(420 days)
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:
| Feature | EZ-SPLINT EZ-SPLINT PM | Dr. HAYS BITE GUARD | NTI TENSION SUPPRESSION SYST. |
|---|---|---|---|
| Indication for Use | 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. | Same | Same and for the prophylactic treatment of migraine pain. |
| Design | Adjustable, pre-formed oral appliance. The bite pads may be moved to adjust to the patient to prevent contact of posterior teeth and to provide a resilient break in the teeth clenching cycle. | Full mouth appliance that is custom molded by the practitioner for the patient. | Customized by the practitioner for the patient, fitted over the two maxillary central incisors with a dome shaped protrusion which extends lingually to prevent posterior of canine tooth contact |
| Materials | Elvax strap, Polypropylene and Kraton bite pads | Lexan and Elvax | Polycarbonate |
| Method of Manufacture | Injection molded | Dental laboratory molded | Injection molded |
| Prescription Device | Yes | Yes | Yes |
| Reusable | Yes, single patient | Same | Same |
| Method of de-infection | Warm water, soap, and toothbrush | Same | Same |
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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