The intended use of PerioGlas 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 PerioGlas® with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

Device Description

PerioGlas is a one-component resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate designed specifically for its absorbability and osteoconductive nature. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects. It is supplied sterile. At time of use, the device is mixed with sterile water, saline, the patient's own blood or marrow, or with autogenous or allograft bone to form a wet sandy paste that is applied to the defect. PerioGlas is progressively resorbed and replaced by new bone tissue during the healing process.

AI/ML Overview

The provided text is a 510(k) summary for the PerioGlas – Bone Graft Particulate device, seeking to expand its product claims to include "osteostimulative" properties. The document does not contain specific acceptance criteria with numerical targets or a study validating these criteria. Instead, it describes supporting data for the new claim.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document. However, based on the information provided, I can construct responses for the other requested points related to the supporting study.

Acceptance Criteria and Study for PerioGlas – Bone Graft Particulate (Osteostimulative Claim)

As stated, the document does not present a formal table of acceptance criteria with numerical targets. The purpose of the submission is to add a claim of "osteostimulative" properties based on in vitro and in vivo data. The acceptance here is the FDA's concurrence that the presented data supports this additional claim, implying that the provided evidence met their thresholds for substantiating a new product claim for a previously cleared device.

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria: Not explicitly stated as numerical targets in the document. The implicit acceptance criterion is that the presented in vitro and in vivo data sufficiently demonstrates "osteostimulative" activity as defined by increased osteoblast proliferation, differentiation, and superior osteoconduction/bone formation compared to hydroxyapatite devices at early time points.
Reported Device Performance:
- In vitro: Stimulation of osteoblast proliferation and differentiation as evidenced by increased DNA content and elevated osteocalcin and alkaline phosphatase levels in cell culture studies.
- In vivo: Superior rate of osteoconduction and bone formation at early post-implantation periods compared to hydroxyapatite devices.

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

Sample Size (In vitro): Not specified. The document states "in vitro osteoblast cell culture studies" but does not detail the number of experiments, replicates, or controls.
Sample Size (In vivo): Not specified. The document states "in vivo study data" but does not detail the number of animals, specimens, or experimental groups.
Data Provenance: Not explicitly stated. Given it's a pre-market notification, it's presumed to be data generated by or for the manufacturer. It does not mention country of origin or whether it was retrospective/prospective.

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

Not applicable to this type of submission. This premarket notification relies on scientific study data (in vitro and in vivo) to support a physiological claim, not on expert adjudication of diagnostic interpretations. The ground truth is established by the experimental results themselves.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth is derived from scientific experimental measurements and comparisons, not human expert consensus needing adjudication.

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 particulate, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a bone graft particulate, not an AI or standalone algorithm.

7. The Type of Ground Truth Used:

In vitro: Experimental measurements of biological markers (DNA content, osteocalcin, alkaline phosphatase levels) in osteoblast cell cultures.
In vivo: Histological and/or other observational data on osteoconduction and new bone formation in animal models, measured and compared against a control (hydroxyapatite devices).

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" of the device is its inherent biological and material properties validated through scientific studies.

9. How the Ground Truth for the Training Set was Established:

Not applicable as there is no "training set" in the context of this device. The scientific and engineering principles behind the device's design and its biological interactions are established through foundational research in biomaterials and bone biology.

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 in black and white, with the word "NOVABONE" in large, bold letters. A star-like shape is in the middle of the word. Below the word "NOVABONE" is the phrase "SYNTHETIC BONE GRAFT PRODUCTS" in smaller letters.

K05387

FEB 1 4 2006

12/01/05

510(k) Summary PerioGlas - Bone Graft Particulate

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

2. Name of Device:

Trade Name:	PerioGlas – Bone Graft Particulate
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[K040278, K992416, K962492, K930115](Also named as NovaBone per Special 510(k) K000149)
Predicate #2:	NovaBone -- Resorbable Bone Graft Substitute[K052494, K021336]

Device Description 4.

ડ. Intended Use

PerioGlas is indicated to be packed into bony voids or gaps to fill and/or augment oral, dental intraosseous, and craniofacial defects. These defects may include: periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant

NOVABONF PRODUCTS. LLC

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

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Image /page/1/Picture/0 description: The image shows the text "K03387" in a handwritten style, with a line drawn underneath it. Below the line, the word "Confidential" is printed in a smaller, more formal font. The text suggests that the document or information is sensitive and should be kept private.

preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. PerioGlas 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 device is designed as an osteoconductive space-filling particulate device to be gently packed into defect sites and used as a non-structural scaffold for the body's natural healing and bone regeneration process. The device acts as a particulate, synthetic, inorganic, biocompatible and osteoconductive material.

PerioGlas is a single-phase bioactive glass (45S5 Bioglass) particulate device. No changes to the device or its indications have been made with this submission. The purpose of this premarket notification is to expand the product claims to cover the claim of the device being osteostimulative. After implantation, surface reactions result in the absorption of the device material and concurrent new bone tissue formation. These surface reactions result in an osteostimulative affect, defined as the stimulation of osteoblast proliferation and differentiation during in vitro osteoblast cell culture studies as evidenced by increased DNA content and elevated osteocalcin and alkaline phosphatase levels.

7. Complications

No modifications have been made to the PerioGlas device. 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, gingival recession, flap sloughing, resorption or ankylosis of the treated root, abscess formation

8. Conclusion

PerioGlas functions as a bone void filler for non-structural osseous defects. In vivo study data were presented supporting a superior rate of osteconduction and bone formation at early post-implantation periods compared to hydroxyapatite devices. In vitro cell culture data were presented to demonstrate and define the osteostimulative nature of the PerioGlas device. The addition of this claim does not modify the characteristics of the device, which has not been modified for this submission.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three figures representing health, services, and human needs.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFB 1 4 2006

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

Re: K053387

Trade/Device Name: Perioglas Bone Graft Particulate Regulation Number: 21 CFR 872.3930 Regulation Name: Tricalcium phosphate granules for dental bone repair Regulatory Class: II Product Code: LYC Dated: December 1, 2005 Received: December 9, 2005

Dear Mr. Gaisser:

We have reviewed your Section 510(k) premarket notification of intent to market the device we mayors we and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in muronomons for acce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to act 1000 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 approvisions of the Act. The general controls provisions of the Act include controls providers or a 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 (1 mr.), it and 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. David M. Gaisser

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvised that I DA 3 issualled on that your device complies with other requirements mean that FDA has made a decemmanen until Joan administered by other Federal agencies. of the Act or ally rederal statutes and regulations, but not limited to: registration You must comply with an the Fee s requirement) and 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gDD manufacturing practice and listing (21 CFR Part 807), laboling (21 creating (21 CFR Part 820); and if requirents as set form in the quality of seatly of stone (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 5 10(k) This letter will anow you to begin mailering your antial equivalence of your device to a premits of the results in the PDF intellige of 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), If you desire specific advice for your de at (240) 276-0115. Also, please note the regulation prease contact the Office or Compe to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inay obtain other general international and Consumer Assistance at its toll-free Division of 01 01 01 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Synette y. Michael Davis

Chia 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 PerioGlas - Bone Graft Particulate

ticulate
K03387

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ______________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

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 PerioGlas® 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)

Siner Ruang

physiology, General Hospital,
Infection Control, Dental Devices

Number: K053387

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.