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The Ora-GUARD Dental Grind Guard is a device that is indicated for protection against bruxism, nighttime teeth grinding, and jaw clenching. It is intended to reduce damage to teeth and prevent the noise associated with teeth grinding and bruxism.

Ora-GUARD Dental Grind Guard is an over-the-counter dental protector, which is used as a barrier between teeth for individuals who grind their teeth. The Ora-GUARD Dental Grind Guard is intended to be worn while sleeping (e.g., at night or while napping). The material is comfortable to wear, and it can be self-fit by submerging in hot water to make the material malleable to fit on the lower teeth of the oral cavity. Ora-GUARD Dental Grind Guard is constructed of a soft EVA, which contacts the tooth surface and a hard base, which protects bite-through by user when bruxing (polycarbonate). Ora-GUARD Dental Grind Guard is provided in one size that fits most (comfortably fits palate sizes ranging from two to two and one half inches wide).

The provided text is a 510(k) summary for the Ora-GUARD Dental Grind Guard, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does NOT describe the acceptance criteria for a study demonstrating device performance against specific metrics, nor does it present the results of such a study.

Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and intended use. The "Performance data" section refers to testing related to its physical properties and how it functions as a spacer, rather than clinical efficacy or accuracy metrics against a defined standard.

Therefore, I cannot provide the requested information in the format you asked, as the input document does not contain it. The information is geared towards regulatory clearance based on substantial equivalence, not a detailed performance study with acceptance criteria.

However, I can extract what is available regarding the "performance data" provided in the document:

What the document does mention about "Performance data":

• Testing type: "Testing related to the measurement of tooth surface spacing with Ora-GUARD Dental Grind Guard and its ability to neutralize anterior/posterior imbalance of teeth grinding on tooth surfaces was conducted."
• Physical properties tested: "The physical properties of the materials were identified including flexural strength, water solubility, and shore hardness and determined to be appropriate for its intended use."
• Method for spacing measurement: "Measuring the tooth surface spacing with and without the subject device using CAT Scan demonstrated that Ora-GUARD Dental Grind Guard acts as a spacer between the upper and lower tooth surfaces, similar to the DenTek Custom Comfort Nightguard Version 2 (K091660)."
• Biocompatibility: "A biocompatibility assessment was conducted according to ISO 10993-1 on the subject device and cytotoxicity testing according to ISO 10993-5 on the materials was provided."

Based on the provided text, I cannot answer the following questions because the information is not present:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improve with AI vs without AI assistance. (This device is not an AI-driven device).
6. If a standalone (algorithm only) performance study was done. (This device is not an algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set. (Not applicable, this is not an algorithm).
9. How the ground truth for the training set was established. (Not applicable, this is not an algorithm).

Summary of what is available (though not in the requested tabular format for acceptance criteria):

The "Performance data" section describes the types of testing performed to demonstrate that the Ora-GUARD Dental Grind Guard functions as intended and is safe.

• Functional Testing: It was demonstrated, using CAT Scans, that the Ora-GUARD acts as a spacer between upper and lower teeth, similar to the predicate device (DenTek Custom Comfort Nightguard Version 2). This essentially confirms its physical function in creating separation. No specific quantitative metrics or acceptance criteria for "spacing" are provided, other than it being "similar" to the predicate.
• Material Properties: Flexural strength, water solubility, and shore hardness were measured and deemed "appropriate for its intended use." No specific values or acceptance ranges are given.
• Biocompatibility: Assessments were conducted according to ISO 10993-1 and ISO 10993-5 (cytotoxicity) for the materials. These tests ensure the materials are not harmful to the body. Passing these standards would be the acceptance criterion.

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Prescription indications: To protect against tooth damage bruxism and clenching caused by occlusal interferences, Provide short term relief from muscle spasm due to occlusal interferences, and Prevention of pain and chronic tension of temporomandibular joint syndrome components that are caused by chronic jaw clenching.

The Grind Guard is appliance is to be worn at night, covering the teeth of the upper arch. It is composed of a soft, thermoformable material that is heated and briefly cooled and molded to fit user's upper teeth; shock-absorbing material cushions teeth on all sides. This device may not be used as an athletic mouth guard. This device should not be used by persons under the age of 18.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets said criteria in the format requested. The document is a 510(k) summary for a medical device (Grind Guard), focusing on its substantial equivalence to predicate devices rather than reporting on a de novo clinical trial with specific performance metrics.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: There are no explicit, quantifiable acceptance criteria (e.g., "device must reduce pain by X% in Y% of patients"). The document instead relies on a claim of "effectiveness" supported by a published study.

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

• Sample Size for Test Set: Not specified. The document only states "An independent clinical study published by JADA supports the effectiveness."
• Data Provenance (country of origin, retrospective/prospective): Not specified.

