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The SleepRight® Original is indicated for the protection against bruxism or night time teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

An adjustable protector that provides a barrier between the upper and lower posterior teeth. The flexible connecting strap provides 5 adjustments for the bite pads.

The provided document, K100545, is a 510(k) summary for the SleepRight® Original Mouthguard, which is a device intended for the protection against bruxism or nighttime teeth grinding. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the SleepRight® -Low profile (K071404).

Based on the provided text, there is no acceptance criteria or a study described that proves the device meets specific acceptance criteria in the typical sense of a clinical trial with quantitative endpoints like sensitivity, specificity, or improvement in human reader performance. This 510(k) summary is a premarket notification for a Class I/Unclassified device, and the primary focus is on demonstrating "substantial equivalence" to a predicate device rather than presenting a performance study against predefined acceptance criteria.

The submission highlights comparisons of technical characteristics to a predicate device. This is a common approach for unclassified or Class I devices seeking 510(k) clearance, where safety and effectiveness are established by showing the new device is as safe and effective as a device already on the market.

Here's an analysis based on your requested information, acknowledging the limitations of a 510(k) summary for this type of device:

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

As stated above, this document does not present specific quantitative acceptance criteria and device performance metrics (e.g., accuracy, sensitivity, specificity) as one would find for an AI/clinical diagnostic device. Instead, the "acceptance" is based on demonstrating "substantial equivalence" to a predicate device across various features.

The key "performance" reported is essentially the similarity of the device to the predicate device in terms of its intended use, design, materials, and other characteristics.

Here's a table summarizing the comparison of the subject device (SleepRight® Original) to the predicate device (SleepRight® -Low profile), which serves as the basis for substantial equivalence:

Summary of "Performance": The device's "performance" is considered acceptable because it shares the same fundamental scientific technology, intended use, and similar design and operating principles as the predicate device, with minor differences that do not raise new questions of safety or effectiveness. Notable differences (e.g., 5 adjustments vs. 4, Polypropylene only vs. Polypropylene and Kraton for bite pads, Not flavored vs. flavored) are implicitly deemed not significant enough to alter substantial equivalence.

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. This document does not describe a test set or data from a study with a sample size for performance evaluation. The submission relies on a comparison of technical characteristics 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 test set or ground truth established by experts is mentioned in this 510(k) summary. The ground for acceptance is substantial equivalence to a previously cleared device.

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

• Not applicable. No test set or adjudication method is mentioned.

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. Therefore, an MRMC study and effects on human reader improvement are not relevant and not documented.

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

• Not applicable. This device is a physical mouthguard, not an algorithm.

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

• Not applicable. The concept of "ground truth" as typically applied in AI/diagnostic studies is not relevant here. The basis for clearance is the demonstrated substantial equivalence to a predicate device which has already established its safety and effectiveness for the intended use.

8. The sample size for the training set

• Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

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

• Not applicable. As above, no training set or ground truth establishment is relevant to this type of device submission.

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Prescription Indications for Use:
. Protection against teeth grinding, bruxism & jaw clenching.
Short-term pain relief from muscle spasm due to occlusal interference. .
For the prevention of chronic tension and TMJ caused by chronic jaw clenching of . the mandibular and maxillary teeth by the temporalis muscle.

OTC Indications for Use:
The SleepRight® adjustable night guard is indicated for the protection against bruxism or night time teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

An adjustable protector that provides a barrier between the upper and lower posterior teeth. The flexible connecting strap provides 4 adjustments for articulating bite pads.

This document is a 510(k) premarket notification for a medical device called "SleepRight® -Select, SleepRight®-Low Profile and SleepRight®-Advance, SleepRight® - Low Profile Rx and SleepRight® - Advance Rx". It is a mouthguard/nightguard intended for protection against teeth grinding (bruxism) and jaw clenching, and for short-term pain relief from muscle spasms.

The document does not describe a study that establishes acceptance criteria and then proves the device meets those criteria. Instead, it describes a substantial equivalence determination, comparing the device to legally marketed predicate devices.

