K Number

Device Name

Manufacturer

WRIGHT MEDICAL TECHNOLOGY, INC.

Date Cleared

2004-04-02

(585 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

OSTEOSET® DBM Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. OSTEOSET® DBM Pellets are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Device Description

OSTEOSET® DBM Pellets are made of surgical grade calcium sulfate incorporating Human Demineralized Bone Matrix (DBM) and stearic acid as a tableting aid. OSTEOSET® DBM Pellets are provided as preformed 3.0 mm or 4.8 mm pellets. The biodegradable, radiopaque pellets are used to fill bone voids and are resorbed in approximately 30-60 days when used according to labeling. This product is supplied sterile for single patient use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called OSTEOSET® DBM Pellets. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical efficacy trial with specific acceptance criteria as might be seen for novel drug or high-risk device approvals.

Therefore, the concept of "acceptance criteria" in the context of this 510(k) is primarily tied to demonstrating that the new device performs similarly to the predicate device, not necessarily against pre-defined numerical thresholds for a specific clinical outcome. The study described focuses on establishing this equivalence.

Here's an analysis based on the information provided, addressing your points where possible:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate device. The study's "performance" is the lack of difference when compared to the predicate in relevant metrics.

Acceptance Criterion (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance
Material Composition and Design	OSTEOSET® DBM Pellets are made of surgical grade calcium sulfate incorporating Human Demineralized Bone Matrix (DBM) and stearic acid as a tableting aid, provided as preformed 3.0 mm or 4.8 mm pellets. This is presented as substantially equivalent in materials and mode of action to the predicate device.
Biocompatibility/Safety	The DBM processing method underwent viral inactivation potential testing against a panel of model human viruses, demonstrating "suitable viral inactivation potential." The overall safety is supported by substantial equivalence to the predicate.
Resorption Characteristics	Anticipated to be resorbed in approximately 30-60 days. This characteristic is implied to be similar or acceptable compared to the predicate, though direct comparative data on resorption rate isn't explicitly detailed, it contributed to the overall equivalence assessment.
Radiopacity	The pellets are described as radiopaque, which is a design feature for clinical visualization.
Functional Performance (e.g., bone formation, mechanical)	"There was no difference in radiographic, mechanical, histological and quantification of new bone formation at the end of the study" when compared to the predicate device in a canine model. This is the primary 'performance' metric reported and serves as the confirmation of equivalence. The DBM component's osteoinductivity was assayed in vitro, showing a correlation (coefficient 0.850, p<0.0005) with in vivo rat muscle implantation and correlation to human healing (92% vs 33% with >0.20 and ≤0.20 osteoinductivity index).

Study Information

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The primary performance testing was conducted in a canine model. The specific number of animals is not provided in the summary.
- Data Provenance: Animal model (canine), prospective study design (comparing the new device to a predicate). The in-vitro DBM osteoinductivity bioassay and athymic rat model data are also mentioned, along with human clinical correlation data from prior studies (presumably retrospective, as they are used to validate the bioassay's predictive power for DBM generally, not directly for this specific device).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the use of human experts or ground truth establishment in the traditional sense for the animal model study. Performance was evaluated via "radiographic, mechanical, histological and quantification of new bone formation." These are objective measurements typically conducted by trained laboratory personnel or pathology specialists, rather than clinical experts providing a subjective "ground truth."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / None specified. The animal study relied on objective measurements rather than subjective assessments requiring adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or decision-support tools where human reader performance is a key outcome. The OSTEOSET® DBM Pellets are a bone void filler, not an imaging or AI diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is not applicable. The device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the canine model, the "ground truth" for performance was based on objective measures: radiographic imaging, mechanical testing, histological analysis, and quantitative assessment of new bone formation. These are direct biological and physical measurements, rather than human expert interpretation or consensus.
- For the DBM osteoinductivity, the in-vitro bioassay was correlated with in-vivo bone formation in an athymic rat muscle model (pathology) and prior human clinical healing rates (outcomes data) from different studies to demonstrate its predictive power for the DBM component generally.
The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The DBM bioassay mentions having been correlated with past studies, which could be considered historical data sets, but there's no "training set" in the context of the device itself.
How the ground truth for the training set was established:
- Not applicable. As the device is not an AI/ML algorithm, there is no training set or associated ground truth establishment for a training set. The bioassay's predictive power was established by correlating its results with in vivo new bone formation in rats and human clinical healing rates from previously published work.

