Vitoss Scaffold Synthetic Cancellous Bone Void Filler is intended only 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 gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). 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 µm (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 provided text describes a 510(k) summary for the "Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler" and its comparison to a predicate device, Pro Osteon 500R. The submission focuses on demonstrating substantial equivalence to the predicate device, not on meeting specific, quantitative acceptance criteria through a standalone study with a device performance table, as might be done for an AI/software device. Hence, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth for a study is not present in this document.

Here's an analysis of what information is available from the text in relation to your request:

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

The document does not explicitly state quantitative "acceptance criteria" in the format of a performance table with specific thresholds that the new device must meet to be considered "accepted." Instead, it presents a comparison to a predicate device (Pro Osteon 500R) across various characteristics, implying that performance comparable to or better than the predicate is the criterion for substantial equivalence.

Comparison to Predicate (Vitoss Scaffold vs. Pro Osteon 500R):

Feature/Performance Metric	Vitoss™ Scaffold (Submitted Device)	Pro Osteon 500R (Predicate Device)
Intended Use	Synthetic Bone Void Filler for individuals with bony defects resulting from surgery or trauma	Synthetic Bone Void Filler for individuals with bony defects resulting from surgery or trauma
Target Population	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 (extremities, spine, pelvis)	Bony voids or gaps of the skeletal system (extremities, spine, pelvis)
Labeling	Same intended use, contraindications, warnings, precautions, adverse events as predicate	Same intended use, contraindications, warnings, precautions, adverse events as Vitoss
Chemical Composition	Calcium salt	Calcium salts
Mineral Phase(s)	β-Tricalcium Phosphate Ca3(PO4)2	Hydroxyapatite Cajo(PO4)g(OH)2, Calcium Carbonate CaCO3
- Physical Structure	Trabecular structure similar to cancellous bone	Trabecular structure similar to cancellous bone
· Porosity	Approximately 90%	Approximately 55%
· Pore Size (range)	1-1000 µm	280-779 µm
Osteoconductivity	Osteoconductive	Osteoconductive
Resorption®	Demonstrated as 76% resorbed at six weeks and 86% resorbed at twelve weeks	Reported as 20% resorbed at six weeks and 45% resorbed at twelve weeks
Bone Remodeling	Demonstrated as 0.6 (ratio of bone in implant to adjacent bone) at six weeks and 1.2 at twelve weeks	Demonstrated as 0.4 (ratio of bone in implant to adjacent bone) at six weeks and 0.5 at twelve weeks
Mechanical Strength	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
Biocompatibility	Established	Established
Dosage Form(s)	Morsels (1-4 mm sizes) and blocks (9x23mm cylinder)	Morsels (1-4 mm sizes)

The "study" proving the device meets the "acceptance criteria" (which is substantial equivalence to the predicate) is the Non-clinical Performance Data.

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

The document refers to "Pre-clinical animal data" and "Results from animal studies" to demonstrate performance characteristics like resorption and bone ingrowth.

Sample size: Not specified.
Data provenance: "Animal studies." No country of origin is mentioned. These would be prospective animal studies.

The document also refers to "clinical practice for more than 25 years" and "dentistry and oral reconstructive surgery" and "orthopedic problems" for calcium-based ceramic materials in general, and a "review of FDA's Manufacturer and User Facility Device Experience Database (MAUDE), conducted on 12/13/1999" regarding the predicate device (Pro Osteon 500R) and other devices with product code MQV.

Sample size: Not specified for the historical clinical data. MAUDE review would cover any reported incidence but not a specific study size.
Data provenance: Historical clinical data (likely worldwide, though not specified) and the MAUDE database (US data). This would be retrospective for the MAUDE review and general clinical use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The "ground truth" for the animal studies would likely involve histological analysis or other objective measurements in the animals, not human expert interpretation in the way one might evaluate an AI diagnostic device.

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

This information is not provided as it's not applicable to the type of pre-clinical animal studies or MAUDE database review described.

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

No MRMC comparative effectiveness study was done. This is a medical device (bone void filler), not an AI/software diagnostic tool.

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

No standalone algorithm performance study was done. This is a medical device, not an algorithm.

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

For the animal studies:

Ground Truth Type: Likely objective measurements of bone ingrowth, resorption rates, and tissue integration, probably based on histological analysis or imaging (e.g., X-rays, micro-CT) of the animal models. The document mentions "bone growth," "bone ingrowth," and "bone remodeling."

For the MAUDE database review:

Ground Truth Type: Real-world adverse event reports.

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device requiring a training set.

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

This information is not applicable as this is not an AI/machine learning device.

