Integra MOZAIK™ Osteoconductive Scaffold - Putty, combined with bone marrow aspirate, 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. Integra MOZAIK Putty 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 MOZAIK Putty is resorbed and replaced with bone during the healing process.

Device Description

The Integra MOZAIK Osteoconductive Scaffold - Putty is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages.

The Integra MOZAIK Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Integra MOZAIK Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate.

Integra MOZAIK Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Integra MOZAIK™ Osteoconductive Scaffold - Putty. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing specific performance acceptance criteria through the types of studies typically performed for novel AI/software devices.

Therefore, the information requested in categories 1-9 is largely not applicable or not detailed in this document because the regulatory pathway chosen (510(k)) for this device (a physical resorbable bone void filler) does not require a clinical trial with specific performance metrics against pre-defined acceptance criteria in the same way an AI-powered diagnostic device might.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined as quantitative acceptance criteria in this 510(k) submission. The primary "acceptance criteria" here is Substantial Equivalence to the predicate device (VITOSS® Scaffold Foam Bone Graft Matrix, K032288) in terms of function and intended use.	Animal Study Results: The device "has been demonstrated to support bone growth in an animal study, where it was ultimately resorbed and replaced by remodeled bone." This demonstrates the intended biological function and resorption profile. Compatibility with Characterization Studies & Performance Testing: The document states that these results, in conjunction with product characterization studies and performance testing, affirmed that the device is equivalent to its predicate. While specific data points for these tests are not provided, they would likely include material properties, sterility, biocompatibility, and perhaps mechanical strength suitable for its intended use as a void filler.

Acceptance Criteria

Reported Device Performance

Not explicitly defined as quantitative acceptance criteria in this 510(k) submission. The primary "acceptance criteria" here is Substantial Equivalence to the predicate device (VITOSS® Scaffold Foam Bone Graft Matrix, K032288) in terms of function and intended use.

Animal Study Results: The device "has been demonstrated to support bone growth in an animal study, where it was ultimately resorbed and replaced by remodeled bone." This demonstrates the intended biological function and resorption profile. Compatibility with Characterization Studies & Performance Testing: The document states that these results, in conjunction with product characterization studies and performance testing, affirmed that the device is equivalent to its predicate. While specific data points for these tests are not provided, they would likely include material properties, sterility, biocompatibility, and perhaps mechanical strength suitable for its intended use as a void filler.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "an animal study." The number of animals, species, and specific experimental design are not detailed.
Data Provenance: Not specified. Assuming the animal study was conducted by or for the manufacturer, it's likely domestic (USA) but not explicitly stated. The study type was prospective in nature, as it involved implanting the device and observing its performance over time.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Experts for Ground Truth: Not specified. For an animal study evaluating bone growth and resorption, ground truth would typically be established by veterinary pathologists or bone histomorphometry experts, but their number and qualifications are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable/specified. This type of adjudication is typically used in clinical trials or reader studies for diagnostic devices, not for a biological implant performance study. The animal study would involve scientific observation and analysis.

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

MRMC Study: No, this document does not mention an MRMC comparative effectiveness study. This type of study is relevant for AI-powered diagnostic imaging devices, not for a physical bone void filler.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth Type: Based on the description, the ground truth for the animal study would be histopathology/pathology (evaluating bone growth and resorption through tissue analysis) and potentially imaging (e.g., radiography or micro-CT) for assessing bone formation, and gross observation for overall healing.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. As there is no training set for an AI model, this question does not apply.

Summary of Device Performance and Equivalence Claim:

The crucial performance information provided in the 510(k) is:

Animal Study: The device "has been demonstrated to support bone growth in an animal study, where it was ultimately resorbed and replaced by remodeled bone." This is the key functional performance evidence.
Product Characterization Studies and Performance Testing: These were also conducted to further support the claim of equivalence.

The core of this 510(k) is the demonstration of substantial equivalence to the predicate device, VITOSS® Scaffold Foam Bone Graft Matrix (K032288), in terms of intended use and function, supported by the animal study and product characterization. The FDA's clearance (DEC 20 2006) indicates they agreed with this assessment of substantial equivalence.

Summary

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510(k) Premarket Notification K062353 Integra MOZAIK™ Osteoconductive Scaffold-- Putty Integra LifeSciences Corporation

510(K) SUMMARY

Integra MOZAIK™ Osteoconductive Scaffold

Submitter's name and address:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA

(609) 275-9445

Contact person and telephone number:

Diana Bordon Manager, Regulatory Affairs Telephone: (609) 275-0500

Date Summary was prepared:

December 4, 2006

Name of the device:

Fax:

Proprietary Name: Integra MOZAIK™ Osteoconductive Scaffold - Putty Common Name: Bone Void Filler Classification Name: Filler, Bone Void, Calcium Compound MQV Product Code:

Substantial Equivalence:

Integra MOZAIK Osteoconductive Scaffold - Putty is substantially equivalent in function and intended use to VITOSS® Scaffold Foam Bone Graft Matrix which has been cleared to market under Premarket Notification 510(k) K032288.

Device Description:

Intended Use:

Integra MOZAIK Putty, combined with bone marrow aspirate, 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. Integra MOZAIK Putty 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 MOZAIK Putty is resorbed and replaced with bone during the healing process.

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Performance Data:

Integra MOZAIK Putty has been demonstrated to support bone growth in an animal study, where it was ultimately resorbed and replaced by remodeled bone. These results, in when it was anninatery resorduct characterization studies, performance testing and confametion with The The Strate that Integra MOZAIK Osteoconductive Scaffold - Putty is equivalent to its predicate device.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2006

Integra LifeSciences Corporation c/o Ms. Diana M. Bordon Manager, Regulatory Affairs 311 Enterprise Dr. Plainsboro, NJ 08536

Re: K062353

Trade/Device Name: Integra MOZAIK™ Osteoconductive Scaffold - Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 7, 2006 Received: December 8, 2006

Dear Ms. Bordon:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if

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Page 2 – Ms. Diana M. Bordon

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial aquivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please not the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 601.77). Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark N. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K062353

Integra MOZAIK™ Osteoconductive Scaffold - Putty Device Name:

Indications For Use: Integra MOZAIK™ Osteoconductive Scaffold - Putty, combined with bone marrow aspirate, 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. Integra MOZAIK Putty 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 MOZAIK Putty 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)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K062353

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A - 007

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.