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510(k) Data Aggregation
(56 days)
Hemasorbplus Resorbable Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
Orthocon HEMASORBPLUS press Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, resorbable material of putty-like consistency intended for use in the management of bleeding from the cut or damaged surface of bone. The material contains a mixture of alkylene oxide polymer based materials, vitamin E acetate, granular calcium phosphate and sodium carboxymethylcellulose. The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. The bone putty requires no kneading prior to application and does not soften appreciably at body temperature.
When applied manually to surgically incised or traumatically damaged bone, HEMASORBPLUS press Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
The provided text describes the Hemasorbplus Press Resorbable Hemostatic Bone Putty. Because this is a medical device and not a diagnostic AI/ML algorithm or system, many of your requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information, ground truth types) are not applicable. The information focuses on device performance and testing for substantial equivalence to predicates, rather than the accuracy of a diagnostic output.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench/In Vivo) | Reported Device Performance |
|---|---|
| Original Configuration Testing (Predicate Device) | |
| Device's handling properties (smearability, stickiness, stiffness) | Testing was conducted and verified the device's handling properties. (Specific results not detailed, but implied to be acceptable for substantial equivalence). |
| Device's performance over a range of temperatures (temperature sensitivity) | Testing was conducted to characterize performance over a range of temperatures. (Specific results not detailed, but implied to be acceptable for substantial equivalence). |
| Device's dissolution and swelling properties | Testing was conducted. (Specific results not detailed, but implied to be acceptable for substantial equivalence). |
| Biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation/subacute toxicity, hemolysis, pyrogenicity) for final, finished, gamma-irradiation sterilized device (ISO 10993 compliant, GLP) | Testing was conducted and found acceptable. (Specific results not detailed, but implied to be acceptable for substantial equivalence). |
| Intraoperative in vivo hemostasis | Demonstrated via animal studies. |
| Resistance to irrigation | Demonstrated via animal studies. |
| Ability to remove the device | Demonstrated via animal studies. |
| Safety and absorption time (in vivo) | Characterized via animal studies. |
| Strip Configuration Testing (New Device - Hemasorbplus Press) | |
| Cytotoxicity of the polypropylene mesh | Testing was performed. (Implied to be acceptable in allowing substantial equivalence). |
| USP and rabbit pyrogen testing | Testing was performed. (Implied to be acceptable in allowing substantial equivalence). |
| Usability testing to verify the device's handling properties | Testing was performed. (Implied to be acceptable, as it was considered "suitable for its indicated use" and established substantial equivalence). The text specifically states the device is "soft, moldable," "can be spread easily with minimal adhesion to surgical gloves," and "requires no kneading prior to application and does not soften appreciably at body temperature," which are handling properties. |
| Testing to evaluate product interface with the mesh | Testing was performed. (Implied to be acceptable in allowing substantial equivalence). |
| Package stability testing | Testing was performed. (Implied to be acceptable in allowing substantial equivalence). The new product is in a "thin strip sandwiched between two layers of polypropylene mesh." |
| Maintain substantial equivalence to predicate devices for hemostasis by mechanical barrier/tamponade. | "Orthocon, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as Orthocon HEMASORBPLUS press and that Substantial Equivalence to the predicate devices has been established. The data presented demonstrate that the device is suitable for its indicated use." The device achieves local control of bleeding by acting as a mechanical barrier (tamponade) in line with its predicate (HEMOSTATIC BONE PUTTY 3). The new configuration is also compared to AHBPpress™, which is packaged similarly with polypropylene mesh, further supporting the substantial equivalence argument for the new form factor. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The studies mentioned are "bench studies" (e.g., smearability), "biocompatibility testing" (in vitro and in vivo models), and "animal studies." For the "strip configuration," further "usability testing" and specific material tests were performed.
- Data Provenance: Not specified. Animal studies and bench tests were performed by Orthocon, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the device is a hemostatic bone putty, not a diagnostic AI/ML system that requires expert interpretation for a "ground truth" test set. Its performance is evaluated through physical, chemical, and biological tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the reasons mentioned above.
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 device is a medical product, not a diagnostic AI system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here is established through well-defined scientific and regulatory standards:
- Benchmarking/Predicate Equivalence: Comparison to the established performance characteristics of the predicate devices.
- ISO 10993 Standards: For biocompatibility.
- GLP (Good Laboratory Practice) Requirements: For biocompatibility testing.
- Animal Models: For in vivo performance (hemostasis, resistance to irrigation, removal, safety, absorption).
- USP (United States Pharmacopeia) Norms: For pyrogenicity testing.
- Risk Analysis (FMEA approach): For validation of modifications to the device (new strip configuration).
8. The sample size for the training set
- Not applicable as this is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/ML algorithm.
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