(18 days)
OSTENE®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
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, derived from ethylene oxide and propylene oxide. * 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. * A substitution has been made in a neutral excipient copolymer.
This submission describes a medical device, Ostene®CT, which is a bone hemostasis implant material. The document provided is primarily a 510(k) summary for a Special 510(k) submission, indicating a modification to an already legally marketed device. Therefore, the focus is on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report typical for novel devices.
Given the nature of a Special 510(k) and the provided text, there is no specific performance study with defined acceptance criteria in the way one might expect for a new, high-risk device requiring detailed clinical trial data. The device is for bone hemostasis and is classified as "Unclassified," which typically means less stringent performance study requirements for demonstrating substantial equivalence, especially when it's a modification of a predicate.
The primary "study" is the demonstration that a "substitution has been made in a neutral excipient copolymer" and that the modified Ostene®CT "has the same intended use and fundamental scientific technology as the legally marketed Ostene®CT Soluble Bone Hemostasis Implant."
Here's an attempt to answer your questions based on the provided text, noting where specific information is absent due to the type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a Special 510(k) for a modified device, the "acceptance criteria" are generally that the modified device remains substantially equivalent to the predicate device and that the change (a neutral excipient copolymer substitution) does not adversely affect safety or effectiveness. Specific numerical performance targets are not provided in the document for the new Ostene®CT against the predicate.
| Acceptance Criteria (Implied for Special 510(k)) | Reported Device Performance (Summary) |
|---|---|
| Same intended use as predicate | Ostene®CT has the "same intended use." |
| Same fundamental scientific technology as predicate | Ostene®CT has the "same fundamental scientific technology." |
| No new questions of safety or effectiveness | Not explicitly stated as a separate finding, but implied by 510(k) clearance. The modification is a "neutral excipient copolymer." |
| Effective in controlling bone bleeding | As a bone hemostasis agent, it "stops bone bleeding by the creation of a physical barrier... This plug prevents further bleeding." (This is a description of its mechanism, not a quantified performance measure from a new study against acceptance criteria). |
| Sterile by irradiation | Provided "sterile by irradiation." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. Clinical trial data with defined sample sizes and test sets are not presented in this 510(k) summary. The submission focuses on the modification of an excipient in an already cleared device.
- Data Provenance: Not applicable in the context of a performance study; the submission details the device composition and its mechanism of action, emphasizing its similarity to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no mention of a clinical "test set" requiring ground truth established by experts in this 510(k) summary.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This device is a bone hemostasis implant material, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done
- Not applicable. This device is a physical implant material, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable in the context of a typical performance study for diagnostic AI or imaging devices. For a medical device like this, "ground truth" often relates to established scientific principles of material compatibility and physiological function, as well as pre-clinical testing (e.g., biocompatibility, hemostatic efficacy in animal models), which are standard for medical device development but not detailed in this 510(k) summary. The primary "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set."
Summary based on the document:
This 510(k) submission for Ostene®CT is for a modified version of an already cleared device. The "study" proving it meets acceptance criteria is primarily the demonstration of substantial equivalence to the predicate device (Ceremed, Inc. Ostene® Soluble Bone Hemostasis Implant Material, K082491), especially considering a "substitution has been made in a neutral excipient copolymer." The acceptance criteria are implicitly met if the FDA determines that the modified device has the same intended use, fundamental scientific technology, and does not raise new questions of safety or effectiveness compared to the predicate. Details on specific performance metrics, sample sizes, or expert adjudication for clinical performance studies are not provided in this regulatory summary.
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