Integra MOZAIK™ Osteoconductive Scaffold - Strip is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremittes, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK™ Osteoconductive Scaffold - Strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIKTM Osteoconductive Scaffold - Strip is resorbed and replaced with bone during the healing process.

Device Description

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is a porous resorbable bone void filler made from highly purified bovine Type I collagen and calcium salt (8-Tricalcium phosphate Ca3(PO4)2 per ASTM F1088).

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip bone grafting construct is designed to facilitate the repair of bony defects. The matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The three dimensional pore structure quickly imbibes fluids, making it easy to combine bone marrow aspirate.

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip guides bone regeneration across a critical defect site into which the products are implanted. New bone forms in apposition to the matrix surface when the grafts are placed in direct contact with viable host bone. Ultimately, the matrices are resorbed and remodeled into bone.

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is provided sterile, nonpyrogenic, for single use in double peel packages.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Integra MOZAIK™ Osteoconductive Scaffold - Strip (5cc):

It is important to note that the provided documents (FDA 510(k) summary) describe a substantial equivalence determination for a new size (5cc) of an existing medical device. This means the primary "study" demonstrated that the 5cc device is equivalent to a previously cleared 15cc device, rather than proving the 5cc device's de novo clinical efficacy through a traditional clinical trial with specific acceptance criteria on performance metrics like sensitivity, specificity, etc. Therefore, many of the requested fields (e.g., sample size for test set, number of experts, MRMC study, ground truth for training set) are not applicable or explicitly stated in the context of this 510(k) submission.

Acceptance Criteria and Device Performance

Acceptance Criteria Objective	Acceptance Criteria (Implicit)	Reported Device Performance
Material Equivalence	The 5cc device should have the same materials as the predicate (15cc) device.	"The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip has the same materials... as the commercially marketed devices, 10cc and 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip (K063124)." It is made from "highly purified bovine Type I collagen and calcium salt (β-Tricalcium phosphate Ca3(PO4)2 per ASTM F1088)."
Design Equivalence	The 5cc device should have a similar design (e.g., porous resorbable bone void filler with a three-dimensional trabecular network) to the predicate device.	"The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip has the same... design... as the commercially marketed devices, 10cc and 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip (K063124)." It is described as a "porous resorbable bone void filler made from highly purified bovine Type I collagen and calcium salt (β-Tricalcium phosphate Ca3(PO4)2 per ASTM F1088)." The "matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone."
Performance Equivalence	The 5cc device should exhibit similar performance characteristics and meet specifications as the predicate device.	"Performance tests were conducted to demonstrate equivalence between the 5cc and 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip and to ensure that 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip meets specification." The report states: "All test results were acceptable." The 5cc device guides bone regeneration and is resorbed and remodeled into bone, consistent with the predicate. Biocompatibility and in vivo performance testing from the 15cc predicate were applied to the 5cc device.
Intended Use Equivalence	The 5cc device should have the same indications for use as the predicate device.	"The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip has the same... intended use as the commercially marketed devices, 10cc and 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip (K063124)." The indications described are identical to those of the predicate device.
Safety and Effectiveness	The modifications (change in size) should not raise any new issues of safety or effectiveness.	"The modifications expressed in this 510(k) Premarket Notification do not change the intended use or fundamental scientific technology of the device, and do not raise any new issues of safety or effectiveness."

Study Details (as inferable from a 510(k) submission for substantial equivalence):

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a clinical test set for performance metrics like sensitivity/specificity. The "test set" here refers to the actual 5cc device being compared against the predicate.
- Data Provenance: The document does not specify a separate "test set" derived from studies involving patients. Instead, the basis of data provenance for equivalence is likely derived from laboratory testing (mechanical, chemical, physical properties) of the 5cc device and a reliance on the existing pre-clinical and clinical data of the predicate 15cc and 10cc devices. The phrase "biocompatibility and in vivo performance testing will be applied to the 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip" suggests the previous study's data is leveraged, rather than new, separate human/animal studies for the 5cc, specifically for biocompatibility and in vivo performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in this context, would relate to clinical outcomes or expert diagnoses, which are not directly assessed for the 5cc device in this submission, as it relies on equivalence to a predicate. The "ground truth" for the equivalence claim is the established safety and effectiveness of the existing predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is used in studies where multiple human readers review cases to establish a consensus ground truth for evaluating AI performance. This submission does not involve such a process.
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, a MRMC comparative effectiveness study was not done. This device is a bone void filler, not an AI diagnostic tool that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the established safety and effectiveness profile of the legally marketed predicate device (15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip (K063124)). This profile would have been based on a combination of:
  - Laboratory testing (physical, chemical, mechanical properties)
  - Biocompatibility testing (in vitro and/or in vivo animal studies)
  - In vivo performance testing (animal studies demonstrating bone regeneration and resorption)
  - Potentially clinical outcomes data from the predicate's use.
- For the 5cc device, the ground truth is its verified similarity in materials, design, and performance to this well-established predicate.
The sample size for the training set:
- Not applicable. This device is a physical product, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable. As above, this device is not an AI model.

