The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels, combined with bone marrow aspirate, are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine (posterolateral spinal fusions only), and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are 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 Moldable Morsels and Integra OS Moldable Morsels are resorbed and replaced with bone during the healing process.

Device Description

The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are resorbable bone void fillers made from a porous highly purified collagen matrix that has high purity beta tricalcium phosphate (B-TCP) granules and cubes dispersed throughout. The implant is provided sterile, non-pyrogenic, for single use in double peel packages.

The Integra Mozaik Moldable Morsels and Integra Moldable Morsels bone grafting construct are 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 Moldable Morsels and Integra OS Moldable Morsels quickly imbibe fluids, making it easy to combine with bone marrow aspirate.

Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels guide the regeneration of bone across the defect site into which the Moldable Morsels are 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 a medical device (Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels). This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a new device's efficacy through extensive clinical trials with an AI component.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details.

The document primarily focuses on:

Device Description: What the device is made of and how it works.
Intended Use: The clinical situations for which the device is designed.
Substantial Equivalence: A claim that the device is similar in function and intended use to an already marketed predicate device (Integra MOZAIK Osteoconductive Scaffold - Putty (K062353)).
Conclusion: States that "Valid scientific evidence through physical property testing provide reasonable assurance that Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are safe and effective under the proposed conditions of use..." This refers to non-clinical, benchtop testing, not clinical studies in the context of diagnosing or detecting conditions with AI.

To answer your request based on the provided text:

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

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for a diagnostic or AI device. The general acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness.
Reported Device Performance: The document states that "Valid scientific evidence through physical property testing provide reasonable assurance that Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are safe and effective under the proposed conditions of use." Specific performance values (e.g., sensitivity, specificity, accuracy) are not provided as this is not an AI diagnostic device.

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

Not Applicable. This document describes a bone void filler, not an AI or diagnostic device that would typically use clinical test sets of patient data. The "testing" mentioned refers to physical property testing of the material, not clinical data analysis.

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)

Not Applicable. No ground truth establishment by experts for a test set is described, as this is not an AI diagnostic device.

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

Not Applicable. No test set or adjudication method is 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

Not Applicable. This is a medical implant, not an AI-assisted diagnostic device.

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

Not Applicable. This is a medical implant, not an algorithm.

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

Not Applicable. No ground truth in the context of diagnostic performance is described. The "ground truth" for this device would relate to its material properties (e.g., porosity, resorption rate, mechanical strength), which are assessed through physical property testing.

8. The sample size for the training set

Not Applicable. This device is not an AI model that requires a training set.

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

Not Applicable. This device is not an AI model that requires a training set or ground truth establishment in that context.

Summary

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XO9/302

DEC - 4 2009

Special 510(k) Premarket Notification Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels Integra LifeSciences Corporation

510(K) SUMMARY

Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels

Submitter's name and address: Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA

Contact person and telephone number:

Marilyn Konicky Director, Regulatory Affairs (609) 936-5563

Date: November 30, 2009

Name of the device:

Proprietary Name:	Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels Bone Void Filler
Common Name:	Filler, Bone Void, Calcium Compound, Product Code MQV
Classification Name:	Class II Regulation Number 888.3045 Orthopedic

Classification Panel:

Substantial Equivalence:

Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are substantially equivalent in function and intended use to the currently marketed Integra MOZAIK Ostecondcutive Scaffold -Putty (K062353).

Intended Use:

Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels combined with bone marrow aspirate, are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine (posterolateral spinal fusions only), and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are 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 Moldable Morsels and Integra OS Moldable Morsels are resorbed and replaced with bone during the healing process.

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Device Description:

Conclusion:

Valid scientific evidence through physical property testing provide reasonable assurance that Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are safe and effective under the proposed conditions of use, and are, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.

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Image /page/2/Picture/1 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" around the perimeter. Inside the circle is a stylized image of a human figure, with the head, torso, and legs represented by flowing lines. The figure is facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Integra LifeSciences Corporation % Mr. Peter Allan Regulatory Affairs Project Manager 311 Enterprise Drive Plainsboro, New Jersey 08536

DEC = 4 2009

Re: K091302

Trade/Device Name: Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: November 05, 2009 Received: November 06, 2009

Dear Mr. Allan:

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 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

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Page 2 - Mr. Peter Allan

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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INDICATIONS FOR USE

510(k) Number: K091302

Device Name: Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels

Indications for Use:

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)

FOR M. MELKERSON
Page 1 of 1

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091302

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.