NovaBone Resorbable Bone graft substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Description

NovaBone® is a synthetic resorbable osteoconductive bone graft substitute particulate entirely composed of a calcium phospho-silicate material. The inorganic calcium and phosphorous components are thermally incorporated in a sodium silicate network designed specifically for its resorbability and osteoconductive nature. NovaBone is progressively resorbed and replaced by host bone during the healing process

AI/ML Overview

The provided text describes NovaBone®, a resorbable bone graft substitute, and its substantial equivalence to predicate devices based on pre-clinical studies. It does not contain information about acceptance criteria in the typical sense of quantitative metrics for clinical performance, nor does it describe a study involving human readers or expert panels.

Here's a breakdown of the requested information based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than meeting specific quantitative performance metrics like sensitivity or specificity. The reported performance focuses on comparative biological responses in animal models.

Acceptance Criteria (Demonstrated Substantial Equivalence to Predicates)	Reported Performance of NovaBone
Intended Use: Non-structural osteoconductive bone void filler for osseous defects.	Same as predicate devices.
Indications: Bony voids or gaps of the skeletal system (extremities, spine, pelvis).	Same as predicate devices.
Application: Gently packed into defect sites as a non-structural scaffold for healing.	Same as predicate devices.
Material: Inorganic calcium phospho-silicate.	Different from predicates (Bioglass®) but functionally similar for osteoconduction.
Device Action: Ion diffusion/exchange leads to calcium phosphate surface layer, acting as osteoconductive scaffold; material resorption.	Functions as described, similar to predicates in effect.
Performance (Bone Infiltration): Bone infiltration via osteoconduction, leading to increased graft site mechanical stiffness and strength.	Similar to predicate devices; new bone formation greater than predicates in some studies. Biomechanical properties similar to predicates.
Bone Remodeling: New bone grows, material absorbed and replaced by host bone.	Similar to predicate devices.
Resorption Rate: Majority absorbed by six months.	Similar to Pro Osteon 500R (slower than Wright Plaster of Paris Pellets, but still "substantially absorbed" within six months, consistent with bone remodeling).
Biocompatibility: Biocompatible, non-antigenic.	Similar to predicate devices. No evidence of local or systemic adverse effects observed in studies.
Mechanical: Particulate, not intended for load-bearing defects without fixation.	Similar to predicate devices.
Sterility: ETO sterilization.	Different from predicates (Gamma) but achieves sterility.
Voluntary Standards Met: Trace element levels as cited in ASTM F 1538-94.	Met specific ASTM standard; predicates had "None known."

2. Sample size used for the test set and the data provenance

Test Set (Pre-clinical Studies):
- Study A (NovaBone vs. ProOsteon 500R): Rabbits. The exact number of rabbits is not specified, but it refers to "the same animal" for comparison, implying a paired study design. The defect was 6mm in diameter in the distal femur.
- Study B (NovaBone vs. Wright Plaster of Paris Pellets): Goats. The exact number of goats is not specified. The defect was 10mm in diameter in the distal femur.
- Study C (NovaBone vs. Wright Plaster of Paris Pellets): Sheep. The exact number of sheep is not specified. Unicortical defects and a reamed channel in the iliac crest.
Data Provenance: The studies are pre-clinical animal studies. The country of origin for the studies is not specified in the provided text, but it's presumed to be conducted by or for NovaBone Products, LLC (based in Alachua, FL, USA). The data is retrospective in the sense that it was collected prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The studies are pre-clinical animal studies evaluating biological response (e.g., residual graft material, new bone formation, biomechanical properties) which are typically assessed through objective measurements and histological analysis by trained researchers or pathologists, rather than expert consensus on image interpretation. The text does not specify the number or qualifications of experts involved in the assessment.

4. Adjudication method for the test set

Not applicable. The assessment of animal study results (histology, biomechanics) does not involve an adjudication method like 2+1 or 3+1, which are typically used for establishing ground truth in human image interpretation studies.

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. This is a medical device for bone graft substitution, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study and AI assistance effect size are not relevant to this submission.

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

No. This is a medical device for bone graft substitution, not an algorithm.

7. The type of ground truth used

The "ground truth" in these pre-clinical animal studies was established through objective measurements and histological analysis of tissue samples from the defect sites. This includes assessment of:

Residual graft material area
Biomechanical properties of the graft site
New bone formation (histologically)

8. The sample size for the training set

Not applicable. This is a manufactured medical device, not a machine learning model. Therefore, there is no "training set."

