Accell Evo3 is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use as a bone graft extender in the spine, extremities and pelvis. Accell Evo3 may also be used as a bone void filler in the posterolateral spine, extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Device Description

Accell Evo3 is a moldable putty that contains ground, cortical de-mineralized bone marrix (DBM) in particulate and solubilized forms as well as a poloxamer reverse phase medium for proper handling. The device is packaged in a prefiled open-bore polycarbonate syringe and terminally sterilized by e-beam radiation. The DBM used to manufacture Accell Evo3 is only obtained from AATB-accredited facilities.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

Acceptance Criteria and Device Performance

The acceptance criteria are implied by the claim of "effective bone formation through fusion" and "equivalence to autograft." The device performance is the demonstration that it met these criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Effective bone formation through fusion	Demonstrated effective bone formation through fusion (in posterolateral rabbit spine model)
Equivalence to autograft	Radiographic, histological, and biomechanical evidence of equivalence to autograft (in posterolateral rabbit spine model)
Provides a favorable environment that stimulates bone growth and remodeling (Osteoconductivity)	Accell Evo3 is an osteoconductive bone void filler. It creates a favorable environment for bone growth and remodeling.
Osteoinductive potential	Assayed in vitro for bone morphogenetic protein-2, with in vitro assay validated to an in vivo (athymic mouse) osteoinductive assay.
Biocompatible and safe	DBM processing methods evaluated for viral inactivation potential, determined to provide significant viral inactivation.
Resorption over time	Device is resorbed over time.

Study Information

Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of rabbits, but the study was conducted in a "posterolateral rabbit spine model."
- Data Provenance: Animal study (rabbit model), likely prospective (an experimental study designed to test the device). Country of origin is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The assessment involved "Radiographic, histological and biomechanical evidence," suggesting evaluation by relevant experts in these fields (e.g., veterinary radiologists, histopathologists, biomechanical engineers), but their number or specific qualifications are not provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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 was not an MRMC study comparing human readers or AI assistance. It was an animal study evaluating direct device performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This device is a bone void filler, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established through radiographic, histological, and biomechanical evidence from the animal model. This combines imaging findings, tissue analysis (pathology), and functional/mechanical testing to assess bone formation and fusion.
The sample size for the training set:
- N/A. This is not an AI/machine learning device, so there is no "training set."
How the ground truth for the training set was established:
- N/A.

Summary

{0}------------------------------------------------

510(k) SUMMARY

Date of Preparation December 20, 2010

Company Integra LifeSciences 2 Goodyear Irvine, CA 92618

Contact

Jenny Fam Director of Regulatory Affairs Integra Orthobiologics 949-595-8710

Proprietary Name Accell Evo3

Common Name

Bone Void Filler

Classification

21 CFR 888.3045; Resorbable calcium salt bone void filler

Product Codes

MQV: Filler, Bone Void, Calcium Compound MBP: Filler, Bone Void, Osteoinduction (Without Human Growth Factor)

Predicate Devices

The device is substantially equivalent to Integra Accell DBM Family (K061880) and Ostectech Grafton DBM Putty (K051195).

Indications for Use

Accell Evo3 is intended to fill voids and gaps in the skeletal system that are not intrinsic to the bony structure. The product is indicated for use as a bone graft extender in the spine, extremities and pelvis. Accell Evo3 may also be used as a bone void filler in the posterolateral spine, extremittes and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Device Description

Device Performance

Accell Evo3 is an osteoconductive bone void filler. The device is resorbed over time and provides a favorable environment that stimulates bone growth and remodeling. Accell Evo3 has been assayed in vitro for bone morphogenetic protein-2. The in vitro assay has been validated to an in vivo (athymic mouse) osteoinductive assay. It is unknown how osteoinductive polential measured via the in vivo assays will correlate with human clinical performance.

Viral Inactivation

The methods for processing the DBM contained in Accell Evo3 have been evaluated for viral inactivation potential. A panel of model potential human viruses representing various wirus types and genomes were evaluated. The DBM processing methods have been determined to provide significant viral inactivation for a wide range of potential viruses.

Determination of Substantial Equivalence

Accell Evo3 demonstrated effective bone formation through fusion when tested in the postero-lateral rabbit spine model. Radiographic, histological and biomechanical evidence of the device's equivalence to autograft The in vivo and in vitro tests performed on Accell Evo3 demonstrate substantial equivalence in terms of controls. intended use, technological characteristics and performance to its predicate devices.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three wing-like strokes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Integra LifeSciences IsoTis Orthobiologics % Ms. Jenny Fam Director of Regulatory Affairs 2 Goodyear Irvine, California 92672

MAR 1 7 2011

Re: K103742

Trade/Device Name: Accell Evo36 Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MBP, MQV Dated: December 20, 2010 Received: December 28, 2010

Dear Ms. Fam:

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.

{2}------------------------------------------------

Page 2 - Ms. Jenny Fam

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 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 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/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 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/MedicalDevices/Resourcesfor You/industry/default.htm.

Sincerely vours.

Az. B. M. h

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

Enclosure

{3}------------------------------------------------

INDICATIONS FOR USE

510(k) Number:

Device Name: Accell Evo38

Indications for Use:

Prescription Use X (Part 21 CFR 801 Sub-part D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Sub-part C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign Off

(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic.
Division torotive Devices Division of Surgical
and Restorative Devices

Page 1 of 1

510(k) Number K103742

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.