(76 days)
For the prevention of chronic tension and temporal mandibular joint syndrome that is r of the provenion of the posterior mandibular and maxillary teeth by the temporalis muscle. The device is custom made for the individual.
The device is custom made for the individual.
The provided text contains information about an FDA 510(k) clearance for a device called the "NTI Clenching Suppression System." However, it does not include details about acceptance criteria, specific study designs, performance metrics, sample sizes for training or test sets, expert qualifications, or ground truth methodologies that are typically found in a study report. The document is an FDA clearance letter, which confirms substantial equivalence to a predicate device, but doesn't elaborate on the underlying studies in the requested format.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be stated based on the provided text:
- Device Name: NTI Clenching Suppression System
- Regulatory Status: Unclassified, 510(k) clearance (K981546)
- Indication For Use: "For the prevention of chronic tension and temporal mandibular joint syndrome that is r of the provenion of the posterior mandibular and maxillary teeth by the temporalis muscle. The device is custom made for the individual."
The following information is NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: This document is an FDA clearance letter, not a study report. It states substantial equivalence but does not provide specific performance metrics or acceptance criteria.
- Sample sizes used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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 mentioned. The device is a "Clenching Suppression System," suggesting a physical medical device, not an AI/software device that would involve human readers or AI assistance in interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, the provided document does not contain the detailed study information required to answer most of your questions. It is a regulatory clearance letter, not a scientific study publication or summary.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded 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
Ms. Cheryl V. Zimmerman Managing, Ouality Assurance and Regulatory Affairs Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517
Re: K981546
Trade/Device Name: NTI Clenching Suppression System Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MQC Dated: April 28, 1998 Received: April 30, 1998
Dear Ms. Zimmerman:
This letter corrects our substantially equivalent letter of July 15, 1998.
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.
{1}------------------------------------------------
Page 2 – Mr. Zimmerman
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 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,
Smite G. M. Chein Suad
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
{2}------------------------------------------------
510(k) Number (if Known): New submission
Device Name: NIT Clenching Suppression System
Indications For Use:
For the prevention of chronic tension and temporal mandibular joint syndrome that is r of the provenion of the posterior mandibular and maxillary teeth by the temporalis muscle. The device is custom made for the individual.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K981546 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)
N/A