MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs Putty 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 Putty resorbs and is replaced with bone during the healing process.

Device Description

MagnetOs Putty is a synthetic, resorbable and osteoconductive bone void filler for the repair of bony defects, containing 65-75% Tri-Calcium Phosphate (TCP, Cas(PQ2)>) and 25-35% Hydroxyapatite (HA. Cag(PO2)3OH) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.

MagnetOs Putty is gamma-sterilized, comes in four sizes in block form and is sterile packaged for single use only.

AI/ML Overview

The provided document is a 510(k) premarket notification for the MagnetOs Putty device. It details the device's substantial equivalence to existing predicate devices, focusing on non-clinical testing. However, it does NOT provide the acceptance criteria or a study that uses such criteria to prove the device meets them in the context of diagnostic accuracy or performance against specific metrics as would be expected for an AI/CADe device.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies for AI are not applicable to this document. The document describes a comparison to predicate devices, which is a different type of assessment than proving performance against defined acceptance criteria typically seen for diagnostic devices.

Here's the closest possible interpretation of the requested information based on the provided text:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that the device must achieve. Instead, it demonstrates "substantial equivalence" to predicate devices through various non-clinical tests. The "performance" is implicitly deemed acceptable if it is found to be equivalent to the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent chemical composition to predicate devices	Achieved through XRD, FTIR, NMR, OVI, ICP/MS analysis
Equivalent physical properties to predicate devices	Achieved through Mercury intrusion porosimetry, dissolution, IV analysis
Equivalent surface microstructure and bioactivity to predicate devices	Achieved through SEM and in vitro SBF immersion study
Biocompatibility in accordance with ISO 10993 standards and USP <151>	Assessed using methodology described in ISO 10993-1, -3, -5, -6, -10, -11 and USP <151>
Equivalent performance in a posterolateral spine fusion animal model to predicate devices	Demonstrated in a posterolateral spine fusion animal model
Same intended use as predicate devices	MagnetOs Putty has the same intended use.
Same product classification and product code (MQV)	MagnetOs Putty has the same classification and product code.
Similar Indications for Use as predicate devices	MagnetOs Putty has similar Indications for Use.
Same operating principle as predicate devices	MagnetOs Putty uses the same operating principle.
Same basic design as predicate devices	MagnetOs Putty incorporates the same basic design.
Same or very similar materials as predicate devices	MagnetOs Putty incorporates the same or very similar materials.
Manufactured at the same facility using very similar processes as predicate MagnetOs Granules (K161859)	Manufactured at the same facility using very similar processes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions an "animal model" for the posterolateral spine fusion study. However, it does not specify the sample size (number of animals or cases) used for this test set, nor does it provide details on data provenance beyond acknowledging it was an "animal model." The studies are pre-clinical, meaning they are conducted in a laboratory setting or on animals, not human patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. Given that the testing included an "animal model" and material characterization, the "ground truth" would likely be established by experimental measurements and observations by laboratory personnel or veterinary specialists, rather than clinical experts like radiologists.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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 such MRMC comparative effectiveness study was described, as this device is a bone void filler, not an AI/diagnostic imaging device that would assist human readers.

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

This concept is not applicable to the MagnetOs Putty device, which is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the material characterization, the "ground truth" would be established by scientific measurement techniques (e.g., XRD, FTIR, SEM, ICP/MS, porosimetry) and comparison to known material properties of the predicate devices. For the animal study, the "ground truth" would be established by histological analysis, imaging, or other relevant assessment of bone healing and fusion in the animal model.

8. The sample size for the training set

The concept of a "training set" is not applicable as this is not an AI/machine learning device.

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

Not applicable.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

August 24, 2017

Re: K171563

Trade/Device Name: MagnetOs Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: May 23, 2017 Received: May 30, 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Mark N. Melkerson -S

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

Enclosure

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K171563 Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171563

Device Name

MagnetOs Putty

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.

