The ROMEO® 2 Posterior Osteosynthesis System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the ROMEO® 2 Posterior Osteosynthesis System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The ROMEO® 2 Posterior Osteosynthesis System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The ROMEO 2 Posterior Osteosynthesis System comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCr rods, and various connectors available in several sizes and models to accommodate different patient anatomies. ROMEO implantable components are single-use device provided sterile (gamma radiation) and supplied with dedicated surgical instruments.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a medical device called the "ROMEO® 2 Posterior Osteosynthesis System." It provides information about the device, its intended use, and its equivalence to previously marketed predicate devices.

Based on the provided document, there is no information regarding acceptance criteria, device performance results, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for an AI/ML-driven medical device.

This document pertains to a traditional spinal implant system, not a device that relies on artificial intelligence or machine learning for its functionality or medical decision-making. The "Discussion of Testing" section explicitly mentions "non-clinical tests" like "Axial Rotation" and "Axial Push Down" per ASTM F1798, which are mechanical performance tests for orthopedic implants.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving device performance as there is no relevant information in the provided text for an AI/ML device.

Summary

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

September 26, 2017

Spineart Franck Pennesi Chief Technical Officer 3 Chemin du Pré Fleuri 1228 Plan Les Ouates Geneva. Switzerland

Re: K172101

Trade/Device Name: ROMEO® 2 Posterior Osteosynthesis System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: July 10, 2017 Received: July 12, 2017

Dear Mr. Pennesi:

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

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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 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 (DICE) 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 (DICE) 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.

Ronald P. Jean - 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K172101

Device Name

ROMEO® 2 Posterior Osteosynthesis System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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510(k) SUMMARY

510k	TRADITIONAL
Basis for submission	The purpose of this submission is to make modifications to the indications for use, to addadditional sizes and a new connector design to the ROMEO® 2 Posterior OsteosynthesisSystem cleared under K081165, K093170, K093936, K101678, K111127, K112108, K130267,K140948 and K151695
Submitted by	SPINEART3 Chemin du Pré Fleuri1228 PLAN LES OUATESGENEVA SWITZERLAND
Contacts	Franck PENNESI Chief Technical OfficerPhone : +41 22 570 1200 Fax : +41 22 594 8306Mail : fpennesi@spineart.comRegulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr
Date Prepared	Revised September 8, 2017
Common Name	Pedicle screw spinal system
Trade Name	ROMEO® 2 Posterior Osteosynthesis System
Classification Name	Thoracolumbosacral Pedicle Screw System
Class	II
Product Code	NKB, KWP
CFR section	888.3070
Device panel	ORTHOPEDIC
Legally marketedpredicate devices	Primary predicate: ROMEO (Ellipse) Posterior Osteosynthesis System (K081165) manufactured by SpineartAdditional predicates: ROMEO Posterior Osteosynthesis System (K093170, K093936, K101678, K111127, K112108, K130267, K140948, K151695) manufactured by Spineart,Reform Pedicle Screw System (K143248) manufactured by Precision Spine, Inc and Xia (K142381) / Xia - Mantis (K133188) manufactured by Stryker Spine
Indications for use	The ROMEO®2 Posterior Osteosynthesis System is intended to provide immobilization andstabilization of spinal segments in skeletally mature patients as an adjunct to fusion in thetreatment of the following acute and chronic instabilities or deformities of the thoracic,lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture;dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion(pseudarthrosis).When used for posterior non-cervical pedicle screw fixation in pediatricpatients, the ROMEO®2 Posterior Osteosynthesis System is indicated as an adjunct tofusion to treat adolescent idiopathic scoliosis. The ROMEO®2 Posterior OsteosynthesisSystem is intended to be used with autograft and/or allograft. Pediatric pedicle screwfixation is limited to a posterior approach

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Description of the device	The ROMEO 2 Posterior Osteosynthesis System comprises polyaxial screws, monoaxialscrews, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCr rods,and various connectors available in several sizes and models to accommodate differentpatient anatomies. ROMEO implantable components are single-use device provided sterile(gamma radiation) and supplied with dedicated surgical instruments.
Technologicalcharacteristics comparedto the predicate devices	The line extension to the ROMEO®2 Posterior Osteosynthesis System include additionallengths of polyaxial Screws, additional lengths and diameters of spondylolisthesisscrews and addition of a new design of open Iliac Connector.As was established in this submission through a side by side comparison, previouslycleared and added components included in the ROMEO Posterior OsteosynthesisSystem are substantially equivalent and have the same technological characteristicsto predicate devices in areas including indications for use, function, material composition,design, range of sizes and mechanical performance.
Discussion of Testing	The following non-clinical tests were conducted to demonstrate that the open IlliacConnector is substantially equivalent to its predicate device: Axial Rotation (rotationaround the rod) and Axial Push Down (slipping along the rod) tests per ASTM F1798.Results demonstrate comparable mechanical properties to the predicate devices.It has been demonstrated that the ROMEO®2 Screw Line Extension range does notintroduce new worst-case design and remains substantially equivalent to the predicatedevices.
Conclusion	Based on the design features, technological characteristics, feature comparisons,indications for use, and non-clinical performance testing, the ROMEO 2 PosteriorOsteosynthesis System has demonstrated substantial equivalence to the identifiedpredicate devices.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.