PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The PRO-DENSE® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K. Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

PRO-DENSE® is provided sterile for single use only.

Device Description

PRO-DENSE® is indicated as a bone graft substitute to be injected and/or digitally packed into open bone voids/gaps that are not intrinsic to the structural stability of the skeletal system to cure in-situ. It is supplied in separate powder and liquid vials along with the instruments for mixing it into a paste and delivering it to the defect site. The triphasic resorption of PRO-DENSE® results in a scaffold that is osteoconductive allowing tissue infiltration and must eventually be degraded through osteoclastic action as bone remodels within the scaffold. The clinical use of calcium sulfate, calcium phosphate, and composites thereof as a bone void filler has been well established through many peer reviewed publications.

AI/ML Overview

This document describes the PRO-DENSE® Bone Graft Substitute. However, it is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a formal study with acceptance criteria and device performance metrics in the way a clinical trial for a new drug or a novel AI diagnostic device would.

Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission. The document relies heavily on demonstrating the technological characteristics of the device are identical to its predicate and uses a literature review to support an expanded indication.

Here's an attempt to answer your questions based on the provided text, with clear indications where information is N/A or not provided:

1. A table of acceptance criteria and the reported device performance

This document does not define specific acceptance criteria (e.g., a required sensitivity or specificity threshold) or report quantitative device performance metrics in the way a study for a diagnostic device would. The "performance" is demonstrated by substantial equivalence to a predicate device and a literature review supporting an expanded indication.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. No specific test set in the traditional sense was used for a direct performance comparison with acceptance criteria. The "evidence" came from a literature review.
Data Provenance: Not applicable. The "data" consisted of published literature. The document does not specify the origin (country, etc.) or nature (retrospective/prospective) of the studies included in this literature review.

3. 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)

Not applicable. No ground truth establishment by experts for a test set is described. The literature review served as the basis for the expanded indication.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned as there was no test set requiring such a process.

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 device is a bone graft substitute, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader performance are irrelevant.

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

Not applicable. This device is a bone graft substitute, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" or evidence supporting the device's efficacy and safety (particularly for the expanded indication) was based on a literature review discussing the clinical use of calcium sulfate, calcium phosphate, and composites thereof as bone void fillers, as well as specific literature establishing the safety and effectiveness of PRO-DENSE® for benign bone cysts/tumors. This implicitly relies on clinical outcomes and expert observations reported in those publications.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device, so there is no training set in that context.

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

Not applicable. No training set, thus no ground truth for it.

Summary

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

<11387)
1/2

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR 2 5 2013

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of PRO-DENSE® Bone Graft Substitute.

Submitted By:	Wright Medical Technology, Inc.
Date:	March 15, 2013
Contact Person:	Samir Ibrahim, PhD, RACRegulatory Affairs Specialist II901-290-5909samir.ibrahim@wmt.com
Proprietary Name:	PRO-DENSE® Bone Graft Substitute
Common Name:	Bone Void Filler
Classification Name and Reference:	21 CFR 888.3045 - Resorbable CalciumSalt Bone Void Filler Device - Class II
Device Product Code and Panel Code:	Orthopedic/87/MQV
Predicate Device:	K070437 - PRO-DENSE® Bone Graft Substitute

DEVICE INFORMATION

A. INTENDED USE

PRO-DENSE® is provided sterile for single use only.

B. DEVICE DESCRIPTION

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

that is osteoconductive allowing tissue infiltration and must eventually be degraded through osteoclastic action as bone remodels within the scaffold. The clinical use of calcium sulfate, calcium phosphate, and composites thereof as a bone void filler has been well established through many peer reviewed publications.

C. MATERIALS

PRO-DENSE® is a calcium sulfate - calcium phosphate composite bone graft substitute consisting of a powder component and an aqueous mixing solution. When the two components are mixed according to directions, an injectable paste forms and subsequently hardens via hydration reactions. The benefits of this composite include:

. Calcium Sulfate
- Primary osteoconductive filler :
- Resorbs first primarily through simple dissolution to allow early vascular . infiltration
- . Excellent clinical history
Calcium Phosphate ●
- Osteoclastic resorption .
- I Secondary porous scaffold that is resorbed after primary filler
- 파 TCP granules are resorbed in the third and final phase

D. SUBSTANTIAL EQUIVALENCE INFORMATION

Technological Characteristics Comparison

The technical features of PRO-DENSE® in this submission remain identical to the predicate product cleared in K070437.

Non-Clinical Evidence

N/A

Clinical Evidence

A literature review was conducted to establish the safety and effectiveness of PRO-DENSE® for use in voids resulting from resected benign bone cysts/tumors in both adult and pediatric patients. This evidence was used to change the indications statement to include this patient population.

Conclusion

The design characteristics of the subject device are identical to the predicate device and do not raise any new types of questions of safety or effectiveness. A literature search was conducted to support the addition of adult/pediatric benign bone cysts/tumor to the indications statement. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate system(s).

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized emblem resembling an abstract eagle or bird-like figure with three curved lines forming its body and wings. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle.

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

March 25, 2013

Wright Medical Technology, Incorporated % Samir Ibrahim, Ph.D., RAC Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K113871

Trade/Device Name: PRO-DENSE® Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: March 18, 2013 Received: March 19, 2013

Dear Dr. Ibrahim:

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.

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

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

Page 2 - Samir Ibrahim, Ph.D., RAC

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/CDRH0ffices/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,

Erin Keith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number: K113871

Device Name:

PRO-DENSE® Bone Graft Substitute

Indications For Use:

PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the scheral system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous or oefers or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The PRO-DENSE® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support the carder healing process.

PRO-DENSE® is provided sterile for single use only.

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

Prescription Use V (Per21 CFR 801.109)

Over-The Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D: Coyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K113871

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.