Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss BiModal Foam Strip is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Vitoss BiModal Foam Strip is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during process.

Device Description

Vitoss BiModal Foam Strip is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 to 1000 um.

Vitoss BiModal Foam Strip guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss BiModal Foam Strip is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

AI/ML Overview

This document is a 510(k) Summary for the Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip. It describes the device, its intended use, and demonstrates its substantial equivalence to predicate devices. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. The "Summary of the Performance Data" section lists various verification tests but does not provide quantitative acceptance criteria or detailed results of those tests.

Therefore, much of the requested information cannot be extracted from this document alone.

Here's what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Wettability and Fluid Retention Verification	Predefined acceptance criteria was met
Porosity Verification	Predefined acceptance criteria was met
Bioactivity Verification	Predefined acceptance criteria was met
Clinical Handling Verification	Predefined acceptance criteria was met
Product Stability throughout shelf-life	Predefined acceptance criteria was met
Biocompatibility	Predefined acceptance criteria was met
Design Validation	Predefined acceptance criteria was met

Note: The document states "the predefined acceptance criteria was met" for each, but does not specify what those criteria were (e.g., " Wettability > X %," "Porosity within Y-Z range"). It also does not provide the quantitative results (e.g., "Wettability = 95%").

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

This information is not provided in the document. The document refers to "risk analysis" and "design verifications and validations" but does not detail the methodology, sample sizes, or data provenance for these tests.

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 in the document. The document refers to "verifications" and "validations" but does not mention expert involvement in establishing ground truth. This is likely a submission for a medical device that does not involve imaging or diagnostic accuracy studies where expert ground truth is typically assigned.

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

This information is not provided in the document.

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:

This information is not applicable/provided in the document. This device is a bone graft substitute, not an AI diagnostic tool.

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

This information is not applicable/provided in the document. This device is a physical bone graft substitute, not an algorithm.

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

The "ground truth" for this type of device would generally be established through various engineering, biocompatibility, and animal (if applicable) studies that confirm the device materials and performance meet established standards and benchmarks. The document mentions "Design Validation," "Biocompatibility," "Wettability," "Porosity," and "Bioactivity Verification." These would each have their own associated methods for establishing "truth" or meeting specifications, often through laboratory testing, not human consensus on diagnostic images. The specific type of "ground truth" used for each verification is not detailed in this summary.

8. The sample size for the training set:

This information is not applicable/provided in the document. As a physical medical device, there is no "training set" in the context of machine learning.

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

This information is not applicable/provided in the document.

Summary

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

February 12, 2016

Orthovita, Incorporated Ms. Meriam Gabera Senior Regulatory Affairs Specialist 59 Route 17 South Allendale, New Jersey 07401

Re: K153608

Trade/Device Name: Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 21, 2016 Received: January 22, 2016

Dear Ms. Gabera:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K153608

Device Name

Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

510(k) Summary: Vitoss BiModal Foam Strip
Submitter:	Stryker Orthobiologics
	74 East Swedesford Road
	Malvern, PA 19355
Contact Person	Meriam Gabera
	Senior Regulatory Affairs Specialist
	Phone: 201-749-8043
	Fax: 201-831-3000
	Email: Meriam.Gabera@Stryker.com
Date Prepared	December 16, 2015
Trade Name	Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip
Common Name	Resorbable calcium salt bone void filler device
Proposed Class	Class II
Classification Nameand Number	Filler, Bone Void, Calcium Compound
	888.3045
Product Code	MQV
Predicate Devices	Primary PredicateSecondary Predicate
	Vitoss BA Foam Strip (K072184)Vitoss BiModal Foam Pack (K103173)
Device Description	Vitoss BiModal Foam Strip is a resorbable porous bone void filler for therepair of bony defects. It is an osteoconductive, porous implant with atrabecular structure that resembles the multidirectional interconnectedporosity of human cancellous bone. Pore diameters in the scaffold rangefrom 1 to 1000 um.
	Vitoss BiModal Foam Strip guides the three-dimensional regeneration ofbone in the defect site into which it is implanted. When Vitoss BiModalFoam Strip is placed in direct contact with host bone, new bone grows inapposition to the surfaces of the implant. As the implant resorbs, bone andother connective tissues grow into the space previously occupied by thescaffold.
Intended Use	Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip is intended foruse as a bone void filler for voids or gaps that are not intrinsic to thestability of the bony structure. Vitoss BiModal Foam Strip is indicated foruse in the treatment of surgically created osseous defects or osseous defectscreated from traumatic injury to the bone.
510(k) Summary: Vitoss BiModal Foam Strip
	Vitoss BiModal Foam Strip is intended to be used for filling bony voids orgaps of the skeletal system (i.e., the extremities, pelvis and posterolateralspine) and may be combined with saline, autogenous blood, and/or bonemarrow. Following placement in the bony void or gap, the scaffold resorbsand is replaced with bone during the healing process.
Summary of theTechnologicalCharacteristics	As established in this submission, Vitoss BiModal Foam Strip was shownto be substantially equivalent and has equivalent technologicalcharacteristics to its predicate device through comparison in areasincluding intended use, material composition, principles of operation anddesign.
Summary of thePerformance Data	Risk analysis was performed to demonstrate that Vitoss BiModal FoamStrip is substantially equivalent to its predicate devices. The risk analysisdetermined that the predefined acceptance criteria was met for thefollowing:• Wettability and Fluid Retention Verification• Porosity Verification• Bioactivity Verification• Clinical Handling Verification• Product Stability throughout shelf-life• Biocompatibility• Design Validation
Conclusion	The proposed Vitoss BiModal Foam Strip has identical indications,technological characteristics, and principles of operation as its predicates.The risk analysis performed demonstrates that any minor differences do notimpact device performance as compared to the predicates. The designverifications and validations performed as a result of the risk analysis andpresented herein demonstrate the proposed device does not raise newquestions of safety or effectiveness. Thus, the predicate devices (K072184and K103173) and proposed device are considered substantially equivalent.

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K153608

Vitoss BiModal Foam Strip

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.