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OSTENE® CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Ostene is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired.

Ostene is comprised of a sterile mixture of water-soluble alkylene oxide copolymers. derived from ethylene oxide and propylene oxide. Ostene contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.

As a bone hemostasis agent, Ostene stops bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. Ostene, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.

Ostene is provided sterile by irradiation and must not be resterilized.

This appears to be a 510(k) summary for a medical device (Ostene®CT Soluble Bone Hemostasis Implant Material) that claims substantial equivalence to a predicate device (Ostene® Soluble Bone Hemostasis Implant Material). The provided text describes the device, its intended use, and indicates that it is substantially equivalent to a legally marketed device.

However, the document is a regulatory submission for substantial equivalence, not a study report demonstrating the device meets specific acceptance criteria through clinical trial or performance testing with quantitative results. Therefore, the information needed to answer the questions about acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader effectiveness is not present in this document.

The document mainly focuses on establishing that the modified Ostene®CT has the "same intended use fundamental scientific technology as the legally marketed Ostene® Soluble Bone Hemostasis Implant." This implies that extensive new studies to prove performance against novel acceptance criteria may not have been required for this specific 510(k) submission, as it relies on the predicate device's established safety and effectiveness.

Based on the provided text, the requested information cannot be fully extracted for the following reasons:

• No specific acceptance criteria are stated. The document asserts substantial equivalence to a predicate device, implying that the predicate's established performance is the benchmark.
• No new study data is presented to prove specific acceptance criteria. The submission is about modifications to an already cleared device and proving its equivalence, not a new device requiring a de novo clinical trial with defined performance metrics.
• Details on sample size, data provenance, expert ground truth, adjudication, or MRMC studies are absent. These elements would typically be found in a clinical study report or a 510(k) submission for a device requiring performance data.
• No standalone algorithm performance or training set details are relevant as this is a physical medical device (bone hemostasis material), not an AI/software device.

Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. The document describes a regulatory pathway (510(k) Special) rather than a detailed performance study with quantifiable results against acceptance criteria.

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