DBX® Demineralized Bone Matrix is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. DBX® Putty can be used to fill bone voids in the extremities, posterolateral spine, pelvis and cranium. DBX® Paste and Mix can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.

DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that may be and and sectors. It can be used in the:

Paste and Mix	Putty
extremities	extremities
pelvis	posterolateral spine
	pelvis

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

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 processed human cortical bone; the DBX® Mix is composed of processed human corticocancellous bone. The bone granules are mixed with sodium hyaluronate ("NaHA") in varying combinations to form the DBX® Putty, Paste and Mix. All versions of DBX® are available in five sizes.

AI/ML Overview

This document is a 510(k) summary for the DBX® Demineralized Bone Matrix products. It focuses on regulatory approval and product description rather than a detailed study proving performance against acceptance criteria in the typical sense of a medical device with measurable outcomes like accuracy or sensitivity.

Instead, the "acceptance criteria" here refer to proving the device's osteoinductive potential to show substantial equivalence to legally marketed predicate devices. The "study" proving this is an in vivo assay.

Here's a breakdown of the requested information based on the provided text, acknowledging that some details common in AI/diagnostic device studies are not applicable or explicitly stated here:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Osteoinductive Potential	DBX® is assayed in vivo for its osteoinductive potential. Standard testing DDA = 15 assayed metco 101 15 - 800 - 15 - 800 - 15 (This fragmented text likely describes a specific in vivo assay method or result but is incomplete and not fully decipherable in the provided snippet).

Note: The provided text is a regulatory submission for a bone void filler focusing on "substantial equivalence" to predicate devices, which means it doesn't typically include a clinical study with traditional acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, as would be found for a diagnostic AI device. The primary "performance" aspect highlighted is the osteoinductive potential, which is a biological activity.

Additional Study Information:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document mentions "DBX® is assayed in vivo for its osteoinductive potential." This implies an animal model or in vivo biological assay.
- Sample Size: Not specified for the in vivo assay.
- Data Provenance: Not specified. Given it's a US regulatory submission, the assay was likely conducted in the US, but this is not explicitly stated.
- Retrospective or Prospective: Unspecified, but in vivo assays are typically prospective experiments.
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):
- This question is not applicable in the context of an in vivo osteoinductivity assay. Ground truth would be established by histological examination or other biological markers by qualified scientific personnel, not by medical experts interpreting images or clinical data as in a diagnostic study. The document does not provide details on such personnel.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for an in vivo osteoinductivity assay.
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 device is a bone void filler, not an AI or diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a bone void filler, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the osteoinductive potential, the "ground truth" would be the biological evidence of new bone formation obtained through methods like histology, radiography, or biomechanical testing in the in vivo assay. Specifics are not provided in the document beyond "assayed in vivo."
The sample size for the training set:
- Not applicable. This device is a bone void filler, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model.

In summary, the provided document is a regulatory submission for a medical device (bone void filler) under a 510(k) pathway, which focuses on demonstrating substantial equivalence. The "study" mentioned refers to an in vivo assay for osteoinductivity, a biological characteristic, rather than a clinical trial or performance evaluation of a diagnostic or AI device. Therefore, many of the requested details, which are standard for AI or diagnostic device studies, are not present or applicable in this regulatory filing.

Summary

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Kosolo Call

MAR 1 7 2005

AR 17 2005

510(k) SUMMARY OF SAFETY & EFFECTIVENESS XI.

PROPRIETARY NAME:	DBX® Demineralized Bone Matrix PuttyDBX® Demineralized Bone Matrix PasteDBX® Demineralized Bone Matrix Mix
COMMON NAME:	Bone Void Filler Containing HumanDemineralized Bone Matrix (DBM)
PROPOSED REGULATORYCLASS:	Class II
CLASSIFICATIONIDENTIFICATION:	21 C.F.R. §888.3045 Resorbable calcium saltbone void filler device
PRODUCT CODE:	MQV
PANEL CODE:	87 - Orthopedic Devices
SPONSOR:	Musculoskeletal Transplant Foundation125 May StreetEdison, NJ 08837732-661-0202

INDICATIONS FOR USE:

DEVICE DESCRIPTION:

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OSTEOINDUCTIVE POTENTIAL:

DBX® is assayed in vivo for its osteoinductive potential. Standard testing DDA = 15 assayed m etco 101 15 - 800 - 15 - 800 - 15

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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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines representing its wings or feathers.

MAR 1 7 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kathleen M. Laffan, RAC Regulatory Submission Specialist Musculoskeletal Tissue Foundation 125 mav Street Edison, NJ 08837

Re: K040262

DBX® Demineralized Bone Matrix Putty, Paste, and Mix Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV, GXP Dated: December 22, 2004 Received: December 23, 2004

Dear Ms. Laffan:

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 -- Kathleen M. Laffan, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manetally your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your dove premarket notification. The PDA miding of basification 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 If you desire specific advice ion your ac not the complexe note the regulation entitled, Contact the Office of Complance at (210) = 16 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 ( = 0 = 0 ( = 0 = 0 ( = 0 = 0 ( = 0 " Misoranumy by reference to premaixed notilities under the Act from the Division of Small other gelleral Information on your responser Assistance at its toll-free number (800) 638-204 or Manufacturers, International and Consailters http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

K. Malle A. Melleman

Miriam C. Provost, Ph.D. Acting 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

K040262 510(k) Number (if known):

DBX Demineralized Bone Matrix Putty, Paste and Mix Device Name:

Indications for Use:

DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that
and the may be and and sectors. It can be used in the: DBX is intended for use as a Deinment and and work. It can be used in the:

Paste and Mix	Putty
extremities	extremities
pelvis	posterolateral spine
	pelvis

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

DBX® is for single patient use only.

Prescription Use __X (Per 21 CFR 801 Subpart D) AND/OR

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

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

510(k) Num

Concurrence of ODRH, Office of Device Evaluation (ODE)

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

K040267

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.