BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to guide tissue growth, bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive and bacterialgrowth inhibiting material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P>O5 4%. BonAlive™ products are supplied as granules and plates. Both are bone grafting materials intended to fill, augment, or reconstruct bony defects of the cranial and maxillofacial region. BonAlive™ granules and plates are sterilized in hot dry air. The granules are available as different granule and unit sizes. The plates are available in different shapes and sizes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for BonAlive™ Granules and BonAlive™ Plates. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific, quantitative acceptance criteria through a formal statistically powered study. Therefore, the information typically requested in your prompt (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, standalone performance) is largely not applicable in this context.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not provide explicit acceptance criteria. Instead, it compares the new device to predicate devices based on descriptive information and summarizes preclinical (biocompatibility, solubility, surface structure, dissolution, animal studies) and clinical observations.

Descriptive Information	BonAlive™ Granules and Plates (New Device)	Porous HDPE Surgical Implants, K022665 (Predicate 1)	PerioGlas® Bone Graft Particulate, K053387 (Predicate 2)
Intended Use	Augmentation or reconstruction of the cranio-maxillofacial skeleton.	Augmentation or reconstruction of the cranio-maxillofacial areas.	Same as BonAlive™ device.
Material and properties	S53P4 Bioactive Glass - synthetic, osteoconductive, bacterial growth inhibiting.	Alloplastic, porous high density polyethylene (HDPE).	45S5 Bioactive Glass - same properties as BonAlive.
Product Form	Granules and plates.	Block, sheet, anatomical shapes.	Particulates.
Mode of Action	Tissue bonds to bioactive glass due to silica-gel layer and calcium phosphate precipitation, bonding to surrounding bone.	Porous HDPE allows for bony tissue ingrowth into its pores.	Same as BonAlive™ device.
Resorption Rate	Slowly, over a period of years.	Not applicable.	Six months.
Biocompatibility	Biocompatible.	Biocompatible.	Biocompatible.
Sterilization Method	Hot dry air.	Sterile.	EtO.

Summary of Performance Testing (Observations, not quantitative criteria fulfillment):

Preclinical: Biocompatibility tests showed the device was safe. Solubility, surface structure, and dissolution tests indicated low release of Si and P, suggesting good stability. Ca release created a suitable environment for calcium phosphate layer formation and new bone.
Animal Studies: BAG produced more and faster new bone than hydroxyl apatite (control). Proper blood circulation in the periosted flap was important for healing with both materials.
Clinical Observations:
- Frontal Sinus Obliteration: BAG is well-functioning, stable, safe, and well-tolerated. Remnants of glass particles maintained bone formation. The healing process and stability were assessed using ROI assessments.
- Orbital Floor Fractures, Septum Perforations, Nasal Cavity Narrowing: Well-functioning and well-tolerated, no harmful reactions observed.

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

Not applicable. This is not a study designed to meet specific performance metrics with a defined test set sample. The preclinical and clinical observations are summarized without specific sample sizes for particular "test sets." The "data provenance" is implied as preclinical (lab/animal studies) and clinical observations (human patients), but specific countries or retrospective/prospective details are not provided.

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

Not applicable. Ground truth, in the typical sense of a diagnostic agreement for a fixed test set, is not described. Clinical observations were likely made by treating physicians.

4. Adjudication method for the test set

Not applicable.

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 biomaterial, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a biomaterial.

7. The type of ground truth used

For animal studies, the "ground truth" for bone formation would likely be histological analysis of tissue samples. For human clinical observations, the "ground truth" for healing and stability would be clinical assessment, imaging (e.g., "ROI assessments" for frontal sinus obliteration), and patient outcomes. There is no mention of pathology reports or external outcome data as a primary "ground truth" for a specific test set.

8. The sample size for the training set

Not applicable. This is a biomaterial, not a machine learning model.

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

Not applicable.

Summary

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510(k) Summary

CCT 1 9 2007

Submitter: Vivoxid Ltd. Turku, Finland

Contact Information: Constance G. Bundy C. G. Bundy Associates, Inc. 6470 Riverview Terrace Fridley, MN 55432

Submission Date: July 10, 2007

Device Name and Classification: BonAlive™ Granules and Plates

Image /page/0/Figure/8 description: The image shows the text "Product Code: KKY" and "Class II per 21 CFR 878.3500". The text is black and is on a white background. The image is a close-up of the text.

