NovaBonc-BBG - Resorbable Bone Graft Substitute is indicated to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/ maxillo-facial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. NovaBone-BBG may be used alone in a manner comparable to autogenous hone graft chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. NovaBone-BBG is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Device Description

NovaBone-BBG is a synthetic resorbable ostcoconductive bone graft substitute composed of two similar calcium phospho-silicate bioactive glass materials. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects. The major component is a melt-derived calcium-phosphorus-sodiumsilicate (Bioglass) designed specifically for its absorbability and ostcoconductive nature. The second component is a calcium-phosphorus-silicate bioactive glass, chemically similar to the major component, but derived via a solution-gelation (sol-gel) process. The secondary sol-gel component is more rapidly absorbed from the graft site than the standard melt-derived component, opening additional space between the Bioglass particles for more rapid tissue infiltration and replacement by host bone during the healing process.

AI/ML Overview

The provided document is a 510(k) Summary for NovaBone-BBG - Resorbable Bone Graft Substitute. It focuses on establishing substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study proving the device meets them in the way clinical studies for diagnostic or AI devices would.

Therefore, many of the requested points from your prompt cannot be directly extracted from this type of regulatory submission. The document emphasizes technological characteristics and intended use in comparison to existing devices.

However, I can extract information related to the comparison and the nature of the "study" mentioned, as well as the 'acceptance criteria' in the context of substantial equivalence.

Here's the breakdown of what can be inferred or directly stated from the document:

1. Table of Acceptance Criteria and Reported Device Performance

In the context of a 510(k) for a medical device like a bone graft substitute, "acceptance criteria" for demonstrating substantial equivalence are generally centered around similarity in:

Intended Use: The new device should have the same intended use as legally marketed predicate devices.
Technological Characteristics: The new device should have technological characteristics that are substantially equivalent to the predicate devices. Differences should not raise new questions of safety or effectiveness.
Performance: The performance (e.g., biocompatibility, osteoconductivity, resorption profile) should be comparable to the predicate device.

The document discusses these aspects to support substantial equivalence.

Acceptance Criteria (for Substantial Equivalence to Predicates)	Reported Device Performance (NovaBone-BBG)
Intended Use: (Similar to Predicates)	NovaBone-BBG is indicated for filling and/or augmenting dental intraosseous, oral, and cranio-/maxillofacial defects, similar to predicates. It resorbs and is replaced by bone. Can be used alone or mixed with allograft/autograft.
Technological Characteristics: (Similar to Predicates)	NovaBone-BBG, PerioGlas, and Biogran are all osteoconductive, space-filling particulates, synthetic, inorganic, biocompatible. NovaBone-BBG contains Bioglass and a sol-gel derived bioactive glass. The sol-gel component's faster absorption is highlighted as a technological difference but is presented as an improvement in absorption rate rather than a safety concern.
In Vivo Performance: (Comparable to Predicates)	"In vivo performance data comparing NovaBone-BBG and/or the individual sol-gel component to PerioGlas are summarized." (No specific quantitative metrics or formal acceptance thresholds are provided in this summary, but the conclusion states "side-by-side comparative in vivo performance data were presented" to show equivalence).
Material Composition: (Similar to Predicates)	Major component is melt-derived calcium-phosphorus-sodium-silicate (Bioglass). Second component is calcium-phosphorus-silicate bioactive glass (sol-gel derived), similar to Bioglass but without sodium. Both are calcium phospho-silicate bioactive glass materials.
Resorption Profile: (Comparable to Predicates)	"Essentially absorbed within the six-month timeframe normally associated with bone remodeling, the devices being replaced by new bone tissue." The sol-gel phase is "more soluble" and allows "more rapid initial absorption."
Warnings/Precautions: (Similar to Predicates)	"NovaBone-BBG does not possess sufficient mechanical strength to support load bearing defects prior to soft and hard tissue ingrowth." (Implies similar mechanical limitations to other bone graft substitutes lacking structural support).
Complications: (Similar to Predicates)	"Possible complications are the same as to be expected of autogenous bone grafting procedures." (Lists wound infection, delayed union, loss of reduction, failure of fusion, etc., implying a similar risk profile to existing methods/materials.)

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

Sample Size: Not specified in the provided summary. The phrase "In vivo performance data comparing NovaBone-BBG and/or the individual sol-gel component to PerioGlas are summarized" indicates a study was performed without providing details on the number of subjects or cases.
Data Provenance: Not specified. It's an "in vivo" study, which suggests it could be animal or human, but details like country of origin or retrospective/prospective nature are not in this summary.

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

This information is not applicable and not provided. The study is about comparing the biological performance of a graft material, not about expert assessment of diagnostic images or clinical interpretations. "Ground truth" would refer to biological outcomes (e.g., new bone formation, graft resorption) which are typically assessed via histology or imaging, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

Not applicable and not provided for this type of device submission. Adjudication methods like 2+1 or 3+1 are typically for reconciling differences in expert interpretations, which is not the nature of the studies discussed here.

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 is a bone graft material, not an AI or diagnostic imaging device.

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

Not applicable. This is a bone graft material, not an AI or diagnostic imaging device.

