(74 days)
A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:
- Comminuted fractures of the naso-ethmoidal infraorbital areas
- Comminuted fractures of the frontal sinus wall
- Pediatric midface or craniofacial trauma
- Orbital floor fractures
- Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
B. General Indication: reconstructive procedures of the midface or craniofacial skeleton Specific Indications:
- Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma etc.)
- Tumor reconstruction in midface or craniofacial procedures
- Bone graft procedures in the midface or craniofacial skeleton
- Pediatric reconstructive procedures
- Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
- Craniotomy flap fixation
The LactoSorb® Panels consist of sheets of LactoSorb® available in various sizes. The panels can be heated to malleable state and cut/shaped to conform to the bony anatomy. Heating is done using a sterile LactoSorb® Heat Pack. At the time of surgery, drill holes can be placed as needed to accept LactoSorb® screws and rivets. These devices are not for use in the mandible or other load bearing indications. The LactoSorb® Panels are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. The polycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in both soft tissue and bone tissue. The material retains its strength for at least 8 weeks and completely resorb by 9-15 months.
The provided text describes the LactoSorb® Panels, a medical device used for fixation in craniofacial and midface trauma and reconstructive procedures. However, the document does not contain any information about acceptance criteria, a specific study proving device performance against acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth establishment, or clinical effectiveness studies (MRMC or standalone).
The text primarily focuses on:
- Indications for Use: Listing specific trauma and reconstructive procedures where the LactoSorb® Panels are intended to be used.
- Device Description: Explaining that the panels are made of bioresorbable and biocompatible polymers (lactic and glycolic acids) that degrade over time.
- Predicate Device Comparison: Stating that the LactoSorb® Panels are used similarly to LactoSorb® mesh and thin metal meshes, and that "Biomechanical testing has proven that the LactoSorb® Panels will be as effective as the predicate devices in midface and craniofacial procedures." There are no details provided about this biomechanical testing.
- FDA Clearance: The document includes an FDA 510(k) clearance letter, indicating the device was found substantially equivalent to predicate devices.
Therefore, I cannot populate the requested table and information as the source document does not contain the necessary details.
To answer your request, a different document that describes the specific studies, methodologies, and results used to demonstrate the device's performance against defined acceptance criteria would be needed.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.