(205 days)
The Gnathometer is a jaw tracking apparatus designed to provide maxillofacial surgeons with an accurate means to measure distances relative to a defined three-dimensional reference system of x-y-z coordinates on the patient's head. The Gnathometer is intended for use only by maxillofacial surgeons performing corrective surgical procedures on patients with dentofacial deformittes. The Gnathometer's use during surgery is intended to assist in confirming the location and relocation of the patient's teeth and jaws with prescribed, pre-surgically designed relocations that remedy the patients dentofacial deformities. The Gnathometer is intended only to make contact with a patient at four (4) predetermined points on the skull via tightening screws and a halo device, and not to be attached to the jaws.
The Gnathometer is a jaw tracking apparatus.
This FDA 510(k) clearance letter and Indications for Use statement for "The Gnathometer" does not contain the information needed to describe acceptance criteria and a study proving the device meets those criteria, as typically found in comprehensive performance studies for AI/software-driven medical devices.
The provided document is a regulatory clearance for a physical medical device (a jaw tracking apparatus), not an AI algorithm or a software as a medical device (SaMD). Therefore, the concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not applicable in the context of this document.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- Device Type: The Gnathometer is described as a "jaw tracking apparatus" and a "bone plate" (although the bone plate classification might be broad for billing/regulatory purposes, the description points to a physical device). It's intended to be used by maxillofacial surgeons to measure distances and assist in confirming jaw relocations during surgery. This is a mechanical/hardware device.
- Regulatory Pathway: The document is a 510(k) clearance letter, which means the device was found "substantially equivalent" to a legally marketed predicate device. This pathway typically relies on demonstrating similarity in technological characteristics and indications for use to an existing device, rather than requiring extensive de novo clinical performance studies with detailed statistical metrics, especially when not dealing with an AI/software component.
- Absence of Performance Metrics: The document details the regulatory classification, the manufacturer, and the intended use. It does not include any data from performance studies, clinical trials, sensitivity/specificity, accuracy, precision, or any other quantitative metrics that would be associated with acceptance criteria for a new, performance-driven medical device, particularly one involving AI.
- Focus on Substantial Equivalence: The letter explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This is the core regulatory finding, not a review of clinical study results against predefined performance targets.
In summary, none of the requested information regarding acceptance criteria, study design, expert involvement, or AI performance metrics is present in these documents. The documents relate to the regulatory clearance of a physical medical device based on substantial equivalence.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2004
Ortho Gnathics LLC C/O Mr. Kenneth J. Polk Kenneth J. Polk P.C. 5001 Baum Boulevard Suite 799 Pittsburgh, Pennsylvania 15213-1856
Re: K033092
Trade/Device Name: The Gnathometer Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 20, 2004 Received: February 23, 2004
Dear Mr. Polk:
We have reviewed your Scction 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 application (PMA). You may, thereforc, 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 such 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. Polk
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 begin 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 (301) 594-4613. 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Kevin Mcley
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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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K0330092
STATEMENT OF INDICATIONS FOR USE SECTION F.
Page __ of _
510(k) Number (if known): _ Ko 33092
The Gnathometer Device Name:
Indications for Use:
The Gnathometer is a jaw tracking apparatus designed to provide maxillofacial surgeons with an accurate means to measure distances relative to a defined three-dimensional reference system of x-y-z coordinates on the patient's head. The Gnathometer is intended for use only by maxillofacial surgeons performing corrective surgical procedures on patients with dentofacial deformittes. The Gnathometer's use during surgery is intended to assist in confirming the location and relocation of the patient's teeth and jaws with prescribed, pre-surgically designed relocations that remedy the patients dentofacial deformities. The Gnathometer is intended only to make contact with a patient at four (4) predetermined points on the skull via tightening screws and a halo device, and not to be attached to the jaws.
(STEATE DO NOT WRITE BELOW THIS LINE-COMUNICE ON ANOTHER PACE OF MEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K033092 |
|---|---|
| ---------------- | --------- |
| Prescription Use | Over-The-Counter Use |
|---|---|
| (Per 21 FR 801.109) |
(Optional Format 3-10-98)
Section F, Statement of Indications for Use, Page 1 of 1
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.