The ROCCIA® ACIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ROCCIA ACIF is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the ROCCA ACIF device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

Device Description

The ROCCIA ACIF was developed for primary stabilization of the cervical spine. Treatment is carried out using anterior cervical discectomy and fusion (ACDF) surgery for patients with symptomatic degenerative disc problems. The system as a cage design improves interbody fusion as its generously proportioned design allows for the insertion of either bone or bone substitute materials. At the same time, the cage has a broad supporting surface that largely prevents sinking when implanted correctly.

The ROCCIA ACIF Cage is manufactured from PEEK material. The cage has a large cylindrical hollow in the middle which can be filled with bone material or bone substitute material. The large volume of filling material is in direct contact with the patient's vertebra and supports the fusion of the cage with the bone. The load transmission from the vertebra to the cage is effected via a solid frame construction around the hollow recess. The base and cover plates of the cage have a serrated surface which supports the primary anchorage of the cage.

The cage is available in two different versions: a wedge-shaped version and an anatomic version. The design of the upper and lower surface of the cage corresponds to the respective opposite surface of the intervertebral disc. The upper surface component of the anatomic cage is convex, while the lower side is aligned straight in order to match the natural anatomy of the end plate. The four (4) titanium markers project from the surface of the cage above and below and penetrate into the vertebrae when the cage is inserted. This penetration serves for preliminary fixation of the cage. The markers furthermore support the location and verification of correct positioning of the X-ray images. This positioning is additionally supported by two integrated horizontal titanium marker pins.

The ROCCIA instrumentation is ergonomically appropriate and designed as modular components. The ROCCIA insertion device enables the user to perform various instrumentation steps with just a single instrument. The instruments are designed to be used with the ROCCIA ACIF, and are made of materials common for medical devices used in implantable device instrumentation tools. The instruments are intended to be cleaned, sterilized, and reused for the purposes of the multiple implantation procedure.

The ROCCIA ACIF Cage is manufactured from PEEK conforming to ASTM F2026 and the titanium markers are manufactured from Ti6A4V ELI, conforming to ASTM F136. The ROCCIA instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F898.

AI/ML Overview

This document is a 510(k) summary for the ROCCIA® ACIF intervertebral body fusion device. It does not describe a study that proves the device meets acceptance criteria in the typical sense of a clinical performance study with defined acceptance criteria for efficacy or safety. Instead, it aims to demonstrate substantial equivalence to a predicate device based on non-clinical performance data.

Therefore, many of the requested categories for a clinical effectiveness study will not be applicable or directly available from this document. I will fill in the information that is present and indicate where information is not available.

Acceptance Criteria and Device Performance (based on Non-Clinical Testing for Substantial Equivalence)

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to a previously cleared predicate device (K150362, NuVasive CoRoent Small Interbody System). This means the device must perform comparably to the predicate device in non-clinical tests and not raise new questions of safety or effectiveness. The document lists the tests performed and states that the device "passed" or showed "comparable results."

Acceptance Criteria Category	Reported Device Performance
Mechanical Load Testing	Passed the requirements required by standards ASTM 2077 and ASTM 2267 for static axial compression, static compression, static axial torsional, cyclic compression, and cyclic torsion.
Mechanical Load Testing Aged	After placing product for one (1) year and five (5) year aging, passed the requirements for standard ASTM 2077 for cyclic compression.
Finite Element Analysis (FEA)	Comparison performed with subject device and predicate device showed acceptable results as compared to the predicate device.
Subsidence Behavior Testing	Comparison performed with subject device and predicate device showing comparable results.
Static Expulsion Testing	Comparison performed with subject device and predicate device showing comparable results.
Biocompatibility	Biological evaluation was performed on known materials supporting that no toxic substances or materials are used; materials used in marketed implant devices.
Cleaning and Sterilization Testing	Passed the requirements for sterilization for irradiation to ISO 11137 meeting an SAL of 10⁻⁶ and cleaning validation passed the established requirements.
Shelf Life Testing	Packaging and shelf life were validated for 5 years.
Storage and Transport Testing	Shipping and transport validation supported there were no adverse effects to the product packaging and remained in a sterile state.
Overall Design, Sterilization, Performance	Meets all the requirements for overall design, sterilization, biocompatibility, and performance testing results confirming that the design output meets the design inputs and specifications for the device.
Safety and Effectiveness (Clinical)	Not directly assessed by a clinical study for this 510(k). The submission states: "These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device." The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

Study Details Pertaining to Device Performance (from the document)

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

Test Set Sample Size: Not applicable. The "test set" in this context refers to the ROCCIA® ACIF devices and materials subjected to non-clinical performance testing (mechanical, structural, biological). The document does not specify the number of units or samples used for each non-clinical test.
Data Provenance: The tests were conducted to specific national and international standards (e.g., ASTM, ISO). The location of the testing laboratories is not specified, but the sponsor is based in Germany.

