(78 days)
This device is intended for use in patients requiring alveolar ridge augmentation of the mandible or maxilla secondary. This includes conditions secondary to trauma, periodontal disease or birth abnormality. The device is intended to provide temporary stabilization and gradual expansion of the alveolar ridge.
The Chin Distractor is a distraction osteogenesis system consisting of two bone plates, a threaded activation rod and a distraction instrument. The plates attach to bone using bone screws and then gradually distract the osteotomized segment via activation of the threaded rod with a distraction instrument. The implanted components of the device are manufactured from titanium.
The provided text describes the 510(k) premarket notification for the Chin Distractor device. This document is a regulatory submission for a physical medical device (a distraction osteogenesis system), not a software or AI-based device.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this type of device and is not contained within the provided 510(k) summary. These criteria are typically associated with performance studies for diagnostic devices, particularly those involving algorithms or AI.
The 510(k) process for a device like the Chin Distractor focuses on demonstrating substantial equivalence to a predicate device already legally marketed. This typically involves comparing:
- Indications for Use: Are they the same or very similar?
- Technological Characteristics: Are the materials, design, and operating principles similar?
- Performance Data (if applicable): This might include biocompatibility testing, mechanical testing (e.g., strength, fatigue), and sterility testing, to ensure the new device performs as intended and is as safe and effective as the predicate. It does not typically involve the kinds of clinical performance studies with human readers or AI algorithms that your prompt suggests.
The 510(k) summary explicitly states: "The Chin Distractor is substantially equivalent to several other legally marketed devices." It lists four predicate devices to which it is compared.
In summary, none of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, or AI performance can be extracted from the provided text because it pertains to a physical medical device cleared via the substantial equivalence pathway, not an AI or diagnostic algorithm.
§ 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.