(21 days)
The BIOFOAM™ Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
- · Opening wedge osteotomies of Hallux Valgus
- · Evans lengthening osteotomies
- · Metatarsal/cuneiform arthrodesis.
The BIOFOAM™ Bone Wedge is not intended for use in the spine.
The BIOFOAM™ Bone Wedge is a titanium metal foam wedge used for angular correction of small bones in the ankle and foot. It is offered in one distinct design with varying widths and thicknesses to accommodate a variety of small bone applications.
The provided text describes a 510(k) submission for the BIOFOAM™ Bone Wedge, and it does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a previously cleared device, rather than detailed performance study results against specific acceptance criteria.
Here's why the prompt's requested information cannot be extracted from the provided text:
- Acceptance Criteria & Reported Performance: The document states, "The safety and effectiveness of the BIOFOAM™ Bone Wedge is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." It does not provide a table of pre-defined acceptance criteria or specific performance metrics.
- Sample Size (Test Set) & Data Provenance: This information is typically found in a detailed clinical or non-clinical study report, which is not part of this summary. The 510(k) relies on "materials information, and analysis data," implying bench testing, but no specifics are given.
- Number of Experts, Qualifications, Adjudication Method: These points are relevant to studies involving expert review (e.g., image-based diagnostic devices). The BIOFOAM™ Bone Wedge is a physical implant, and its evaluation would not typically involve expert ground truth establishment in this manner.
- MRMC Comparative Effectiveness Study: This type of study is for diagnostic devices where human readers interpret results, often with and without AI assistance. This is not applicable to a bone wedge implant.
- Standalone Performance: While the "analysis data" mentioned likely includes standalone performance (e.g., mechanical testing), the specifics of how it was measured and against what thresholds are not provided in this summary.
- Type of Ground Truth: For an implantable device, ground truth would usually refer to successful implantation, biocompatibility, mechanical integrity, and clinical outcomes. The document does not detail how this was established beyond "substantial equivalence."
- Sample Size (Training Set) & Ground Truth (Training Set): These are relevant for AI/ML device development. This device is a physical implant, not an AI/ML algorithm, so these concepts do not apply in this context.
In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device, which is the primary mechanism for 510(k) clearance. It does not include the detailed study design, acceptance criteria, and performance results that would be present in a comprehensive study report for a novel or more complex device.
§ 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.