(293 days)
The Craniofacial Calcium Phosphate Ceramic Bone Filler is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects as well as in the augmentation and restoration of bony contour in the craniofacial skeleton.
The Craniofacial Calcium Phosphate Ceramic Bone Filler is comprised of a calcium phosphate powder and a liquid component. The two components are mixed to produce a homogenous paste, which can then be applied to burr holes, bone gaps, and other defect sites.
This document is a 510(k) submission summary for a medical device called "Craniofacial Calcium Phosphate Ceramic Bone Filler." It describes the device, its intended use, and states that it has been found substantially equivalent to a predicate device based on biocompatibility and mechanical testing.
However, the provided text does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way you've outlined for an AI/algorithm-based device. This document is for a physical medical implant, not a software algorithm.
Therefore, many of the requested fields cannot be answered from the given text.
Here's an attempt to answer what can be extracted or reasonably inferred, and note where information is missing for your specific request format:
Acceptance Criteria and Device Performance Study Details
| Criteria Aspect | Acceptance Criteria (Not Explicitly Stated for this Device Type) | Reported Device Performance (as stated in the summary) |
|---|---|---|
| Biocompatibility | Expected: Non-toxic, non-mutagenic, non-hemolytic, non-pyrogenic. | "The Craniofacial Calcium Phosphate Ceramic Bone Filler is a biocompatible material... found to be non-toxic, non-mutagenic, non-hemolytic, and non-pyrogenic." |
| Mechanical Strength | Expected: Adequate strength for intended non-load bearing use. | "Mechanical testing determined the material has adequate strength for the intended use." |
| Substantial Equivalence (Overall Safety & Effectiveness) | Expected: Performance similar to a legally marketed predicate device for the same indications. | Device found to be "substantially equivalent" to predicate device. |
Detailed Study Information (Based on the provided text for a physical device)
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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. This summary refers to "biocompatibility testing" and "animal studies" for safety, and "mechanical testing" for strength. It does not describe a "test set" in the context of an algorithm's performance evaluation or patient data.
- For biocompatibility: In vitro assays and in vivo animal studies (provenance and specific sample sizes not detailed).
- For mechanical strength: In vitro testing (provenance and specific sample sizes not detailed).
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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. This is not relevant for the type of device (bone filler) and studies mentioned (biocompatibility, mechanical strength, animal studies). Ground truth in the context of expert consensus isn't applicable here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided.
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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 a physical bone filler, not an AI or imaging device involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's safety and effectiveness determination is based on:
- Biocompatibility standards and test results: Proving non-toxicity, non-mutagenicity, non-hemolysis, non-pyrogenicity.
- Mechanical properties: Measured strength against established requirements for the intended application (non-load bearing).
- Similarity to predicate device: The predicate device has an established safety and effectiveness record.
- The "ground truth" for this device's safety and effectiveness determination is based on:
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The sample size for the training set
- Not Applicable. This is not an algorithm with a training set.
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How the ground truth for the training set was established
- Not Applicable. This is not an algorithm with a training set.
Summary based on the document:
The device, Craniofacial Calcium Phosphate Ceramic Bone Filler, was deemed safe and effective through:
- Biocompatibility testing and animal studies: Demonstrating the material is non-toxic, non-mutagenic, non-hemolytic, and non-pyrogenic.
- Mechanical testing: Confirming adequate strength for its non-load bearing applications.
- Substantial Equivalence: Comparison to a legally marketed predicate device with a history of safe and effective use for the same indications.
The document does not detail specific acceptance criteria in a quantifiable manner (e.g., "strength must be > X MPa") or specific study protocols, sample sizes, or data provenance beyond stating that tests were performed and results were positive. This type of information would typically be found in more detailed sections of a 510(k) submission, not necessarily in the summary provided.
§ 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).