Summary of the "Study" Proving Equivalence:

The "study" in this context is a bench and literature-based comparative analysis as part of a 510(k) submission. Integra LifeSciences Corporation demonstrated that the 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip meets the acceptance criteria for substantial equivalence to its predicate (the 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip, K063124) by:

Asserting identical materials, design, performance, and intended use.
Conducting performance tests on the 5cc device to ensure it meets specifications, with all results being acceptable.
Leveraging the biocompatibility and in vivo performance testing data from the predicate device based on FDA guidance for Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (June 2, 2003).

The conclusion is that the change in size (from 15cc to 5cc) does not alter the fundamental scientific technology or raise new issues of safety or effectiveness, thus proving substantial equivalence rather than independent clinical efficacy.

Summary

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

August 1, 2014

Integra LifeSciences Corporation Ms. Nicole C. Harlan Specialist, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K141841

Trade/Device Name: Integra MOZAIK™ Osteoconductive Scaffold - Strip (5cc) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 7, 2014 Received: July 8, 2014

Dear Ms. Harlan:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Nicole C. Harlan

forth in the quality systems (QS) 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 vours.

Lori A. Wiggins

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

510(k) Number (if known): K141841

Device Name: Integra MOZAIK™ Osteoconductive Scaffold - Strip (5cc)

Indications For Use: Integra MOZAIK™ Osteoconductive Scaffold - Strip is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremittes, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK™ Osteoconductive Scaffold - Strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIKTM Osteoconductive Scaffold - Strip is resorbed and replaced with bone during the healing process.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K141841

Page 1 of 1

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510(K) SUMMARY

Integra MOZAIK™ Osteoconductive Scaffold - Strip (5cc)

Submitter's name and address:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA

Contact person and telephone number:

Nicole C. Harlan Specialist, Regulatory Affairs Telephone: 609.750.2836 Fax: 609.275.9445

Date Summary was prepared:

July 3, 2014

Name of the device:

Proprietary Name:	Integra MOZAIK™ Osteoconductive Scaffold – Strip
Common Name:	Bone void filler
Classification Name:	Filler, Bone Void, Calcium Compound
Product Code:	MQV

Substantial Equivalence:

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is indentical in formulation, function and intended use to the predicate device, 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip, detailed in the following table.

510(k) Number	Product Code	Trade Name	Manufacturer
K063124	MQV	Integra MOZAIK™OsteoconductiveScaffold - Strip	Integra LifeSciencesCorporation

Device Description:

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The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is provided sterile, nonpyrogenic, for single use in double peel packages.

Intended Use:

Integra MOZAIK™ Osteoconductive Scaffold - Strip is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure. The 5cc Integra MOZAIKTM Osteoconductive Scaffold - Strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is resorbed and replaced with bone during the healing process.

Substantial Equivalence Comparison:

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip has the same materials. design, performance, and indications for use as the commercially marketed devices, 10cc and 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip (K063124). The only difference between products will be in the mass and dimensions, the 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip being a smaller size offering.

Testing and Test Results:

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip has the same materials, critical specifications and intended use as the 10cc and 15cc Integra MOZAIKTM Osteoconductive Scaffold - Strip.

Based on the recommendations of Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (June 2, 2003), the 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip biocompatibility and in vivo performance testing will be applied to the 5cc Integra MOZAIKTM Osteoconductive Scaffold - Strip.

Performance tests were conducted to demonstrate equivalence between the 5cc and 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip and to ensure that 5cc Integra MOZAIKTM Osteoconductive Scaffold - Strip meets specification. All test results were acceptable.

Conclusion:

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is substantially equivalent to the commercially marketed device, 15cc Integra MOZAIK™ Osteoconductive Scaffold - Strip (K063124).

The modifications expressed in this 510(k) Premarket Notification do not change the intended use or fundamental scientific technology of the device, and do not raise any new issues of safety or effectiveness.

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.