BonePlast® QS Bone Void Filler is indicated to be injected into open voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BonePlast® QS Bone Void Filler is indicated only for bone voids or gaps that are not intrinsic to the bone structure (i.e., the extremities, spine and pelvis). The device is limited to be used in posterolateral spinal fusion procedures only.

Device Description

BonePlast OS Bone void filler is a sterile calcium suffate powder, which is supplied dry. When mixed with sterile setting solution intra-operatively, it becomes an injectable filling material for use in non-load bearing procedures. The filler is biogradable and resorbs in approximately eight to twelve weeks, depending on the defect size, based on animal studies.

AI/ML Overview

The provided text is a 510(k) Summary for the BonePlast® QS Calcium Sulfate Bone Void Filler. This document focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices rather than establishing novel acceptance criteria or conducting a study to prove meeting said criteria for a new device's performance.

Therefore, many of the requested categories related to performance studies, ground truth, and expert evaluation are not applicable in this context. The 510(k) process for this device relies on non-clinical testing and comparison to predicates, not on clinical performance studies.

Here's the breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance (BonePlast® QS)
Material Composition	Similar/identical to predicate devices.	Identical in chemistry and formulation to the predicate device Calcigen™ S Bone Void Filler (K013790).
Design/Sizes	Similar/identical to predicate devices.	Similar to or identical to that of the predicate devices.
Indications for Use	Substantially equivalent to predicate devices.	"BonePlast® QS is indicated to be injected into open voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BonePlast® QS Bone Void Filler is indicated only for bone voids or gaps that are not intrinsic to the stability of the bone structure (i.e., the extremities, spine, and pelvis). The device is limited to be used in posterolateral spinal fusion procedures only." - This is deemed substantially equivalent to the predicate devices' indications.
Sterility	Sterile.	Supplied sterile.
Injectability	Injectable when mixed intra-operatively.	Becomes an injectable filling material when mixed with sterile setting solution intra-operatively.
Biodegradability	Biodegradable and resorbable.	Biodegradable and resorbs in approximately eight to twelve weeks, depending on the defect size, based on animal studies.
Functionality	Functional within its intended use.	Non-clinical laboratory testing performed to determine substantial equivalence indicated that the device was functional within its intended use.

"Study that proves the device meets the acceptance criteria":

The "study" in this context is a non-clinical laboratory testing to demonstrate substantial equivalence to legally marketed predicate devices, specifically:

Calcigen™ S Bone Void Filler K013790
MIIG III K024336

The overarching acceptance criterion for this 510(k) submission is that the BonePlast® QS Calcium Sulfate Bone Void Filler is substantially equivalent to these predicate devices in terms of technological characteristics (materials, design, sizes, and indications for use).

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 human clinical "test set" in the traditional sense was used to evaluate performance against specific criteria, as this was a 510(k) submission based on substantial equivalence and non-clinical testing.
Data Provenance: Not specified, but likely from internal laboratory testing given it's "non-clinical laboratory testing."

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

Not applicable. No ground truth for a "test set" was established by experts for performance evaluation; the assessment relied on technical specifications and comparison to predicates.

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

Not applicable. No adjudication method for a clinical test set was employed.

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 and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

The "ground truth" for this submission is the established performance and safety of the legally marketed predicate devices. Substantial equivalence is demonstrated by showing the new device is as safe and effective as the predicates, primarily through material composition, design, and non-clinical functionality assessments. Biodegradability was based on animal studies.

8. The sample size for the training set

Not applicable. No "training set" in the machine learning sense was used or described.

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

Not applicable. No "training set" or establishment of ground truth for such a set occurred.

Summary

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K070864

JUN - 1 2007

510(K) SUMMARY

BonePlast® QS Calcium Sulfate Bone Void Filler

Preparation Date:	May 16, 2007
Applicant/Sponsor:	Biomet Osteobiologics100 Interpace ParkwayParsippany, NJ 07054Establishment Registration Number: 1450662
Contact Person:	Debra BingDirector of Regulatory Affairs
Proprietary Name:	BonePlast® QS Calcium Sulfate Bone Void Filler
Common Name:	Injectable Bone Void Filler
Classification Name:	Filler, Bone Void, Calcium Compound (MQV/888.3045)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Calcigen™ S Bone Void Filler K013790, June 11, 2002 (Biomet Orthopedics, Inc., Warsaw, IN)
MIIG III K024336, March 04, 2003 (Wright Medical Technology, Inc., Arlington, TN)

Device Description: BonePlast OS Bone void filler is a sterile calcium suffate powder, which is supplied dry. When mixed with sterile setting solution intra-operatively, it becomes an injectable filling material for use in non-load bearing procedures. The filler is biogradable and resorbs in approximately eight to twelve weeks, depending on the defect size, based on animal studies.

Intended Use: BonePlast® QS is indicated to be injected into open voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BonePlast® QS Bone Void Filler is indicated only for bone voids or gaps that are not intrinsic to the stability of the bone structure (i.e., the extremities, spine, and pelvis). The device is limited to be used in posterolateral spinal fusion procedures only.

Summary of Technological The technological characteristics (materials, design sizes, and indications) are similar to or identical to that of the predicate devices to which substantial equivalence is claimed. The product is also identical in chemistry and formulation to the predicate device Calcigen™ S Bone Void Filler ( K013790).

Non-Clinical Testing: The information presented demonstrates that the BonePlast® OS Calcium Sulfate Bone Void Filler is substantially equivalent to currently marketed predicate devices. Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

Pg 1 of 1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Osteobiologics % Palaniswamy Vijay, MPH, Ph.D. Manager, Applied Regulatory Technology Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587

JUN - 1 2007

Re: K070864

Trade/Device Name: BonePlast® QS Calcium Sulfate Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: MQV Dated: May 16, 2007 Received: May 17, 2007

Dear Mr. Vijay:

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 - Mr. Palaniswamy Vijay

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 toll-free number (800) 638-2041 or (240) 276-3150 or on the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Melheisen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DIGEST

INDICATIONS FOR USE

510(k) Number (if known): K070864

Device Name: BonePlast® QS Calcium Sulfate Bone Void Filler

Indications for Use:

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

Over-The-Counter Use_ NO . (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)

Mark N. Milkerson

(Division Sign-C (Division Sign-Chi)
Division of General, Restorative,

510(k) Number

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.