(292 days)
For pediatric patients, for external fixation of mandibular fractures or for mandibular distraction.
The micro distractor/external fixator introduced by NewMedical Technology, Inc., is a device which is substantially equivalent to other external fixators /distractors. Its indications for use are substantially the same, that is, external fracture fixation and/or distraction.
There are many unique features that make this distractor an improvement over those currently available. The main advantages over other devices include its' smaller size and lightweight construction. The recessed distraction actuating screw is tamper resistant and hence better for use in pediatric patients. The device can only be actuated with the use of a custom actuator which is provided in the kit with the device. Hence, this tamper resistant design is useful when the device is used as an external bone fixation device for the treatment of fractures. Similarly, the conversion to a static from a dynamic fixator does not require any adjustment or addition of parts. The alloy metals used provide for excellent stability.
In summary, the features incorporated into the NewMedical Micro Distractor/External Fixator have specific advantages over other substantially equivalent products to enhance ease of placement along with the care and comfort of the patient requiring external fixation/distraction of the mandible or small bones.
The provided document is a 510(k) summary for the NewMedical Micro Bone Distractor/Fixator. It describes the device, its intended use, materials, design, and operational principles, and states its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, or clinical study design elements (like MRMC studies or expert qualifications).
Therefore, I cannot fulfill the request for information on acceptance criteria and the study that proves the device meets them based solely on the provided text.
The rejection letter from the FDA (pages 2-4) also reiterates the substantial equivalence determination but does not provide performance data.
The document focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed performance data against specific acceptance criteria.
To provide the requested information, a different type of document, such as a full clinical study report or a detailed performance validation report, would be necessary.
§ 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.