(77 days)
OSTENE®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces in cardiothoracic surgery surgery following sternotomy .
Ostene® CT is a water-soluble surgical implant material for use in cardiothoracic surgery. Ostene CT 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 CT is comprised of a sterile mixture of water-soluble alkylene oxide copolymers. Ostene®CT 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®CT 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 CT, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Ostene CT is provided sterile by irradiation and must not be resterilized.
The provided text is a 510(k) summary for the Ostene®CT Soluble Bone Hemostasis Implant Material. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance. As such, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, or standalone algorithm performance) is not available in the provided document.
However, I can extract the following:
1. Acceptance Criteria and Reported Device Performance:
The document states: "The non-clinical evaluations used to determine substantial equivalence included indications, intended use, design, materials, sterilization, and performance. The comparison demonstrates that the device in this substantially equivalent in indications and intended use; and is identical in design, materials, sterilization, and performance to the predicate Ostene®CT (K091636)."
This indicates that the acceptance criterion was "identical performance" to the predicate device. Specific quantitative performance metrics are not provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Identical performance to the predicate device (K091636) in design, materials, sterilization, and performance. | The device is identical to the predicate device (K091636) in design, materials, sterilization, and performance. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The evaluations were "non-clinical."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified, as this appears to be a non-clinical evaluation comparing device characteristics to a predicate, not an evaluation against a clinical ground truth established by experts.
4. Adjudication method for the test set:
- Not applicable/Not specified.
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 is not an AI/software device.
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:
- For the non-clinical evaluation, the "ground truth" was essentially the established characteristics and performance of the predicate device (Ostene®CT, K091636).
8. The sample size for the training set:
- Not applicable. This is not a study involving a training set in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable.
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