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

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance. (This is irrelevant, as the device is not an AI-assisted diagnostic tool).
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done (This is irrelevant, as the device is not an algorithm).
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Key Information from the Document:

The document focuses on establishing substantial equivalence to existing predicate devices based on:

• Identical Indications for Use (OTC):
  • Subject Device (SleepRight®): Protection against bruxism or nighttime teeth grinding. Intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
  • Predicate Device (Doctor's NightGuard): Protection against bruxism or nighttime teeth grinding. Intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
• Similar Indications for Use (Rx):
  • Subject Device (SleepRight® Rx): Protection against teeth grinding, bruxism & jaw clenching; Short-term pain relief from muscle spasm due to occlusal interference; Prevention of chronic tension and TMJ caused by chronic jaw clenching.
  • Predicate Device (EZ Splint): Protection against teeth grinding, bruxism & jaw clenching; Short-term pain relief from muscle spasm due to occlusal interference; Prevention of chronic tension and TMJ caused by chronic jaw clenching.
• Physical Characteristics: Materials (Elvax® strap, Polyurethane/Pellethane bite pads for Advance; Polypropylene/Kraton® bite pads for Select/Low Profile) are compared to predicates.
• Method of Manufacture: Both are "Injection Molded" (same as predicates).
• Design: Shared similarities with the EZ Splint (partial coverage, preformed oral appliance with adjustable bite pads, no boiling required), distinguishing it from the Doctor's NightGuard (full coverage, boil and bite technology).
• Reusability: "Yes, single consumer" (same as predicates).

The FDA determined that the device is substantially equivalent to legally marketed predicate devices, which allows it to be marketed. This determination is not based on performance data against acceptance criteria in the way a clinical trial for a novel drug or a new AI diagnostic algorithm would be. Instead, it relies on the similarities in indications, technological characteristics, and safety profiles to already cleared devices.

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Protection against teeth grinding, bruxism and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth.

The devices are constructed of a thermal sensitive Elvax 4. strap and polypropylene and Kraton® bite pads. The bite pads may be adjusted for the individual patient. Although the two products look similar, the EZ-Splint, PM has an anatomically contoured shape for maximum cheek retention and stability during sleep. The EZ-Splint was designed as small as possible for speech and maximum flexibility when used in conjunction with dental and orthodontic work. The EZ-Splint's narrow shape makes it favorable for daytime use.

The provided document does not describe an acceptance criteria or a study that proves a device meets specific acceptance criteria in the way typically expected for performance-based medical device studies (e.g., diagnostic accuracy, efficacy trials).

Instead, this document is a 510(k) summary for the EZ-Splint and EZ-Splint PM, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Here's the breakdown based on your requested information, highlighting what is and is not present in the document:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics. The implicit "acceptance criterion" for a 510(k) submission is to demonstrate "substantial equivalence" to a predicate device. This is primarily established through comparison of indications for use, design, materials, method of manufacture, and regulatory status (prescription device, reusable, method of disinfection).
• Reported Device Performance: No quantitative performance metrics are reported. The document states in its conclusion that "The E.Z-Splint and the EZ-Splint PM are safe and effective for their intended use," but this is a declarative statement based on the substantial equivalence argument, not on performance data.

The comparison presented is primarily a feature-by-feature comparison to predicate devices:

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. The document explicitly states: "Non clinical tests were not performed" and "Clinical tests were not performed." Therefore, there is no test set, sample size, or data provenance relevant to performance evaluation described.

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. As no clinical or non-clinical tests were performed for this device, there was no "ground truth" established as part of a performance study. The ground truth for regulatory clearance in a 510(k) is the established safety and effectiveness of the predicate devices.

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

• Not applicable. No test set or performance study was conducted for this device.

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 oral appliance, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with/without AI assistance is entirely irrelevant to this submission.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable in the context of a performance study for this device. For a 510(k) submission, the "ground truth" for demonstrating safety and effectiveness implicitly relies on the regulatory clearance and established performance of the predicate devices. The substantial equivalence argument posits that because this new device is similar enough to already-approved devices, it shares their safety and effectiveness profile.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" as it is a physical device, not a machine learning model.

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

• Not applicable. As there is no training set, there is no ground truth to establish for one.

Summary of Findings from the Document:

The provided document is a 510(k) premarket notification for the EZ-Splint and EZ-Splint PM. The key takeaway regarding performance studies and acceptance criteria is:

• No new clinical or non-clinical performance studies were conducted or reported for the EZ-Splint and EZ-Splint PM to establish its own safety and effectiveness.
• The manufacturer is asserting "substantial equivalence" to predicate devices (Dr. Hays Bite Guard and NTI Tension Suppression System) based on a comparison of indications for use, design, materials, manufacturing method, and regulatory attributes.
• The FDA's letter confirms that the device was found substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls. This means the FDA accepted the argument that the device's similarities to already-approved devices were sufficient to deem it safe and effective for its intended use without requiring new performance studies from the applicant.

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