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510(k) Data Aggregation
(264 days)
MCP Bone Putty
MCP Bone Putty is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCP Bone Putty is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCP Bone Putty is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.
MCP Bone Putty is a bone graft substitute comprising biphasic mineral granules suspended in a porous type I collagen matrix, provided terminally sterile and for single patient use. The device is to be combined with autologous bone marrow aspirate to facilitate packing into bony defects and upon implantation, provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
The provided text describes the 510(k) premarket notification for "MCP Bone Putty," a bone graft substitute. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial for a novel drug or a standalone AI diagnostic device might.
However, I can extract the relevant information from the performance testing section to construct an answer regarding acceptance criteria and the studies conducted. It's important to note that the "acceptance criteria" here are implied by the focus on demonstrating "equivalence" to existing devices in terms of safety and performance, rather than explicit numerical thresholds the device must surpass on its own.
Here's the breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Equivalence to Predicate) | Reported Device Performance (as demonstrated in animal studies) |
|---|---|
| Safe support of bone healing in critical-sized femoral defects. | MCP Bone Putty demonstrated equivalence to the Vitoss predicate device in supporting bone healing in critical-sized femoral defects. No device-related adverse reactions were observed. |
| Safe support of spine fusion healing when used as an autograft extender. | MCP Bone Putty, when used as an autograft extender, demonstrated equivalence to both the Mastergraft Putty predicate and iliac crest autograft control in supporting spine fusion healing. No device-related adverse reactions were observed. |
| Meeting relevant physical and chemical characterization requirements. | Met requirements of ASTM F1185-03, F1088-04a, and F2212-11. Collagen raw materials met essential safety requirements of ISO 22442. |
| Meeting biocompatibility requirements. | Met all ISO 10993 biocompatibility requirements relevant to bone void filler devices. |
| Passing viral inactivation, packaging, and shelf life stability evaluations. | Performed with passing results. |
2. Sample size used for the test set and the data provenance
- Femoral Defect Animal Study:
- Test Set Sample Size: 14 defect sites implanted with MCP Bone Putty (total of 19 rabbits for both test and predicate groups).
- Data Provenance: Prospective animal study conducted in a rabbit model.
- Posterolateral Spine Fusion Animal Study:
- Test Set Sample Size: The number of MCP Bone Putty test subjects is not explicitly separated from the total per test group, but the study included 25 rabbits, with 8 evaluated at 4 weeks and 12 at 12 weeks across the MCP Bone Putty, Mastergraft Putty, and autograft control groups.
- Data Provenance: Prospective animal study conducted in a rabbit model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" in these animal studies would be established through scientific assessments (macroscopic, radiographic, microCT, histological, biomechanical) by researchers and veterinarians, but their specific number and qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. While assessments were made, the specific adjudication method for interpreting images/histology is not described.
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
No. This document describes animal studies for a physical bone graft substitute. It does not involve a multi-reader multi-case (MRMC) comparative effectiveness study for human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This document describes animal studies for a physical bone graft substitute. It does not involve algorithm-only performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the animal studies, the "ground truth" was established through:
- Pathology/Histology: Histological assessments of the implant site/fusion site.
- Imaging Data: Radiographic and microCT assessments.
- Macroscopic Assessment: Visual inspection.
- Biomechanical Assessment: For the spine fusion study, biomechanical assessments were performed to evaluate fusion strength.
- Safety Outcomes: Observation for device-related adverse reactions.
8. The sample size for the training set
This information is not applicable as this is not an AI/algorithm-based device requiring a training set in that context. The "training" for this device would be its development and iterative testing.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/algorithm-based device.
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