(36 days)
Orthocon HEMASORBpress 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. The material may be used during surgical procedures and in treating traumatic injuries. HEMASORBpress Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
Orthocon HEMASORBpress™ 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 surface of bone. The material is a mixture of calcium stearate (a wax-like tamponade), Vitamin E Acetate (for handling properties) and an alkylene oxide copolymer (a dispersing agent). 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 broken bone, Hemasorb Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and resorbed within a period of 30 days.
The provided text is a 510(k) summary for the Orthocon HEMASORBpress™ Resorbable Hemostatic Bone Putty. This document focuses on demonstrating substantial equivalence to predicate devices for a medical device and does not describe a study involving an AI algorithm or its performance against acceptance criteria for an AI-driven task like image analysis.
Therefore, I cannot extract the requested information regarding AI device acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Instead, the document details physical and biological testing conducted on the HEMASORBpress device and its predicate. Here's a summary of the device-specific testing mentioned, as it relates to demonstrating safety and effectiveness for a physical medical device, not an AI:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of quantitative acceptance criteria with corresponding reported device performance values in the format usually seen for AI or diagnostic devices. Instead, it lists the types of tests conducted to ensure the device's properties and safety/effectiveness are comparable to predicate devices. The implicit "acceptance criteria" here are that the device performs satisfactorily and similarly to predicate devices in these tests.
| Acceptance Criteria Category (Implicit) | Reported Device Performance Summary |
|---|---|
| Material Properties: | * Handling Properties (Original Device): Tested for smearability, stickiness, stiffness, and temperature sensitivity. (Implicit: Satisfactory handling and stability over temperature range.) |
- Handling Properties (Strip Configuration): Usability testing performed to verify handling. (Implicit: Satisfactory handling for the new configuration.)
- Dissolution & Swelling Properties (Original Device): Evaluated. (Implicit: Acceptable dissolution and swelling profile.)
- Product Interface with Mesh (Strip Configuration): Tested. (Implicit: Satisfactory interaction between bone putty and polypropylene mesh.) |
| Biocompatibility: | * ISO 10993 Compliance (Original Device): Cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation/subacute toxicity, hemolysis, and pyrogenicity studies conducted on final, finished, gamma-irradiation sterilized device, in accordance with GLP requirements. (Implicit: Biocompatible, passes all specified tests per ISO 10993.) - Cytotoxicity (Strip Configuration): Cytotoxicity testing of the polypropylene mesh performed. (Implicit: Polypropylene mesh is biocompatible.)
- Pyrogen Testing (Strip Configuration): USP and rabbit pyrogen testing performed. (Implicit: Non-pyrogenic.) |
| In Vivo Performance: | * Animal Studies (Original Device): Demonstrated intraoperative in vivo hemostasis, resistance to irrigation, ability to remove the device, and characterized safety and absorption time. (Implicit: Device effectively controls bleeding, is resistant to irrigation, removable, safe, and absorbs within an acceptable timeframe in vivo.) |
| Packaging Stability: | * Package Stability Testing (Strip Configuration): Performed. (Implicit: Packaging maintains device integrity and sterility over time.) |
2. Sample size used for the test set and the data provenance:
- No information provided regarding sample sizes for individual tests. The document only "Testing was conducted" or "Testing included animal studies."
- Data Provenance: Not explicitly stated for each test, but generally, these are laboratory bench tests and animal studies conducted by or for the manufacturer (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 document describes a physical medical device, not an AI algorithm requiring expert ground truth for diagnostic or interpretative tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the type of device testing described.
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 as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical properties and biocompatibility, the "ground truth" is based on standardized test methods and validated measurements against defined parameters (e.g., ISO standards for biocompatibility, specific physical property measurements).
- For in vivo performance, the "ground truth" is derived from direct observation and measurement in animal models (e.g., cessation of bleeding, absorption time).
8. The sample size for the training set:
- Not applicable, as this is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
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