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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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