DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the:

Putty	Mix	Paste
Extremities	Extremities	Extremities
Pelvis	Pelvis	Pelvis
Posterolateral Spine	Spine
Cranium
DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® Mix may be used as a bone void filler in the spine. DBX® can be used with bone marrow. DBX® is for single patient use only.

Device Description

DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of cadaveric cortical bone; the DBX® Mix is composed of cadaveric corticocancellous bone. The bone granules are mixed with sodium hyaluronate (NaHy) in varying combinations to form the DBX® Putty, Paste, and Mix. DBX® Putty is available in five sizes and DBX® Paste and Mix are available in four sizes.

AI/ML Overview

The provided text does not contain detailed information about a study proving the device meets specific quantitative acceptance criteria in a robust clinical or comparative effectiveness setting. Instead, it focuses on the device's characteristics, safety aspects, and regulatory approval processes.

Here's a breakdown of the available information and what's missing, formatted to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the primary "acceptance criteria" are related to biocompatibility and osteoinductive potential for lot release. There are no specific quantitative performance metrics like sensitivity, specificity, or improvement effect sizes from a clinical study.

Acceptance Criteria (Stated)	Reported Device Performance (Implied/Stated)
Biocompatibility	Established through long history of safe/effective clinical use & ISO 10993 testing.
Sterility	Tested per current USP <71>.
Osteoinductivity Potential (Lot Release)	"Standard testing performed in an athymic mouse must prove positive for lot release."
Viral Clearance/Inactivation	Processing methods determined to provide "significant viral inactivation potential."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of a clinical performance study as described by the text. The "test set" mentioned refers to individual lots of the product being tested for osteoinductivity. The number of samples (e.g., mice) used for this per lot is not specified.
Data Provenance: Not applicable for a clinical performance study. The osteoinductivity testing is described as an in vivo assay in an athymic mouse model, not human data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable as there is no human-involved "test set" for performance evaluation described in the provided text. The ground truth for osteoinductivity is established via the athymic mouse model.

4. Adjudication Method for the Test Set

This question is not applicable as there is no human-involved "test set" for performance evaluation described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted or reported. The document focuses on regulatory approval based on substantial equivalence to predicate devices, safety, and laboratory/animal testing, not a clinical effectiveness study comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This device is a medical product (bone void filler), not an AI algorithm.

7. The Type of Ground Truth Used

Osteoinductivity: In vivo assay results in an athymic mouse model.
Biocompatibility: Demonstrated through in vitro laboratory testing (ISO 10993) and a history of clinical use.
Sterility: USP <71> testing.
Viral Clearance: Laboratory evaluation of processing methods using model viruses.

8. The Sample Size for the Training Set

Not applicable. This product is a medical device (bone void filler), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set for an AI algorithm is involved.

Summary of Device Evaluation in the Provided Text:

The document describes the DBX® Demineralized Bone Matrix device, its composition, indications for use, and a summary of its safety and effectiveness based on:

Biocompatibility: Established by a long history of safe and effective clinical use and ISO 10993 laboratory testing.
Sterility: Tested per USP <71>.
Osteoinductive Potential: Assayed in vivo in an athymic mouse model. This is used as a lot-release criterion, meaning every lot of the final product must test positive for osteoinductive potential. However, the document explicitly states: "Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects."
Viral Clearance and Inactivation: Evaluation of the DBM processing method for its ability to inactivate a panel of model human viruses.

The FDA's decision to clear the device (K063676) is based on substantial equivalence to legally marketed predicate devices, not on the demonstration of specific clinical performance criteria from a new clinical study.

Summary

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X. 510(k) SUMMARY OF SAFTEY & EFFECTIVENESS

MAR 0 5 2007

PROPREIETARY NAME:	DBX® Demineralized Bone Matrix
COMMON NAME:	Bone Void Filler Containing Human DemineralizedBone Matrix (DBM)
PROPOSED REGULATORYCLASS:	Class II
CLASSIFICATIONIDENTIFICATION:	21 C.F.R. §888.3045 Resorbable calcium salt bonevoid filler device
PRODUCT CODE:	MBP, MQV
PANEL CODE:	87—Orthopedic Devices
SPONSOR:	Musculoskeletal Transplant Foundation125 May StreetEdison, NJ 08837732-661-0202723-661-2189 fax

INDICATIONS FOR USE:

DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the:

Putty	Mix	Paste
Extremities	Extremities	Extremities
Pelvis	Pelvis	Pelvis
Posterolateral Spine	Spine
Cranium

DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® Mix may be used as a bone void filler in the spine. DBX® can be used with bone marrow.

DBX® is for single patient use only.

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DEVICE DESCRIPTION:

SAFETY AND EFFECTIVENESS INFORMATION:

Biocompatibility of DBX® materials has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. DBX® is single-donor processed using aseptic techniques and is tested for sterility per current USP <71>.

OSTEOINDUCTIVITY POTENTIAL:

DBX® is osteoconductive, and has been shown to have osteoinductivity potential in an athymic mouse. Every lot of final product will be tested to ensure the osteoinductive potential of the final product. Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects.

VIRAL CLEARANCE AND INACTIVATION:

The method for processing the DBM contained in DBX® was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses.

OSTEOINDUCTIVE POTENTIAL:

DBX will be assayed in vivo for its osteoinductive potential. Standard testing performed in an athymic mouse must prove positive for lot release.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Musculoskeletal Transplant Foundation % Ms. Nancy Bennewitz Regulatory Affairs Submission Specialist 125 May Street Edison, New Jersey 08837

MAR 0 5 2007

K063676 Re:

Trade/Device Name: DBX® Demineralized Bone Matrix Mix Regulation Number: 21 CFR 888.3045 Regulation Name: resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: December 7, 2006 Received: December 11, 2006

Dear Ms. Bennewitz:

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. Nancy Bennewitz

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 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,

for
Mark N. Melkers

lkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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IV. INDICATIONS FOR USE

K063676 510(k) Number (if known):

Device Name: DBX® Demineralized Bone Matrix

Indications for Use:

DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the:

Putty	Mix	Paste
Extremities	Extremities	Extremities
Pelvis	Pelvis	Pelvis
Posterolateral Spine	Spine
Cranium

DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX® Putty can be used as an extender in the spine with autograft. DBX® Mix may be used as a bone void filler in the spine. DBX® can be used with bone marrow.

DBX® is for single patient use only.

Prescription Use _ X OR (Per 21 CFR 801 Subpart D)

Over-The-Counter Use _ (Per 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)
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Pellm

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

1.063626 510(k) Number

Confidential

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.