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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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