(200 days)
- Protection of teeth and restorations from the forces of bruxism.
- For the prevention of TMJ syndrome through reduction of trigeminally innervated muscular activity.
The Myohealth Clenching Inhibitor disrupts the activity of the perieranial musculature by providing contact between the ental contact provided by this intraoral device modifies the rearward tectir. The mounted contraction of the pericranial musculature and the associated bruxism and temporal mandibular disorders.
The MCI is an anterior device custom fabricated for each patient. The Myohealth The MCI Is an amerior dories do for treating conditions diagnosed by medical professionals.
The MCI Clenching Inhibitor is designed to span 6 teeth, from upper cuspid to cuspid. The larger size of the MCI greatly reduces the risk of inhalation or swallowing this appliance. The MCI Clenching Inhibitor has a thermoplastic lining. This lining ensures excellent long term retention.
This FDA 510(k) summary for the MCI Clenching Inhibitor does not contain the detailed information requested regarding acceptance criteria, device performance studies, and ground truth establishment.
A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than providing extensive de novo clinical trial data with specific performance metrics and ground truth analysis as would be expected for a novel high-risk device or a more rigorous clinical study.
Therefore, most of the requested information cannot be extracted directly from the provided text. I will explain what can be inferred or what is explicitly missing.
Here's a breakdown of the requested information, indicating what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given 510(k) summary. A 510(k) typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than defining and proving specific acceptance criteria for performance through a standalone study with quantitative results. The comparison provided (see section 2 of the input) is for attributes of the device (indications, materials, method of action), not performance metrics against acceptance criteria.
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. The document does not describe a specific clinical study with a test set of data.
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 specific test set or study is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 information is not provided. The device described is a physical occlusal stent, not an AI or imaging device that would typically involve a multi-reader multi-case study or human-in-the-loop AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not provided. The device is a custom-fabricated physical device, not an AI model that would have a training set.
9. How the ground truth for the training set was established
This information is not provided.
Summary of what is present and relevant to the "study" in a 510(k) context:
The "study" in a 510(k) submission, particularly for a device like this, is primarily a comparative analysis of attributes to a predicate device, aiming to demonstrate substantial equivalence.
- Predicate Device: NTI Clenching Suppression System (K981546)
- Comparison Attributes (Table from input section 2):
- Indications for use: Both protect teeth from bruxism forces and address TMJ/TMD related to clenching. The MCI device broadens the TMJ indication slightly to "Recovery from temporal mandibular disease (TMD) in which bruxism is a contributing factor" and "prevention of TMJ syndrome through reduction of trigeminally innervated muscular activity."
- Method of manufacture: Both custom fabricated.
- Single patient, intraoral device: Both yes.
- Material: Both Thermoplastic acrylic.
- Method of action/intended use: Both are anterior bite stops that inhibit masticatory musculature.
- Risk of material exposure: Both none.
The "proof" presented in this 510(k) summary for the MCI Clenching Inhibitor meeting acceptance criteria (implicitly, the criteria for substantial equivalence) rests on this direct comparison of features and intended use with the legally marketed predicate device (NTI Clenching Suppression System, K981546). The FDA's issuance of the 510(k) clearance letter (input section 3) indicates their agreement that substantial equivalence was demonstrated based on this comparison, allowing the device to be marketed.
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AUG 2 7 2004
MCI Clenching Inhibitor
510(k) Summary of Safety and Effectiveness
Device Generic Name Occlusal Stent Device Trade Name MCI Clenching Inhibitor Regulation Number and Name 21 CFR 872.5570 Device, Jaw Positioning Product Code LQZ Panel Code Dental Applicant Name and Address MCI-Myohealth Systems 6B Inga Parade, Mt. Martha VIC 3934 AUSTRALIA Contact Information Dave Balding Consultant 26552 Tampico Place Mission Viejo CA 92691 USA
Phone: (949) 412-0619 or (949) 916-2663
Device Description
Description
The Myohealth Clenching Inhibitor disrupts the activity of the perieranial musculature by The Myoncardi Cleneining minoner an Aparanting contact of opposing providing contact between the ental contact provided by this intraoral device modifies the rearward tectir. The mounted contraction of the pericranial musculature and the associated bruxism and temporal mandibular disorders.
The MCI is an anterior device custom fabricated for each patient. The Myohealth The MCI Is an amerior dories do for treating conditions diagnosed by medical professionals.
The MCI Clenching Inhibitor is designed to span 6 teeth, from upper cuspid to cuspid. The larger size of the MCI greatly reduces the risk of inhalation or swallowing this appliance. The MCI Clenching Inhibitor has a thermoplastic lining. This lining ensures excellent long term retention.
(949) 916-2663 Fax:
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Comparison to Predicate Device
| Attribute | Myohealth ClenchingInhibitor | Predicate(NTI Clenching SuppressionSystem, K981546) |
|---|---|---|
| Indications for use | Protection of teeth andrestorations from the forces ofbruxism.Recovery from temporalmandibular disease (TMD) inwhich bruxism is acontributing factor. | For the prevention of chronictension and temporal jointsyndrome that is caused bychronic clenching of theposterior mandibular andmaxillary teeth by thetemporalis muscle. |
| Method of manufacture | Custom fabricated | Custom fabricated |
| Single patient, intraoraldevice | yes | yes |
| Material | Thermoplastic acrylic | Thermoplastic acrylic |
| Method ofaction/intended use. | An anterior bite stop thatinhibits masticatorymusculature. | An anterior bite stop thatinhibits masticatorymusculature. |
| Risk of materialexposure | None | None |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
JUL 1 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MCI-Myohealth Systems C/O Mr. David Balding Consultant and Authorized Contact David Balding 26552 Tampico Place Mission Viejo, California 92691
Re: K040315
Trade/Device Name: MCI-Myohealth Clenching Inhibitor Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MQC Dated: August 19, 2004 Received: August 23, 2004
Dear Mr. Balding:
This letter corrects our substantially equivalent letter of August 27, 2004.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Balding
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Suette Y. M. chein Oud.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
K040315 MCI-MyoHealth Clenching Inhibitor
Device Name:
Indications For Use:
-
Protection of teeth and restorations from the forces of bruxism.
-
For the prevention of TMJ syndrome through reduction of
the prevention of TMJ syndroptivity trigeminally innervated muscular activity.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rino
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Anesthoology.
Infection Control, Dental Devices
510(k) Number.
N/A