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OSTENE® 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 document is a 510(k) submission for the Ceremed, Inc. AOC Bone Wax (marketed as Ostene®). It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain a study that proves the device meets acceptance criteria.

The 510(k) summary (page 9-1 and 9-2) explicitly states: "The modified Ostene® Bone Hemostasis Material has the same intended use fundamental scientific technology as the legally marketed Ostene® Bone Hemostasis Material." This indicates that the submission relies on the substantial equivalence principle, asserting that the new device is as safe and effective as a legally marketed predicate device, rather than providing new clinical or performance data for acceptance criteria.

Therefore, I cannot populate the table or answer most of the questions as the provided text does not describe a study.

Here's what can be inferred from the provided text:

1. A table of acceptance criteria and the reported device performance:
Not provided in the document. The submission claims substantial equivalence and does not detail specific performance acceptance criteria or report results from a study designed to meet such criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No new study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No new study data is presented.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No new study data is presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a bone hemostasis material, not an AI or imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a bone hemostasis material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No new study data is presented.

8. The sample size for the training set:
Not applicable. No new study data is presented.

9. How the ground truth for the training set was established:
Not applicable. No new study data is presented.

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