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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.

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OSSIOfiber® Cannulated Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The OSSIOfiber® Cannulated Trimmable Fixation Nails are fixation devices made of degradable poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from materials 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 degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Cannulated Trimmable Fixation Nails are cannulated, supplied sterile, for single patient use only, and non-pyrogenic. The additional device included in this submission is 100 mm long and 3.5mm core diameter (4.0 mm outer diameter).

The OSSIOfiber® Cannulated Trimmable Fixation Nails are designed to be used with commonly available orthopedic surqical tools such as ISO 9714 compatible instrumentations.

This document does not describe acceptance criteria or a study proving that the device meets those criteria. Instead, it is an FDA 510(k) clearance letter for a medical device called the OSSIOfiber® Cannulated Trimmable Fixation Nail.

The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K203465), rather than proving performance against specific acceptance criteria through new clinical or non-clinical studies.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria or Performance Data: The document explicitly states: "Non-clinical performance testing was not performed as the subject device does not represent a new mechanical performance worst-case for the OSSIOfiber® Cannulated Trimmable Fixation Nail cleared family." This means the submission did not include new studies to generate performance data for this particular longer nail length against new acceptance criteria.
• Focus on Substantial Equivalence: The entire submission hinges on the claim that the new device (a longer version of an existing nail) has "the same intended use, indications for use, material composition, design characteristics, manufacturing and sterilization methods and principles of operation as the predicate device (K203465)." Because of this, new performance studies were deemed unnecessary by the manufacturer and accepted by the FDA for this specific 510(k) submission.
• No AI Component: The device described is a physical medical implant (a bone fixation nail), not an AI/ML-driven diagnostic or therapeutic device. Therefore, concepts like acceptance criteria for AI performance, training/test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not relevant to this submission.

In summary, the provided text does not contain the information required to answer your prompt because the 510(k) submission for this device did not involve new performance studies with acceptance criteria, as it was based on demonstrating substantial equivalence to a predicate device.

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