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

Not applicable. There is no training set for this device.

Summary

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510(k) Premarket Notification - 510(k) Summary NovaBone Products, LLC NovaBone® - Resorbable Bone Graft Substitute

JUL 2 5 2002

4/24/02 510(k) Summary NovaBone® - Resorbable Bone Graft Substitute

Submitter Information: 1.

Name:	NovaBone Products, LLC
Address:	One Progress Boulevard, #33Alachua, FL 32615
Telephone:	(386) 462-7660
Facsimile:	(386) 418-1636
Contact:	David M. Gaisser

1. Name of Device:

Trade Name:	NovaBone – Resorbable Bone Graft Substitute
Common Name:	Osteoconductive Bone Void FillerSynthetic Resorbable Bone Graft Material
Classification Name:	Unknown

Legally Marketed Predicate Device: 3.

Predicate #1:	Pro Osteon 500R [K980817]
Predicate #2:	Wright Plaster of Paris Pellets [K963562]

4. Device Description

1. Intended Use
  NovaBone Resorbable Bone graft substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone Products, LLC

1 Progress Blvd. Suite 33 Alachua, FL 32615 Tel: 386.462.7660 Fax: 386.418.1636

Image /page/0/Picture/16 description: The image shows the logo for NovaBone Products. The logo is in black and white and features the words "NovaBone" in a stylized font, with a world map underneath. Below the world map, the word "Products" is written in a simple font. Above the logo, the number "K021336" is written.

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510(k) Premarket Notification - 510(k) Summary NovaBone Products, LLC NovaBone® - Resorbable Bone Graft Substitute

Technological Characteristics 6.

The technological characteristics of NovaBone, ProOsteon 500R, and Wright Plaster of Paris Pellets are similar, although not identical. NovaBone, ProOsteon 500R, and Wright Plaster of Paris Pellets are designed to be osteoconductive space-filling particulates to be gently packed into defect sites and to be used as a non-structural scaffold for the body's natural healing and bone regeneration process. To meet this design. NovaBone, ProOsteon 500R, and Wright Plaster of Paris Pellets are similar in nature; all three devices are particulate, synthetic, inorganic, biocompatible and osteoconductive materials.

The main technological characteristic difference between NovaBone , ProOsteon 500R, and Wright Plaster of Paris Pellets is their composition, each being composed of a different synthetic material. NovaBone is composed of Bioglass® (see description), ProOsteon 500R is composed of calcium carbonate with a thin calcium phosphate coating, and Wright Plaster of Paris Pellets is composed of calcium sulfate with stearic acid as a tableting aid. These different materials have different absorption rates. The Wright Plaster of Paris Pellets are absorbed between four and eight weeks, depending on the graft site, size and material used. NovaBone and ProOsteon 500R have a similar, slower absorption rate, but both are still substantially absorbed within the six-month timeframe normally associated with bone remodeling. For all three devices, bone forms throughout the graft site with the material being absorbed and replaced by new bone tissue.

The performance of NovaBone has been compared to ProOsteon 500R and to Wright Plaster of Paris Pellets in side-by-side comparison studies. Three such studies were conducted:

A. A 6mm diameter defect in the distal femur of rabbits to compare NovaBone and ProOsteon 500R in the same animal. At three months, both materials showed similar residual graft material area, with a substantial reduction in NovaBone graft particulate area from initial post-implantation values. The graft site biomechanical properties were not statistically different between graft materials while new bone formation was greater for NovaBone than for the ProOsteon 500R.
B. Comparisons between NovaBone and Wright Plaster of Paris Pellets were conducted in a goat femoral model. A 10mm diameter defect was created in the distal femur and evaluated at six weeks and six months. The Wright Plaster of Paris Pellets was mostly absorbed by six weeks, while some residual NovaBone was observed out to six months. The graft site biomechanical properties were similar between graft materials, with new bone formation greater for NovaBone than for the Wright Plaster of Paris Pellets.

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510(k) Premarket Notification - 510(k) Summary NovaBone Products, LLC NovaBone® - Resorbable Bone Graft Substitute

C. Comparisons between NovaBone and Wright Plaster of Paris Pellets were also conducted in an iliac crest model in sheep. Unicortical defects were made and a channel was reamed in the cancellous space of the superior iliac crest. Both NovaBone and Wright Plaster of Paris Pellets showed better bone regeneration than empty control sites at six weeks and six months. Histologically, the NovaBone defects had greater amounts of new bone formation at six weeks.
Warnings and Precautions 7.

