(358 days)
PolyBone is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defiect as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
PolyBone consists of beta-tricalcium phosphate, monocalcium monobasic, calcium sulfate hemihydrate and polyphosphate. PolyBone is indicated for use as cranioplasty cement.
1. A table of acceptance criteria and the reported device performance
| Property | Acceptance Criteria (Predicate: Stryker Instruments K043334) | Reported Device Performance (PolyBone) |
|---|---|---|
| Doughing Time | Similar to predicate | Similar to predicate |
| Setting Time | Similar to predicate | Similar to predicate |
| Working Time | Similar to predicate | Similar to predicate |
| pH | Similar to predicate | Similar to predicate |
| Compressive Strength | Minimum 2.6 MPa (ISO 7490:2000 Type 2) | 22.7 MPa |
| Dissolution Rate | Not explicitly stated as acceptance criteria | More rapid rate than the predicate |
| Biocompatibility | Pass ISO 10993-1:2003 standards | Biologically safe |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not mention a specific "test set" in the context of clinical studies for performance comparison or data provenance. The performance similarities are based on comparative material property testing.
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)
This information is not applicable as the submission details material property comparisons and biocompatibility testing, not a clinical study involving experts for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable.
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
This information is not applicable as this device is an artificial bone substitute, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a medical device (bone substitute), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the material properties (doughing time, setting time, working time, pH, compressive strength, dissolution rate), the "ground truth" or reference was derived from established standards (e.g., ISO 7490:2000 for compressive strength) and comparison to a legally marketed predicate device. For biocompatibility, the ground truth was based on compliance with ISO 10993-1:2003 guidelines.
8. The sample size for the training set
This information is not applicable as this is a medical device (bone substitute), not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable.
§ 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).