The intended use of NovaBone Dental Morsels is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. It is used in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone). Typical uses include:

· Periodontal / infrabony defects
· Ridge augmentation (sinusotomy, osteotomy, cystectomy)
(ridge maintenance/augmentation, sites implant preparation/ · Extraction placement)
· Sinus lifts
· Cystic cavities
· Oral and maxillofacial augmentation

Device Description

NovaBone Dental Morsels is an osteoconductive, bioactive, bone void filler device. The device is intended for dental intraosseous, oral, and maxillofacial bony defects. It is a one-component, resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate, fused into a bulk porous form having a multidirectional interconnected porosity. The device is supplied sterile, packaged in a disposable PET-G tray with heat-sealed lid. On implantation, NovaBone Dental Morsels undergoes a time-dependent surface modification, resulting in the formation of a calcium phosphate layer on the device surfaces. The device acts as a scaffold, with new bone infiltrating the porous structure. NovaBone Dental Morsels is progressively resorbed and replaced by new bone tissue during the healing process.

AI/ML Overview

The provided document is a 510(k) summary for the NovaBone Dental Morsels – Bioactive Synthetic Bone Graft, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria and a study to prove meeting those criteria in the way a clinical study for a diagnostic algorithm might.

Here's an analysis based on the information provided, highlighting what's present and what is not typically part of this type of submission:

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

This type of table, common for outlining quantitative performance metrics of a device against pre-defined thresholds, is not present for the NovaBone Dental Morsels in the provided document. The submission focuses on a comparative analysis with predicate devices to establish substantial equivalence.

Instead, the document provides a "Substantial Equivalence Comparison" (Table 3.1) of the new device (NovaBone Dental Morsels) to two predicate devices (PerioGlas and NovaBone Porous) across various characteristics:

Characteristic	NovaBone Dental Morsels (New Device)	Predicate #1 (PerioGlas)	Predicate #2 (NovaBone Porous)
Intended Use	A non-structural osteoconductive bone void filler for osseous defects.	Same as new device	Same as new device
Indications	To fill and/or augment oral, dental intraosseous, and maxillofacial bone defects. Classif. Code: LYC	Same as new device. Classif. Code: LYC	Orthopedic bony voids in gaps of the skeletal system (i.e., the extremities and pelvis). Classif. Code: MQV
Application	Gently packed into defect sites as a non-structural scaffold for the body's natural healing and bone regeneration processes.	Same as new device	Same as new device
Material	Inorganic calcium phospho-silicate, thermally formed and bound together in a sodium silicate network. Individual particles fused to form porous graft material.	Same material as new device, but the individual particles are not fused together to create a porous material.	Same as new device
Device Porosity	Interconnected pore structure, with 40-60% pore volume and 50-400 micron pore size.	Dense individual particles. Space between packed particles provides approx 50% pore volume.	Same as new device
Particle Sizes	500 - 1000 microns and 1000 - 2000 microns.	90 - 710 microns (Smaller than new device).	2000 - 5000 microns (Larger than new device).
Device Action	Ion diffusion and exchange at particle surfaces form a calcium phosphate surface layer, which acts as a scaffold for new bone formation throughout the graft site via osteoconduction. Continued ion diffusion and exchange results in material resorption.	Same as new device	Same as new device
Performance	Bone infiltration occurs throughout the graft site via osteoconduction, resulting in increased graft site mechanical stiffness and strength.	Same as new device	Same as new device.
Bone remodeling	New bone grows into the graft area via osteoconduction. The material is slowly absorbed and replaced by the host bone.	Same as new device	Same as new device.
Resorption Rate	Majority absorbed by six months.	Same as new device	Same as new device
Biocompatibility	Biocompatible, non-antigenic; full ISO 10993 testing.	Same as new device	Same as new device
Mechanical	Particulate material; not intended for use in load-bearing defects without proper internal or external fixation.	Same as new device	Same as new device
Package Format	PETG cups with Tyvek® lids.	PETG cup / Tyvek lid and PP syringe in foil pouch.	PETG cup / Tyvek lid and PP syringe in foil pouch.
Sterility	Gamma Irradiation, SAL 10-6.	EO Gas (cups/lids); and Gamma (syringe), both SAL 10-6.	EO Gas (cups/lids) and Gamma (syringe), both SAL 10-6.

