Search Results

The HBP6 Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

The HBP6 Settable, Resorbable Hemostatic Bone Paste is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The single use HBP6 device contains two separate components of paste-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the HBP6 device form a resorbable paste-like material that can be applied directly to bleeding bone by means of a single-use applicator (delivery device). The resulting hardening paste is primarily comprised of calcium phosphate. HBP6 is mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone, HBP6 Settable, Resorbable Hemostatic Bone Paste achieves local control of bleeding by acting as a mechanical barrier (tamponade).

The provided document is a 510(k) summary for a medical device cleared by the FDA. It does not describe an AI/ML powered device, nor does it detail acceptance criteria and a study that proves the device meets those criteria in the context of an algorithm's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this document's content, as it pertains to a physical medical device (hemostatic bone paste), not an AI algorithm.

However, I can extract the information relevant to the device's performance testing and how it demonstrates "acceptance" in the context of a 510(k) submission.

Device: HBP6 Settable, Resorbable Hemostatic Bone Paste

Acceptance Criteria & Device Performance (as demonstrated for Substantial Equivalence):

The "acceptance criteria" in the context of a 510(k) for a physical device like this are framed around demonstrating substantial equivalence to a legally marketed predicate device, largely through showing similar technological characteristics and comparable performance in relevant tests. The performance is "accepted" if it falls within expected ranges for the device type and is consistently similar to the predicate.

Information Not Applicable or Not Provided in this Document (due to the nature of the device and submission type):

1. Sample size used for the test set and the data provenance: Not specified for bench or animal testing, as this typically isn't a statistical study to prove a diagnostic algorithm's performance on human data. The "test set" here refers to the actual samples or animals used in the physical properties and biological tests. Data provenance (country, retrospective/prospective) is not mentioned for animal or bench studies.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical hemostat is established via objective physical measurements (e.g., set time, dissolution rate) and observed biological effects (e.g., hemostasis in an animal model, toxicity in biocompatibility tests). There are no "experts" interpreting diagnostic images or clinical outcomes in this context.
3. Adjudication method: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is for diagnostic or AI-assisted devices, not a physical hemostat.
5. If a standalone performance was done: Not applicable in the context of an algorithm. For a physical device, "standalone performance" is implicitly demonstrated through the bench and animal tests, showing the device functions as intended on its own.
6. The type of ground truth used:
   • Bench Testing: Mechanical properties (e.g., stiffness, set time, dissolution rates) are measured directly based on established testing standards.
   • Biocompatibility Testing: Results are determined based on standardized ISO 10993 biological endpoints (e.g., cell viability, irritation scores, genetic mutations).
   • Animal Testing: In vivo hemostasis and resistance to irrigation are direct observations in animal models.
7. The sample size for the training set: Not applicable; there is no "training set" for a physical medical device.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device