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 sense of clinical expert consensus or pathology for diagnostic performance, is not relevant for this type of non-clinical substantial equivalence submission. The "ground truth" for these tests comes from established engineering and biocompatibility standards.

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

Not applicable. Adjudication methods are typically associated with clinical studies where expert consensus is needed to establish a definitive diagnosis or outcome. Here, performance is measured against objective engineering and material standards.

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 an intervertebral body fusion device, not a diagnostic imaging AI tool. No MRMC study was conducted or is relevant.

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

Not applicable. This is not an algorithm or AI device. The device's performance is standalone in the sense that its mechanical and biological properties are tested intrinsically and compared to standards/predicate devices.

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

Non-Clinical Ground Truth: Established engineering standards (e.g., ASTM F2077, ASTM F2267) for mechanical properties, ISO 11137 for sterilization, and biocompatibility standards for materials (ASTM F2026, ASTM F136). The predicate device's performance also serves as a comparative "ground truth" for achieving substantial equivalence.
Clinical Ground Truth: No clinical ground truth (expert consensus, pathology, outcomes data) was used or required for this 510(k) submission, as it relied on substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of this 510(k) submission, as it's not a machine learning or AI device.

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

Not applicable. See point 8.

Summary

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

January 26, 2017

Silony Medical GmbH % Mr. Richard Vincins Vice President, QA/RA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K162587

Trade/Device Name: ROCCIA® ACIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 23, 2016 Received: December 28, 2016

Dear Mr. Richard Vincins:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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/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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Indications for Use

510(k) Number (if known) K162587

Device Name ROCCIA® ACIF

Indications for Use (Describe)

The ROCCIA ACIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ROCCIA ACIF is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the ROCCA ACIF device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

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)

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510(k) Summary

ROCCIA® ACIF

K162587

1. Submission Sponsor

Silony Medical GmbH

Leinfelder Straße 60

70771 Leinfelden-Echterdingen

GERMANY

Phone number: +49 711 78 25 25 40

Contact: Bircan YILMAZ

Title: Head of Quality Management and Regulatory Affairs

2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746

Office Phone: (512) 327.9997

Contact: Richard A. VINCINS, Vice President, QA/RA

Email: project.management@emergogroup.com

3. Date Prepared

25 January 2017

4. Device Identification

Trade/Proprietary Name:	ROCCIA® ACIF
Common/Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Body Fusion Device

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Regulation Number:	888.3080
Product Code:	ODP, Intervertebral Fusion Device with Bone Graft, Cervical
Device Class:	Class II
Classification Panel:	Orthopedic

5. Legally Marketed Predicate Device

Primary Predicate: K150362, NuVasive CoRoent Small Interbody System, NuVasive Incorporated

6. Device Description

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7. Indication for Use Statement

The ROCCIA® ACIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ROCCIA ACIF is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the ROCCIA ACIF device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

8. Substantial Equivalence Discussion

The ROCCIA ACIF has been shown to be substantially equivalent to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing.

9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of ROCCIA ACIF and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Silony Medical completed a number of non-clinical performance tests. The ROCCIA ACIF meets all the requirements for overall design, sterilization, biocompatibility, and performance testing results confirming that the design output meets the design inputs and specifications for the device.

The ROCCIA ACIF passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

. Mechanical Load Testing – Passed the requirements required by standards ASTM 2077 and ASTM 2267 for static axial compression, static compression, static axial torsional, cyclic compression, and cyclic torsion
. Mechanical Load Testing Aged – After placing product for one (1) year and five (5) year aging, passed the requirements for standard ASTM 2077 for cyclic compression
Finite Element Analysis – Comparison performed with subject device and predicate device showed acceptable results as compared to the predicate device
Subsidence Behavior Testing – Comparison performed with subject device and predicate device showing comparable results
. Static Expulsion Testing – Comparison performed with subject device and predicate device showing comparable results
Biocompatibility – Biological evaluation was performed on known materials supporting that no toxic substances or materials are used; materials used in marketed implant devices

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Cleaning and Sterilization Testing Passed the requirements for sterilization for ● irradiation to ISO 11137 meeting an SAL of 10 ° and cleaning validation passed the established requirements
. Shelf Life Testing – Packaging and shelf life were validated for a 5 years
Storage and Transport Testing – Shipping and transport validation supported there were no adverse effects to the product packaging and remained in a sterile state

10. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).

The ROCCIA ACIF, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.