The acceptance criteria are implicitly that the NovaBone Dental Morsels are substantially equivalent to the predicate devices in terms of these characteristics. The reported device performance is described within each row of Table 3.1.

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 mentions "in vivo bone void testing" and "Additional supporting in vitro data were supplied." However, it does not specify the sample size, country of origin, or whether the in vivo study was retrospective or prospective. The focus is on demonstrating similar behavior to existing devices rather than a detailed clinical trial.

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 "in vivo bone void testing" would likely involve histological analysis by pathologists, but details on the number and qualifications of experts involved in establishing ground truth are absent.

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

This information is not provided.

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

This type of study is not applicable to this device. The NovaBone Dental Morsels is a bone graft material, not an AI-powered diagnostic device. Therefore, there are no "human readers" in the context of interpretation of images with or without AI assistance.

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

This is not applicable as the device is a physical bone graft material, not a standalone algorithm.

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

The "in vivo bone void testing" suggests that histological analysis (a form of pathology) would be used to assess new bone formation, material resorption, and tissue infiltration. The document states: "In vivo study data were presented supporting the osteoconductive nature of the device demonstrating new bone formation at early post-implantation periods, with no evidence of local or systemic adverse effects related to the device observed." This indicates a pathology-based ground truth for the in-vivo study.

8. The sample size for the training set

This information is not applicable as there is no "training set" in the context of this type of device submission. The device is not an AI/ML algorithm.

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

This information is not applicable for the same reason as point 8.

In summary:

The provided document is a 510(k) summary demonstrating substantial equivalence for a medical device (bone graft material). It outlines the device's characteristics and compares them to predicate devices. It briefly mentions "in vivo bone void testing" and "biocompatibility results" (ISO 10993) to support its safety and effectiveness, implying a pathology-based ground truth for the in-vivo studies. However, it does not contain the detailed performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods typically required for AI/ML or diagnostic device submissions. The "acceptance criteria" here are fundamentally met by demonstrating substantial equivalence to already marketed devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for NOVABONE. The logo is in black and features the company name in a bold, sans-serif font. Below the company name is the tagline "DRIVING INNOVATION IN OSTEOBIOLOGICS" in a smaller font.

K112428

DEC 1 6 2011

08/19/11 510(k) Summary NovaBone Dental Morsels - Bioactive Synthetic Bone Graft

Submitter Information: 1.

Name:	NovaBone Products, LLC
Address:	13631 Progress Boulevard, Suite 600Alachua, FL 32615
Telephone:	(386) 462-7661
Facsimile:	(386) 418-1636
Contact:	David M. Gaisser

Name of Device: 2.

Trade Name:	NovaBone Dental Morsels – Bioactive Synthetic Bone Graft
Common Name:	Osteoconductive Bone Void FillerSynthetic Resorbable Bone Graft Material
Regulation Number:	21 CFR 872.3930
Regulation Name:	Bone Grafting Material, Synthetic
Regulatory Class:	Class II
Product Code:	LYC

Legally Marketed Predicate Device: 3.

Predicate #1:	PerioGlas - Bone Graft Particulate[K053387, K040278, K992416, K962494, K930115]
Predicate #2:	NovaBone Porous – Bone Graft Scaffold[K060432, K090731]

Device Description 4.

Indications for Use ട.

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osteotomy, cystectomy); extraction sites (ridge maintenance/augmentation, implant preparation/ placement); sinus lifts; cystic cavities; oral and maxillofacial augmentation.

Technological Characteristics and Substantial Equivalence 6.

The technological characteristics of the NovaBone Dental Morsels device are similar to the predicate devices. A side-by-side comparison of the devices is given in Table 3.1. The new device and the predicates are designed as osteoconductive space-filling devices that aid in the bone repair process. The device indications are unchanged from those of the PerioGlas predicate device. The device is intended to be used alone, or in combination with autogenous or allograft bone.

The technological characteristics of the NovaBone Dental Morsels are similar to those of the predicates in terms of the device material. All three devices are a single-phase, calcium phospho-silicate material. Physically, the Dental Morsels device has an open pore structure identical to the NovaBone Porous predicate. The Dental Morsels particle size is between that of the PerioGlas predicate and the larger orthopedic NovaBone Morsels device.

