(154 days)
OsteoSeal® Bone Hemostat is indicated for use in the control of bleeding from cut or damaged bone surfaces by acting as a mechanical barrier. The material may be used during surgical procedures or in treating traumatic injuries. OsteoSeal® Bone Hemostat is intended for use under the direction of a licensed healthcare provider.
The Hemostasis OsteoSeal® Bone Hemostat stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, OsteoSeal® forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure. OsteoSeal® is based upon known biodegradable polymeric chemistry that forms a ready-to-use bone hemostatic agent. OsteoSeal® Bone Hemostat consists of a dispersion of hydroxyapatite particles within a proprietary synthetic polylactic acid polymer. The material is virtually odorless, off-white in color and can be spread easily. OsteoSeal® is available in two forms: a bone hemostat ingot and a bone hemostat stick in an applicator. The bone hemostat ingot can be molded and formed by the surgeon to fit the damaged bone, while the applicator allows direct application of the bone hemostat to the bleeding area.
The provided document is a 510(k) premarket notification for the OsteoSeal® Bone Hemostat. It describes the device, its indications for use, and the testing performed to demonstrate its substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of "acceptance criteria" with specific quantitative targets. Instead, it refers to "product specifications" and general performance evaluations.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Hemostasis | Met product specifications for hemostasis; performed at least as well, and in some cases better, than the standard commercially available bone wax control. |
| Placement Retention | Met product specifications for placement retention; performed at least as well, and in some cases better, than the standard commercially available bone wax control. |
| Appearance | Design verification bench testing included appearance. (No specific detail on meeting a criterion, only that it was tested). |
| Handling | Design verification bench testing included handling. (No specific detail on meeting a criterion, only that it was tested). |
| Applicator Function | Design verification bench testing included applicator function. (No specific detail on meeting a criterion, only that it was tested). |
| Melt Point | Design verification bench testing included melt point. (No specific detail on meeting a criterion, only that it was tested). |
| Biocompatibility | Complies with biocompatibility requirements for its intended use, based on ISO 10993 and FDA guidance. |
| Sterility | Sterilized using a validated gamma radiation method to assure a sterility assurance level (SAL) of 10-6. |
| Packaging & Shelf Life | Successfully completed testing. |
| Pathological Safety (Tissue Irritation) | Demonstrated tissue irritation results that were at least as good, and in some cases better, than the standard commercially available bone wax control in a 13-week rabbit implant study. |
| Pathological Safety (Bone Healing) | Demonstrated bone healing results that were at least as good, and in some cases better, than the standard commercially available bone wax control in a 13-week rabbit implant study. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Animal Studies):
- Acute Porcine Animal Model: Not specified, only referred to as "an acute porcine animal model."
- 13-week Rabbit Implant Study: Not specified, only referred to as "a 13 week rabbit implant study."
- Data Provenance: The document does not specify the country of origin for the animal studies or whether they were retrospective or prospective. Given the context of a 510(k) submission, these would typically be prospective studies conducted in a controlled environment (e.g., contract research organization).
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)
This information is not provided in the document. The studies are animal models and bench tests, not human reader studies requiring expert consensus or ground truth establishment in the clinical sense. Pathological safety in the rabbit study would likely be assessed by a veterinary pathologist, but details are not given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. The studies described are not "test sets" in the context of diagnostic performance involving human interpretation or adjudication.
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
This information is not applicable and therefore not provided. The device (bone hemostat) is not an AI diagnostic tool and does not involve human readers in the way an MRMC study would assess.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical device (bone hemostat), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the hemostasis and placement retention in the acute porcine model, "product specifications" served as the basis for evaluation, implying predefined objective measures or expert veterinary assessment of outcomes. The "control" was a standard commercially available bone wax.
- For the pathological safety (tissue irritation and bone healing) in the 13-week rabbit implant study, histopathological examination would be the ground truth, comparing the device to a control bone wax. This is a form of pathology data.
- For the bench testing (appearance, handling, applicator function, melt point), the ground truth would be engineering specifications and direct measurements/observations.
8. The sample size for the training set
This information is not applicable and therefore not provided. The device is a physical product and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided, as there is no "training set" for this type of device.
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