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

Grind No More is a posterior-only occlusive mouthguard, consisting of two molar bite plates connected by a buccal retention band.

This document is a 510(k) summary for Placontrol, Inc.'s "Grind No More" mouthguard. It states that the device is substantially equivalent to a predicate device and provides its intended use. However, it does not describe any specific acceptance criteria or an analytical study that proves the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (DenTek Oral Care Inc.'s Comfort Fit NightGuard, K072147), rather than providing detailed performance data against specific acceptance criteria.

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

1. A table of acceptance criteria and the reported device performance: Not provided. The submission argues substantial equivalence based on intended use, technological characteristics, and principles of operation, rather than specific performance metrics against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set is described.
4. Adjudication method for the test set: Not applicable as no test set is described.
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 mouthguard, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a mouthguard, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no specific test data or ground truth establishment is described. The basis for approval is substantial equivalence to a predicate device.
8. The sample size for the training set: Not applicable as no training set is described.
9. How the ground truth for the training set was established: Not applicable as no training set is described.

Summary from the document:

The document outlines the regulatory submission for a Class I unclassified medical device (mouthguard). The core of the submission is a claim of substantial equivalence to a predicate device (DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147)). The arguments for substantial equivalence are based on:

• Same intended uses and similar indications: "Grind No More is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding." which is similar to the predicate device.
• Similar technological characteristics: Both devices are posterior-only occlusive mouthguards with two molar bite plates connected by a buccal retention band.
• Similar principles of operation.

The FDA found the device substantially equivalent for the stated indications for use, without requiring specific performance testing against pre-defined acceptance criteria as would be expected for a device with novel technology or higher risk classification.

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