Summary

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K'022828

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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 OSTEOSET® DBM Pellets.

Submitted By:	Wright Medical Technology, Inc.
Date:	February 16, 2004
Contact Person:	Roger D. BrownSr. Director, Clinical and Regulatory Affairs
Proprietary Name:	OSTEOSET® DBM Pellets
Common Name:	Bone Void Filler
Classification Name and Reference:	Filler, Calcium Sulfate Preformed Pellets - Class II888.3045
Device Product Code and Panel Code:	Orthopedics/MOV

DEVICE INFORMATION

A. INTENDED USE

B. DEVICE DESCRIPTION

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, materials, and mode of action of OSTEOSET® DBM Pellets are substantially equivalent to the predicate device. The safety and effectiveness of OSTEOSET® DBM Pellets is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.

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DBM Osteoinductivity Potential Testing

The DBM incorporated into OSTEOSET® DBM Pellets is assayed in vitro for its osteoinductive potential. The bioassay measures the proliferation of Saos human osteosarcoma cells in the presence of human DBM compared to positive and negative controls (osteoinductivity index). Results from the bioassay were correlated with results from implantation of DBM into athymic rat muscle2, which demonstrated a correlation coefficient of 0.850 (p<0.0005)' and accurately predicted the in vivo osteoinductivity of 99 of 101 donor lots. Additionally, clinical results using DBM with >0.20 and ≤0.20 demonstrated a significant difference in healing as evaluated by radiography, 92% and 33% healing, respectively.3

Adkisson HD. Strauss-Schoonberger J. Gillis M. Wilkins R. Jackson M. and Hruska KA. Rapid Quantitative 1 Bioassay of Osteoinduction, J Ortho Res, 2000, 18:503-511.
2 Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in composite grafts of bone marrow and bone matrix, Clin Orthop 1980 Jul-Aug (150):288-300.
3 Wilkins RM, Clinical Effectiveness of Denineralized Bone Matrix Assayed in Human Cell Culture, Advances in Tissue Banking. 1999 3:113-124

The osteoinductivity of the OSTEOSET® DBM Pellets has not been established and it is unknown how osteoinductivity of the DBM component, measured via the in vitro bioassay, will correlate with human clinical performance of Osteoset DBM Pellets.

Viral Inactivation Potential

The method for processing the DBM contained in OSTEOSET® DBM Pellets 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 viral inactivation testing demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses.

Product Performance Testing

Performance of OSTEOSET® DBM Pellets was compared to the predicate device in a canine model by radiographic, mechanical, histological and quantification of new bone formation. There was no difference in radiographic, mechanical, histological and quantification of new bone formation at the end of the study.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2004

Roger D. Brown Director, Regulatory Affairs Wright Medical Technology 5677 Airline Road Arlington, Tennessee 38002

Re: K022828 Trade Name: OSTEOSET DBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: January 6, 2004 Received: January 7, 2004

Dear Mr. Brown:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 madc 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

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Page 2 - Mr. Roger D. Brown

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.

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

/ Mark H. Milliken

Celia M. Witten, Ph.D. M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS STATEMENT

510(K) Number (if known): K022828

OSTEOSET® DBM Pellets Device Name: ______________

Indications for Use:

Prescription Use X (Per21 CFR 801.109) OR

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)

Mark N Milburn

ral. Restorative, and Neurological Devices

510(k) Number K02

Page 1 of 1

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.