The intended use of NovaBone Dental Putty is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include:

· Periodontal/Infrabony defects
· Ridge Augmentation (sinusotomy, osteotomy, cystectomy)
· Extraction · sites (ridge maintenance/augmentation, implant preparation/ placement)
Sinus lifts
· Cystic cavities
· Cranio-facial augmentation

For larger defects, a mixture of NovaBone Dental Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

Device Description

NovaBone Dental Putty is an osteoconductive, bioactive, bone void filler device. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects and is supplied sterile. It is composed of a calcium-phosphorussodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles are slowly absorbed and replaced by new bone tissue during the healing process. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects. It is supplied sterile.

AI/ML Overview

The provided text is a 510(k) summary for NovaBone Dental Putty, a bioactive synthetic bone graft. It describes the device, its intended use, technological characteristics, warnings, precautions, complications, and a conclusion stating its substantial equivalence to predicate devices. However, the document does NOT contain information about specific acceptance criteria or a dedicated study with performance metrics in the format requested.

The document states: "In vivo performance data were presented. Additional supporting in vitro data were supplied." implying that studies were conducted and results were provided to the FDA as part of the 510(k submission), but these specific results, acceptance criteria, sample sizes, ground truth establishment, or expert involvement are not detailed within this summary.

Therefore, I cannot populate the table or provide detailed answers to most of your questions based solely on the provided text.

Here's what can be inferred or explicitly stated based on the text for the questions that can be answered:

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

Cannot be provided from the given text. The document states "In vivo performance data were presented. Additional supporting in vitro data were supplied," but does not detail the acceptance criteria or reported performance results.

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

Cannot be provided from the given text. The text only mentions "In vivo performance data were presented" without details on sample size, study design (retrospective/prospective), or data provenance.

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)

Cannot be provided from the given text. No information about experts or ground truth establishment for a test set is included.

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

Cannot be provided from the given text. No information about adjudication methods is included.

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

Not applicable. This device is a bone graft product, not an AI diagnostic tool that would involve human readers or comparative effectiveness studies of AI assistance.

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

Not applicable. This device is a bone graft product, not an algorithm.

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

Cannot be explicitly stated from the given text for "ground truth". However, for a bone graft, "in vivo performance data" would typically involve histological analysis (pathology) of bone formation, imaging, and potentially outcomes data related to healing and defect fill, but this is not explicitly detailed as "ground truth" or how it was established.

8. The sample size for the training set

Not applicable / Cannot be provided from the given text. As this is a medical device (bone graft) and not an AI/ML algorithm, there isn't a "training set" in the computational sense. The "in vivo performance data" mentioned would be analogous to clinical/pre-clinical study data.

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

Not applicable / Cannot be provided from the given text. Similar to point 8, there's no concept of a "training set" for establishing ground truth in the context of this device.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than detailing a specific clinical study with explicit acceptance criteria and performance metrics against a defined ground truth, which is common for AI/ML device submissions.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for NOVABONE synthetic bone graft products. The logo is black and white and features the word "NOVABONE" in large, bold letters. Below the word "NOVABONE" is the phrase "SYNTHETIC BONE GRAFT PRODUCTS" in smaller letters. Above the word "NOVABONE" is the text "K063549" in a stylized font.

FEB 12 2007
K-6.

11/21/06

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ીને

510(k) Summary NovaBone Dental Putty - Bioactive Synthetic Bone Graft

1. Submitter Information:

Name:	NovaBone Products, LLC
Address:	13709 Progress Boulevard, #33Alachua, FL 32615
Telephone:	(386) 462-7660
Facsimile:	(386) 418-1636
Contact:	David M. Gaisser

2. Name of Device:

Trade Name:	NovaBone Dental Putty – Bioactive Synthetic Bone Graft
Common Name:	Osteoconductive Bone Void FillerSynthetic Resorbable Bone Graft Material
Classification Name:	Endosseous Implant for Bone Filling and/or Augmentation

