Vitoss Scaffold Synthetic Cancellous Bone Void Filler 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 Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Device Description

Vitoss Scaffold is a porous calcium phosphate resorbable 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 um to 1000 um (1 mm). The implant is provided sterile in block and morsel forms.

Vitoss Scaffold guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold. Results from animal studies demonstrate that eighty percent of Vitoss Scaffold is resorbed within twelve weeks.

AI/ML Overview

The Vitoss® Scaffold Synthetic Cancellous Bone Void Filler is a resorbable bone void filler for repairing bony defects. The device underwent a 510(k) review (K032409), indicating that its substantial equivalence to predicate devices (WMT-TCP and chronOS) was demonstrated based on various performance characteristics rather than a clinical study with specific acceptance criteria and a detailed study design.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a medical device and not a diagnostic AI, the acceptance criteria are based on demonstrating substantial equivalence to predicate devices across several key performance and material characteristics, rather than specific accuracy metrics. The "reported device performance" reflects how Vitoss Scaffold compares to its predicates.

Characteristic	Acceptance Criteria (Substantial Equivalence to Predicates)	Reported Vitoss Scaffold Performance
Intended Use	Same as predicate devices	Resorbable Synthetic Bone Void Filler (matches WMT-TCP, ChronOS)
Target Population	Individuals with bony defects from surgery/trauma	Individuals with bony defects resulting from surgery or trauma (matches WMT-TCP, ChronOS)
Anatomical Locations	Skeletal system (extremities, spine, pelvis)	Bony voids or gaps of the skeletal system, i.e., extremities, spine and pelvis (matches WMT-TCP, ChronOS)
Labeling	Same intended use as predicates	Labeling contains same intended use as predicate devices
Materials	β-Tricalcium Phosphate (satisfies ASTM F 1088)	β-Tricalcium Phosphate $Ca_3(PO_4)_2$ satisfies ASTM F 1088 (matches WMT-TCP, ChronOS)
Design: Physical Structure	Trabecular structure similar to cancellous bone	Trabecular structure similar to cancellous bone (matches WMT-TCP, ChronOS)
Design: Porosity	"Highly porous" (WMT-TCP) or 60-70% (ChronOS)	Approximately 90%
Design: Pore Size (range)	100-500μm (ChronOS)	1-1000μm
Performance: Osteoconductivity	Osteoconductive	Osteoconductive (matches WMT-TCP, ChronOS)
Performance: Resorption	"Resorbable" (WMT-TCP) or 6-12 months (ChronOS)	Demonstrated as 80% resorbed at twelve weeks
Performance: Mechanical Strength	Does not impart mechanical strength	Does not impart mechanical strength to surgical site (matches WMT-TCP, ChronOS)
Sterility	Gamma radiation, single use	Sterilized by gamma radiation, single use only (matches WMT-TCP, ChronOS)
Biocompatibility	Established	Established (matches WMT-TCP, ChronOS)
Dosage Form(s)	Granules/Blocks (WMT-TCP, ChronOS)	Morsels and Blocks

The primary study mentioned proving the device's performance is an animal study demonstrating resorption.

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

The provided document refers to "animal studies" as the basis for resorption performance.

Sample Size: Not explicitly stated as "sample size" in the context of a clinical study; it refers to the number of animals used in the study. This number is not specified in the document.
Data Provenance: Animal studies (implies pre-clinical, laboratory setting, potentially domestic, but country of origin is not specified).
Retrospective or Prospective: Animal studies are typically prospective in design, where interventions are applied, and outcomes are observed.

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

N/A. This is a medical device for bone void filling, not a diagnostic AI device requiring expert-established ground truth for image interpretation or similar tasks. The "ground truth" for resorption would have been established through methods like histology, imaging, or biochemical assays in the animal model.

4. Adjudication Method for the Test Set

N/A. Not applicable to a non-diagnostic medical device study where ground truth is established through experimental measurements rather than human interpretation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is relevant for diagnostic devices (especially imaging-based AI) to assess the impact of AI assistance on human reader performance.

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

N/A. This is a physical bone void filler, not an algorithm or AI system. Its performance is intrinsic to its material properties and biological interaction.

