(192 days)
Orthocon® Absorbable Hemostatic Bone Putty is indicated for use as an absorbable implant material in the control of bleeding from bone surfaces.
Orthocon Absorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, water soluble and absorbable material of putty-like consistency intended for use in the control of bleeding from bone surfaces by acting as a mechanical barrier or tamponade. The material is a mixture of alkylene oxide polymer based materials and carboxymethylcellulose sodium salt. 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.
The provided text describes Orthocon Absorbable Hemostatic Bone Putty and its substantial equivalence to predicate devices, rather than a device that employs AI or requires complex performance metrics. Therefore, many of the requested categories (numbers 3, 4, 5, 6, 8, 9) regarding AI-specific evaluation methodologies are not applicable to this document.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Outcome | Reported Device Performance |
|---|---|---|
| Bench Testing | Handling Properties: Smearability, Stickiness, Stiffness, Temperature Sensitivity. Dissolution and Swelling Properties | "Bench Testing was conducted to verify the device's handling properties, to characterize the device's performance over a range of temperatures and to evaluate the device's dissolution and swelling properties. The following bench studies were completed: smearability, stickiness, stiffness, temperature sensitivity, and dissolution and swelling." |
| "All of the testing demonstrated that Orthocon Absorbable Hemostatic Bone Putty met its design criteria and, as relevant, performed in a manner equivalent to the predicate devices." | ||
| Biocompatibility Testing | ISO 10993 recommendations: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Genotoxicity, Implantation/Subacute Toxicity, Hemolysis, Pyrogenicity. | "Biocompatibility Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, sterilized device in accordance with GLP requirements: cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation/subacute toxicity, hemolysis, and pyrogenicity." |
| "All of the testing demonstrated that Orthocon Absorbable Hemostatic Bone Putty met its design criteria and, as relevant, performed in a manner equivalent to the predicate devices." | ||
| In vivo Testing (Animal) | Intraoperative hemostasis, Resistance to irrigation, Ability to remove the device, Absorption time. | "In vivo Testing included comparative animal studies to demonstrate intraoperative hemostasis, resistance to irrigation, ability to remove the device, and to characterize its absorption time." |
| "All of the testing demonstrated that Orthocon Absorbable Hemostatic Bone Putty met its design criteria and, as relevant, performed in a manner equivalent to the predicate devices." | ||
| Substantial Equivalence | Equivalence in technological characteristics (resorbable, water-soluble putty formulations, alkylene oxide polymers, carboxymethylcellulose component) and mechanism of action (mechanical tamponade) to predicate devices. | "The technological characteristics (i.e., resorbable, water-soluble putty formulations) are equivalent to the characteristics of the Ceremed and Synthes predicates. Both of these predicates and Orthocon Absorbable Hemostatic Bone Putty incorporate alkylene oxide polymers in the formulation. The Synthes predicate also shares a carboxymethylcellulose component. Each of these devices (and the predicate Ethicon bone wax) accomplish their clinical purpose through mechanical tamponade." |
| "Orthocon, Inc. believes that it's the information provided establishes that similar legally-marketed devices have been used for the same clinical indications as Orthocon Absorbable Hemostatic Bone Putty and that the device is substantially equivalent to previously cleared bone wax devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes for bench, biocompatibility, or animal studies. It describes the types of tests conducted, but not the number of units tested, animals used, or subjects involved in any human studies (which are implied not to have been the primary method for this type of device clearance).
- Provenance: This testing was conducted by Orthocon, Inc. to support their 510(k) submission. The exact location or 'country of origin' of the data isn't specified beyond being submitted to the US FDA. The studies are described in the context of device development and regulatory submission, implying they are prospective studies specifically designed to demonstrate safety and effectiveness for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is not an AI diagnostic tool and does not involve interpretation by human experts to establish "ground truth" in the way an AI medical imaging device would. Performance is demonstrated through physical, chemical, and biological testing.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
Not applicable. No expert adjudication process is described as the device's performance is demonstrated through objective physical, chemical, and biological tests, not through interpretation of complex data by human experts.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is defined by its ability to meet specific engineering, chemical, and biological criteria, as established by accepted standards (e.g., ISO 10993 for biocompatibility) and comparison to predicate devices. For instance:
- Bench Testing: Engineering measurements and physical property characterization (e.g., specific values for smearability, dissolution rates).
- Biocompatibility Testing: Regulatory standards (ISO 10993) defining acceptable biological responses.
- In vivo Testing: Direct observation and measurement of physiological responses in animal models (e.g., cessation of bleeding, degree of absorption, ease of removal).
8. The sample size for the training set
Not applicable. This is not an AI device that relies on a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
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