(119 days)
HBP4 Hardening, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
HBP4 Hardening, Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use HBP4 device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the HBP4 device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting hardening material is primarily comprised of calcium phosphate. HBP4 must be mixed immediately prior to use.
When applied to surgically cut or traumatically damaged bone. HBP4 Hardening, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
The provided text describes the HBP4™ Hardening, Resorbable Hemostatic Bone Putty and its substantial equivalence to predicate devices, rather than a study with acceptance criteria for a specific outcome measure like AI performance. Therefore, I cannot construct a table of acceptance criteria and reported device performance from the given information in the context of AI.
However, I can extract the testing performed to demonstrate substantial equivalence, which aims to show the device meets certain performance characteristics relative to existing devices.
Here's a breakdown of the requested information based on the provided text, adapted to reflect what is available:
Acceptance Criteria and Study for HBP4™ Hardening, Resorbable Hemostatic Bone Putty
The document describes performance testing conducted to demonstrate the substantial equivalence of the HBP4™ device to legally marketed predicate devices. The "acceptance criteria" in this context are implicitly met if the HBP4™ device demonstrates similar performance and characteristics to the predicate devices across various tests.
1. Table of Acceptance Criteria and Reported Device Performance
As the document is a 510(k) summary, it focuses on demonstrating substantial equivalence rather than explicit quantitative acceptance criteria for a novel AI device. Therefore, a direct table of acceptance criteria in the AI sense and reported performance is not present. However, the document does list the types of tests performed to demonstrate acceptable performance relative to predicate devices. The "reported device performance" in this context refers to the successful completion of these tests, implying the device performed comparably to or within acceptable limits of the predicate devices.
| Performance Characteristic (Type of Test) | Implied Acceptance Criteria (relative to predicates) | Reported Device Performance (as stated in document) |
|---|---|---|
| Bench Testing | Demonstrate appropriate handling properties, performance over temperature range, and dissolution properties. | "Bench testing... demonstrate that the device is substantially equivalent to predicate devices in intended use, technological characteristics, and performance." This included relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution, and swelling tests. |
| Biocompatibility Testing | Meet ISO 10993 recommendations for biological safety. | "Biocompatibility Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993." Studies included irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, subacute systemic toxicity, chronic systemic toxicity, hemolysis, endotoxicity, and pyrogenicity. |
| Animal Testing | Demonstrate intraoperative in vivo hemostasis, resistance to irrigation, and characterize resorption time comparable to predicates. | "Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis, resistance to irrigation, and to characterize resorption time." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each test. The document mentions "animal studies" but does not give the number of animals used.
- Data Provenance: The studies were conducted by Orthocon, Inc. specific to the HBP4™ device. The nature of these studies (e.g., in-house bench tests, contracted animal studies) implies prospective testing for this specific submission. Country of origin not specified, but the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a medical product (bone putty), not an AI algorithm requiring expert-established ground truth for a test set. Its performance is evaluated through material science, biological, and in-vivo testing, not diagnostic accuracy reviews.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
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 device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI device.
7. The Type of Ground Truth Used
- For Bench Testing: Measurements against established material science parameters and potentially comparison to predicate device characteristics.
- For Biocompatibility Testing: Adherence to ISO 10993 standards and established biological responses from in-vitro and in-vivo models.
- For Animal Testing: Direct observation of hemostasis, resistance to irrigation, and histological/imaging assessment of resorption in animal models.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI device. There is no concept of a "training set" for this product.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
Summary of Device and its Purpose:
The HBP4™ Hardening, Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material designed to control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. It consists of two components that are mixed prior to use to form a hardening putty. Its 510(k) clearance was based on demonstrating substantial equivalence to several predicate bone wax and hemostatic implant devices.
N/A