NovaBone Dental Morsels and the predicates are designed to be gently packed into defect sites, functioning as a non-structural scaffold for the body's natural healing and bone regeneration process. The Dental Morsels and the PerioGlas predicate are indicated for oral and dental indications while NovaBone Porous is intended for orthopedic bone defects. The device acts as a synthetic, inorganic, biocompatible and osteoconductive scaffold into which new bone will grow.

Information provided in this submission includes compositional analysis, in vivo bone void testing, and ISO 10993 biocompatibility results. Test results indicate that this material is biocompatible and safe for its intended use.

7. Conclusion

The NovaBone Dental Morsels device serves as a bone void filler for nonstructural osseous defects for dental intraosseous, oral, and maxillofacial indications. The device physical structure is modified from the PerioGlas predicate to provide a device with interconnected porosity for tissue ingrowth. This device modification does not result in a change in technological characteristics of the device. In vivo study data were presented supporting the osteoconductive nature of the device demonstrating new bone formation at early post-implantation periods, with no evidence of local or systemic adverse effects related to the device observed. Additional supporting in vitro data were supplied.

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Substantial	New Device	Predicate #1	Predicate #2
EquivalenceComparison	NovaBone Dental Morsels	PerioGlas[K040278, K992416,K962494, K930115]	NovaBone Porous[K060432, K090731]
Intended Use	A non-structuralosteoconductive bone voidfiller for osseous defects.	Same as new device	Same as new device
Indications	To fill and/or augment oral,dental intraosseous, andmaxillofacial bone defectsClassif. Code: LYC	Same as new deviceClassif. Code: LYC	Orthopedic bony voidsin gaps of the skeletalsystem (i.e., theextremities and pelvis)Classif. Code: MQV
Application	Gently packed into defect sitesas a non-structural scaffold forthe body's natural healing andbone regeneration processes.	Same as new device	Same as new device
Material	Inorganic calcium phospho-silicate, thermally formed andbound together in a sodiumsilicate network.Individual particles fused toform porous graft material	Same material as newdevice, but the individualparticles are not fusedtogether to create aporous material.	Same as new device
Device Porosity	Interconnected pore structure,with 40-60% pore volume and50-400 micron pore size,	Dense individualparticles. Space betweenpacked particles providesapprox 50% pore volume	Same as new device
Particle Sizes	500 - 1000 micronsand1000 - 2000 microns	90 - 710 micronsSmaller than new device	2000 - 5000 micronsLarger than new device
Device Action	Ion diffusion and exchange atparticle surfaces form a calciumphosphate surface layer, whichacts as a scaffold for new boneformation throughout the graftsite via osteoconduction.Continued ion diffusion andexchange results in materialresorption.	Same as new device	Same as new device
Performance	Bone infiltration occursthroughout the graft site viaosteoconduction, resulting inincreased graft site mechanicalstiffness and strength	Same as new device	Same as new device.
SubstantialEquivalenceComparison	New DeviceNovaBone Dental Morsels	Predicate #1PerioGlas[K040278, K992416,K962494, K930115]	Predicate #2NovaBone Porous[K060432, K090731]
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	Same as new device
Biocompatibility	Biocompatible, non-antigenic;full ISO 10993 testing	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
Package Format	PETG cups with Tyvek® lids	PETG cup / Tyvek lidandPP syringe in foil pouch	PETG cup / Tyvek lidandPP syringe in foil pouch
Sterility	Gamma IrradiationSAL 10-6	EO Gas (cups/lids);andGamma (syringe)both SAL 10-6	EO Gas (cups/lids)andGamma (syringe)both SAL 10-6

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

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, rendered in a simple, bold line drawing.

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

Mr. David M. Gaisser Vice President -- Operations/RA/OA NovaBone Products, LLC 13631 Progress Boulevard. Suite 600 Alachua, Florida 32615

DEC 1 6 2011

Re: K112428

Trade/Device Name: NovaBone Dental Morsels - Bioactive Synthetic Bone Graft Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: November 29, 2011 Received: December 15, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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); medical device reportung (reporting of medical device-related adverse events) (21 CFR 803); 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.

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 vours.

hr for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

NovaBone Dental Morsels - Bioactive Synthetic Bone Graft Device Name:

Indications For Use:

· Periodontal / infrabony defects
· Ridge augmentation (sinusotomy, osteotomy, cystectomy)
(ridge maintenance/augmentation, sites implant preparation/ · Extraction placement)
· Sinus lifts
· Cystic cavities
· Oral and maxillofacial augmentation

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)

Clee

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112428

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.