(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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BioStructures, LLC % Patsy J. Trisler, JD, RAC Regulatory Consultant Trisler Consulting 5600 Wisconsin Avenue, #509
Chevy Chase, Maryland 20815
January 16, 2015
Re: K142276
Trade/Device Name: MCS Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 8, 2014 Received: December 9, 2014
Dear Ms. Trisler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing
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Page 2 - Patsy J. Trisler. JD. RAC
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K142276 |
|---|---|
| --------------------------- | --------- |
Device Name: MCS Bone Graft
Indications for Use:
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.
Type of Use (Select one or both, as applicable)
| X Prescription Use(Part 21 CFR 801 Subpart D) | _ Over-The-Counter Use(21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------- | -------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section 5 510(k) Summary
| Submitter Name: | BioStructures, LLC |
|---|---|
| Submitter Address: | 1201 Dove Street, Suite 470Newport Beach, CA 92660 |
| Contact Person: | John Brunelle, Ph.D.Chief Technology Officer |
| Phone Number: | 949.553.1717 |
| Date Prepared: | August 14, 2014 |
| Device Trade Name: | MCS Bone Graft |
| Common Name:Classification Name: | Bone void filler |
| Resorbable Calcium Salt Bone Void Filler Device | |
| Classification Number: | 21 CFR 888.3045 |
| Product Code: | MQV |
| Device Class: | 2 |
| Predicate Device(s): | K032288, Vitoss® Scaffold Foam Pack, Stryker/OrthovitaK051774, MBCP™, Biomatlante |
| Indications for UseStatement: | MCS Bone Graft is a bone void filler device intended for use in bony voidsor gaps that are not intrinsic to the stability of the bony structure. Thesedefects may be surgically created osseous defects or osseous defectscreated from traumatic injury to the bone. MCS Bone Graft is indicated tobe 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 duringthe healing process. |
| Device Description: | Device Identification and Materials of Use:MCS Bone Graft is a resorbable bone void filler device comprised ofbiphasic mineral granulate suspended in a porous type I collagen matrix.Device Characteristics:The implant is designed to be hydrated with bone marrow aspirate priorto implantation to facilitate handling and placement in bony defects. Thedevice is supplied freeze dried in strip form, and packaged in a sterilebarrier foil pouch. The device is provided sterile, for single use, in avariety of sizes.Body Contact: |
| The device is a permanent resorbable implant in bone tissue |
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Mechanism of Action:
The device's composition allows for resorption and remodeling over time. It is an osteoconductive scaffold for new bone regeneration.
Environment of Use:
The device is for use only in a health care facility/hospital.
Summary of Testing: Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidance documents as applicable.
Raw materials characterization testing was performed according to ASTM standards: F1185-03, F1088-04a, F2212-11.
Biocompatibility testing, according to ISO 10993 for a long-term implant product, demonstrated the device is biocompatible and non-toxic.
Packaging, sterilization and shelf life testing according to the following standards are presented in the 510(k):
- Packaging: ISO 11607, ASTM F2096-11 & F88-09, and ISO 11137.
- . Sterilization and Shelf Life; ISO 11137 and ASTM F1980.
Animal performance testing was performed in a femoral cancellous defect rabbit model to evaluate the safety and performance of the MCS Bone Graft compared to a predicate device. The test results showed equivalent in vivo performance in safety, graft resorption and new bone formation.
Comparison to the MCS Bone Graft has the same intended use and the same principles of Predicate Devices: operation as all the predicates, which serve as osteoconductive scaffolds for new bone formation.
MCS Bone Graft is similar technologically to the two predicates.
The technological differences presented by the composition of materials in MCS Bone Graft do not raise new issues of safety or effectiveness, as demonstrated by the side-by-side evaluation in the animal performance studies.
- Substantial Equivalence The comparisons and study data presented in the 510(k) lead to the Conclusion: conclusion that MCS Bone Graft is substantially equivalent to the predicate devices.
§ 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.