(19 days)
OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². OsteoVation CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.
OsteoVation is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.
This document is a 510(k) premarket notification for the OsteoVation™ CMF Bone Void Filler. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a new clinical study. Therefore, most of the requested information about acceptance criteria, specific study design, and performance metrics is not present in this document.
Here's an breakdown of what is available and what is not:
1. A table of acceptance criteria and the reported device performance
- Not Applicable/Not Provided: This 510(k) is based on substantial equivalence to predicate devices (Callos Bone Void Filler and Callos CMF Bone Void Filler), not on meeting specific, defined acceptance criteria from a new clinical study for performance. The "performance" being demonstrated here is primarily the equivalence of the modified material to the predicate, ensuring it doesn't negatively impact safety or efficacy. No numerical performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical properties with acceptance thresholds) are listed as they would be for a new device requiring de novo authorization or a PMA.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: No clinical "test set" in the context of an algorithm or diagnostic device performance evaluation is described. The submission focuses on material modification and substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Provided: As there is no "test set" and no evaluation of an algorithm's diagnostic performance, there is no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: There is no "test set" or diagnostic performance evaluation described which would require an adjudication method.
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/Not Provided: This device is a bone void filler, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided: This device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided: Ground truth in the context of diagnostic accuracy is not relevant to this type of device submission. The "truth" being established is that the modified device is substantially equivalent to existing, cleared devices in terms of its safety and efficacy for its intended use. This is typically established through a combination of bench testing, biocompatibility studies, and comparisons to predicate device characteristics.
8. The sample size for the training set
- Not Applicable/Not Provided: There is no "training set" as this is not an AI/algorithm device.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: This is not relevant to the device.
Summary regarding Acceptance Criteria and Study:
The document describes a Special 510(k) submission (K051784) for the OsteoVation™ CMF Bone Void Filler.
The "study" or justification for clearance is based on demonstrating substantial equivalence to existing predicate devices (Callos Bone Void Filler K051123; Callos CMF Bone Void Filler K042072).
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Acceptance Criteria (Implied): The implied "acceptance criteria" for this 510(k) is that the modified OsteoVation CMF Bone Void Filler is substantially equivalent to its predicate devices in terms of:
- Indications for use (which remained the same)
- Technology
- Principle of operation
- Packaging
- Sterilization parameters
- Safety and effectiveness (despite a material modification, the submission asserts it is not a substantial change and does not significantly affect safety or efficacy).
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The "Study" / Justification: The document states:
"This Special 510(k) proposes a modification in materials for Osteo Vation, which was previously cleared under K042072 on June 3, 2005. The indications for use, technology, principle of operation, packaging, and sterilization parameters of Osteo Vation remain the same as in the predicate cleared 510(k)s."
"OsteoVation, as described in this submission, is substantially equivalent to the predicate, unmodified Callos CMF. The proposed modification in materials, is not a substantial change or modification, and does not significantly affect the safety or efficacy of OsteoVation."
This type of submission relies on comparison to a legally marketed predicate, rather than generating new clinical data to meet predefined performance metrics. The FDA's clearance letter confirms this by stating they have "determined the device is substantially equivalent... to legally marketed predicate devices."
In essence, the "study" is a comparison to predicate devices, and the "acceptance criteria" is that the modified device maintains substantial equivalence to those predicates.
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).