HEALOS® FX Bone Graft Substitute ("HEALOS FX"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS® FX is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.

The HEALOS® FX Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® FX to a surgical site.

Device Description

HEALOS® FX Bone Graft Substitute:

HEALOS® FX Bone Graft Substitute ("HEALOS® FX"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. The principal components of the HEALOS FX Bone Graft Substitute are Type I bovine collagen and hydroxyapatite that are resorbed and remodeled into new bone as part of the natural healing that are

HEALOS® FX Graft Mixing and Delivery System:

The HEALOS® FX Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® FX to a surgical site.

AI/ML Overview

Acceptance Criteria and Study Details for HEALOS® FX Bone Graft Substitute and HEALOS® FX Graft Mixing and Delivery System

This submission pertains to the HEALOS® FX Bone Graft Substitute and its associated Graft Mixing and Delivery System. The provided documentation primarily focuses on establishing substantial equivalence to predicate devices rather than detailing specific acceptance criteria and a standalone performance study with quantifiable metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided documents, specific acceptance criteria with quantifiable metrics for the HEALOS® FX Bone Graft Substitute and the HEALOS® FX Graft Mixing and Delivery System are not explicitly stated. The submission relies on demonstrating substantial equivalence to existing predicate devices.

Feature/Aspect	Acceptance Criteria	Reported Device Performance
HEALOS® FX Bone Graft Substitute	(Not explicitly stated as quantifiable metrics. Implied: Safety and effectiveness comparable to predicate devices.)	"A performance evaluation has been included to support the safety and effectiveness of HEALOS®FX compared to the predicate devices." (Details of this evaluation are not provided in the summary.)
HEALOS® FX Graft Mixing and Delivery System	(Not explicitly stated as quantifiable metrics. Implied: Equivalence in design, principles of operation, indications, and intended use as predicate devices.)	"The substantial equivalence of the HEALOS® FX Graft Mixing and Delivery System to the predicate devices (Symphony Graft Delivery System (K003286), Harvest Graft Delivery System (K043261), and Imbibe II Syringe (K030208) is based upon equivalence in design, principles of operation, indications and intended use."

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

The provided 510(k) summary does not specify a sample size or data provenance for a distinct "test set" in the context of acceptance criteria. The performance evaluation mentioned for the HEALOS® FX Bone Graft Substitute likely refers to pre-clinical testing or comparative analysis with predicate device data, the details of which are not included in this summary.

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

This information is not provided in the 510(k) summary. The submission focuses on substantial equivalence based on in vitro or in vivo studies (details not provided) rather than expert-derived ground truth on a specific test set.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the absence of a clearly defined "test set" and expert ground truth establishment, an adjudication method would not be applicable in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, as this device is a bone graft substitute and delivery system, not an AI or imaging diagnostic device where human reader performance would be a primary metric. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study for an algorithm was not conducted, as this device is a physical medical device (bone graft substitute and delivery system), not a software algorithm.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used for the performance evaluation of the HEALOS® FX Bone Graft Substitute. Given its nature as a bone graft material, it is likely that performance was evaluated through in vitro biocompatibility tests, mechanical property assessments, and in vivo animal studies or clinical observations comparing bone regeneration and remodeling, which would eventually rely on histological analysis (pathology) or imaging (outcomes data) in the context of bone healing. However, these specifics are not detailed in the summary.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical medical device and not an AI or machine learning model that requires a training set.

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

This information is not applicable as the device is a physical medical device and not an AI or machine learning model that requires a training set.

Summary of Device Performance Evaluation from the Document:

HEALOS® FX Bone Graft Substitute: "A performance evaluation has been included to support the safety and effectiveness of HEALOS®FX compared to the predicate devices." (Detailed results of this evaluation are not provided in the 510(k) summary).
HEALOS® FX Graft Mixing and Delivery System: "No performance standards have been established for this type of device. The substantial equivalence... is based upon equivalence in design, principles of operation, indications and intended use."

Summary

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K062495 Pg1/2

XI. 510(k) Summary

SUBMITTER:	DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02780Tel: 508-828-3537Fax: 508-828-3711	OCT 13 2006
CONTACT PERSON:	Melanie Archer
DATE PREPARED:	August 23, 2006
CLASSIFICATION NAME:	Resorbable calcium salt bone void fillerPiston Syringe
PROPRIETARY NAME:	HEALOS® FX Bone Graft SubstituteHEALOS® FX Graft Mixing and Delivery System
PREDICATE DEVICES:	HEALOS® Bone Graft Substitute (K012751 and K043308)Vitoss® Scaffold Foam Bone Graft Material (K032288)Symphony® Graft Delivery System (K003286)Harvest® Graft Delivery System (K043261)Imbibe® II Syringe (K030208)

DEVICE DESCRIPTION:

HEALOS® FX Bone Graft Substitute:

HEALOS® FX Graft Mixing and Delivery System:

The HEALOS® FX Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® FX to a surgical site.

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Ko6245 1/2

INTENDED USE:

HEALOS® FX Bone Graft Substitute:

HEALOS® FX Bone Graft Substitute ("HEALOS FX"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS®FX is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.
HEALOS® FX Graft Mixing and Delivery System Indications for Use: The HEALOS® FX Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® FX to a surgical site.

MATERIALS:

HEALOS® FX Bone Graft Substitute: Calcium salt with Type I bovine collagen.

HEALOS® FX Graft Mixing and Delivery System: Makrolon Rx2530-1118, Cycolac ABS MG47MD, EPDM, Loctite cyanoacrylate, polyethylene, acrylic copolymer.

PERFORMANCE

DATA:

HEALOS® FX Bone Graft Substitute:

A performance evaluation has been included to support the safety and effectiveness of HEALOS®FX compared to the predicate devices.

HEALOS® FX Graft Mixing and Delivery System:

No performance standards have been established for this type of device. The substantial equivalence of the HEALOS® FX Graft Mixing and Delivery System to the predicate devices (Symphony Graft Delivery System (K003286), Harvest Graft Delivery System (K043261), and Imbibe II Syringe (K030208) is based upon equivalence in design, principles of operation, indications and intended use.

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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 stylized eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 2006

DePuy Spine, Inc % Ms. Melanie Archer Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K062495

Trade/Device Name: HEALOS® FX Bone Graft Substitute, HEALOS® Graft Mixing and Deliver Systems Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, FMF Dated: August 23, 2006 Received: August 25, 2006

Dear Ms. Archer:

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, and 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 – Ms. Melanie Archer

This letter will allow you to begin marketing your device as described in your Section 510(k) I mb lotter will and hyb your e 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

For

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

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Indications for Use IV.

KO62495 510(k) Number (if known):

HEALOS® FX Bone Graft Substitute Device Name: HEALOS® FX Graft Mixing and Delivery System

HEALOS® FX Bone Graft Substitute Indications For Use:

HEALOS® FX Graft Mixing and Delivery System Indications for Use:

The HEALOS® FX Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® FX to a surgical site.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

14062493 510(k) Number

DePuy Spine, Inc.

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.