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

• Number of Experts: Not applicable, as this device does not involve expert image interpretation or diagnosis. The "ground truth" would likely be patient-reported outcomes or clinical assessments.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since this is not a diagnostic device requiring expert review of results, an adjudication method for a test set (like 2+1 for image interpretation) is not relevant to the information provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC study was not done. The device is a "mouthguard, prescription" and not an imaging or diagnostic AI tool that would typically involve human readers.
• Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as it's not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

• Standalone Study: Not applicable. This is a physical medical device (mouthguard), not an algorithm or AI system.

7. Type of Ground Truth Used

• Type of Ground Truth: The document implies that the effectiveness was assessed through clinical outcomes, specifically "relief of orofacial pain associated with temporomandibular disorders." It does not specify whether this was patient-reported, physician-assessed, or a combination. The "independent clinical study published by JADA" would contain these details.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

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

• How Ground Truth for the Training Set was Established: Not applicable, as it's not a machine learning model.

Summary of Device-Specific Information from the Text:

• Device Name: Grind Guard
• Indications for Use:
  • Protect against tooth damage from bruxism and clenching due to occlusal interferences.
  • Provide short-term relief from muscle spasm due to occlusal interferences.
  • Prevention of pain and chronic tension of temporomandibular joint syndrome components caused by chronic jaw clenching.
• Proof of Effectiveness: An independent clinical study published by JADA (Journal of the American Dental Association) is cited as supporting the device's effectiveness for relief of orofacial pain associated with temporomandibular disorders.
• Predicate Devices: Archtek OTC Grind Guard (K073446) and SleepRight adjustable night guard (K071404). The Grind Guard is stated to be identical in design and material to K073446.

In conclusion, the provided text from the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and referencing a published clinical study for effectiveness. It does not contain the granular detail about acceptance criteria, study design parameters (like sample sizes for test/training sets, expert qualifications, or ground truth establishment methods) that would be typical for a de novo submission or a detailed clinical study report, especially for AI/algorithm-based devices.

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Protection against bruxism or nighttime teeth grinding; to reduce damage to teeth, and to prevent the noise associated with bruxism or grinding.

The Grind Guard is appliance is to be worn at night, covering the teeth of the upper arch, as a protection for those who suffer form the night time grinding of the teeth. It is composed of a soft, thermoformable material that is heated and briefly cooled and molded to fit user's upper teeth: shock-absorbing material cushions teeth on all sides during nocturnal bruxing.

The provided text is a 510(k) summary for the Grind Guard device. A 510(k) submission is typically for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through extensive studies in the same way a novel high-risk device might.

The information provided does not include a detailed study that defines "acceptance criteria" for the Grind Guard's performance or a study demonstrating the device meets such criteria. The submission focuses on showing substantial equivalence to a predicate device based on indications for use, technological characteristics, principle of operation, and material.

Therefore, many of the requested items (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) are not available in the provided text, as they are not typically required for a 510(k) submission of this type.

Here’s a breakdown of what can be extracted and what is not present:

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

No explicit acceptance criteria or reported device performance metrics (e.g., in terms of effectiveness for reducing bruxism, preventing tooth damage, or reducing noise)
are provided in the document. The submission is based on substantial equivalence to a predicate device, implicitly meaning it is expected to perform similarly to the predicate without requiring a new detailed performance study.

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 performance studies or test sets are described. The submission is based on comparison to a predicate device.

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 performance studies or ground truth establishment for a test set are described.

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

Not applicable. No performance studies or test set adjudication are 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. The Grind Guard is a medical device, not an AI software, and no comparative effectiveness study, MRMC, or human reader assistance is mentioned.

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

Not applicable. The Grind Guard is a physical medical device, not an algorithm.

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

Not applicable. No performance studies or ground truth are described. The basis for approval is substantial equivalence to the predicate device, which implies the predicate was deemed safe and effective for its stated indications.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is a physical device, not an AI/ML algorithm.

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

Not applicable. No training set or ground truth establishment for a training set is described.

Summary of Device and Approval Process from the Text:

• Device Name: Grind Guard
• Intended Use: Protection against bruxism or nighttime teeth grinding; to reduce damage to teeth, and to prevent the noise associated with bruxism or grinding.
• Device Type: Mouthguard, Over-the-Counter
• Approval Method: 510(k) Premarket Notification, which demonstrates substantial equivalence to a predicate device.
• Predicate Device: Doctor's Night Guard (K053580) by Dental Concepts.
• Basis for Equivalence: Indications for use, general technological characteristics, principle of operation, and material.
• Conclusion: The FDA reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed subject to general controls.

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