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Orthocon Permatage Settable Bone Putty is a self-setting cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. Permatage Settable Bone Putty should be used only in skeletally mature individuals.

Permatage Settable Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in repair of cranial defects. The single use Permatage device contains two separate components of putty-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyether-based polymers. When mixed together, the components of the Permatage device form a nonabsorbable cohesive, putty-like material that adheres to the bone surface and remains in place following application. The resulting hardening material is primarily calcium phosphate and nonabsorbable polymer materials. Permatage components must be mixed immediately prior to use.

The provided text is a 510(k) summary for the Orthocon Permatage Settable Bone Putty, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a traditional clinical study with performance metrics like sensitivity or specificity.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment for an AI/algorithm-based device is not applicable to this document. The document describes a traditional medical device (bone putty) and its regulatory clearance process, which relies on biocompatibility testing, bench testing, and in-vivo animal testing to demonstrate substantial equivalence to an existing device, not an AI or software algorithm.

Here's a breakdown of why each section of your request cannot be fulfilled from the provided text:

1. Table of acceptance criteria and reported device performance: Not present. The "Performance Data" section lists various tests (e.g., Visual Inspection, Paste Stiffness, Package Leak Test) and states that they "met specification" or "passed," but it does not provide specific numerical acceptance criteria or quantitative performance results.
2. Sample sized used for the test set and the data provenance: Not present for a "test set" in the context of an algorithm. The in-vivo animal testing mentions demonstrating substantial equivalence in "an animal model," but does not specify the sample size of animals or their provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here. The in-vivo animal testing involved "histopathologic evaluation," which would have been performed by experts, but their number and qualifications are not specified.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted device.
6. Standalone performance (algorithm only without human-in-the-loop): Not applicable, as this is not an AI/algorithm device.
7. Type of ground truth used: For the in-vivo animal testing, "histopathologic evaluation" served as a form of ground truth for assessing the bone defect repair.
8. Sample size for the training set: Not applicable, as there is no training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary based on available information:

The document describes the regulatory clearance of a bone putty device (Permatage Settable Bone Putty) based on its substantial equivalence to another marketed device (Stryker HydroSet Injectable Cement). The evaluation involved:

• Biocompatibility Testing: Conducted in accordance with ISO 10993, including tests for cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, pyrogenicity, and neurotoxicity. All tests were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with GLP requirements.
• Bench Testing:
  • Visual Inspection: Evaluated paste color using a reference scale. Conclusion: Paste color met specification.
  • Paste Stiffness: Evaluated paste stiffness using a reference scale. Conclusion: Paste stiffness met specification.
  • Package Leak Test: Bubble emission leak test. Conclusion: All test articles passed.
  • Temperature Sensitivity: Acceptable maximum temperature increase observed. Conclusion: Acceptable maximum temperature increase observed.
  • Water Uptake, Swelling, and Dissolution: Measured volume and mass changes over time. Conclusion: Acceptable water uptake, swelling, and dissolution.
• In-Vivo Testing:
  • Study Design: Used to demonstrate substantial equivalence in the repair of a critical-sized cranial bone defect in an animal model compared to the comparator device.
  • Ground Truth: Substantial equivalence was assessed based on histopathologic evaluation.
  • Sample Size/Provenance: Not specified beyond "an animal model."
• Clinical Testing: No clinical studies were conducted in support of this 510(k).

The document concludes that the device is substantially equivalent to the predicate device, and the conducted tests passed stated requirements and recognized standards.

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