Vitoss BA Injectable 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 BA Injectable is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Vitoss BA Injectable is intended to be used for filling bony voids and gaps of the skeletal system (i.e. the extremities and pelvis), 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 the healing process.

Device Description

Vitoss BA Injectable bone graft substitute is a synthetic resorbable porous bone void filler for the repair of bony defects made from a combination of beta tricalcium phosphate and bioactive glass in a carrier of porcine gelatin and sodium carboxymethyl cellulose. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.

Vitoss BA Injectable is provided prepackaged in a syringe. At the time of use a specified volume of hydration fluid is combined with the dry component of the device. Mixing is facilitated by a syringe to syringe mixing system. The resulting material can be administered to the treatment site by injection through a cannula or by manual application. After injection or insertion into the defect site 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vitoss Bioactive (BA) Injectable device, formatted to address your questions.

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for novel acceptance criteria. Therefore, some information you're asking for (like multi-reader multi-case studies, detailed ground truth establishment for a training set, or effect sizes for human readers with AI assistance) is not applicable or detailed in this type of regulatory submission because the device is a bone void filler, not an AI diagnostic tool.

Device: Vitoss Bioactive (BA) Injectable
Device Type: Resorbable Calcium Salt Bone Void Filler

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states that a "risk analysis was performed to demonstrate that Vitoss BA Injectable is substantially equivalent to its predicate devices." The acceptance criteria are broadly defined by the "predefined acceptance criteria" being met for several types of testing. The performance is summarized as demonstrating substantial equivalence to the predicate devices.

Acceptance Criteria Category	Reported Device Performance
Comparative Animal Performance	Met predefined acceptance criteria; demonstrated substantial equivalence to predicate.
Bioactivity Testing (in-vitro)	Met predefined acceptance criteria; exhibited calcium phosphate growth on the surface in simulated body fluid (phenomenon not observed in control samples without bioactive glass component). Note: Bioactivity not evaluated in human clinical trials.
Permeability Testing	Met predefined acceptance criteria.
Irrigation Testing	Met predefined acceptance criteria.
Usability Testing	Met predefined acceptance criteria.
Extrusion Testing	Met predefined acceptance criteria.
Packaging and Shelf Life Validations	Met predefined acceptance criteria.
Sterilization Validation	Met predefined acceptance criteria.
Biocompatibility	Met predefined acceptance criteria.

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

Sample Size: Not explicitly stated for each test in terms of number of subjects, samples, or tests performed. The document broadly refers to "comparative animal performance testing in a rabbit model" but does not give the number of rabbits or the specific endpoints measured.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified. Animal performance testing would be prospective in nature. In-vitro testing is laboratory-based.

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

Given this is a medical device for bone void filling, and not an AI diagnostic system evaluating images, the concept of "experts establishing ground truth for a test set" in the context of human interpretation (like radiologists for an imaging AI) does not directly apply here.

The "ground truth" for this device would be established through:

In-vitro testing standards: Laboratory tests demonstrating material properties, bioactivity, permeability, etc.
Animal model outcomes: Histological analysis, imaging, and mechanical testing of bone formation and resorption in the rabbit model, interpreted by researchers/pathologists specializing in bone healing.

The number and specific qualifications of the experts or analysts who conducted these evaluations are not detailed in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and the types of tests described. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in human-AI diagnostic studies, where there's potential for inter-reader variability in interpreting complex data. Performance testing for a bone void filler involves objective measurements (e.g., mechanical properties, biological response under controlled conditions).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks (e.g., radiology interpretation). This device is a bone void filler, not a diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

This question is not applicable. The device is a physical medical implant, not an algorithm. Its performance is inherent to its physical and biological properties.

7. The Type of Ground Truth Used

The "ground truth" in this context is established through a combination of:

Objective Laboratory Measurements: For physical properties (permeability, extrusion, packaging, sterilization).
Biological Response in Animal Models: For comparative animal performance (e.g., histological evidence of bone ingrowth, resorption, and integration). This would involve standard pathological evaluation techniques.
In-Vitro Bioactivity Assays: Chemical and structural analysis demonstrating calcium phosphate growth.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a "training set." The testing described (animal studies, in-vitro tests) is for validation of the device's performance against predefined criteria and comparison to predicate devices, not for training a model.

