AttraX Putty is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects resulting from traumatic injury to the bone. AttraX Putty is intended to be used in conjunction with autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. AttraX Putty provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Device Description

AttraX Putty is a synthetic, osteoconductive and resorbable bone void filler device consisting of ceramic granules premixed with a polymeric binder that provides cohesion between the granules of AttraX Putty are composed of beta-tricalcium phosphate (beta-TCP > 90%) and hydroxyapatite (HA <10 %). The granule size range is from 500 to 1000 um. The premixed binder is alkylene oxide copolymer (AOC). AttraX Putty is provided in various configurations as cylinders, strips, and blocks.

AI/ML Overview

The provided text is a 510(k) summary for the medical device AttraX Putty. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain acceptance criteria for device performance or a detailed study proving the device meets specific acceptance criteria in the format requested.

Instead, it relies on non-clinical testing and an animal study to demonstrate substantial equivalence to legally marketed predicate devices. The document aims to show that AttraX Putty is as safe and effective as existing devices, rather than meeting predefined numerical performance targets.

Here's a breakdown of what can be extracted and what information is missing based on your request:

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

This information is not present in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices based on similarities in design, materials, and overall performance in non-clinical and animal studies, rather than against specific quantitative acceptance criteria for device performance.

While the document states, "The analytical characterization demonstrated equivalent chemical composition, physical properties and performance characteristics for the subject AttraX Putty and the predicate AttraX Granules," and "The performance of the subject AttraX Putty was compared to that of the predicate AttraX Granules 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," these are qualitative statements about equivalence, not numerical acceptance criteria or performance metrics.

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

Sample size for the test set: The specific sample size for the "posterolateral spine fusion animal model" is not explicitly stated.
Data provenance: The country of origin and whether the study was retrospective or prospective are not specified. The submitter, Progentix Orthobiology B.V., is located in The Netherlands, which might suggest the study was conducted there or overseen by them, but this is not definitively stated for the animal model.

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 present. The study referenced is an "animal model" and doesn't mention human experts establishing ground truth for a test set in the way an AI diagnostic study would.

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

This information is not applicable and not present. Adjudication methods are typically used in studies involving human readers or expert panels to resolve discrepancies in ground truth establishment for diagnostic performance evaluation, which is not the focus here.

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 information is not present and not applicable. The document describes a medical device (a bone void filler), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be part of this 510(k) submission.

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

This information is not present and not applicable. This is a medical device, not an algorithm.

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

For the "posterolateral spine fusion animal model," the "ground truth" would likely be based on:

Histopathology/Microscopic analysis: To assess new bone formation, resorption of the material, and tissue integration.
Imaging (e.g., X-ray, CT): To evaluate bone fusion and material degradation over time.
Biomechanical testing: To assess the strength of the fusion.

However, the specific methods are not detailed beyond stating "The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate."

8. The sample size for the training set:

There is no mention of a "training set" as this is not an AI/machine learning device. The non-clinical and animal studies serve as verification and validation activities for the device itself.

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

Not applicable, as there is no training set mentioned for an AI/machine learning context.

Summary of what the document DOES provide regarding studies:

The document mentions several types of studies and testing without providing explicit "acceptance criteria" or detailed performance metrics as requested for an AI diagnostic device.

Non-clinical testing:
- Biocompatibility testing: Performed using methods described in ISO 10093-1, ISO 10093-3, ISO 10093-5, ISO 10093-6, ISO 10093-10, and ISO 10093-11. (Results: Not detailed, but implied to be acceptable for substantial equivalence).
- Material characterization:
  - Chemical composition and crystallinity by x-ray diffraction (XRD), Fourier transform infrared spectroscopy (FTIR), and organic volatile impurity analysis (OVI).
  - Trace elemental analysis by inductively coupled plasma/mass spectroscopy (ICP/MS).
  - Surface microstructure and mineralization by scanning electron microscopy (SEM).
  - Physical properties including porosity by mercury intrusion porosimetry, dissolution, and water content.
  - Reported performance: "The analytical characterization demonstrated equivalent chemical composition, physical properties and performance characteristics for the subject AttraX Putty and the predicate AttraX Granules."
Animal study:
- Study type: "posterolateral spine fusion animal model."
- Purpose: Compared the performance of AttraX Putty to the predicate AttraX Granules.
- Reported performance: "The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate."