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FORM FDA 3881 (8/14)

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510(k) Summary MagnetOs Putty

Date: 09Aug17

ADMINISTRATIVE INFORMATION

Submitter details:
Name	Kuros Biosciences 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 Putty
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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INDICATIONS FOR USE

MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MaqnetOs Putty 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 Putty resorbs and is replaced with bone during the healing process.

DEVICE DESCRIPTION

MagnetOs Putty is gamma-sterilized, comes in four sizes in block form and is sterile packaged for single use only.

EQUIVALENCE TO MARKETED DEVICE

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

Xpand Biotechnology B.V., MaqnetOs (granules), cleared under K161859; .
Note: Xpand Biotechnology B.V. is the previous company name of Kuros Biosciences B.V.
Proqentix Orthobiology B.V., AttraX Putty, cleared under K151584; .
. Biostructures LLC, Signafuse Bioactive Bone Graft Putty; cleared under K132071;
Synthes; chronOS Composite; cleared under K071046. .

The subject device and predicate devices K161859, K151584, K132071, and K071046 have the same intended use, the same product classification and product code (MQV), and have similar Indications for Use.

MagnetOs Putty is substantially equivalent to the predicate MagnetOs Granules (K161859). MaqnetOs Putty consists of the identical MagnetOs ceramic granules cleared under K161859 which are therefore equivalent with respect to design, structure, materials, manufacturer, methods of production and testing, mechanism of action, and Indications for Use in the posterolateral spine. The only difference between the two devices is that MagnetOs Putty has the granules premixed with a rapidly resorbing polymeric binder (LEOL) that acts as a temporary binder for the granules to facilitate handling and has no effect on device functionality after in vivo implantation.

The LEOL binder is a PLA-PEG-PLA that resorbs rapidly after implantation into PEG and PLA components. These components have a known history of use in binder formulation for ceramic granules in the predicate devices: AttraX Putty (K151584); Bioactive Bone Graft Putty (K132071), and ChronOS Composite (K071046), all bone void fillers with Indication for use similar to those of MagnetOs Putty.

The LEOL binder material is rapidly resorbed after implantation, allowing for osteoconductive bone growth on the granules. As a result. MagnetOs Putty and the predicate MagnetOs Granules are equivalent in term of mechanism of action (same fundamental technology): they both provide the same osteoconductive calcium salt bone

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void filler which resorbs and is replaced by bone during the natural process of bone healing. Both devices have equivalent Indications for Use.

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included chemical composition, physical properties, biocompatibility, and performance characteristics in accordance with FDA recognized consensus standards and FDA guidance documents as applicable.

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, ISO10993-11 and USP <151>.

Material characterization performed included the following:

. chemical composition was analyzed by x-ray diffraction (XRD), and Fourier transform infrared spectroscopy (FTIR), Nuclear Magnetic Resonance (NMR), Organic Volatile Impurities (OVI)
. trace elemental analysis was performed by inductively coupled plasma/mass spectroscopy (ICP/MS).
surface microstructure and bioactivity were evaluated by scanning electron microscopy (SEM) and in vitro surface mineralization study (following immersion in simulated body fluid (SBF)), and
physical properties including porosity by mercury intrusion porosimetry, dissolution, molecular weight by inherent viscosity (IV).

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

The performance of the subject MaqnetOs Putty 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 Putty generated equivalent results in the comparative bench, biocompatibility and pre-clinical animal testing performed compared to the predicate devices.

Overall, MaqnetOs Putty 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. MagnetOs Granules (K161859).

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CONCLUSION

The above testing demonstrates that MagnetOs Putty is as safe, as effective and performs as well as or better than the legally marketed predicate devices MagnetOs Granules (K161859, Xpand Biotechnology B.V.), AttraX Putty (K151584, Progentix B.V.), Signafuse Bioactive Bone Graft Putty (K132071, Biostructures LLC) and chronOs Composite (K071046, Synthes).

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.