Summary

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DEC 1 4 2000

K994337

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	Angie IdeDirector, Regulatory Affairs
	Subject Device	Predicate Device
	Vitoss™ Scaffold SyntheticCancellous Bone Void Filler	Pro Osteon 500R ResorbableBone Void Filler
Common Name	Bone Void Filler	Bone Void Filler
Classification Name	Filler, Calcium SulfatePreformed Pellets	Filler, Calcium SulfatePreformed Pellets
	COMPARISON TO PREDICATE
	toss Scaffold	Pro Osteon 500R
Intended Use	Synthetic Bone Void Filler	Synthetic Bone Void Filler
Target Population	Individuals with bony defectsresulting from surgery or trauma	Individuals with bony defectsresulting from surgery or traumaBony voids or gaps of the
Anatomical Locations	Bony voids or gaps of theskeletal system, i.e., theextremities, spine and pelvis	skeletal system, i.e., theextremities, spine and pelvis
Labeling	Labeling contains same intendeduse, contraindications,warnings, precautions, andadverse events as predicate	Labeling contains same intendeduse, contraindications,warnings, precautions, andadverse events as Vitoss
Materials ====================================================================================================================================================================
Chemical Composition	Calcium salt	Calcium salts
Mineral Phase(s)	B-Tricalcium PhosphateCa3(PO4)2	HydroxyapatiteCajo(PO4)g(OH)2Calcium Carbonate CaCO3
Design
- Physical Structure	Trabecular structure similar tocancellous bone	Trabecular structure similar tocancellous bone
· Porosity	Approximately 90%	Approximately 55%
· Pore Size (range	1-1000um	280-779um
Performance
Osteoconductivity	Osteoconductive	Osteoconductive
Resorption®	Demonstrated as 76% resorbedat six weeks and 86% resorbedat twelve weeks	Reported as 20% resorbed at sixweeks and 45% resorbed attwelve weeks
Bone RemodelingRecorded as ratio of bone inimplant to adjacent be	Demonstrated as 0.6 at sixweeks and 1.2 at twelve weeks	Demonstrated as 0.4 at sixweeks and 0.5 at twelve weeks
Mechanical Strength	Does not impart mechanicalstrength to surgical site	Does not impart mechanicalstrength to surgical site
Sterility.	Sterilized by gamma radiation,single use only	Sterilized by gamma radiation,single use only
Biocompatibility	Established	Established
Dosage Form(s)	Morsels (1-4 mm sizes) andblocks (9x23mm cylinder)	Morsels (1-4 mm sizes)

Device Description:

Intended Use:

Vitoss Scaffold Synthetic Cancellous Bone Void Filler is intended only 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 gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void

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or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Comparison to Predicate:

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Summary of S & E Vitoss Scaffold Orthovita, Inc.

Non-clinical Performance Data:

Pre-clinical animal data demonstrate that Vitoss Scaffold supports bone growth into a metaphyseal defect. These data show that Vitoss Scaffold resorbs at an early time period, accompanied by early bone ingrowth and bone remodeling. These results, in conjunction with biocompatibility data, demonstrate that Vitoss Scaffold Bone Void Filler is as safe and as effective as the predicate device, Pro Osteon 500R.

Clinical Performance Data:

Calcium-based ceramic materials, including tricalcium phosphate, have been used in clinical practice for more than 25 years with no remarkable safety issues. Early successful results were achieved in dentistry and oral reconstructive surgery. Subsequently, successful results have been demonstrated in the treatment of many orthopedic problems, including filling defects secondary to trauma, benign turnors and cysts, and the filling of metaphyseal defects of long bones.

In terms of safety, calcium-based bone void fillers have the advantage of avoiding the potential morbidity associated with the harvesting of bone autografts and the potential for disease transmission by allografts. To date there have been no reports in the literature of adverse reactions to calcium-based ceramic materials. A review of FDA's Manufacturer and User Facility Device Experience Database (MAUDE), conducted on 12/13/1999, showed no records of adverse device experience with Pro Osteon 500R, the device to which Vitoss Scaffold claims substantial equivalence. Only two records were found reported for all devices with the product code MQV. These two records were for Wright Medical's product, Osteoset, the device to which Pro Osteon 500R was determined to be substantially equivalent. This confirms the continued safe use of the bone void fillers currently in commercial distribution.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized wing segments and a flowing tail.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2000

Ms. Angie Ide Director, Regulatory Affairs Orthovita Company 45 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K994337

Trade Name: Vitoss "Scaffold Synthetic Cancellous Bone Void Filler Regulatory Class: Unclassified Product Code: MQV Dated: October 26, 2000 Received: October 27, 2000

Dear Ms. Ide:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Angie Ide

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

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

Enclosure

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Vitoss Scaffold 510(k) Notification Orthovita, Inc. December 7, 2000

INDICATIONS FOR USE STATEMENT

510(k) Number: K994337

Device Name: Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler

Indications For Use:

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

	Coffcurrence of CDB Office of De add Thaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices510(k) Number _

Prescription Use (Per 21 CFR 801.109)

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.