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Provides a soft barrier between wired mouth hardware and oral mucosa to help relieve discomfort for convalescing oral and maxillofacial surgery patients.

The Wired Mouth Protector consists of a non-sterile strip of non-latex foam with a slit in the middle that is inserted into the front of the mouth between the teeth and lip area with the slit in the center to provide a soft barrier to help protect the oral mucosa from contact with wired mouth hardware. It is changed three times daily or more often if needed.

The provided text describes a 510(k) premarket notification for a medical device called the "Wired Mouth Protector." The document indicates that the device has undergone biocompatibility testing. However, it does not include information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of clinical performance (e.g., efficacy in relieving discomfort in patients).

Therefore, based on the provided text, I cannot complete all sections of your request. Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Device Performance:

The document focuses on biocompatibility and substantial equivalence to a predicate device, rather than detailed clinical performance metrics with acceptance criteria.

Information that cannot be extracted from the provided text:

• Sample size used for the test set and the data provenance: The biocompatibility tests were conducted on animal models (rabbits, mice) and cell lines. No human clinical "test set" for performance evaluation is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no clinical test set with ground truth established by experts mentioned.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: For biocompatibility, the chemical and biological responses in standardized tests serve as the "ground truth." For clinical efficacy (e.g., discomfort relief), no such study with defined ground truth is presented.
• The sample size for the training set: Not applicable. This device does not have a "training set" in the context of machine learning.
• How the ground truth for the training set was established: Not applicable.

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Brace Eze is intended to provide relief from the discomfort and irritation to the inside of the cheek and lips caused by orthodontic brace.

Brace Eze is an orally applied gel that is applied to the brackets of orthodontic braces.

The provided document is a 510(k) summary for the medical device "Brace Eze," an orally applied gel intended to provide relief from discomfort and irritation caused by orthodontic braces. This document focuses on demonstrating substantial equivalence to a predicate device ("Ortho Wax") rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a novel device with performance claims.

Therefore, the requested information regarding acceptance criteria and a detailed study proving performance against them is largely not present in this document. The document describes a regulatory submission for a Class I medical device, which typically relies on demonstrating substantial equivalence to an already marketed predicate device, rather than conducting extensive clinical efficacy trials with detailed performance metrics.

However, I will extract any relevant information that can be inferred or directly stated regarding performance and testing, and explicitly state what is not available.

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

Explanation: The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device, "Ortho Wax." This means that the FDA determined Brace Eze performs similarly and is intended for the same use as a device already on the market. The document does not provide specific quantitative performance metrics (e.g., "reduces pain by X%," or "lasts for Y hours") or corresponding acceptance thresholds against which the device was tested.

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 provided in the document. As a 510(k) for a Class I device seeking substantial equivalence, it's unlikely that a formal clinical "test set" with a specified sample size for performance evaluation (in the sense of a clinical trial) was required or performed in the manner this question implies. The submission relies on comparison to an existing 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)

This information is not provided as no such ground truth establishment process is described for a "test set" in this document.

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

This information is not provided as no such adjudication process is described for a "test set" in this document.

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 and not provided. Brace Eze is an orally applied gel, not an AI-powered diagnostic device or a system involving "human readers." Therefore, an MRMC study is not relevant to this device.

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

This is not applicable and not provided. Brace Eze is an orally applied gel, not an algorithm.

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

This information is not provided. For a substantial equivalence claim, the primary "ground truth" is the established safety and efficacy profile of the predicate device. Direct "ground truth" for Brace Eze's performance in the context of a dedicated clinical trial is not described.

8. The sample size for the training set

This information is not provided and is not applicable. As an orally applied gel, there is no "training set" in the context of machine learning or AI algorithms.

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

This information is not provided and is not applicable. There is no "training set" for this device.

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