The ROCCIA TLIF and ROCCIA ALIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment.

The ROCCIA TLIF Cage implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12- L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

The ROCCIA TLIF and ROCCIA ALIF Cage implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ROCCIA TLIF Cage implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Device Description

The ROCCIA® Transforaminal Lumbar Interbody Fusion (ROCCIA® TLIF) and ROCCIA® Anterior Lumbar Interbody Fusion (ROCCIA® ALIF) cages are implants for the primary stabilization and restoration of the physiologic lordosis of the lumbar and thoracic spine. Subject device implants are manufactured from Titanium Alloy Ti6Al4V ELI per ASTM F136. The ROCCIA® TLIF and ROCCIA® ALIF cages are offered in a variety of sizes to facilitate a variety of patient anatomies.

The ROCCIA® instrumentation is ergonomically appropriate and designed as modular components. The instruments are designed to be used with the ROCCIA® Transforaminal Lumbar Interbody Fusion (TLIF) and ROCCIA® Anterior Lumbar Interbody Fusion (ALIF), and are made of materials commonly used to manufacture medical device instruments. The instruments are intended to be cleaned, sterilized, and reused for the purposes of future implantation procedures.

AI/ML Overview

This document is a 510(k) summary for the ROCCIA® TLIF and ROCCIA® ALIF intervertebral body fusion devices. It's a regulatory submission to the FDA, demonstrating substantial equivalence to previously approved devices. Therefore, it does not include information on acceptance criteria for device performance in a clinical study to assess its diagnostic accuracy or effectiveness against a clinical outcome, as would be typical for AI/ML-driven diagnostic devices.

Instead, the "acceptance criteria" here refer to the mechanical performance of the implantable device, which is evaluated against recognized ASTM standards for intervertebral body fusion devices. The "study" proving this is a series of non-clinical, laboratory-based mechanical tests.

Here's the breakdown of the information you requested, based on the provided document:

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

Test Mode	Acceptance Standard	Reported Device Performance (Summary)
Static axial compression	ASTM F2077-11	Demonstrated substantially equivalent mechanical performance compared to predicate devices.
Static shear compression	ASTM F2077-11	Demonstrated substantially equivalent mechanical performance compared to predicate devices.
Dynamic axial compression	ASTM F2077-11	Demonstrated substantially equivalent mechanical performance compared to predicate devices.
Dynamic compression-shear	ASTM F2077-11	Demonstrated substantially equivalent mechanical performance compared to predicate devices.
Static Subsidence	ASTM F2267-04	Demonstrated substantially equivalent mechanical performance compared to predicate devices.
Static Expulsion	S-01:2013 (likely an internal or industry standard)	Demonstrated substantially equivalent mechanical performance compared to predicate devices.

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

This document discusses non-clinical mechanical testing, not clinical studies with patient data. Therefore, the concept of a "test set" and "data provenance" as applied to clinical data does not directly apply. The "sample size" would refer to the number of devices tested in the lab for each mechanical test. This specific number is not explicitly stated in the provided text. The tests are conducted in a laboratory setting, not a clinical one.

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 is a non-clinical mechanical performance evaluation. There were no experts establishing ground truth in terms of clinical diagnoses or outcomes, as no human-based diagnostic performance is being evaluated. The "ground truth" for these tests are the established physical properties and behaviors defined by the ASTM standards themselves.

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

Not applicable, as this is non-clinical mechanical testing, not a clinical study requiring human expert adjudication of results.

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 document is for an implantable medical device (intervertebral body fusion cage), not an AI/ML diagnostic or assistive device.

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.

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

The ground truth used for these tests are the established mechanical testing standards (ASTM F2077-11, ASTM F2267-04, and S-01:2013) for intervertebral body fusion devices. These standards define the parameters and acceptable ranges for static and dynamic loading, subsidence, and expulsion.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym followed by the words "U.S. Food & Drug Administration" on the right. The Department of Health and Human Services logo is a stylized human figure, while the FDA text is in blue.

Silony Medical GmbH % Ms. Meredith May Vice President Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K180963

Trade/Device Name: ROCCIA® TLIF and ROCCIA® ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM Dated: March 5, 2018 Received: April 12, 2018

Dear Ms. May:

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 mav, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

July 11, 2018

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

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Brent Showalter -S" in a large, sans-serif font. The text is black and stands out against a light background. The name is likely that of a person, and the "-S" could be an initial or some other identifier.

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)	K180963
Device Name	ROCCIA® TLIF and ROCCIA® ALIF
Indications for Use (Describe)	The ROCCIA TLIF and ROCCIA ALIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment.The ROCCIA TLIF Cage implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12- L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).The ROCCIA TLIF and ROCCIA ALIF Cage implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ROCCIA TLIF Cage implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ 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 ServicesFood 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."

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

510(K) SUMMARY

ROCCIA® TLIF AND ROCCIA® ALIF

1. Submission Sponsor

Silony Medical GmbH Leinfelder Straße 60 70771 Leinfelden-Echterdingen GERMANY Phone number: +49 711 78 25 25 40 Contact: Bircan TASDELEN Title: Head of Quality Management and Regulatory Affairs

2. Submission Correspondent

Contact: Meredith May, MS, RAC Phone number: 719-337-7579 Email: MeredithMay@EmpiricalConsulting.com

3. Date Prepared 05-Apr-2018

4. Device Identification

Trade/Proprietary Name:	ROCCIA® TLIF and ROCCIA® ALIF
Common/Usual Name:	Intervertebral Fusion Device
Classification:	Intervertebral Body Fusion Device
Regulation Number:	888.3080
Product Code:	MAX, Intervertebral Fusion Device with Bone Graft, LumbarPHM, Intervertebral Fusion Device with Bone Graft, Thoracic

Device Class:	Class II
Classification Panel:	Orthopedic

5. Predicate Devices

Primary Predicate: K171434, ROCCIA® MultiLIF Cage, Silony Medical Additional Predicate: K141217, AccuLIF® TL and PL Cage, Stryker Additional Predicate: K072253, SynFix-LR, Synthes Additional Predicate: K151214, ALIF Interfixed System, NuVasive® Additional Predicate: K153720, ENZA Zero-Profile Anterior IBFD, Camber Spine

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

6. Device Description

7. Indications for Use

The ROCCIA TLIF Cage implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

8. Substantial Equivalence Discussion

ROCCIA® TLIF and ROCCIA® ALIF cages has shown to be substantial equivalent to the predicate devices with respect to principles of operation, indications for use, materials of manufacture, implant size range, sterility.

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

9. Non-Clinical Performance Data

The ROCCIA® TLIF and ROCCIA® ALIF cages has been tested in the following test modes:

Static axial compression per ASTM F2077-11
Static shear compression per ASTM F2077-11
Dynamic axial compression per ASTM F2077-11 ●
Dynamic compression-shear per ASTM F2077-11 ●
Static Subsidence per ASTM F2267-04 ●
Static Expulsion per S-01:2013 ●

The results of this non-clinical testing demonstrates the substantially equivalent mechanical performance of the ROCCIA® TLIF and ROCCIA® ALIF as compared to legally marketed predicate devices.

10. Statement of Substantial Equivalence

Based on the comparison and analysis above, the ROCCIA® TLIF and ROCCIA® ALIF cages are determined to be substantially equivalent to the referenced predicate devices.

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.