Vitoss BA Bimodal Bioactive Bone Graft Substitute 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 Bimodal is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Vitoss BA Bimodal Bioactive Bone Graft Substitute 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 the healing process.

Device Description

Vitoss BA Bimodal Bioactive Bone Graft Substitute 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. The implant is >70% porous and the pore diameters range from 1 um to 1000 um.

Vitoss BA Bimodal Bioactive Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss BA Bimodal Bioactive Bone Graft Substitute 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

The provided text describes the 510(k) summary for Vitoss™ BA Bimodal Bioactive Bone Graft Substitute, a Class II medical device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific performance acceptance criteria for a new type of device.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical acceptance criteria for clinical performance that would typically be seen in a de novo device study (e.g., sensitivity, specificity, accuracy for an AI device). Instead, the performance demonstrated is against established standards for general medical grade materials and through comparative testing to a predicate device.

Performance Attribute	Acceptance Criteria (Implied)	Reported Device Performance
Material Composition	Satisfy ASTM F 1088-04a (Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation)	Vitoss BA Bimodal is a medical grade beta-tricalcium phosphate which satisfies the requirements of ASTM F 1088-04a.
Biocompatibility	Established in accordance with ISO 10993-1, Biological evaluation of medical devices -Part 1: Evaluation and testing	Data supplied demonstrate that Vitoss BA Bimodal Bioactive Bone Graft Substitute is substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness. (Implies meeting biocompatibility as per predicate)
Physical/Chemical Properties	Comparable to predicate device (Vitoss Bioactive Foam Pack and NovaBone AR)	Comparative testing included wettability, fluid retention, wash away resistance, homogeneity, radiopacity, bioactivity, dissolution, and SEM comparisons. XRD, FTIR ICP and porosity were evaluated for the predicate device.
Substantial Equivalence	"Same intended uses and indications, technological characteristics, and principles of operation as its predicate device."	Vitoss BA Bimodal Bioactive Bone Graft Substitute has the same intended uses and indications, technological characteristics, and principles of operation as its predicate device. Minor differences raise no new issues of safety or effectiveness.

2. Sample Size and Data Provenance for Test Set (Clinical/Performance Data)

The submission does not describe a standalone test set with human subject data used to evaluate specific clinical performance metrics. The performance data presented are primarily technical and material characterization tests.
The "comparative testing" mentioned (wettability, fluid retention, etc.) was likely conducted in a laboratory setting on samples of the device and its predicate, not on a human test set. Therefore, there is no information on data provenance (country of origin, retrospective/prospective) in the context of a clinical test set.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

Not applicable. The submission does not detail a study involving expert assessment of a test set for ground truth establishment. The ground truth for material properties is based on accepted scientific standards and laboratory measurements.

4. Adjudication Method (Test Set)

Not applicable. No expert adjudication method is described as there is no human-evaluated test set for performance metrics.

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

No MRMC comparative effectiveness study is mentioned. This type of study is more common for diagnostic imaging AI devices, where the goal is to assess improvement in human reader performance with AI assistance. The Vitoss BA Bimodal device is a bone graft substitute, not a diagnostic AI tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a material implant, not an algorithm. Therefore, there is no "standalone performance" in the context of an AI algorithm. Its performance is inherent to its physical and chemical properties.

7. Type of Ground Truth Used (Test Set)

For the material and technical performance, the "ground truth" is based on:
- Accepted Industry Standards: ASTM F 1088-04a for beta-tricalcium phosphate.
- Laboratory Measurements: Data from tests like wettability, fluid retention, SEM, XRD, FTIR, ICP, porosity, and dissolution.
- Biocompatibility Standards: ISO 10993-1.

8. Sample Size for the Training Set

Not applicable. As this is not an AI device, there is no concept of a "training set" in the machine learning sense. The device's properties are designed and manufactured based on established material science and engineering principles, not through a data-driven training process.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI algorithm.

Summary

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510(k) SUMMARY Vitoss™ BA Bimodal Bioactive Bone Graft Substitute FEB - 7 2011

January 10, 2011

510(k) Number (if known): K103173

1. Contact Person

Deborah L. Jackson, RAC Senior Regulatory Affairs Specialist (e-mail) djackson@orthovita.com

Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355 (t) 610-640-1775 - (f) 484-323-8803

Device Name and Classification 2.

Product Name: Classification Name: Common or Usual Name: Classification Panel: Regulation Number: Device Class: Product Code:

Vitoss BA Bimodal Bioactive Bone Graft Substitute Filler, bone void, calcium Resorbable calcium salt bone void filler device Orthopedic 888.3045 Class II MQV

Predicate Device(s) 3.

Orthovita's Vitoss Bioactive Foam Pack Bone Graft Substitute (K081439, K083033) NovaBone Products, LLC's NovaBone AR - Resorbable Bone Graft Substitute (K041613)

4. Device Description

5. Indications for Use

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Vitoss BA Bimodal Bioactive Bone Graft Substitute 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 the healing process.

Performance Data 6.

Vitoss BA Bimodal is a medical grade beta-tricalcium phosphate which satisfies the requirements of ASTM F 1088-04a, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation. Comparative testing included wettability, fluid retention, wash away resistance, homogeneity, radiopacity, bioactivity, dissolution, and SEM comparisons. XRD, FTIR ICP and porosity were evaluated for the predicate device. Biocompatibility of the implant has been established in accordance with ISO 10993-1, Biological evaluation of medical devices -Part 1: Evaluation and testing. Data supplied demonstrate that Vitoss BA Bimodal Bioactive Bone Graft Substitute is substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.

7. Substantial Equivalence

Vitoss BA Bimodal Bioactive Bone Graft Substitute, subject of the Special 510(k), is a product line extension to the Vitoss Bioactive Foam product line. Vitoss BA Bimodal Bioactive Bone Graft Substitute has the same intended uses and indications, technological characteristics, and principles of operation as its predicate device. The minor differences between Vitoss BA Bimodal Bioactive Bone Graft Substitute and the predicate device raise no new issues of safety or effectiveness. Thus, Vitoss BA Bimodal Bioactive Bone Graft Substitute is substantially equivalent to Vitoss Bioactive Foam.

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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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

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

Orthovita, Inc. % Ms. Deborah L. Jackson, RAC Senior Regulatory Affairs Specialist 45 Great Valley Parkway Malvern, Pennsylvania 19355

FEB - 7 201

. . . . . . . . . . . . . . . .

Re: K103173

Trade/Device Name: Vitoss™ BA Bimodal Bioactive Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: January 10, 2011 Received: January 11, 2011

Dear Ms. Jackson:

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 indictions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate commerce prior to May 28, 1976, the enactment date of the Medical In medical in medically 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, isting 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 muching.

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 devine 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

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Page 2 - Ms. Deborah L. Jackson. RAC

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

A. B. R.

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K103173

Device Name: Vitoss™ BA Bimodal Bioactive Bone Graft Substitute

Indications for Use:

Prescription Use (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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(Divisi (Division Sign of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K103173

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.