The ROCCIA PLIF System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the ROCCIA PLIF System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Device Description

The ROCCIA PLIF cage is manufactured from polyetheretherketone (PEEK) according ASTM F2026. The cage is equipped with a chamber system that can be filled with autogenous bone graft. The integrated x-ray markers which are made of tantalum according ASTM F560 enable a presentation of the implant during insertion and postoperative control examinations.

The ROCCIA PLIF cage is available in different sizes and angles. The implants are single use devices. 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 PLIF, 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 instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F899.

AI/ML Overview

This document is a 510(k) premarket notification for the ROCCIA® PLIF intervertebral body fusion device. The focus of the document is to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than establishing acceptance criteria or proving device performance through specific studies with reported metrics in the way a clinical trial for an AI/ML device would.

Therefore, many of the requested categories related to acceptance criteria, study design, and performance metrics are not applicable in this context. The document relies on non-clinical performance data and the established safety and efficacy of the predicate devices.

Here's a breakdown of the information as it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information (specific performance metrics with acceptance criteria) is not present in the provided document. The submission is focused on demonstrating that the new device is "substantially equivalent" to existing predicate devices based on non-clinical testing and shared characteristics, rather than meeting novel performance thresholds in a clinical study.

The closest to "acceptance criteria" are the standards the device passed:

Acceptance Criteria Category	Standard / Requirement Met
Mechanical Performance	ASTM F2077 (for Intervertebral Body Fusion Devices)
Mechanical Performance	ASTM F2267 (for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression)
Performance	Static expulsion testing (Passed)
Performance	Subsidence testing (Passed)
Biocompatibility	ISO 10993-1 (Met)
Cleaning and Sterilization	ISO 11137 (Met)
Shelf Life	5 years (Testing passed)
Storage and Transport	Testing passed

The document does not provide specific numerical performance values for these tests (e.g., specific load resistance in Newtons, or subsidence displacement in mm), only that the device "passed all the testing in accordance with internal requirements, national and international standards."

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

Test Set Sample Size: Not applicable. This submission relies on non-clinical ( benchtop/laboratory) testing, not a clinical test set of patient data.
Data Provenance: Not applicable. The "data" are from mechanical, material, and sterilization tests performed on the device itself, not patient data.

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

Number of Experts: Not applicable. Ground truth, in the sense of clinical annotations by experts, is not established for this type of submission.
Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring adjudication was used.

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

MRMC Study: No. This device is a physical intervertebral body fusion device, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC study and effects on human reader improvement are not relevant.

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

Standalone Performance: No. This is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For the non-clinical performance data, the "ground truth" is defined by the specifications within the relevant ASTM and ISO standards (e.g., ASTM F2077, ASTM F2267, ISO 10993-1, ISO 11137). The device components and materials are also specified to conform to relevant ASTM standards (e.g., PEEK according to ASTM F2026, tantalum according to ASTM F560, stainless steels conforming to ISO 16061 and ASTM F899).

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/ML device that requires training data.

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

Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

Summary of the K181899 Submission:

The K181899 submission for the ROCCIA® PLIF device is a traditional 510(k) pathway to market. It demonstrates substantial equivalence by:

Comparing the device's indications for use, principles of operation, technological characteristics, and materials to legally marketed predicate devices.
Providing non-clinical performance data (mechanical, biocompatibility, sterilization, shelf life, storage, transport testing) showing that the ROCCIA PLIF meets established design input specifications and relevant national and international standards (e.g., ASTM F2077, ASTM F2267, ISO 10993-1, ISO 11137).
Stating that no human clinical testing was required due to the equivalence to predicate devices with proven safety and efficacy.

This regulatory pathway does not involve the types of clinical studies, expert-based ground truth, or AI/ML performance metrics that your request primarily focuses on.

Summary

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

December 13, 2018

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Silony Medical GmbH Bircan Tasdelen Head of Quality Management and Regulatory Affairs Leinfelder Strasse 60 Leinfelden-Echterdingen. 70771 DE

Re: K181899

Trade/Device Name: Roccia® PLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 8, 2018 Received: November 13, 2018

Dear Bircan Tasdelen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 medical devices and radiation-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,

Melissa Hall -S

For 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	DEPARTMENT OF HEALTH AND HUMAN SERVICES
Expiration Date: 06/30/2020See PRA Statement below.	Food and Drug Administration

Indications for Use

510(k) Number (if known)	K181899
Device Name	ROCCIA® PLIF
Indications for Use (Describe)	The ROCCIA PLIF System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the ROCCIA PLIF System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
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 (7/17)	Page 1 of 1
----------------------	-------------

PSC Publishing Services (301) 443-6740 EF

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

510(k) Summary

ROCCIA® PLIF

K181899

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

Silony Medical GmbH Leinfelder Straße 60 70771 Leinfelden-Echterdingen GERMANY Contact: Bircan TASDELEN Office Phone: +49 711 78 25 25 40 Email: BTasdelen@silony-medical.com

3. Date Prepared

03rd July 2018

4. Device Identification

Trade/Proprietary Name:	ROCCIA® PLIF
Common/Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Body Fusion Device with Bone Graft, Lumbar
Regulation Number:	888.3080
Product Code:	MAX
Device Class:	II
Classification Panel:	Orthopedic

5. Legally Marketed Predicate Device

Primary Predicate Device K133650; CAPSTONE® Spinal System; Medtronic Sofamor Danek USA, Inc.

Additional Predicate Device

K071983; Aesculap PEEK Spinal Implant System (ProSpace); Aesculap® Implant Systems, Inc. K122317; TETRIS™ II; SIGNUS Medizintechnik GmbH K122639; Synthes SynCage Evolution Spacer; DePuy Synthes Spine

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

6. Device Description

7. Indication for Use Statement

The ROCCIA PLIF System is indicated for interbody fusion with autogenous bone graft in patients with Deqenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the ROCCIA PLIF System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.

These implants may be implanted via an open posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

8. Substantial Equivalence Discussion

The ROCCIA PLIF has shown to be substantial equivalent to the predicate device with respect to indications for use, principles of operations, technological characteristics, materials, and performance testing.

9. Non-Clinical Performance Data

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

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

-Mechanical performance according ASTM F2077 for Test Methods for Intervertebral Body Fusion Devices and ASTM F2267 for Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
-Static expulsion testing
-Subsidence testing

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

Biocompatibility according ISO 10993-1 -
-Cleaning and Sterilization Testing according ISO 11137
-Shelf Life Testing for 5 years
-Storage and Transport Testing

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 use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11.Statement of Substantial Equivalence

The ROCCIA PLIF 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.