In conclusion, this document is a regulatory submission for a traditional medical device demonstrating substantial equivalence, not an AI performance study with explicit acceptance criteria and detailed study parameters for an algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.

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

October 8, 2015

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

Re: K151584 Trade/Device Name: AttraX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 27, 2015 Received: August 31, 2015

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

{1}------------------------------------------------

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/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 Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

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) K151584

Device Name AttraX 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.

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)

{3}------------------------------------------------

510(k) Summary AttraX Putty

Date: 10 June 2015

ADMINISTRATIVE INFORMATION

Classification Regulations

Product Code

Classification Panel

Reviewing Branch

Submitter details:
Name	Progentix Orthobiology 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@progentix.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name	AttraX Putty
Common Name	Filler, bone void, calcium compound
Classification Name	Resorbable calcium salt bone void filler device

MQV

21 CFR 888.3045, Class II

Restorative Devices Branch

Orthopaedic and Rehabilitation Devices Panel

{4}------------------------------------------------

INTENDED USE

AttraX Putty is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. AttraX Putty is intended to be used in conjunction with autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. AttraX Putty provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

DEVICE DESCRIPTION

AttraX Putty is a synthetic, osteoconductive and resorbable bone void filler device consisting of ceramic granules premixed with a polymeric binder that provides cohesion between the granules of AttraX Putty are composed of beta-tricalcium phosphate (β-ΤCP > 90%) and hydroxyapatite (HA <10 %). The granule size range is from 500 to 1000 um. The premixed binder is alkylene oxide copolymer (AOC). AttraX Putty is provided in various configurations as cylinders, strips, and blocks.

EQUIVALENCE TO MARKETED DEVICE

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

Progentix Orthobiology B.V., CuriOs™, cleared under K090641; and

ApaTech Limited, Actifuse™ Shape, cleared under K080736.

"AttraX Granules" is an alternate name for the predicate CuriOs™ device cleared under K090641. Therefore, the name AttraX Granules is used when referring to the predicate K090641 CuriOs™ device throughout this 510(k) submission.

The subject device and predicate devices K090641, and K080736 have the same intended use, the same product classification and product code (MQV), and have similar Indications for Use. Moreover, the subject device has the same AOC binder component as the predicate device K080736.

AttraX Putty is substantially equivalent to the predicate AttraX Granules (K090641) because AttraX Putty consists of equivalent ceramic granules with respect to design, structure, materials, testing, mechanism of action, and similar Indications for Use in the posterolateral spine. The 500 to 1000 um granules size range used in K090641 is the exact same granules used in AttraX Putty to facilitate optimal handling. The only difference is that AttraX Putty has the granules premixed with a rapidly dissolving polymeric binder (AOC) that acts as a temporary binder for the granules. The polymeric binder used is Alkylene Oxide Copolymer (AOC). which also has been cleared in a similar bone void filler (Actifuse™ Shape, K080736).

Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.

{5}------------------------------------------------

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included chemical composition, physical properties, biocompatibility, and performance characteristics. Biocompatibility testing was performed using methods described in ISO 10093-1, ISO 10093-3, ISO 10093-5, ISO 10093-6, ISO 10093-10, and ISO 10093-11.

Material characterization performed included the following:

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

The analytical characterization demonstrated equivalent chemical composition, physical properties and performance characteristics for the subject AttraX Putty and the predicate AttraX Granules. In addition, the same AOC binder is used in combination with calcium phosphate granules in the predicate device Actifuse™ Shape, K080736.

The performance of the subject AttraX Putty was compared to that of the predicate AttraX Granules 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.

Overall, AttraX 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 by same o manufacturer using same processes as predicate. AttraX Granules (K090641).

CONCLUSION

The above testing demonstrates that AttraX Putty is as safe, as effective and performs or well as or better than the legally marketed predicate devices CuriOs™ (Progentix Orthobiology), and Actifuse™ Shape (Apatech).

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.