3. Legally Marketed Predicate Device:

Predicate #1:	PerioGlas - Synthetic Bone Graft Particulate[K053387, K040278, K992416, K962492, K930115](Also named as NovaBone per Special 510(k) K000149)
Predicate #2:	NovaBone Putty II - Bioactive Synthetic Graft[K060728]
Predicate #3:	Exactech Resorbable Bone Paste - [K020078]
Predicate #4:	Grafton DBM - [K051195]

4. Device Description

5. Intended Use

NovaBone Dental Putty is indicated to be packed into bony voids or gaps to fill and/or augment oral, dental intraosseous, and craniofacial defects. These defects

NOVABONE PRODUCTS, LLC

13709 PROGRESS BLVD., #33 • ALACHUA, FL 32615 • (386) 462-7660 • FAX (386) 418-1636

www.novabone.com

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Confidential
K063549

include: periodontal/infrabony defects; alveolar ridge may augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. NovaBone Dental Putty may be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either as a bone graft extender.

Technological Characteristics 6.

The technological characteristics of the NovaBone Dental Putty device are similar to those of the predicates. The device and the predicates are designed as osteoconductive space-filling devices to be gently packed into defect sites and used as non-structural scaffolds for the body's natural healing and bone regeneration process. The device indications are the same as for the PerioGlas predicate.

The NovaBone Dental Putty device is identical in composition and formulation to the NovaBone Putty II predicate device. The primary component of NovaBone Dental Putty is identical to the bioactive glass (45S5 Bioglass) particulate found in the PerioGlas and NovaBone Putty II predicates. This synthetic material is both biocompatible and osteoconductive. NovaBone Dental Putty also includes a synthetic binder as an inert carrier for ease of handling and delivery, forming a premixed cohesive material. The binder is biocompatible and is absorbed after implantation, opening space between the bioactive glass particles for cell infiltration and bone formation. The bioactive glass particulate remains for a longer post-implantation period, acting as a scaffold for bone ingrowth. This particulate is absorbed and replaced by new bone tissue.

7. Warnings and Precautions

NovaBone Dental Putty does not possess sufficient mechanical strength to support load-bearing defects prior to hard tissue ingrowth. In cases where load support is required, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes.

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

8. 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. Complications specific to oral/dental use are those as may be typically observed for similar bone grafting procedures and may include: tooth sensitivity,

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510(k) Premarket Notification NovaBone Products, LLC NovaBone Putty II - Bioactive Synthetic Graft

Confidential

K063549

gingival recession, flap sloughing, resorption or ankylosis of the treated root, abscess formation.

9. Conclusion

NovaBone Dental Putty is claimed to be substantially equivalent to the PerioGlas, NovaBone Putty, Exactech Resorbable Bone Paste, and Grafton DBM predicate devices as a non-structural osteoconductive bone void filler for osseous defects. In vivo performance data were presented. Additional supporting in vitro data were supplied.

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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 and 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 pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David M. Gaisser Vice President NovaBone Products, LLC One Progress Boulevard, Suite 33 Alachua, Florida 32615

EB 1 2 2007

Re: K063549

Trade/Device Name: NovaBone Dental Putty-Bioactive Synthetic Bone Graft Regulation Number: 872. 3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: November 21, 2006 Received: December 4, 2006

Dear Mr. Gaisser:

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.

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Page 2 - Mr. Gaisser

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 (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.

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours.

Guglia y. Michael MD.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Confidential

510(k) Premarket Notification NovaBone Products, LLC NovaBone Dental Putty - Bioactive Synthetic Bone Graft

K063549

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: NovaBone Dental Putty - Bioactive Synthetic Bone Graff

Indications For Use:

· Periodontal/Infrabony defects
· Ridge Augmentation (sinusotomy, osteotomy, cystectomy)
· Extraction · sites (ridge maintenance/augmentation, implant preparation/ placement)
Sinus lifts
· Cystic cavities
· Cranio-facial augmentation

For larger defects, a mixture of NovaBone Dental Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

Prescription Use _XX

OR (Per 21 CFR 801.109) Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Supa Runos

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K96354

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.