(298 days)
The BIOFOAM® Bone Wedge is intended to be used for internal bone fractures, fusions, or osteotomies in the ankle and foot, such as:
- · Cotton and Evans Wedges:
- · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
- · Opening wedge of Medial Cuneiform or Cotton osteotomies
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- · Metatarsal/Cuneiform arthrodesis
- · Midfoot Wedges:
- · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
- · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
- Subtalar Implant:
- Hindfoot Arthrodesis
This device is intended for use with ancillary fixation. The BIOFOAM® Bone Wedge is not intended for use in the spine.
The BIOFOAM® Bone Wedge is a titanium metal foam implant used for angular correction of small bones of the foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.
This document is a 510(k) summary for the BIOFOAM® Bone Wedge, a medical device for internal bone fixation. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design parameters (like sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies), for a software or AI device is not applicable or present in this document.
However, I can extract what is available regarding the device and its testing:
Device: BIOFOAM® Bone Wedge
Type: Titanium metal foam implant used for angular correction of small bones of the foot.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue Life: The device must withstand repeated stress cycles without failure, demonstrating sufficient durability for its intended use. (Implicitly, the device must meet or exceed the performance of the predicate device). | Fatigue testing was provided to support the substantial equivalence of the subject device. (Specific quantitative results or an explicit acceptance threshold are not provided in this summary, but the FDA's acceptance of the 510(k) implies the test results were satisfactory.) |
Explanation: The document states that "Fatigue testing was provided to support the substantial equivalence of the subject device." This suggests that the acceptance criterion was related to the device's ability to withstand fatigue, likely to a standard or a level comparable to the predicate device. The "reported performance" is that the testing was conducted and presumably met the (unspecified in this summary) criteria.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not applicable in the context of a clinical study. The test involved a non-clinical (mechanical) evaluation of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical, mechanical fatigue test, not a study requiring expert clinical assessment of ground truth.
4. Adjudication method for the test set:
- Not applicable. This was a non-clinical, mechanical fatigue test.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/software device and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/software device.
7. The type of ground truth used:
- Not applicable. The "ground truth" for a mechanical fatigue test would typically be the physical observation of material failure or the number of cycles completed under defined load conditions.
8. The sample size for the training set:
- Not applicable. This is not an AI/software device and no training set was involved.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/software 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.