(234 days)
The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.
The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the mandibular body and mandibular ramus where gradual bone distraction is required in adults and pediatric patients. DePuy Synthes CMF Distraction System is intended for single use only.
Mandible
- The 1.0 mm plates and screws are intended for neonates and infants under the age of 12 months
- The 1.3 mm plates and screws are intended for neonates, infants, and children 4 years of age and younger
- The 1.5 mm and 2.0 mm plates and screws are intended for infants, children, adolescents, and adults 1 year of age and older
DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the mandibular body and mandibular ramus in adults, adolescents, children, infants, and neonates. The distractor implant consists of several components; the distractor body, footplates, extension arms, and bone screws, many of which are available in a variety of configurations to meet patient and surgeon needs as detailed the table below.
| Component | Distractor Body | Footplates | Extension Arms | Bone Screws |
|---|---|---|---|---|
| Dimensions | 10, 15, 20, 25, 30, | |||
| 35, and 40 mm | ||||
| lengths | Cloverleaf, mesh, | |||
| and elevated mesh | ||||
| designs | ||||
| Accept 1.0, 1.2, 1.3, | ||||
| 1.5, 1.7, 2.0, and 2.4 | ||||
| mm diameter | ||||
| screws | Rigid lengths are 20, | |||
| 40, and 60 mm | ||||
| Flexible lengths are | ||||
| 30, 40, and 60 mm | 1.0, 1.2, 1.3, 1.5, 1.7, | |||
| 2.0, and 2.4 mm | ||||
| diameter | ||||
| 4 – 12 mm lengths | ||||
| Materials | ● TAN (ASTM | |||
| F1295) | ||||
| ● L605 (ASTM | ||||
| F90) | ||||
| ● CoCrMo (ASTM | ||||
| F1537) | ||||
| ● MP35N (ASTM | ||||
| F562) | ● CP2 and CP4 | |||
| Titanium (ASTM | ||||
| F67) | ● TAN (ASTM | |||
| F1295) | ||||
| ● L605 (ASTM | ||||
| F90) | ||||
| ● MP35N (ASTM | ||||
| F562) | ||||
| ● Silicone (ASTM | ||||
| F2042) | ● CP Titanium | |||
| (ASTM F67) | ||||
| ● TAN (ASTM | ||||
| F1295) |
The distractor body is first secured to bone using footplates and screws, and then activation of the distractor is accomplished through the rotation of an advancement/lead screw with an activation instrument either percutaneously or intra-orally.
I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text.
The provided document is a 510(k) premarket notification for a medical device called the "Craniomaxillofacial Distraction System (CMFD)". This type of submission to the FDA focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than on proving the device meets specific performance acceptance criteria through the rigorous study design you've outlined in your request.
Here's why the text doesn't contain the information you're asking for:
- Focus on Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by demonstrating similar technological characteristics, indications for use, and by performing non-clinical testing that shows comparable performance.
- Lack of Clinical Performance Data: Section 5.8 explicitly states: "No clinical performance data is included in this submission." This means there isn't a human clinical study with a test set, ground truth experts, adjudication methods, or MRMC studies.
- Non-Clinical Data: The "Non-clinical performance data" section (5.7) describes engineering and in-vitro tests (e.g., bending strength, torque input/force output, tensile strength, biocompatibility, sterilization) to address the recall issue and support equivalence. These are not the type of studies that would establish the specific acceptance criteria for a "device performance" metric in the way you've described (e.g., accuracy, sensitivity, specificity, etc., typically associated with AI/diagnostic devices).
- No "Acceptance Criteria" Table: The document doesn't present a formalized table of acceptance criteria for diagnostic or performance metrics because it's not a performance study for a novel device, but rather a submission for a modification to an existing one to address a recall.
Therefore, I cannot extract the information for your table (acceptance criteria, reported device performance), nor can I answer your specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to a clinical performance study. The document describes engineering tests and comparisons to a predicate, not the kind of clinical validation study you're asking about.
§ 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.