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

Not applicable, as there is no "training set" for this physical device.

Summary

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

May 2, 2017

Orthovita, Inc. % John Rossman Regulatory Affairs Project Manager Stryker Corporation Stryker Spine 59 Route 17 South Allendale, New Jersey 07401

Re: K163621

Trade/Device Name: Vitoss Bioactive (BA) Injectable Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: March 13, 2017 Received: March 17, 2017

Dear Mr. Rossman:

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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K163621

Device Name Vitoss Bioactive (BA) Injectable

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary:	Vitoss BA Injectable Bone Graft Substitute
Submitter:	Stryker Orthobiologics74 East Swedesford RoadMalvern, PA 19355
Contact Person :	Name: John RossmanPhone: (201) 749-8193Fax: (201) 831-3000Email: john.rossman@stryker.com
Date Prepared:	04/24/2017
Trade Name:	Vitoss Bioactive (BA) Injectable
Common Name:	Resorbable calcium salt bone void filler device
Proposed Class:	Class II
Classification Name:	Filler, Bone Void, Calcium Compound (21 CFR 888.3045)Syringe, Piston (21 CFR 880.5860)
Product Code:	MQVFMF
Predicate Devices:	Primary Predicate:Vitoss BA Foam Pack (K081439)Additional Predicates:Vitoss BA BiModal (K103173)NanOss Bioactive Loaded (K141600)Carricell (K132868)
Device Description:	Vitoss BA Injectable bone graft substitute is a synthetic resorbable porousbone void filler for the repair of bony defects made from a combination ofbeta tricalcium phosphate and bioactive glass in a carrier of porcine gelatinand sodium carboxymethyl cellulose. It is an osteoconductive porous implantwith a trabecular structure that resembles the multidirectionalinterconnected porosity of human cancellous bone.Vitoss BA Injectable is provided prepackaged in a syringe. At the time of use aspecified volume of hydration fluid is combined with the dry component ofthe device. Mixing is facilitated by a syringe to syringe mixing system. Theresulting material can be administered to the treatment site by injectionthrough a cannula or by manual application. After injection or insertion intothe defect site new bone grows in apposition to the surfaces of the implant. Asthe implant resorbs, bone and other connective tissues grow into the spacepreviously occupied by the scaffold.
510(k) Summary: Vitoss BA Injectable Bone Graft Substitute
Intended Use:	Vitoss BA Injectable is intended for use as a bone void filler for voids or gapsthat are not intrinsic to the stability of the bony structure. Vitoss BAInjectable is indicated for use in the treatment of surgically created osseousdefects or osseous defects created from traumatic injury to the bone.Vitoss BA Injectable is intended to be used for filling bony voids and gaps ofthe skeletal system (i.e. the extremities and pelvis), and may be combinedwith saline, autogenous blood, and/or bone marrow. Following placement inthe bony void or gap, the scaffold resorbs and is replaced with bone duringthe healing process.
Summary of theTechnologicalCharacteristics	Vitoss BA Injectable was shown to be substantially equivalent and hasequivalent technological characteristics to its predicate devices throughcomparison in areas including intended use, material composition,principles of operation and design.
Summary of thePerformance Data	Risk analysis was performed to demonstrate that Vitoss BA Injectable issubstantially equivalent to its predicate devices. The risk analysisdetermined that the predefined acceptance criteria was met for the following:• Comparative animal performance testing in a rabbit model• Bioactivity testing included in-vitro studies in which calcium phosphategrowth was induced on the surface of Vitoss Bioactive Injectable in thepresence of simulated body fluid. This phenomenon was not observed incontrol samples in which there was no bioactive glass component. Thebioactivity has not been evaluated in human clinical trials.• Permeability testing• Irrigation testing• Usability testing• Extrusion testing• Packaging and shelf life validations• Sterilization validation• Biocompatibility
Conclusion	The proposed Vitoss BA Injectable has equivalent indications, technologicalcharacteristics, and principles of operation as its predicates. The riskanalysis performed demonstrates that any minor differences do not impactdevice performance as compared to the predicates. The design verificationsand validations performed as a result of the risk analysis and presented in thesubmission demonstrate the proposed device does not raise new questions ofsafety or effectiveness. Thus, the aforementioned predicate devices andsubject device are considered substantially equivalent.

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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.