ROMEO® 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: severe spondylolisthesis (grades 3 and 4) of the L5-S V vertebra: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as a posterior, non-cervical, non-pedicle screw fixation system, ROMEO posterior osteosynthesis system is intended for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion

Device Description

The Romeo® posterior fixation system comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCr rods, and cross connectors. The Romeo® Polyaxial Screws come in various lengths (from 25 to 90 mm) and diameters (4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mm) to accommodate different patient anatomies. The modification to Romeo® posterior osteosynthesis system consists of the addition of a prebent cross connectors and prebent CoCr rods.

AI/ML Overview

This document is a 510(k) premarket notification for the ROMEO® Posterior Osteosynthesis System, seeking to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain information about the acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical study for an AI/ML device would.

Instead, this document focuses on mechanical and material equivalence for a traditional medical device (spinal system components). Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This document doesn't define pass/fail criteria for a study in terms of accuracy, sensitivity, specificity, etc., as it's not a diagnostic or AI/ML device. The "performance" described relates to the physical characteristics and intended use of the spinal components.
Sample size and data provenance for a test set: No test set in the context of an AI/ML or diagnostic study is described.
Number of experts and qualifications for ground truth: Not applicable, as there's no diagnostic ground truth being established.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable, as this is a physical medical device.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How ground truth for the training set was established: Not applicable.

What the document does convey regarding "acceptance criteria" and "study" is related to engineering principles and regulatory compliance for a spinal implant system:

Acceptance Criteria (Implicitly): The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices. This involves showing that the new components (prebent cross connectors and prebent CoCr rods) have equivalent intended use, material, design, mechanical properties, and function to existing cleared devices. The "special controls established for Pedicle screw spinal system" and the "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" (May 3, 2004) serve as the regulatory framework and implicitly contain design and performance expectations.
"Study" (Demonstration of Equivalence): The "study" isn't a traditional clinical trial or performance study with human subjects, but rather a technical assessment and comparison. The document states:
- "No additional testing has been performed for the added prebent cross connectors and prebent CoCr rods." This is a crucial statement and indicates that the manufacturer is relying on the established equivalence of the materials and design to existing cleared components.
- "Verification Activity and Validation Activity demonstrate that the added prebent cross connectors and prebent CoCr rods are substantially equivalent to previously cleared devices." This suggests that internal engineering verification and validation activities (e.g., material testing, mechanical load testing, fatigue testing, dimensional analysis) were conducted to ensure the new components meet the same functional and safety profiles as the predicate components, even if no new testing was deemed necessary beyond that for existing components.

In summary, this document is a regulatory filing for a physical medical device (spinal implant components), not for an AI/ML diagnostic or prognostic tool. Therefore, the questions related to clinical performance metrics, ground truth, and reader studies are not applicable to the information provided.

Summary

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

September 10, 2014

Spineart Mr. Franck Pennesi Director of Industry and Quality 20 route de pré-bois, CP 1813 1215 Geneva 15 SWITZERLAND

Re: K141835

Trade/Device Name: ROMEO® Posterior Osteosynthesis System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: August 12, 2014 Received: August 14, 2014

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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 yours.

Ronald DAean -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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K141835

Device Name

ROMEO® posterior osteosynthesis system

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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:

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FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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510(k) SUMMARY

As required by section 807.92

	SPINEART
Submitted by	International Center Cointrin
	20 route de pré-bois
	CP1813
	1215 GENEVA 15
	SWITZERLAND
Contacts	Franck PENNESI Director of Industry & Quality
	Phone : +41 22 570 1246 Fax : +41 22 799 40 26
	Mail : fpennesi@spineart.com
	Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)idrubaix@nordnet.fr
Date Prepared	September 10th 2014
Common Name	Pedicle screw spinal system
Trade Name	Romeo® posterior osteosynthesis system
Classification Name	Pedicle screw spinal system
Class	II
Product Code	MNH, MNI
CFR section	888.3070
Device panel	ORTHOPEDIC
Legally marketedpredicate devices	Ellipse posterior osteosynthesis system (K081165), Romeo®posterior osteosynthesis system (K101678, K111127, K130267)and TSRH spinal system - CD horizon X10 Crosslink Plates byMedtronic Sofamor Danek, Inc (K032578)
	Indications for use	Romeo® posterior osteosynthesis system is intended to provideimmobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion in the treatment of thefollowing acute and chronic instabilities or deformities of thethoracic, lumbar, and sacral spine: severe spondylolisthesis (grades3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis withobjective evidence of neurologic impairment; fracture; dislocation;scoliosis; kyphosis; spinal tumor; and failed previous fusion(pseudarthrosis).When used as a posterior, non-cervical, non-pedicle screw fixationsystem, Romeo® posterior osteosynthesis system is intended forthe following indications: degenerative disc disease (DDD) (definedas back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies); spondylolisthesis;trauma (i.e., fracture or dislocation); spinal stenosis; curvatures(i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis;and failed previous fusion
		Description of the device	The Romeo® posterior fixation system comprises polyaxial screws,monoaxial screws, spondylolisthesis screws, setscrew, straight andpre-bent Titanium or CoCr rods, and cross connectors. The Romeo®Polyaxial Screws come in various lengths (from 25 to 90 mm) anddiameters (4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mm) toaccommodate different patient anatomies. The modification toRomeo® posterior osteosynthesis system consists of the addition ofa prebent cross connectors and prebent CoCr rods.
		TechnologicalCharacteristics	Prebent Romeo® Multiaxial Cross Connectors are posteriortransverse devices designed to fix the distance between the twolongitudinal rods and thus strengthen posterior construct performedon the thoraco-lumbar spine. Prebent Romeo® Multiaxial CrossConnectors are all made of Titanium alloy Ti6Al4V ELI conformingto ISO 5832.3 and ASTM F136 and come in different sizes.The Romeo® range of prebent rods (Ø 5.4 mm) made of cobaltchromium alloy CrCoMo conforming to ISO 5832-12 and ASTMF1537 has been extended with several lengths (from 200 to 550mm).Romeo® components are delivered sterile (gamma sterilization) ina dedicated packaging or not sterile upon request.
Discussion of Testing		Romeo® posterior osteosynthesis system conforms to specialcontrol established for Pedicle screw spinal system and to « SpinalSystem 510(k)s - Guidance for Industry and FDA Staff Document »issued on: May 3, 2004. No additional testing has been performedfor the added prebent cross connectors and prebent CoCr rods.
Conclusion		The extended range of Romeo® posterior osteosynthesis system issubstantially equivalent to its predicate devices in terms ofintended use, material, design, mechanical properties and function.Verification Activity and Validation Activity demonstrate that theadded prebent cross connectors and prebent CoCr rods aresubstantially equivalent to previously cleared devices.

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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.