The ROCCIA® MultiLIF 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 devices are to be used in patients who have had at least six months of non-operative treatment.

The ROCCIA® MultiLIF 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® MultiLIF 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® MultiLIF implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Device Description

The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy. The cage has a large cylindrical hollow in the middle which can be filled with bone material. The cage has numerous threaded holes that allow for correct placement of the cage.

The ROCCIA MultiLIF cage is available in a range of sizes to accommodate individual patient pathology and anatomical conditions.

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 MultiLlF, 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 future implantation procedures.

The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy conforming to ASTM F136. The ROCCIA instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F899.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ROCCIA® MultiLIF intervertebral body fusion device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials for effectiveness in the same way a PMA would require. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of substantial equivalence to a predicate device, primarily through non-clinical performance testing.

Here's the information extracted and organized based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically met by demonstrating that the device performs equivalently to the predicate device in relevant non-clinical tests. The reported device performance is that it met these equivalence standards.

Acceptance Criteria (Demonstrated Equivalence to Predicate Device)	Reported Device Performance (ROCCIA® MultiLIF)
Mechanical Load Testing (according to ASTM F2077)	Demonstrated comparable results to the predicate device.
Subsidence Behavior Testing (according to ASTM F2267)	Demonstrated comparable results to the predicate device.
Static Expulsion Testing	Demonstrated comparable results to the predicate device.
Materials (Ti6Al4V ELI alloy conforming to ASTM F136 for cage)	Conforms to the specified standard, which is typically considered equivalent to or an acceptable alternative to the predicate's material if it meets performance. Explicit comparison to predicate material not detailed but implied by overall substantial equivalence claim.
Indications for Use	Substantially equivalent to the predicate device (NuVasive® CoRoent® Thoracolumbar System). The text explicitly states "the indications for use are equivalent to the predicate device." Replication of the predicate's intended use in skeletally mature patients for intervertebral body fusion.
Principles of Operation	Substantially equivalent to the predicate device.
Technological Characteristics	Substantially equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of clinical trials with human subjects for this specific submission. The "test set" for performance evaluation involved in vitro mechanical testing of the device and a predicate. The specific number of physical device samples tested for each non-clinical test (mechanical load, subsidence, static expulsion) is not specified in the provided document.
Data Provenance: The data comes from non-clinical performance tests conducted by Silony Medical GmbH, presumably in a laboratory setting. There is no mention of country of origin for this testing, nor is it a retrospective or prospective human clinical data set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. The "ground truth" for the non-clinical tests is established by adherence to recognized international and national standards (e.g., ASTM F2077, ASTM F2267) and internal requirements. There isn't a human expert "ground truthing" process for these engineering performance tests in the same way there would be for an AI diagnostic device.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of cases in clinical studies or for AI ground truth labeling. The "test set" here refers to physical device testing against engineering standards, not human-interpreted data.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a physical intervertebral body fusion device, not a diagnostic AI or imaging device that would typically involve human readers.

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

No standalone (algorithm only) performance study was done. This device is a physical medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For non-clinical performance evaluation, the "ground truth" is defined by established engineering standards and pre-defined acceptable performance ranges for the physical device, typically benchmarked against the predicate device's performance in the same tests. For the overall submission, the primary ground truth is the substantial equivalence of the device to its predicate, as determined by the FDA based on the provided non-clinical data and comparison of intended use, technological characteristics, and materials.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set was used.

Summary

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December 21, 2017

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Silony Medical GmbH % Indraj Bamrah Senior Regulatory Consultant Emergo Global Consulting. LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K171434

Trade/Device Name: ROCCIA® MultiLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM Dated: November 30, 2017 Received: December 4, 2017

Dear Indraj Bamrah:

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

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Page 2 - Indraj Bamrah

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Katherine D. Kavlock -S

for

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) K171434

Device Name ROCCIA® MultiLIF

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)

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510(k) Summary

ROCCIA® MultiLIF

K171434

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

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746

Office Phone: (512) 327.9997

Contact: Indraj Bamrah, Senior Regulatory Consultant

Email: project.management@emergogroup.com

3. Date Prepared

December 19, 2017

4. Device Identification

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

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Page 2 of 4 Regulation Number: 888.3080 Product Code: MAX, Intervertebral Fusion Device with Bone Graft, Lumbar PHM, Intervertebral Fusion Device with Bone Graft, Thoracic Device Class: Class II Classification Panel: Orthopedic

K171434

5. Legally Marketed Predicate Device

Primary Predicate: K153419, NuVasive® CoRoent® Thoracolumbar System, NuVasive, Incorporated.

6. Device Description

The ROCCIA MultiLIF cage is available in a range of sizes to accommodate individual patient pathology and anatomical conditions.

The ROCCIA MultiLIF cage is manufactured from Ti6Al4V ELI alloy conforming to ASTM F136. The ROCCIA instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F899.

7. Indications for Use Statement

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the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

The ROCCIA® MultiLIF implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

8. Substantial Equivalence Discussion

The ROCCIA MultiLIF has 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 MultiLlF and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Silony Medical GmbH completed a number of non-clinical performance tests. The ROCCIA MultiLIF is substantially equivalent to predicate devices.

The ROCCIA MultiLIF 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 – Comparison performed with subject device and predicate device showing comparable results when tested in accordance with ASTM F2077.
Subsidence Behavior Testing – Comparison performed with subject device and predicate device showing comparable results when tested in accordance with ASTM F2267.
. Static Expulsion Testing – Comparison performed with subject device and predicate device showing comparable results when tested.

10. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use are 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.

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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 has different technological characteristics but design control activities show that the differences do not raise new questions of safety and effectiveness when compared to the predicate. Based on the comparison and analysis above, the ROCCIA MultiLIF is determined to be substantially equivalent to the referenced predicate device.

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.