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

The "in vivo performance data" likely involved histological analysis of harvested tissue, imaging (e.g., radiographs, microCT), and/or gross observation of the graft sites to assess parameters like new bone formation, graft resorption, and integration. While not explicitly stated, "pathology" or similar biological outcomes data would be the closest analogue to "ground truth" for this kind of study.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning algorithm.

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

Not applicable. This is a medical device, not a machine learning algorithm.

In summary: The provided document is a 510(k) summary, which is a regulatory document to demonstrate substantial equivalence to existing devices. It focuses on comparing the technological characteristics, intended use, and general performance observations, rather than a detailed report of a clinical efficacy study with specific acceptance criteria and ground truth validation as would be expected for a diagnostic or AI-driven device. The "study" mentioned is an "in vivo performance data" comparison to a predicate device, aiming to show similar biological behavior.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K033994" in a handwritten style, underlined with a black line. Below this, the word "NOVABONE" is printed in bold, black letters, with a star-like design in the middle of the word. Underneath "NOVABONE", the phrase "SYNTHETIC BONE GRAFT PRODUCTS" is printed in smaller, black letters.

MAR 2 5 2004

510(k) Summary NovaBone-BBG - Resorbable Bone Graft Substitute

12/18/03

Submitter Information: 1.

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

Name of Device: 2.

Trade Name:	NovaBone-BBG · Resorbable Bone Graft Substitute
Common Name:	Osteoconductive Bone Void Filler
	Synthetic Resorbable Bone Graft Material
Classification Name:	Unknown

3. Legally Marketed Predicate Device:

Predicate #1:	PerioGlas - Synthetic Bone Graft Particulate[K992416, K962492, K930115](Also named as NovaBone per K000149)
Predicate #2:	Biogran Bioactive Glass Synthetic Bone Graft Material[K952922]

4. Device Description

ನ. Intended Use

NovaBonc-BBG - Resorbable Bone Graft Substitute is indicated to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio

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/ maxillo-facial defects. These defects may be surgically created osseous defects / maxino-facial defects. These derects injury to the bone, including: periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomal/infraoony - cercets) extraction sites (ridge maintenance, implant osteotonly, "Cystcetonly), "centur" cystic defects; craniofacial augmentation. The preparation/placement), onlas intest that resorbs and is replaced with bone during the healing process. NovaBone-BBG may be used alone in a manner comparable the lieaning process. NovaDone DD oraft bone particulate (demineralized frecze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. NovaBone-BBG is indicated only for bony voids marrow that are not intrinsic to the stability of the bony structure.

Technological Characteristics 6.

The technological characteristics of NovaBone-BBG, PerioGlas, and Biogran are similar, although not identical. All are designed to be osteoconductive spacefilling particulates to be gently packed into defect sites and to be used as a nonstructural scaffold for the body's natural healing and bone regeneration process. Structuring bearing the three devices are similar in nature, all being particulate, ro thetic, inorganic, biocompatible and ostcoconductive materials.

The main technological difference between NovaBone-BBG and the two predicate The mani tooming.com the predicates are single-material Bioglass devices, the devices is and contains Bioglass and a second sol-gel derived bioactive glass NovaDone DDG contares Dass is composed of calcium, phosphorus, and silicon, similar to the Bioglass component, but without the sodium. For all three devices, similar to the Diograss antially absorbed within the six-month timeframe normally associated with bone remodeling, the devices being replaced by new bone tissue. The sol-gel phase of the NovaBone-BBG is more soluble than the standard melt-I ne sof get phase of the itting a more rapid initial absorption and therefore derred Broghass, pormising at an earlier period than for the predicates.

In vivo performance data comparing NovaBone-BBG and/or the individual sol-gel component to PerioGlas are summarized.

Warnings and Precautions 7.

NovaBone-BBG does not possess sufficient mechanical strength to support load bearing defects prior to soft and 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.

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NovaBone-BBG is intended for use by clinician familiar with bone grafting and internal/external fixation techniques. NovaBone-BBG 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, dclayed 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, gingival recession, flap sloughing, resorption or ankylosis of the treated root, abscess formation
ੇ. Conclusion
NovaBone-BBG is claimed to be substantially equivalent to PerioGlas and Biogran as a non-structural osteoconductive bone void filler for oral and craniofacial defects. Side-by-side comparative in vivo performance data were presented. Additional supporting in vitro data were supplied.

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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 stylized eagle with three stripes forming its wing. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

MAR 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David M. Gaisser Director, Operations NovaBone Products, LLC 13709 Progress Boulevard, #33 Alachua, Florida 32615

Re: K033994

Trade/Device Name: NovaBonc -BBG- Resorbable Bone Graft Substitute Regulation Number: Unclassified Regulation Name: None Regulatory Class: II Product Code: LYC Dated: December 18, 2003 Received: December 29, 2003

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 and ilsting (2) 2011 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.

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) 594-5613. 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.

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

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

K033994

NovaBone-BBG - Resorbable Bone Graft Substitute Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruaze

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthoolors, Infection Control, Devices

510(k) Number:

Prescription Use

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

() =

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.