(90 days)
The LactoSorb® Pectus Stabilizer provides the surgeon with a means to secure the Pectus Support Bar to the chest wall. The Biomet Microfixation Pectus Bar is used to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shaped deformity. The LactoSorb® Pectus Stabilizer is a resorbable implant and does not require removal.
The provided text is a 510(k) summary for the Biomet Microfixation LactoSorb® Pectus Stabilizer. It describes the device, its intended use, possible adverse effects, and claims substantial equivalence to predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any other data related to a clinical or performance study demonstrating the device meets specific acceptance criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical performance studies with acceptance criteria, as might be seen for novel devices or PMAs.
Therefore, I cannot provide the requested table and study details from the given text.
Summary of what is missing in the provided text to fulfill your request:
- Acceptance Criteria and Reported Device Performance: No specific performance metrics or thresholds are mentioned. The document focuses on device description and intended use.
- Study Details: There is no description of any study (clinical or non-clinical) conducted to evaluate the device's performance against defined acceptance criteria.
- Sample Sizes, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Details: All these elements relate to a performance study, which is not present in the provided 510(k) summary.
§ 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.