MagnetOs is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs resorbs and is replaced with bone during the healing process.

Device Description

MagnetOs is a synthetic, osteoconductive and resorbable bone void filler for the repair of bony defects, containing 65-75% Tri-Calcium Phosphate (TCP, Ca3(PQ4)2) and 25-35% Hydroxyapatite (HA, Cas(PO4)3OH).

MagnetOs is gamma sterilized, comes in various sizes in granular or chip form and is sterile packaged for single use only.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called MagnetOs. It's a regulatory submission to the FDA, not a study report demonstrating the device meets a specific acceptance criterion with detailed performance metrics. Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and ground truth establishment are not present in this type of document.

However, I can extract the information that is available and clarify what is not.

Key takeaway: This document asserts "substantial equivalence" to predicate devices based on non-clinical testing and an animal model study, rather than providing numerical acceptance criteria for a specific performance metric and demonstrating the device meets them with a clinical study.

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

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of explicit numerical acceptance criteria for specific performance metrics (e.g., a certain percentage of bone growth, or a measured strength value) and corresponding device performance data to meet those criteria.

Instead, the document's central claim is "substantial equivalence" to predicate devices. The "performance" is stated in terms of equivalence to predicates in various tests.

Acceptance Criteria (Implied)	Reported Device Performance
Chemical Composition Equivalence to predicates	Equivalent chemical composition (XRD, FTIR, ICP/MS analyses performed)
Physical Properties Equivalence to predicates	Equivalent physical properties (SEM, porosimetry, dissolution analyses performed)
Biocompatibility Equivalence to predicates (ISO 10993 series)	Assessed using ISO 10993-1, -3, -5, -6, -10, -11 methodologies. Results demonstrate equivalence.
Performance in Animal Model Equivalence to predicates	"The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate." (Posterolateral spine fusion animal model)

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

Test Set Sample Size: Not explicitly stated in terms of a numerical count for each test. For the animal study, the sample size is not provided.
Data Provenance: The studies were non-clinical (chemical, physical, biocompatibility) and pre-clinical (animal model). The country of origin for the data is not specified, but the applicant (Xpand Biotechnology B.V.) is based in The Netherlands. The studies are retrospective or prospective depending on when they were conducted in relation to the submission date, which is not specified.

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. "Ground truth" in the context of device performance would likely refer to objective measurements of material properties, biological responses, or animal outcomes, not typically expert panel consensus in the way it applies to image analysis algorithms.

4. Adjudication method for the test set:

Not applicable or not described. This is not a study involving human readers or interpretation requiring 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 is a bone void filler device, not an AI-powered diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For chemical, physical, and biocompatibility tests: The ground truth is the scientific measurement or established biological response according to internationally recognized standards (e.g., ISO 10993 standards for biocompatibility).
For the animal model: The ground truth would be histological analysis, imaging results, or other objective measures of bone fusion and new bone formation observed in the animals.

8. The sample size for the training set:

Not applicable. This is not a machine learning device that requires a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

February 24, 2017

Xpand Biotechnology B.V. Ms. Yvonne P. Bovell QA/RA Manager Professor Bronkhorstlaan 10D, Building 48 3723 MB Bilthoven The Netherlands

Re: K161859

Trade/Device Name: MagnetOs Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: January 19, 2017 Received: January 23, 2017

Dear Ms. Bovell:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Division Director Division of Orthopaedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017 See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES. Food and Drug Administration

Indications for Use

510(k) Number (if known) K161859

Device Name MagnetOs

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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510(k) Summary MagnetOs

Date: 19 January 2017

ADMINISTRATIVE INFORMATION

Submitter details:

Name	Xpand Biotechnology B.V.
Address	Professor Bronkhorstlaan 10, building 483723 MB BilthovenThe Netherlands
Telephone	+31-30-2297280
Fax	+31-30-2297299

Contact person:

Name	Yvonne P. Bovell
Position	QA/RA Manager
Telephone	+31-30-2297212
Email	yvonne.bovell@signifix.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	MagnetOs
Classification Name	Resorbable calcium salt bone void filler device
Classification Regulations	21 CFR 888.3045, Class II
Product Code	MQV
Classification Panel	Orthopaedic and Rehabilitation Devices Panel
Reviewing Branch	Restorative Devices Branch

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INTENDED USE

MagnetOs is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MaqnetOs must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

MagnetOs resorbs and is replaced with bone during the healing process.

DEVICE DESCRIPTION

MagnetOs is gamma sterilized, comes in various sizes in granular or chip form and is sterile packaged for single use only.

EQUIVALENCE TO MARKETED DEVICE

MagnetOs is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

Progentix Orthobiology B.V., CuriOs™, cleared under K090641;
Biomatlante SA, MBCP, cleared under K032268, and ●
. IsoTis N.V.. OsSatura™ BCP. cleared under K030131.

The subject device and predicate devices K090641, K032268 and K030131 have the same intended use, the same product classification and product code (MQV), and have similar Indications for Use.

MagnetOs granules are substantially equivalent to the predicate devices CuriOs™ (K090641), MBCP (K0302268) and OsSatura™ BCP (K030131) with respect to design, structure, materials, mechanism of action, and similar Indications for Use in the posterolateral spine.

Between MagnetOs and the CuriOs™, MBCP and OsSatura™ BCP predicate devices, the limited difference are the total porosity, ratio of beta-tricalcium phosphate and hydroxyapatite.

These aspects do not affect the safety and biocompatibility of MagnetOs because of the identical nature of the building blocks of these materials and the site of application (bone).

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Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included chemical composition, physical properties, biocompatibility, and performance characteristics. Biocompatibility of the device was assessed using the methodology described in ISO 10993-1, ISO10993-3, ISO 10993-5, ISO 10993-6. ISO 10993-10 and ISO10993-11.

Material characterization performed included the following:

. chemical composition and crystallinity was analyzed by x-ray diffraction (XRD), and Fourier transform infrared spectroscopy (FTIR),
. trace elemental analysis was performed by inductively coupled plasma/mass spectroscopy (ICP/MS).
surface microstructure was evaluated by scanning electron microscopy (SEM), and ●
physical properties including porosity by mercury intrusion porosimetry, and dissolution.

The analytical characterization demonstrated equivalent chemical composition, physical properties and performance characteristics for the subject MagnetOs and the predicate devices.

The performance of the subject MagnetOs was compared to that of the predicate devices in a posterolateral spine fusion animal model. The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Test results included in Sections 15, 18 and 19 of this submission demonstrate that MagnetOs generated equivalent results in the comparative bench, biocompatibility and pre-clinical animal testing performed compared to the predicate devices.

Overall. MagnetOs has the following similarities to the predicate devices:

has the same intended use,
has the same product classification and product code (MQV), ●
has similar Indications for Use,
uses the same operating principle,
incorporates the same basic design,
. incorporates the same or very similar materials, and is manufactured at the same facility using very similar processes as predicate, CuriOs™ Granules (K090641).

CONCLUSION

The above testing demonstrates that MagnetOs is as safe, as effective and performs as well as or better than the legally marketed predicate devices CuriOs™ (Progentix Orthobiology B.V.), OsSatura™ BCP (IsoTis N.V.) or MBCP (Biomatlante SA).

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.