DBX® Inject 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 as follows:

Indications for Use	Putty	Paste
Extremities	√	√
Posterolateral spine	√
Pelvis	√	√

DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject Putty can be used as an extender in the spine with autograft. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

Device Description

DBX® Inject is completely resorbable and is composed of donated cortical and cancellous bone. The bone granules are mixed with sodium hyaluronate (Hy). DBX® Inject consists of DBX Putty or Paste with a separate, sterile plastic syringe for delivery directly into the operative site.

AI/ML Overview

The provided text is a 510(k) summary for the DBX® Inject device, a bone void filler. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically seen in studies for diagnostic or AI-powered devices.

Therefore, the information required to populate the requested table and answer the study-related questions for a device performance study as described in the prompt is not present in the provided document. The 510(k) summary describes regulatory compliance, device characteristics, and comparisons to predicate devices.

However, I can extract information related to the device's biological potential and safety testing, which are forms of performance evaluation for this type of medical device.

Here's what can be gathered from the document, acknowledging the difference in scope from the prompt's implied request for clinical performance study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (as described for regulatory purposes)
Osteoinductive Potential:
Lot release must prove positive in athymic mouse model or alkaline phosphatase assay. (Positive correlation between alkaline phosphatase assay and athymic mouse model shown).	Every lot of final DBX® Inject Paste will be assayed in vivo for osteoinductive potential. Every lot of final DBX® Inject Putty product will be tested in an athymic mouse model or in an alkaline phosphatase assay, which has been shown to have a positive correlation with the athymic mouse model, to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse or alkaline phosphatase assay must prove positive for lot release.
Viral Clearance and Inactivation:	DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses.
Donor Suitability:	In compliance with FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation.
Substantial Equivalence to Predicate Devices:	DBX® Inject has been demonstrated to be substantially equivalent to DBX® Demineralized Bone Matrix [K040262] and Sygnal™ DBM [K080405], with no new types of safety and effectiveness questions.

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

Test Set Sample Size: Not applicable in the context of a clinical study on device performance in humans. The testing mentioned is for lot release (biological properties) and viral inactivation.
- For osteoinductive potential: "Every lot of final DBX® Inject Paste will be assayed," and "Every lot of final DBX® Inject Putty product will be tested." The specific number of samples per lot test is not provided, nor is the number of lots tested in the submission.
- For viral clearance: A "panel of model potential human viruses" was evaluated. The specific number of virus types/samples used is not detailed.
Data Provenance:
- Osteoinductive potential: In vivo (athymic mouse model) and in vitro (alkaline phosphatase assay).
- Viral clearance: In vitro (evaluated DBM processing methods).
- Donor suitability: Refers to compliance with FDA regulations for human tissue donors.

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

Not applicable. The ground truth here relates to biological activity (osteoinductivity) and viral inactivation, which are determined by laboratory assays and scientific protocols, not expert consensus on interpretations of images or clinical outcomes.

4. Adjudication Method for the Test Set:

Not applicable. This concept applies to human expert adjudication in clinical or diagnostic studies. The tests mentioned are laboratory-based.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., images), and the device aims to assist or improve their performance. DBX® Inject is a bone void filler, not a diagnostic device.

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

No, a standalone performance study in the context of an algorithm or AI is not applicable. DBX® Inject is a physical medical device. The "performance" evaluated relates to its biological properties and manufacturing safety.

7. The Type of Ground Truth Used:

Osteoinductive Potential: The "ground truth" is established by the qualitative result of the athymic mouse model (positive/negative for osteoinductivity) or the alkaline phosphatase assay, which is correlated to the mouse model. This is a scientific, biological assay result.
Viral Clearance: The "ground truth" is the measured reduction/inactivation of various model viruses by the DBM processing methods. This is based on laboratory virology assays.
Donor Suitability: Compliance with regulatory standards (21 CFR Part 1270 and Part 1271).

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The biological tests are on the final product lots.

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

Not applicable, as there is no "training set" for this type of device submission.

