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 synthetic absorbable osteoconductive bone graft substitute Formosed of a calcium phospho-silicate bioactive glass, Bioglass . The device is in a particulate form of a size range 90-710 um. The device is intended for dental intraosscous, oral, and cranio-/maxillofacial bony defects. It is supplied sterile, packaged either in a Tyvek-sealed PET-G cup or in a filled syringe within a second sterile barrier package. The device packages are protected by an outer shrink-wrapped cardboard box. 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.

AI/ML Overview

The provided document is a 510(k) summary for the PerioGlas – Bioglass Bone Graft Particulate. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about specific acceptance criteria or a dedicated study proving performance against such criteria. Instead, it leverages prior studies and the technological characteristics of the predicate device.

Here's an analysis based on the information available:

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

The document does not explicitly define acceptance criteria as a table with specific metrics and thresholds. Instead, it refers to the performance of the legally marketed predicate device (PerioGlas - Synthetic Bone Graft Particulate, K992416, K962492, K930115). The "reported device performance" is implicitly that it is equivalent to the predicate device, which has been deemed safe and effective.

The primary "performance" being evaluated in this 510(k) is that the modifications to the PerioGlas device (filled syringe packaging and gamma irradiation sterilization) do not negatively impact its safety and effectiveness.

Implicit "Acceptance Criteria" & "Reported Device Performance":

Acceptance Criteria (Implicit)	Reported Device Performance (Summary Statement)
Technological Characteristics: No change in fundamental characteristics.	"The technological characteristics of the proposed device and the unmodified PerioGlas device are identical."
In vivo and clinical performance: Equivalent to predicate.	"The in vivo and clinical performance of this device was previously evaluated in K992416."
Complications: No increase in complications compared to predicate/autogenous bone grafting.	"The modifications made to the PerioGlas device do not result in a change in complications associated with the use of the device. Possible complications are the same as to be expected of autogenous bone grafting procedures."
Safety and Effectiveness: Remains safe and effective as a non-structural osteoconductive bone void filler.	"PerioGlas devices continue to be safe and effective as non-structural osteoconductive bone void fillers for oral and cranio-/maxillofacial defects following modifications to include filled syringe packaging and gamma irradiation sterilization."
Packaging & Labeling: Verification completed.	"Packaging and labeling verification testing resulting from FMEA risk analysis was completed following design control."

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

The document states: "The in vivo and clinical performance of this device was previously evaluated in K992416." This indicates that the safety and effectiveness data for the device's core functionality comes from previous submissions for the predicate device. Therefore, details about the sample size (for the test set) and data provenance (e.g., country of origin, retrospective/prospective) would need to be found in the K992416 submission or the other predicate device submissions (K962492, K930115).

For the current submission (K040278) which focuses on modifications, the "test set" would primarily involve engineering and sterilization validation. The description mentions "Packaging and labeling verification testing resulting from FMEA risk analysis was completed following design control." This implies internal testing, but no sample sizes or specific data provenance are provided for these validations within this document.

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

This information is not provided in the current document. Since the core performance relies on previous studies (K992416, etc.), details about expert involvement in establishing ground truth for those studies would be found in their respective documentation. For the current submission, which focuses on substantial equivalence based on modifications, there's no mention of expert-established ground truth specific to this 510(k).

4. Adjudication method for the test set

This information is not provided in the current document. As with ground truth, any adjudication methods for the performance data would have been part of the predicate device's studies (K992416 etc.).

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, an MRMC comparative effectiveness study, particularly one involving AI, was not done. This device is a synthetic bone graft material, not a diagnostic imaging or AI-assisted device. The document predates widespread AI application in medical devices.

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

No, this is not an algorithm or software device. It is a physical medical device.

7. The type of ground truth used

The document implicitly relies on the ground truth established for the predicate device (K992416, etc.). This would typically involve:

Clinical outcomes data: Healing, bone formation, absence of adverse events in patients.
Histological assessment: Analysis of tissue samples to confirm bone formation or integration.
Radiographic assessment: Imaging to monitor bone regeneration.

The specific details are not in this 510(k) summary, but would be in the predicate device's submissions.

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device that requires a "training set."

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

This information is not applicable as this is not an AI/machine learning device.

Summary

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MAR - 1 2004

Image /page/0/Picture/1 description: The image shows the logo for NOVABONE synthetic bone graft products. Above the logo is the text "K040 278" in a handwritten style. The NOVABONE logo is in bold, black letters, with a stylized sun-like image in the middle of the word. Below the logo, the words "SYNTHETIC BONE GRAFT PRODUCTS" are printed in smaller, sans-serif font.

02/03/04

510(k) Summary PerioGlas - Bioglass Bone Graft Particulate

Submitter Information: 1.

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

Name of Device: 2.

Trade Name:	PerioGlas – Bioglass Bone Graft Particulate
Common Name:	Osteoconductive Bone Void FillerSynthetic Resorbable Bone Graft Material
Classification Name:	Endosseous Implant for Bone Filling and/or Augmentation

Legally Marketed Predicate Device: 3.

Predicate:	PerioGlas - Synthetic Bone Graft Particulate
	[K992416, K962492, K930115]
	(Also named as NovaBone per Special 510(k) K000149)

Device Description 4.

Intended Use 5.

PerioGlas - Bioglass Bone Graft Particulate 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

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510(k) Premarket Notification NovaBone Products, LLC PerioGlas - Bioglass Frone Graft Particulate

maintenance, implant 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 technological characteristics of the proposed device and the unmodified PerioGlas device are identical. The in vivo and clinical performance of this device was previously evaluated in K992416. Packaging and labeling verification testing resulting from FMEA risk analysis was completed following design control.

Complications 7.

The modifications made to the PerioGlas device do not result in a change in complications associated with the use of the 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

The modifications made to the PerioGlas device do not result in a change in technological characteristics of the device. PerioGlas devices continue to be safe and effective as non-structural osteoconductive bone void fillers for oral and cranio-/maxillofacial defects following modifications to include filled syringe packaging and gamma irradiation sterilization.

01.1

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Image /page/2/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 curved lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

MAR = 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040278

Trade/Device Name: PerioGlas- Bone Graft Particulate Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LYC Dated: February 3, 2004 Received: February 1, 2004

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 - Ms. Falk

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 (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) 594-4613. 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.

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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K040278

Confidential

510(k) Premarket Notification NovaBone Products, LLC PerioGlas - Bioglass Bone Graft Particutate

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):	K040278
---------------------------	---------

Device Name:

Indications For Use:

· Periodontal/Infrabony defects
· Ridge Augmentation (sinusotomy, osteotomy, cystectomy)
· Extraction · maintenance/augmentation, implant preparation/ sites (ridge 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Super Rums

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

510(k) Number .

ﮐﺎ 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.