NovaBone does not possess sufficient mechanical strength to support load bearing defects prior to soft and hard tissue ingrowth. In cases of fracture fixation, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes.

NovaBone is intended for use by surgeons familiar with bone grafting and internal/external fixation techniques. NovaBone must not be used to gain screw purchase or to stabilize screw placement.

1. Complications
  Possible complications are the same as to be expected of autogenous bone grafting procedures. These may include: superficial wound infection, deep wound infection, deep wound infection with osteomyelitis, delayed union, loss of reduction, failure of fusion, loss of bone graft, graft protrusion and / or dislodgement, and general complications that may arise from anesthesia and / or surgery.
1. Conclusion
  NovaBone is claimed to be substantially equivalent to ProOsteon 500R and Wright Plaster of Paris Pellets as a non-structural osteoconductive bone void filler for osseous defects. Side-by-side comparative in vivo performance data was presented, with no evidence of local or systemic adverse effects related to the device observed. Additional supporting in vitro and clinical data were supplied.

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SubstantialEquivalenceComparison	This DeviceNovaBone	Predicate #1Pro Osteon 500RK980817	Predicate #2Wright Plaster of ParisPelletsK963562
Intended Use	A non-structuralosteoconductive bone voidfiller for osseous defects.	Same as new device	Same as new device
Indications	Bony voids or gaps of theskeletal system (i.e., theextremities, spine and pelvis)	Same as new device	Same as new device
Application	To be gently packed intodefect sites as a non-structuralscaffold for the body's naturalhealing and bone regenerationprocesses.	Same as new device	Same as new device
Material	Inorganic calcium phospho-silicate, thermally formed andbound together in a sodiumsilicate network.	Inorganic calciumcarbonate core with athin, hydrothermally-formed inorganiccalcium phosphate layer	Inorganic calciumsulfate, pressed andbound into pellets usinga stearic acid tabletingaid.
Device Action	Ion diffusion and ion exchangeoccur between the NovaBoneparticle surfaces and the in vivoenvironment to form a calciumphosphate surface layer. Thesurface layer acts as a scaffoldfor new bone formationthroughout the graft site viaosteoconduction. Continuedion diffusion and exchangeresults in material resorption.	The pre-existingcalcium phosphate layeracts as a scaffold fornew bone formation andingrowth viaosteoconduction. Thecalcium phosphate layeris slowly resorbed toexpose the fasterresorbing calciumcarbonate core.	The pellets react withbodily fluids to dissolveto form calciumphosphate mineraldeposits that act as ascaffold for ingrowingbone, the dissolvedcalcium beingincorporated by newbone tissue.
Performance	Bone infiltration occursthroughout the graft site viaosteoconduction, resulting inincreased graft site mechanicalstiffness and strength	Same as new device	Same as new device.
Bone remodeling	New bone grows into the graftarea via osteconduction. Thematerial is slowly absorbedand replaced by the host bone.	Same as new device	Same as new device.
Resorption Rate	Majority absorbed by sixmonths	Same as new device	Majority absorbed bysix to eight weeks
SubstantialEquivalenceComparison	This DeviceNovaBone	Predicate #1Pro Osteon 500RK980817	Predicate #2Wright Plaster of ParisPelletsK963562
Biocompatibility	Biocompatible, non-antigenic	Same as new device	Same as new device
Mechanical	Particulate material; notintended for use in load-bearing defects without properinternal or external fixation	Same as new device	Same as new device
Sterility	ETO	Gamma	Gamma
VoluntaryStandards met	Trace Element levels as citedin ASTM F 1538--94,"Standard Specification forGlass and Glass CeramicBiomaterials for Implantation"	None known	None known

Table 3.1 Comparison of the New Device to the Marketed Predicate Devices

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its body and wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font. The text is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2002

Mr. David M. Gaisser Director of Operations NovaBone Products, LLC 1 Progress Boulevard. #33 Alachua, FL 32615

Re: K021336

NovaBone®- Resorbable Bone Graft Substitute Regulatory Class: unclassified Product Code: MQV Dated: April 24, 2002 Received: April 26, 2002

Dear Mr. Gaisser:

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 (OS) 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.

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Page 2 - Mr. David M. Gaisser

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.

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) 594-4595. 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, 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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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K021336

Device Name: NovaBone - Resorbable Bone Graft Substitute

Indications For Use:

NovaBone Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). "These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) 1. Restorative

510(k) Number

Prescription Use

OR (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.