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.

Device Description

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 7, 2016

BioStructures, LLC % Ms. Patsy J. Trisler Regulatory Consultant Trisler Consulting 5600 Wisconsin Ave Chevy Chase, Maryland 20815

Re: K160446

Trade/Device Name: MCP Bone Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 23, 2016 Received: September 23, 2016

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Vincent J. Devlin -S

for

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K160446

Device Name

MCP Bone Putty

Indications for Use (Describe)

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 Puty is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 510(k) Summary

Submitter Information:

Name:	BioStructures, LLC
Address:	1201 Dove Street, Suite 470Newport Beach, CA 92660
Contact Person:	John Brunelle, PhDChief Technology Officer
Telephone:	(949) 553-1717
Date Prepared:	February 17, 2016

Device Information:

Trade Name:	MCP Bone Putty
Common Name:	Bone void filler/ Bone graft substitute
Classification:	Class 2
Regulation:	888.3045, Resorbable calcium salt bone void filler device
Product Code:	MQV

Predicate Device(s):

K032288: Vitoss Foam Bone Graft Substitute (Orthovita, Inc.) K142276: MCS Bone Graft (BioStructures, LLC) K071813: Mastergraft® Putty (Medtronic Sofamor Danek)

Indications for Use:

Device Description:

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Performance Testing:

Non-clinical testing was performed in accordance with FDA guidance documents and recognized consensus standards as applicable. Physical and chemical characterization of the implant raw materials and finished device was conducted as recommended in the FDA class II bone void filler guidance document and meet relevant requirements of ASTM F1185-03, F1088-04a and F2212-11. The collagen raw materials meet essential safety requirements for medical devices utilizing animal tissues according to ISO 22442. The device has met all ISO 10993 biocompatibility requirements relevant to bone void filler devices. Viral inactivation, packaging and shelf life stability evaluations have been performed with passing results.

Animal performance testing was conducted using established rabbit defect models to evaluate the safety and performance of the MCP Bone Putty as directly compared to the predicate devices, as described below.

Femoral Defect Animal Study

The device was evaluated in a critical-sized bilateral femoral defect rabbit model in comparison to the Vitoss predicate. The study included 14 defect sites implanted with the MCP Bone Putty and 12 defect sites for the predicate (19 rabbits total), evaluated at time points of 1 day, 6 weeks and 12 weeks after surgery. Both test groups were fully hydrated with autologous bone marrow aspirate prior to implantation. Defects were created in the medial femoral condyles of each rabbit using a surgical drill bit, followed by implantation of the hydrated graft materials. There were no device-related adverse reactions observed regardless of test group or time point. The safety and performance of MCP Bone Putty were evaluated via macroscopic, radiographic, microCT and histological assessments of the implant site. The study demonstrated that the MCP Bone Putty can safely support bone healing in critical-sized femoral defects in equivalence to the Vitoss predicate device.

Posterolateral Spine Fusion Animal Study

The device was evaluated in a posterolateral spine fusion rabbit model in comparison to the Mastergraft Putty predicate device, as well as a control group using autologous iliac crest bone graft. The study included 25 rabbits and per test group, evaluated at 4 weeks (N=8) and 12 weeks (N=12) after surgery. Both the MCP Bone Putty and predicate test groups were fully hydrated with autologous bone marrow aspirate and admixed with autograft bone prior to implantation. Graft materials were implanted bilaterally across the L5-L6 transverse processes. There were no devicerelated adverse reactions observed regardless of test group or time point. The safety and performance of MCP Bone Putty were evaluated via macroscopic, radiographic, microCT, biomechanical and histological assessments of the fusion site. The study demonstrated that the MCP Bone Putty, when used as an autograft extender, can safely support spine fusion healing in equivalence to both the Mastergraft Putty predicate and iliac crest autograft control.

Substantial Equivalence:

MCP Bone Putty has the same intended use, and the same or similar technological characteristics, principles of operation and indications as the predicate devices. MCP Bone Putty, MCS Bone Graft and Mastergraft Putty are all comprised of biphasic mineral granules (mixture of hydroxyapatite and Btricalcium phosphate) and bovine type I collagen. Similarly, the Vitoss predicate comprises β-tricalcium phosphate granules and bovine type I collagen. MCP Bone Putty is provided in strip form, similar to all predicates, and has >90% implant porosity, same as the MCS Bone Graft and Vitoss predicates. The MCP Bone Putty finished device is supplied sterile and is combined with bone marrow aspirate prior

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to use, same as all predicates. MCP Bone Putty is to be used as an autograft extender when used in the posterolateral spine, same as Mastergraft Putty. Any technological differences presented by the MCP Bone Putty do not raise new issues of safety or effectiveness, as demonstrated by the comparative evaluation in the animal studies.

Conclusion:

Performance testing and technological comparisons presented in the 510(k) indicate MCP Bone Putty is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.