In summary: The provided 510(k) summary for DBX® Inject addresses its safety and effectiveness through demonstrating substantial equivalence to predicate devices, biological activity (osteoinductive potential), and viral inactivation capabilities. It does not contain information on clinical trials with human subjects, device performance metrics, or reader studies that would typically apply to diagnostic or AI-powered devices. The "studies" described are primarily laboratory-based assessments of the product's inherent properties and manufacturing process safety.

Summary

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K091218

SEP 2 8 2009

510(k) SUMMARY OF SAFETY & EFFECTIVENESS

General Company Information

Musculoskeletal Transplant Foundation Name: Nancy Bennewitz Joy Contact: Regulatory Affairs Submission Specialist

Address:

125 May Street Edison, NJ 08837 USA

Telephone: Fax: Email:

(732) 661-2381 (732) 661-2189 Nancy Joy@mtf.org

Date Prepared

August 5, 2009

General Device Information

Product Name:

DBX® Inject

Classification:

Bone Void Filler Containing Human Demineralized Bone Matrix (DBM) 21 CFR §888.3045 - Product code: MBP, MQV Class II

Predicate Devices

DBX® Demineralized Bone Matrix Musculoskeletal Transplant Foundation 510(k) K040262

Sygnal™ DBM Musculoskeletal Transplant Foundation 510(k) K080405

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Description

Intended Use (Indications)

DBX® Inject 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 as follows:

Indications for Use	Putty	Paste
Extremities	√	√
Posterolateral spine	√
Pelvis	√	√

DBX® Inject is indicated for treatment of surgically created osseous defects or DBX - Info. In the matic injury. DBX® Inject Putty can be used as an extender in the spine with autograft. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

Substantial Equivalence

This submission supports the position that DBX® Inject is substantially equivalent to a number of previously cleared devices, including:

DBX® Demineralized Bone Matrix - Musculoskeletal Transplant Foundation [K040262] Sygnal™ DBM-Musculoskeletal Transplant Foundation [K080405]

When comparing DBX® Inject to its predicate devices, there are no new types of safety and effectiveness questions. DBX® Inject has been demonstrated to be substantially equivalent to its predicate devices.

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Osteoinductive Potential:

DBX® Inject is osteoconductive, and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final DBX® Inject Paste will be assayed in vivo for osteoinductive potential. Every lot of final DBX® Inject Putty product will be tested in an athymic mouse model or in an alkaline phosphatase assay, which has been shown to have a positive correlation with the athymic mouse model, to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse or alkaline phosphatase assay must prove positive for lot release. It is unknown how the osteoinductive potential, measured in the athymic mouse model or the alkaline phosphatase assay, will correlate with clinical performance in human subjects.

Viral Clearance and Inactivation:

The method for processing the demineralized bone matrix contained in DBX® Inject 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.

Safety and Effectiveness Information

DBX® Inject is single-donor processed. The donor suitability criteria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation.

Conclusion

Musculoskeletal Transplant Foundation believes that the information provided in this 510(k) submission establishes that similar legally marketed devices have been used for the same clinical applications as the DBX® Inject. The materials from which DBX® Inject is fabricated have an established history of use, and the device has been tested in accordance with applicable FDA guidelines.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the eagle.

SEP % 8 2009

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

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

Re: K091218

Trade/Device Name: DBX® Inject Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV, MBP Dated: August 11, 2009 Received: August 12, 2009

Dear Ms. Bennewitz Joy:

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 individe 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 case in to rely 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); 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.

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Page 2 - Ms. Nancy Bennewitz Joy

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 yours,

Mark A. Millhiser

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 (if known): K091218

Device Name: DBX® Inject

Indications for Use:

DBX® Inject 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 as follows:

Indications for Use	Putty	Paste
Extremities	√	√
Posterolateral spine	√
Pelvis	√	√

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

(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------IF NEEDED.)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

FOR M.MELKERSON

(Division Sign-Off) Division of Surgical, Orthopedic, ad Restorative Devices

.(k) Number K091218

MTF®

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.