verification by a third-party lab against a predicate device with similar design.
• User Study: Subjective user feedback on acceptability of adjustable bite pads and approval of the overall fitting process/correct fit.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical night guard, and there is no mention of machine learning or an "algorithm" requiring a 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 an algorithm mentioned.

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The Snore Guard is indicated for use in the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults 18 years of age or older.

The Snore Guard consists of a mouthguard worn on the maxilla, connected to an occlusal stop (called an "occlusal ramp"), which contacts the patient's mandibular incisors. Both the maxillary tray and the occlusal ramp are custom fitted using a "boil-and-bite" process.

This device is cleared through the FDA's 510(k) pathway, which means it demonstrated "substantial equivalence" to a predicate device rather than undergoing a full clinical study to prove its own efficacy against specific acceptance criteria. Therefore, the provided text does not contain the detailed information you've requested regarding acceptance criteria and a study proving those criteria were met.

The submission states: "The Snore Guard has the same intended use and similar indications, principles of operation, and technological characteristics as Snore Guard. The minor differences in the Snore Guard's technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Snore Guard is substantially equivalent to its identified predicate devices."

This means the "study" for this device was a comparison to existing, already cleared devices (Snore Guard Advance (K102118) and SleepRight Original (K100545)). The acceptance criteria were effectively that the new device did not introduce new safety or effectiveness concerns compared to these predicates.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies because this type of information is not typically generated or required for a 510(k) substantial equivalence submission unless specific performance data is needed to demonstrate equivalence for particular features or changes.

Summary of what can be inferred from the provided text:

• Acceptance Criteria and Reported Device Performance: Not explicitly stated as performance metrics. The implicit acceptance criterion was "substantial equivalence" to predicate devices, meaning it should perform comparably to them in its intended use for treating nighttime snoring and mild to moderate Obstructive Sleep Apnea. No specific performance data (e.g., reduction in AHI, snoring events) is reported for this device in the document.
• Study That Proves the Device Meets the Acceptance Criteria: The "study" was a substantial equivalence determination by the FDA, comparing the Snore Guard to the predicate devices. This is a regulatory review process, not a clinical trial with performance endpoints.
• All other questions (Sample size, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set information): This information is not applicable or not provided within a 510(k) substantial equivalence submission unless specific performance testing was conducted to address a particular aspect of the device's design or claims, which is not detailed here.

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The Snore Guard Advance is intended to be used for the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults.

The Snore Guard Advance consists of a mouthguard worn on the maxilla, connected to an occlusal stop (called an "occlusal ramp"), which contacts the patient's mandibular incisors. Both the maxillary tray and the occlusal ramp are custom fitted using a "boil-and-bite" process.

This 510(k) summary for Ranir's Snore Guard Advance does not provide the requested information about acceptance criteria and a study proving the device meets those criteria. The document is a premarket notification for a Class II medical device, focused on demonstrating substantial equivalence to a predicate device rather than presenting performance study results against specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details based on the provided text.

The summary states:

"The Snore Guard Advance has the same intended use and similar indications, principles of operation, and technological characteristics as Hays & Meade Anti-Snoring Device. The minor differences in the Snore Guard Advance's technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Snore Guard Advance is substantially equivalent to its predicate devices."

This indicates that the primary proof was demonstrating equivalence to an already approved device, rather than conducting a new clinical study with predefined acceptance criteria for efficacy and safety.

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The Grind No More Generation II is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Grind No More Generation II is an anterior and posterior occlusive mouthguard, consisting of two molar bite plates and an anterior bite plate connected by a buccal retention band. As with the predicate Grind No More 2, the molar bite plates are grooved with vertical positioners to engage the natural anatomy of the teeth for enhanced retention. The Grind No More Generation II has a similar design to the Grind No More 2, with the addition of the anterior bite plate.

This document describes a Special 510(k) notice for "Grind No More Generation II," a mouthguard designed to protect against bruxism. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies or establishing detailed acceptance criteria through performance testing.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not typically found or required for a Special 510(k) submission for a device like a mouthguard, which primarily relies on technological similarity and established safety/effectiveness of predicate devices.

Here's a breakdown of why specific information is missing and what can be inferred from the provided text:

Missing Information and Reasons:

• 1. A table of acceptance criteria and the reported device performance: Not provided. For a Special 510(k) based on substantial equivalence, specific performance acceptance criteria and new performance data (beyond demonstrating technological similarity) are generally not required if the changes are minor and do not raise new questions of safety or effectiveness. The device's performance is assumed to be similar to its predicate devices.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No new performance study (test set) was conducted to support this Special 510(k). The submission relies on the established safety and effectiveness of the predicate devices.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth assessment by experts for a test set is typically for performance validation studies, which were not performed in this case.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 medical device (mouthguard), not an AI-powered diagnostic or assistive tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed performance studies were not conducted for this device's submission. The "ground truth" for showing substantial equivalence relies on the regulatory approval and safety/effectiveness history of the predicate devices.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Information Available from the Document:

While the requested specifics are not present, we can understand the basis of the submission:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence):

• Acceptance Criteria for Special 510(k): The primary acceptance criterion for a Special 510(k) in this context is demonstrating that the modified device (Grind No More Generation II) is substantially equivalent to its predicate devices (Grind No More 2 and Rest Assured Nite Protector).
• Demonstration of Substantial Equivalence: This is achieved by showing that the new device has:
  • The same intended uses (protection against bruxism/nighttime teeth grinding, reducing damage to teeth, preventing noise).
  • Similar indications.
  • Similar technological characteristics and principles of operation.
  • Minor technological differences that raise no new questions of safety or effectiveness.

Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the comparison to predicate devices and the argument for substantial equivalence, as presented in the Special 510(k) notice.

• Device Performance (as reported):
  • "Grind No More Generation II is as safe and effective as the predicate devices."
  • It "has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices."
  • The "minor technological differences... raise no new questions of safety or effectiveness."

Predicate Devices:

• Ranir, LLC's Grind No More 2 (K091175)
• Ranir, LLC's Rest Assured Nite Protector (K063229)

Technological Characteristics of the Grind No More Generation II:

• Anterior and posterior occlusive mouthguard.
• Consists of two molar bite plates and an anterior bite plate connected by a buccal retention band.
• Molar bite plates are grooved with vertical positioners for enhanced retention (similar to Grind No More 2).
• Addition of an anterior bite plate (the primary modification from Grind No More 2, but technologically similar to the predicate Rest Assured).

In summary, for this specific Special 510(k) submission, the "acceptance criteria" and "study" are less about novel performance data and more about demonstrating that the minor modifications to an already approved device do not alter its fundamental safety and effectiveness compared to its predicates.

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The Grind No More Version 2 and Grind No More Version 3 are indicated for use for protection against bruxism or nighttime teeth grinding. The devices are intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Grind No More 2 and Grind No More 3 are a posterior-only occlusive nightguards, consisting of two molar bite plates connected by a buccal retention band.

This submission is a Special 510(k) for a modified device. Special 510(k)s rely on a comparison to a predicate device and declarations of similarity rather than new clinical studies to demonstrate safety and effectiveness. Therefore, the information typically found in clinical studies (like acceptance criteria, sample sizes, ground truth establishment, etc.) is not present in this document.

Here's a breakdown based on the provided text:

No specific acceptance criteria or device performance data from a clinical study are reported in this document. The submission is focused on demonstrating substantial equivalence to predicate devices, not on validating performance against predetermined criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Grind No More 2 and Grind No More 3 are as safe and effective as the predicate devices. Grind No More 2 and Grind No More 3 have the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between Grind No More 2, Grind No More 3, and the predicate devices raise no new questions of safety or effectiveness." This statement is the primary form of "performance" assessment in this type of submission.

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

• Sample Size: Not applicable. No new test set or clinical study was conducted.
• Data Provenance: Not applicable. The submission relies on a comparison to previously cleared devices.

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

• Not applicable. No new test set requiring ground truth establishment was used.

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

• Not applicable. No new test set requiring adjudication 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 a physical nightguard, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

• Not applicable. This device is a physical nightguard.

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

• Not applicable. No new ground truth was established; the submission relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI or software algorithm that requires a training set.

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

• Not applicable.

Summary of the Study (as described in the 510(k) submission):

The "study" in this context is a Special 510(k) submission designed to demonstrate substantial equivalence between the modified devices (Grind No More Version 2 and Version 3) and previously cleared predicate devices (Placontrol, Inc.'s Grind No More (K082301) and DenTek Oral Care, Inc.'s Comfort Fit NightGuard (K072147)).

The core argument is that:

• The intended uses are the same: "protection against bruxism or nighttime teeth grinding. The devices are intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding."
• Technological characteristics are similar: "posterior-only occlusive nightguards, consisting of two molar bite plates connected by a buccal retention band."
• Principles of operation are similar.
• "Minor technological differences" between the new and predicate devices "raise no new questions of safety or effectiveness."

Therefore, the "device meets the acceptance criteria" in the sense that the FDA has determined it is substantially equivalent to legally marketed predicate devices, implying it is as safe and effective. This determination is based on a comparative analysis of device characteristics, not on new clinical performance data.

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The Rest Assured™ Nite Protector is indicated for protection against bruxism or night time teeth grinding. The device is intended to reduce damage to teeth and prevent noise associated with bruxing or grinding.

The Rest Assured™ Nite Protector, as packaged, is initially composed of two components: (1) a moldable soft upper component made of Elvax® thermoplastic resin and (2) a hard temporary fitting tray made of biocompatible medical grade Santoprene™ When heated and cooled, the upper Elvax® portion of the mouthguard may be molded to fit the consumer's upper teeth. During the brief fitting process, the Santoprene™ temporary fitting tray maintains the shape of the upper material and prevents the user from biting through the upper material. After the desired fit is achieved, the temporary fitting tray is removed and discarded.

The provided document for K063229, "Ranir Rest Assured™ Nite Protector," explicitly states that "No performance data is required for this 510(k) notice."

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

1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are presented.
2. Sample sized used for the test set and the data provenance: No test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth established for a test set.
4. Adjudication method for the test set: No test set, so no adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was conducted, as the device is a dental protector, not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth established.
8. The sample size for the training set: No training set was used.
9. How the ground truth for the training set was established: No training set, so no ground truth established.

Reason for no performance data:

The 510(k) submission seeks substantial equivalence to predicate devices (K053580, K024261, K014079, K022809). The document argues that the "Rest Assured™ Nite Protector" is substantially equivalent in terms of materials (Elvax® and Santoprene™) and intended use, and therefore no new performance data is required to establish its safety and effectiveness. The FDA concurred with this assessment, granting the 510(k) clearance based on substantial equivalence to already legally marketed devices.

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