Equivalent Device Identification: Porous HDPE Surgical Implants, K022665 PerioGlas® Bone Graft Particulate, K053387

Device Description: BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to guide tissue growth, bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive and bacterialgrowth inhibiting material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P>O5 4%. BonAlive™ products are supplied as granules and plates. Both are bone grafting materials intended to fill, augment, or reconstruct bony defects of the cranial and maxillofacial region. BonAlive™ granules and plates are sterilized in hot dry air. The granules are available as different granule and unit sizes. The plates are available in different shapes and sizes.

Intended Use: BonAlive™ Granules and BonAlive™ Plate are intended for the augmentation or reconstruction of the cranio-maxillofacial skeleton.

Vivoxid Ltd. Turku, Finland

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Comparison Table:

DescriptiveInformation	BonAlive™ granules andplates	Porous HDPESurgicalImplants, K022665	PerioGlas BoneGraft Particulate,K053387
Intended Use	BonAlive™ Granules andBonAlive™ Plate areintended for theaugmentation orreconstruction of the cranio-maxillofacial skeleton.	Porous HDPESurgical Implantsare intendedfor the augmentationor reconstructionof the cranio-maxillofacial areas.	Same as BonAlivedevice
Material andproperties	S53P4 Bioactive Glass -synthetic, osteoconductive,bacterial growth inhibiting	Alloplastic, poroushigh densitypolyethylene(HDPE)	45S5 BioactiveGlass - sameproperties asBonAlive
Product Form	Granules and plates	Block, sheet,anatomical shapes	Particulates
Mode of Action	Tissue bonds to thebioactive glass due to theformation of a silica-gellayer on the glass. Thesilica-rich layer acts as atemplate for a calciumphosphate precipitation,which bonds the bioactiveglass to the surroundingbone.	The porous HDPEallows for bonytissue ingrowth intoits pores	Same as BonAlivedevice
Resorption Rate	Slowly, over a period ofyears	Not applicable	Six months
Biocompatibility	Biocompatible	Biocompatible	Biocompatible
Sterilization Method	Hot dry air	Sterile	EtO

K071937

Summary of Perfomance Testing of Bioactive Glass (BAG) S53P4, BonAlive™:

Preclinical testing included biocompatibility, solubility, surface structure and dissolution. The amounts of Si and P released from BAG were extremely low indicating a good stability and safety of this material for clinical use in frontal sinus obliteration gThe amount of calcium (Ca) released from the material seems to create a suitable environment for formation of calcium phosphate layer that is prerequisite for new bone formation. The biocompatibility tests showed the device was safe for the intended uses.

In animal studies BAG produced more and faster new bone than did the hydroxyl apatite that was used as a control. Proper blood circulation in the periosted in flap at early stage predisposed the healing process with both materials. The healing process proceeded after the connective tissue phase to obliteration of bone cavity both in animal and in human clinical studies.

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VivoxID

Clinically BAG is well functioning, stable, safe and well tolerated glass material that creates suitable local environment for permanent filling of frontal sinuses. Remnants of glass particles found in the bony filling seem to maintain the achieved bone formation and closure of sinuses. The healing process and stability of the clinical outcome in sinuses could be assessed reliably by using the ROI assessments.

K071937

In patients with orbital floor fractures the orbital floor prostheses manufactured from BAG have been well functioning and well tolerated. The same conclusion can be made on the use of BAG in septum perforations and narrowing of the nasal cavity. The material itself has not caused any harmful reactions during the clinical follow-up period.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vivoxid Ltd. % C.G. Bundy Associates, Inc. Ms. Constance G. Bundy 6470 Riverview Terrace Fridley, Minnesota 55432

OCT 1 9 2007

Re: K071937

Trade/Device Name: BonAlive™ Granules and BonAlive™ Plates Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: KKY Dated: October 1, 2007 Received: October 4, 2007

Dear Ms. Bundy:

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.

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

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Page 2 - Ms. Constance G. Bundy

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 obhain, other general information on your responsibilities under the Act from the Division of a mall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely your Mark N. Melkers

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Vivoxic

Indications for Use

510(k) Number (if known): K071937

Device Name: BonAlive™ Granules and BonAlive™ Plates

Indications for Use:

BonAlive™ Granules and BonAlive™ Plate are intended for the augmentation or reconstruction of the cranio-maxillofacial skeleton.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR 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)

Page 1 of 1

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

11071937 510(k) Number

Vivoxid Ltd. Turku, Finland

Regulation Number and Section

§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.

(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.