(29 days)
The QuickSet Mimix™ Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures:
- Repair of neurosurgical burr holes
- Craniotomy cuts and other cranial defects
- Augmentation or restoration of bony contour in the craniofacial skeleton area no larger that 25 cm²
The QuickSet Mimix™ is packaged as separate, pre-measured powder and liquid components. The two components are designed to be mixed intraoperatively to produce a homogenous paste, which can then be applied to bone gaps or defects. Because of its apatitic nature, the material is highly biocompatible.
The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate (Na3GHzO7+2H2O). The liquid component is a solution comprised of anhydrous citric acid (CGHsO7) and distilled water (H3O).
This document describes the QuickSet Mimix™ Bone Void Filler. However, the provided text explicitly states:
"Clinical Testing: Clinical testing was not used to establish substantial equivalence."
"Non-Clinical testing demonstrated statistical equivalence between this device and the predicate device."
Therefore, based on the provided information, there is no study that proves the device meets specific acceptance criteria through clinical testing. The device's substantial equivalence was established through non-clinical testing comparing it to a predicate device.
Given this, I cannot fill in most of the requested fields related to clinical studies.
Here's what can be extracted based on the provided text, and where gaps exist due to the lack of clinical testing information:
Acceptance Criteria and Device Performance
| Acceptance Criteria (If Clinical) | Reported Device Performance (If Clinical) |
|---|---|
| Not applicable (No clinical study performed to establish direct acceptance criteria for this device) | Not applicable (No clinical study performed to establish direct device performance for this device) |
| Non-clinical statistical equivalence to Mimix™ Bone Void Filler (K990290) | Demonstrated statistical equivalence to predicate device (Mimix™ Bone Void Filler (K990290)) through non-clinical testing. |
Missing Information due to no Clinical Study:
- Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was used.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set was used.
- 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 bone void filler, not an AI imaging or diagnostic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a bone void filler, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. For non-clinical, the "ground truth" would be the established properties/performance of the predicate device.
- The sample size for the training set: Not applicable, as no clinical training set was used.
- How the ground truth for the training set was established: Not applicable, as no clinical training set was used.
§ 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).