Search Results
Found 1 results
510(k) Data Aggregation
(72 days)
BONE SUPPORT AB
Cerament™ is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Cerament™ is indicated to be injected into bony voids or gaps in the skeletal system, i.e. extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone. Cerament™ provides a bone void filler that resorbs and is replaced by bone during the healing process.
Cerament™ is an injectable bone mineral substitute material intended for stabilization of fractured osteoporotic bone void. The material consists of a powder and a liquid component. The major constituents of the powder component are calcium sulphate hemihydrate and hydroxyl apatite and the liquid component is the radio-contrast agent Iohexol. Mixing of the powder and liquid components results in a viscous mixture suitable for percutaneous injection into the fractured bone void. During resorption of the calcium sulfate dihydrate, the hydroxy apatite remains intact providing osteoconductive support for the in-growth of new bone, which gradually replaces the resorbed calcium sulfate dihydrate.
The bone mineral substitute material is injected into the bone void in a percutaneous procedure with the use of an accompanying injection device. Prior to injection, the powder and liquid components of the substitute material are mixed in a mixing container. The substitute material is injected into the bone void during careful radiographic inspection until the bone void is filled as judged from the radiographic image.
This document describes a pre-market notification (510(k)) for the Cerament™ Bone Void Filler, a medical device. The information provided focuses on the device's characteristics and its substantial equivalence to predicate devices, rather than a clinical study establishing specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove it cannot be directly extracted from the provided text.
However, based on the text, here's what can be gathered regarding "acceptance criteria" through the lens of regulatory submission and information about the device:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of quantitative acceptance criteria with corresponding device performance metrics from a specific study. Instead, it states:
| Criterion Type | Description/Reported Performance |
|---|---|
| Material Composition | Composed of calcium salt and hydroxyapatite, equivalent to predicate devices and in routine clinical use. This implies acceptance is based on established safety and efficacy of these materials in similar devices. |
| Functional Equivalence | "Technologies employed in Cerament™ and in its predicate devices is therefore substantially equivalent." This suggests acceptance is based on demonstrating the device performs its intended function similarly to already approved devices. |
| Indications for Use | "Indications, contraindications, risks and potential adverse events are the same" as predicate devices. Acceptance hinges on the device being suitable for the same conditions and patient populations as legally marketed bone void fillers. |
| Pre-Clinical Testing | "Extensive in vitro and animal testing has shown Cerament™ to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers." This is a general statement indicating that the device passed relevant pre-clinical assessments, but specific acceptance criteria are not detailed. |
| Biocompatibility/Resorption | The device is described as "resorbs and is replaced by bone during the healing process." This is a key functional characteristic, implying acceptance requires demonstration of proper resorption and osteoconductive support. No specific timelines or quantitative metrics are given. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable/not provided. The submission focuses on substantial equivalence, pre-clinical testing, and material properties, not a specific clinical test set for performance metrics.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not provided. The text only mentions "extensive in vitro and animal testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/not provided. This information would typically be part of a clinical study, which is not detailed in this 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable/not provided.
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. This device is a bone void filler, not an AI-powered diagnostic or assistive technology.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the "extensive in vitro and animal testing," the ground truth would likely be based on established scientific methods for evaluating material properties, biocompatibility, resorption rates, and osteoconductivity in relevant animal models. Specific details are not provided.
8. The sample size for the training set:
Not applicable/not provided. The concept of a "training set" is usually associated with machine learning or AI algorithm development, which is not relevant to this device.
9. How the ground truth for the training set was established:
Not applicable.
In summary:
The provided text is a 510(k) summary, aiming to demonstrate substantial equivalence to predicate devices. It relies on the established safety and efficacy of similar materials and functions, supported by general statements about in vitro and animal testing. It does not contain the detailed clinical study data, specific acceptance criteria, or ground truth establishment methods that would be present in a submission for a novel device requiring such proof of performance. The "acceptance criteria" here are broad regulatory requirements and comparisons to existing devices, rather than quantitative performance metrics from a specific human-subjects study.
Ask a specific question about this device
Page 1 of 1