7. Type of Ground Truth Used

The document mentions "Results from animal studies demonstrate that eighty percent of Vitoss Scaffold is resorbed within twelve weeks." This indicates that the ground truth for resorption was likely established through observational data collected from animal models, using methods such as:

Histology: Microscopic examination of tissue samples to assess material presence and bone ingrowth.
Imaging: X-rays or micro-CT to quantify scaffold volume change over time.
Gravimetric analysis: Measuring the remaining mass of the implant.
Biochemical markers: Assessing bone remodeling.

The specific method(s) are not detailed, but it falls under experimental/outcomes data from animal models.

8. Sample Size for the Training Set

N/A. As this is not an AI/ML device, there is no "training set" in the conventional sense. The "training" for the device's design and manufacturing process would come from material science research, preclinical testing, and potentially predicate device data.

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

N/A. No training set for an algorithm is applicable here. The development and validation of the device would rely on established scientific principles for biomaterials, in vitro testing, and the aforementioned animal studies, not on "ground truth" for a training set.

Summary

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K032409

510(k) Summary Vitoss® Scaffold Synthetic Cancellous Bone Void Filler

Submitted by	Address	Telephone	Contact Person
Orthovita, Inc.	45 Great Valley ParkwayMalvern, PA 19355	(610) 640-1775	Andreina Ide, Sr. Director,Regulatory Affairs
		Subject Device	Predicate Devices
Trade Name	Vitoss® Scaffold SyntheticCancellous Bone Void Filler		WMT-TCP K022629 chronOS K013072
Common Name	Resorbable Synthetic Bone Void Filler/Bone Graft Substitute
Classification Name	Resorbable Calcium Salt Bone Void Filler Device

Device Description:

Intended Use:

Vitoss Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood

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and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

	Vitoss Scaffold	WMT-TCP	ChronOS
Intended Use	Resorbable Synthetic Bone Void Filler	Resorbable Synthetic Bone Void Filler	Resorbable Synthetic Bone Void Filler
Target Population	Individuals with bony defects resulting from surgery or trauma	Individuals with bony defects resulting from surgery or trauma	Individuals with bony defects resulting from surgery or trauma
Anatomical Locations	Bony voids or gaps of the skeletal system, i.e., the extremities, spine and pelvis	Bony voids or gaps of the skeletal system, i.e., the extremities, spine and pelvis	Bony voids or gaps of the skeletal system, i.e., the extremities, spine and pelvis
Labeling	Labeling contains same intended use as predicate devices	Labeling contains same intended use as Vitoss Scaffold	Labeling contains same intended use as Vitoss Scaffold
Materials	β-Tricalcium Phosphate $Ca_3(PO_4)_2$ satisfies ASTM F 1088	Tricalcium Phosphate – satisfies ASTM F 1088	β-Tricalcium Phosphate $Ca_3(PO_4)_2$ satisfies ASTM F 1088
Design
• Physical Structure	Trabecular structure similar to cancellous bone	Trabecular structure similar to cancellous bone	Uniform, three-dimensional pore structure
• Porosity	Approximately 90%	Reported as “highly porous”	Approximately 60% to 70%
• Pore Size (range)	1-1000μm		100-500μm
Performance
• Osteoconductivity	Osteoconductive	Osteoconductive	Osteoconductive
• Resorption	Demonstrated as 80% resorbed at twelve weeks	Reported as “resorbable”	Resorption reported to occur between 6 and 12 months.
• Mechanical Strength	Does not impart mechanical strength to surgical site	Does not impart mechanical strength to surgical site	Does not impart mechanical strength to surgical site
Sterility	Sterilized by gamma radiation, single use only	Sterilized by gamma radiation, single use only	Sterilized by gamma radiation, single use only
Biocompatibility	Established	Established	Established
Dosage Form(s)	Morsels and Blocks	Granules and Blocks	Granules, Cylinders and Blocks

Comparison to Predicate:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2003

Ms. Andreina Ide Sr. Director, Regulatory Affairs Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355

Re: K032409

Trade Name: Vitoss Scaffold Synthetic Cancellous Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 1, 2003 Received: August 4, 2003

Dear Ms. Ide:

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 - Ms. Andreina Ide

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: K032409

Device Name: Vitoss® Scaffold Synthetic Cancellous Bone Void Filler

Indications For Use:

(Per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

for
Concurrence of CDRH Office of Device Evaluation (ODE)
(
On Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K032409
Prescription Use OR Over-The-Counter Use

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.