(48 days)
OSSIOfiber® Compression Staple is indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization.
The number and size of the OSSIOfiber® Compression Staples must be adapted to the indication.
The OSSIOfiber® Compression Staple is a fixation implant made of degradable poly (L-lactide-co-D,Llactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made of minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy. fusion, or fracture. Substantial decradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.
The OSSIOfiber® Compression Staples are supplied sterile, for single patient use only, and nonpyrogenic. The additional devices included in this submission are: 9 x 10mm, and 11 x 10 mm.
The OSSIOfiber® Compression Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.
The provided document is a 510(k) Premarket Notification summary for the OSSIOfiber® Compression Staple. It describes the device, its intended use, and the non-clinical data used to demonstrate substantial equivalence to predicate devices. However, this document does not contain information related to an AI/ML-driven medical device, digital health software, or any study involving human readers or ground truth established by experts.
The primary focus of this submission is on the physical and mechanical properties of a medical implant (a compression staple) and its biocompatibility. The acceptance criteria discussed are related to the mechanical performance of the staple and its degradation profile.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for a test set or data provenance for an AI/ML device.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Multi Reader Multi Case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
- Sample size for the training set or how ground truth was established for a training set (as this is not an AI/ML device).
The document specifically mentions:
- Non-Clinical Data: "Static bending, bending fatique and pull-out testing were performed to verify the strength and fixation properties of the OSSIOfiber® Compression Staple, and to compare them to those of the primary predicate device, the OS2®-VP Varisation Staple (K153770). Testing on the subject device were done initially and following in-vitro degradation. The in-vitro degradation profile was characterized."
- Biocompatibility: "Biocompatibility for the implants was established primarily based on the referenced ISO 10993 data from the previously cleared predicate and reference devices (K212594, K203465) as well as a rationale."
These are standard engineering and biocompatibility tests for physical medical devices, not performance metrics for AI/ML algorithms.
§ 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.