BonAlive® granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BonAlive® granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. When used in the extremities and pelvis, BonAlive® granules is intended to be used alone. The device is not intended for use in posterolateral spine applications.

BonAlive® granules is not indicated for use in load-bearing applications, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

Device Description

BonAlive® granules is a sterile medical device made of S53P4 bioactive glass. Bioactive glass is characterized by its 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 material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P2O5 4%. BonAlive® granules functions in contact with body fluids allowing a progressive healing process which develops from the periphery to the central part of the obliteration mass. Best results are obtained by ensuring close contact of the device with surrounding tissue and by carefully following the instructions for clinical use.

When used in the extremities and pelvis, BonAlive® granules is intended to be used alone. BonAlive® granules is sterilized in hot dry air and available in different granule and unit sizes.

AI/ML Overview

This document is a 510(k) Summary for the BonAlive® granules Bone Void Filler Device. It primarily focuses on demonstrating substantial equivalence to a predicate device (NovaBone - Resorbable Bone Graft Substitute) rather than presenting a detailed study with specific acceptance criteria and performance metrics typically found in clinical trials for novel devices.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert adjudication, MRMC studies, and ground truth establishment is not available in this summary. The assessment of the device largely relies on its similarity to existing, approved technology and general biocompatibility/safety testing.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary demonstrating substantial equivalence, explicit quantitative acceptance criteria for performance are not provided in the same way they would be for a de novo submission or clinical trial report. The "acceptance criteria" here are implied by successful comparability to the predicate device and safety.

Acceptance Criterion (Implied)	Reported Device Performance
Material Composition	S53P4 bioactive glass (SiO2 53%, Na2O 23%, CaO 20%, P2O5 4%) - Similar to predicate device's bioactive glass composition.
Intended Use	Bony voids/gaps in extremities and pelvis, not load-bearing. Resorbs and replaced with bone. - Identical to or highly similar to predicate device's intended use.
Mechanism of Action	Forms silica-gel layer, acts as template for calcium phosphate precipitation, bonds to surrounding bone. Promotes new bone formation. - Functions the same as predicate device.
Biocompatibility	Device is safe for intended uses. - Confirmed by biocompatibility tests as stated.
Safety and Effectiveness	Well-functioning, safe, and well-tolerated material that creates a suitable local environment for filling bone cavities. - Confirmed by animal and clinical studies as stated, and comparison to predicate.
Sterilization Method	Sterilized in hot dry air. - Standard and safe method.
Non-Inferiority to Predicate	"BonAlive® granules functions the same as NovaBone products in similar clinical applications and do not introduce any new issues of safety or effectiveness." - This is the core of the substantial equivalence claim.

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

Test Sample Size: Not specified in the summary. The summary mentions "Animal and clinical studies" but does not provide details on their design, sample size, or specific outcomes.
Data Provenance: The summary indicates "Animal and clinical studies showed the device is a well functioning, safe and well tolerated glass material". However, it does not specify the country of origin, whether they were retrospective or prospective, or detailed methodologies.

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 510(k) summary. Given the nature of a substantial equivalence submission relying on existing data and material properties, such detailed expert ground truth establishment for a specific test set is typically not part of the filing itself.

4. Adjudication method for the test set

This information is not provided in the 510(k) summary.

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 is a medical device (bone void filler), not an AI diagnostic/imaging device. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not applicable and was not performed.

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

This is a medical device (bone void filler), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. The type of ground truth used

The "ground truth" for this type of device relates to its biological performance:
- Histological evidence: Formation of a silica-gel layer and subsequent calcium phosphate precipitation, indicating chemical bonding with bone.
- Radiographic evidence: Evidence of bone ingrowth and resorption of the material over time.
- Clinical outcomes: Patient recovery, lack of adverse events, and functional improvement (though not explicitly detailed in this summary).
- These are inferred from the statement: "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." and "Animal and clinical studies showed the device is a well functioning, safe and well tolerated glass material that creates suitable local environment filling of bone cavities."

8. The sample size for the training set

Not applicable as this is a device submission focusing on substantial equivalence, not an AI model requiring a "training set."

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

Not applicable as this is a device submission focusing on substantial equivalence, not an AI model requiring a "training set" and its ground truth establishment.

Summary

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510(k) Summary [K071199]

Date revised: Feb 3, 2012

510(k) owner: BonAlive Biomaterials Ltd. Turku, Finland
Ronald S. Warren Contact: MDCI, an Aptiv Solutions company 11440 W. Bernardo Court, Suite 300 San Diego. CA 92127 United States

Device Name and Classification:

BonAlive® granules Bone Void Filler Device, Product Code: MQV Class II per 888.3045

Equivalent Device Identification:

NovaBone - Resorbable Bone Graft Substitute, K021336

Device Description: BonAlive® granules is a sterile medical device made of S53P4 bioactive glass. Bioactive glass is characterized by its 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.

When used in the extremities and pelvis, BonAlive® granules is intended to be used alone. BonAlive® granules is sterilized in hot dry air and available in different granule and unit sizes.

[K071199]

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BonAlive Biomaterials Ltd Biolinja 12, FI-20750 Turku, Finland t. +358 (0)401 77 4400 f. +358 (0)421 9177 4400 www.bonalive.com

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Image /page/1/Picture/0 description: The image shows the logo for BonAlive Biomaterials Ltd. The logo consists of a circular graphic on the left, followed by the company name "BonAlive" in a serif font. Below "BonAlive" is the text "BIOMATERIALS LTD" in smaller, uppercase letters. The overall design is simple and professional.

Intended Use:

BonAlive® granules is not indicated for use in load-bearing applications, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

Determination of substantial equivalence:

BonAlive® granules is substantially equivalent to the NovaBone Resorbable Bone Graft Substitute. Both products are intended to be used as bone cavity filling materials which are packed into bone cavities of the skeletal system. Both products consist of bioactive glass with only minor differences in the composition and have been studied extensively. BonAlive® granules functions the same as NovaBone products in similar clinical applications and do not introduce any new issues of safety or effectiveness.

The biocompatibility tests showed the device was safe for the intended uses. Animal and clinical studies showed the device is a well functioning, safe and well tolerated glass material that creates suitable local environment filling of bone cavities.

JK071199|

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BonAlive Biomaterials Ltd Biolinja 12, FI-20750 Turku, Finland t. +358 (0)401 77 4400 f. +358 (0)421 9177 4400 www.bonalive.com

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

MAR 2 3 2012

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

Re: K071199

Trade Name: BonAlive Granules Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 15, 2008 Received: January 16, 2008

Dear Ms. Bundy:

This letter corrects our substantially equivalent letter of February 1, 2008.

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 (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 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

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Page 2 - Ms. Constance G. Bundy

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

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/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 yours,

Erine Keith

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

Enclosure

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Indications for Use

510(k) Number (if known): K071199

Device Name:

BonAlive® granules

Indications for Use:

BonAlive® granules is not indicated for use in load-bearing applications, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

Prescription Use × ( (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Division of Surgical, Orthopedic. and Restorative Devices

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510(k) Number K071199

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.