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The GrindGuardN is a mouth guard intended to protect against grinding and clenching.

The GrindGuard® is an oral appliance consisting of a thin exterior tray (shell) that covers approximately half of the lower or upper arch, with a dome shape protrusion (in the center of the device), to be situated over the central incisors and an internal layer which can be melted at low temperatures and molded to the individuals' teeth. The outer tray is manufactured from polysulfone material and is formed by injection molding. The inner, formable layer consists of polycaprolactone. The GrindGuard® is designed to prevent night grinding.

After a brief submersion in water which has been heated in the microwave the thermoplastic liner becomes translucent and formable. The patient centers the device over his/her lower front teeth and bites until pressure is felt on upper and lower two front teeth. Gentle pressure is applied to the ends of the GrindGuard4 for approximately 2 minutes in order to set the thermoplastic material. The rigid polysulfone outer tray helps the softer material maintain shape and conformity with the teeth while forming the device.

The provided text is a 510(k) summary for the GrindGuardN device. Crucially, it states that "No non-clinical testing was performed for this submission" and "No clinical testing was performed in association with this submission." This means there is no acceptance criteria or study data provided in the document to directly address your request.

The 510(k) clearance for GrindGuardN was based on substantial equivalence to predicate devices (GrindGuard® (RX) - K082723 and SmartGuard Night Guard - K123161), meaning it demonstrated similar design, materials, intended use, and technological characteristics to devices already legally marketed. Therefore, the device meets regulatory requirements by showing it is as safe and effective as approved predicate devices, rather than through its own independent performance metrics or studies.

Without specific performance data from a study, I cannot create the table of acceptance criteria or describe the study that proves the device meets those criteria.

However, I can extract the information that is present in the document which implicitly addresses some of your points regarding the basis of its clearance:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria or reported device performance metrics are provided in the document. The clearance is based on substantial equivalence to predicate devices.

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

• Not applicable. No test set was used for this submission as no non-clinical or clinical testing was performed.

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

• Not applicable. No test set and no ground truth establishment from experts were performed for this submission.

4. Adjudication Method for the Test Set:

• Not applicable. No test set was used.

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

• No. An MRMC study was not performed.

6. Standalone (Algorithm Only) Performance Study:

• No. This is a physical medical device (mouthguard), not an algorithm. No standalone performance study, as typically understood for software or AI, was performed.

7. Type of Ground Truth Used:

• Not applicable. No direct ground truth was established for this device's performance through testing. The basis for clearance is substantial equivalence to predicate devices which were previously cleared (presumably with their own supporting data at the time of their clearance).

8. Sample Size for the Training Set:

• Not applicable. This device is a physical mouthguard, not an AI or software device that uses a training set.

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

• Not applicable. No training set was used.

In summary, the 510(k) clearance for GrindGuardN was based on a comparison to legally marketed predicate devices, not on new performance studies conducted for this specific submission.

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The GrindGUARDN is a mouth guard intended to protect against grinding and clenching.

The GrinGUARDN is an oral appliance consisting of a rigid outer tray with a dome shape protrusion in the center of the tray, to be situated over the lower incisors and an internal layer, which can be melted at low temperatures and molded to the individuals' teeth. The outer tray is manufactured from polysulfone material and the inner, moldable layer consists of polycaprolactone.

The provided document is a 510(k) summary for the GrindGUARDN mouthguard, which is a traditional submission asserting substantial equivalence to predicate devices. It describes the device, its intended use, and lists predicate devices. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory submission process and the determination of substantial equivalence, not on the results of performance studies against specific acceptance criteria.

Ask a specific question about this device