(154 days)
MCS Bone Graft is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MCS Bone Graft is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities and pelvis) and is used mixed with bone marrow aspirate. Once implanted, the device resorbs and is replaced with host bone during the healing process.
Device Identification and Materials of Use:
MCS Bone Graft is a resorbable bone void filler device comprised of biphasic mineral granulate suspended in a porous type I collagen matrix.
Device Characteristics:
The implant is designed to be hydrated with bone marrow aspirate prior to implantation to facilitate handling and placement in bony defects. The device is supplied freeze dried in strip form, and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes.
Body Contact:
The device is a permanent resorbable implant in bone tissue
Mechanism of Action:
The device's composition allows for resorption and remodeling over time. It is an osteoconductive scaffold for new bone regeneration.
The provided document is a 510(k) summary for the MCS Bone Graft device, which is a resorbable bone void filler. This type of device is classified as a medical device and its clearance process differs significantly from software or AI-powered devices, which typically involve extensive clinical studies and performance metrics against ground truth.
Therefore, the requested information elements (acceptance criteria, specific study types like MRMC, sample sizes for test/training sets, expert ground truth establishment, etc.) do not directly apply to this document as it describes a non-AI bone graft. The clearance for this device is based on showing substantial equivalence to existing predicate devices, not on a formal evaluation of diagnostic performance against a "ground truth" as you would find for an AI-powered diagnostic tool.
However, I can extract the information that is relevant to the device's validation and substantial equivalence claims as presented in the document:
Device: MCS Bone Graft
Device Type: Resorbable calcium salt bone void filler device
Here's a summary of the validation detailed in the document, framed as closely as possible to your request, but acknowledging the difference in device type:
1. Table of Acceptance Criteria and Reported Device Performance
For the MCS Bone Graft, "acceptance criteria" revolve around demonstrating safety and effectiveness compared to predicate devices, primarily through material characterization, biocompatibility, and animal performance, rather than diagnostic accuracy metrics.
| Acceptance Criteria (Demonstrated through Testing) | Reported Device Performance |
|---|---|
| Biocompatibility: Device classified as long-term implant, must be biocompatible and non-toxic. | Biocompatibility testing according to ISO 10993 demonstrated the device is biocompatible and non-toxic. |
| Material Characterization: Raw materials meet established standards. | Raw materials characterization testing performed according to ASTM standards: F1185-03, F1088-04a, F2212-11. |
| Sterilization & Packaging: Device packaging maintains sterility and integrity, and sterilization process is effective. | Packaging, sterilization, and shelf life testing performed according to ISO 11607, ASTM F2096-11 & F88-09, ISO 11137, and ASTM F1980. |
| In Vivo Performance (Safety, Resorption, New Bone Formation): Performance equivalent to predicate devices in an animal model. | Animal performance testing in a femoral cancellous defect rabbit model showed equivalent in vivo performance in safety, graft resorption, and new bone formation compared to a predicate device. |
| Substantial Equivalence: Demonstrate no new issues of safety or effectiveness compared to predicate devices with similar intended use and principles of operation. | Comparisons and study data presented lead to the conclusion that MCS Bone Graft is substantially equivalent to predicate devices (K032288, Vitoss® Scaffold Foam Pack; K051774, MBCP™). The technological differences in material composition do not raise new issues of safety or effectiveness, as demonstrated by the animal performance studies. |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Performance Study:
- Sample Size: Though not explicitly stated as a number, the study utilized a "femoral cancellous defect rabbit model." The exact number of animals is not provided in this summary.
- Data Provenance: This was an animal study (rabbit model), not human clinical data. The document does not specify the location of the animal study, but it would presumably be a controlled laboratory setting. It is inherently a prospective study in the sense that the animal model was designed and experiments carried out to validate the device's performance.
3. Number of Experts and Qualifications for Ground Truth
- This device clearance relies on technical standards, biocompatibility testing, and animal efficacy studies, not on human expert review for "ground truth" as would be applied to a diagnostic AI tool. Therefore, information on experts establishing ground truth in this context is not applicable. The assessment is made by regulatory bodies (FDA) based on submitted test results.
4. Adjudication Method for the Test Set
- Not applicable for this type of device and study. The "test set" was an animal model, and the outcome measures (e.g., graft resorption, new bone formation) were likely assessed by veterinary pathologists or researchers, but no "adjudication method" in the sense of multiple human readers resolving disagreements is mentioned or relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not conducted. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the function of a bone graft device.
6. If a Standalone (Algorithm Only without Human-in-the-Loop Performance) was done
- Not applicable. The device is a physical bone graft, not a software algorithm. Its "performance" is evaluated functionally within a biological system (an animal model).
7. The Type of Ground Truth Used
- For the animal performance study, the "ground truth" would be established through histological analysis or imaging of the animal's bone healing process, directly assessing graft resorption and new bone formation. This is a form of direct biological/pathological outcome assessment in an animal model.
- For other testing (biocompatibility, material characterization, sterility), the "ground truth" is adherence to established international and national standards (ISO, ASTM).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable for the same reason as point 8.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.