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 a bone graft material. OSTEOSET® DBM Pellets combine the effects of DBM and OSTEOSET® Pellets. The DBM used in OSTEOSET® DBM Pellets is tested to confirm the osteoinductivity of each DBM lot.

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) summary for the OSTEOSET® DBM Pellets, a bone void filler. This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study demonstrating achievement of specific acceptance criteria in the way a new, high-risk device might.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative "acceptance criteria" for the OSTEOSET® DBM Pellets in terms of clinical performance (e.g., bone healing rates, reduction in pain). Instead, it describes performance related to the materials and manufacturing processes that support its substantial equivalence claim.

Acceptance Criteria (related to materials/processes)	Reported Device Performance
Purity/Composition	OSTEOSET® DBM Pellets combine DBM and OSTEOSET® Pellets (calcium sulfate).
Osteoinductivity Potential (of DBM component)	Each lot of DBM is assayed using: 1) in vitro assay (human bone forming cells) correlated to athymic rat model and clinical results. 2) in vitro assay for native protein (BMP-2) correlated to athymic rat model.
Viral Inactivation Potential (of DBM processing)	Processing method evaluated with a panel of model human viruses, showing "suitable viral inactivation potential".
Resorption Rate	Resorbed in approximately 30-60 days.

Important Note: The document explicitly states: "The osteoinductivity of this combination of DBM and calcium sulfate (OSTEOSET® Pellets) has not been established; therefore, it is unknown to what extent the formulation components may alter the osteoinductive character of the DBM. Additionally, it is unknown how osteoinductivity of the DBM component, measured via either in vitro assay, will correlate with human clinical performance of OSTEOSET® DBM Pellets." This highlights that the "performance" described is largely at the component/material level rather than full device clinical performance.

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

Test Set Sample Size: Not applicable in the context of device clinical performance testing. The "tests" mentioned are for raw material (DBM) and processing methods.
- For Osteoinductivity Potential Testing: The "test set" refers to each lot of DBM. The actual sample size of cells or rats used in these assays is not specified, but the methods refer to established models (in vitro human bone forming cells, athymic rat model).
- For Viral Inactivation Potential: A "panel of model potential human viruses" was used. The number of viruses in the panel is not specified.
Data Provenance: Not explicitly stated for all references.
- Reference 1 (Wilkins, 1999) on DBM effectiveness: likely retrospective analysis on human cell culture and athymic rat model correlations.
- Reference 2 (Lindholm TS, Urist MR, 1980) on bone formation analysis: an animal study (bone marrow and bone matrix grafts).
- Reference 3: "Data on file at Wright Medical Technology, Inc." (manufacturer's internal data), likely derived from laboratory testing of DBM batches.
Retrospective or Prospective: The viral inactivation and osteoinductivity assays are prospective tests performed on each batch of materials. The referenced studies that correlate these assays to clinical/animal outcomes could be retrospective analyses of existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as the submission does not detail human-read imaging or diagnostic performance where expert consensus would be required to establish ground truth. The "ground truth" for the osteoinductivity assays would be the biological response observed (e.g., bone formation in rats, cell differentiation), and for viral inactivation, it would be the reduction in viral titer. These are laboratory-based measurements, not expert interpretations.

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

Not applicable. There is no mention of adjudication, as this typically applies to image interpretation or clinical outcome assessment, which are not detailed in this 510(k) summary.

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 void filler, a physical implant. The submission does not involve AI or imaging interpretation, so MRMC studies are irrelevant.

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

Not applicable. The device is a physical product, not an algorithm.

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

For Osteoinductivity Potential: The "ground truth" for the assays is the correlation to the athymic rat model (a biological model for bone formation) and clinical results of DBM (outcomes data). The in vitro assays themselves are surrogates for this biological activity.
For Viral Inactivation Potential: The "ground truth" is the reduction in viral infectivity/titer directly measured in laboratory experiments with model viruses.

8. The sample size for the training set:

Not applicable. This summary does not describe an AI/machine learning device, so there is no concept of a "training set" in this context. The manufacturing processes and material testing are based on established scientific methods and assays, not iterative learning from data.

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

Not applicable. As there is no training set mentioned, this question is not relevant.

Summary

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JAN 2 6 2006

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 the OSTEOSET® DBM Pellets.

Submitted By:	Wright Medical Technology, Inc.
Date:	December 29, 2005
Contact Person:	Theresa Leister
	Regulatory Affairs Specialist
Proprietary Name:	OSTEOSET® DBM Pellets
Common Name:	Bone Void Filler
Classification Name and Reference:	888.3045 - Resorbable Calcium Salt Bone VoidFiller Device (Class II)
Device Product Code and Panel Code:	Orthopedics/87/MQV

DEVICE INFORMATION

A. INTENDED USE

B. DEVICE DESCRIPTION

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C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use and design features of OSTEOSET® DBM Pellets are identical to those of the predicate device. The fundamental scientific technology of the modified device has not changed relative to the predicate device. The safety and effectiveness of the OSTEOSET® DBM Pellets are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

Osteoinductivity Potential Testing

Each lot of demineralized bone matrix (DBM) incorporated into OSTEOSET® DBM Pellets is assayed using either of the following two test methods:

1. in vitro assay using human bone forming cells', which was correlated to the athymic rat model4 and clinical results of the assayed DBM'. OR
1. in vitro assay for a native protein (BMP-2) as a surrogate test marker for osteoinductive potential . Results from this immunoassay were correlated to the athymic rat model 3. Although only one native protein is used as the test marker, it is the combination of various proteins that is responsible for its osteoinductive potential.

Testing each lot of DBM with this cell-based bioassay (1) or immunoassay (2) assures that only DBM with osteoinductive potential is used in the OSTEOSET® DBM Pellets.

The osteoinductivity of this combination of DBM and calcium sulfate (OSTEOSET® Pellets) has not been established; therefore, it is unknown to what extent the formulation components may alter the osteoinductive character of the DBM. Additionally, it is unknown how osteoinductivity of the DBM component, measured via either in vitro assay, 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.

Wikins, R.M. (1999) Clinical Effectiveness of Demineralized Bone Matrix Assayed in Human Cell Culture Advances in Tissue l . Banking. 3:113-124.
This study correlated the results from the in vitro bioassay to results in the athymic rat model and clinical results of the DBM.
1. Lindholm TS, Urist MR. A quantiative analysis of new bone formation in compositive grafts of bone marrow and bone matrix. Clin Orthop 1980 Jul-Aug.(150):288-300
1. Data on file at Wright Medical Technology, Inc.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 2006

Ms. Theresa Leister Regulatory Affairs Specialist Wright Medical Technologies, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K053642

Trade/Device Name: OSTEOSET® DBM Pellets Regulation Number: 21 CFR 888.3045 Regulation Name: filler, bone void, osteoinduction (without human growth factor) Regulatory Class: Class II Product Code: MBP and MQV Dated: December 29, 2005 Received: December 30, 2005

Dear Ms. Leister:

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

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Page 2 - Theresa Leister

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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C. Mark N. Mollenkamp, M.S.

Mark N. Melkerson, M.S. 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

510(k) Number (if known): K053642

Device Name: OSTEOSET® DBM Pellets

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number (053642

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.