For orthopedic use, the OrthoBlast II Paste and Putty are intended for use as an autograft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The OrthoBlast II products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone

Device Description

OrthoBlast® II DBM Putty and Paste is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency.

OrthoBlast® II DBM Putty and Paste are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (OrthoBlast® II DBM Putty and Paste), seeking expanded indications for use. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with specific acceptance criteria and detailed quantitative results for the device itself.

Therefore, many of the requested categories related to a performance study for AI devices (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract information related to the device's characteristics, its intended use, and the basis for its clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance / Basis of Acceptance
Material Composition	Derived from selected donated human bone tissue, processed into particles, demineralized using HCl. Combined with a reverse phase carrier and cancellous chips from the same donor.
Formulation	Formulated to a paste or putty-like consistency.
Osteoconductivity	OrthoBlast® II DBM Putty and Paste is stated to be osteoconductive.
Osteoinductivity	OrthoBlast® II DBM Putty and Paste is stated to be osteoinductive.
Sterility	Provided sterile.
Intended Use (as bone void filler)	For bony voids or gaps that are not intrinsic to the stability of the bony structure (extremities and pelvis).
Intended Use (as autograft extender)	For extremities, spine, and pelvis.
Substantial Equivalence (to Predicate Devices)	OrthoBlast® II is substantially equivalent to DynaGraft II (K040419) and OrthoBlast II Paste and Putty (K050642). Uses ground, human donor, demineralized cortical bone. Incorporates an inactive poloxamer reverse phase carrier (RPM). Identical indications for use.
Osteoinductive Potential (Demonstration Method)	Demonstrated in an athymic mouse model.
Safety and Effectiveness	Adequately supported by substantial equivalence information, materials data, and animal test results provided in the Premarket Notification.

2. Sample size used for the test set and the data provenance

Not Applicable: This document describes a 510(k) premarket notification for a medical device (bone graft material), not a study evaluating an AI device or a diagnostic test with a "test set" in the context of AI/diagnostics. The primary evidence presented is substantial equivalence to legally marketed predicate devices, material characterization, and an animal model for osteoinductivity.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: See point 2.

4. Adjudication method for the test set

Not Applicable: See point 2.

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 not an AI device.

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

Not Applicable: This is not an AI device.

7. The type of ground truth used

For the osteoinductivity claim, the "ground truth" was established through an athymic mouse model. For the overall device clearance, the "ground truth" for safety and effectiveness was largely based on demonstrating substantial equivalence to legally marketed predicate devices, supported by materials data and the results from the animal model.

8. The sample size for the training set

Not Applicable: There is no "training set" in the context of this traditional medical device submission. The device is manufactured from human bone tissue; the "sample size" of donors or processed material is not detailed as a "training set."

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

Not Applicable: See point 8.

Summary

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IsoTis OrthoBiologics, Inc. OrthoBlast® II DBM Putty and Paste 510(k) Premarket Notification

Revised September 25, 2007

REVISED FROM MARCH 5, 2007

5. 510(K) SUMMARY

OCT I 5 2007

510(k) Summary for IsoTis OrthoBiologics, Inc. OrthoBlast II Putty and Paste

5.1 SPONSOR

IsoTis OrthoBiologics, Inc. 2 Goodyear, Suite B Irvine, CA 92618 U.S.A

Contact Person: Telephone: Main Tele: Facsimile: Date Prepared:

Karon Morell (949) - 855-7168 (949) - 595-8710 (949) — 595-8711 December 14, 2006

5.2. DEVICE NAME

Proprietary Name:

Regulation Name: Regulatory Class: Product Code: MQV

OrthoBlast® II Demineralized Bone Matrix Putty and Paste Human Bone Graft Material ll

5.3. Predicate Device

DynaGraft II (Demineralized Bone Matrix): K040419 OrthoBlast II Paste and Puttv K050642

5.4. DEVICE DESCRIPTION

OrthoBlast® II DBM Putty and Paste are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

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ર-ર INTENDED USE (EXPANDED INDICATION FOR SPINE APPLICATIONS)

For orthopedic use, OrthoBlast II Paste and Putty are intended for use as an autograft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The OrthoBlast II products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone.

5.6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

OrthoBlast® II DBM Putty and Paste has obtained previous 510(k) clearance for orthopeadic (K050642) indications.

OrthoBlast II is substantially equivalent to DynaGraft II Putty previously cleared by FDA (K040419). OrthoBlast II is similar to DynGraft II as both products utilize ground, human donor, demineralized cortical bone to manufacture the product. Both products utilize an inactive poloxamer reverse phase carrier (RPM) as a containing agent to provide the product's putty-like consistency and handling characteristics. The proposed and predicate devices have the identical indications for use, are provided sterile, and are intended for single patient use.

The main difference between the two products is that DynaGraft II Putty and Gel contains more demineralized bone by weight and volume and less synthetic carrier than OrthoBlast II pastes and putties. OrthoBlast II also incorporates the cancellous bone tissue in particulate form from the same donor while DynaGraft II does not.

5.7 PERFORMANCE DATA

Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2007

Isotis Orthobiologics, Inc. % Ms. Karon Morell Vice President Quality Assurance and Regulatory Affairs 2 Goodyear, Suite B Irvine. CA 9261

Re: K070751

Trade/Device Name: Orthoblast II DBM Demineralized bone matrix paste and putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MBP, MQV Dated: June 14, 2007 Received: June 18, 2007

Dear Ms. Morell:

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 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Karon Morell

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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 note 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 from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Bneuk

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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IsoTis OrthoBiologics, Inc.

June 14, 2007 Response to Question OrthoBlast® II DBM Putty and Paste 510(k) Premarket Notification

INDICATIONS FOR USE STATEMENT 4)

510(k) Number (if Known): K070751

Device Name: OrthoBlast® II DBM Demineralized Bone Matrix Paste and Putty

Indications for Use:

Indications for Use

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

barbara Buenda to mom

Division of General, Restorative. and Neurological Devices

510(k) Number K070751

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.