ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM by SPINEART

ROMEO posterior osteosynthesis system is 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; 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 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Description

The modifications to ROMEO posterior osteosynthesis system (K081165, K093170, K101678) manufactured by SPINEART consist of addition of addition of R093170, 11010707 manufacturers - Public Public and pedicle hooks and pedicle hooks (angled, Ma These components are supplied either sterile or not sterile.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the "ROMEO posterior osteosynthesis system." It discusses modifications to an existing device, its intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain the level of detail requested regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of device performance metrics like sensitivity, specificity, AUC, or F1 score derived from a clinical or imaging study.

The performance data mentioned is focused on mechanical testing rather than clinical or imaging performance.

Here's a breakdown based on the information provided and what is missing:

The document states:
"Mechanical testing including static compression bending, static torsion, dynamic Mcchanical testing moraing performed according to ASTM F1717-10. Results compression that additional components perform as safely and effectively as their predicate devices."

And:
"ass, matther, performance testing according to special control demonstrate that Non- ellined. Ponents are as safe, as effective, and performs as safely and effectively as their predicate devices."

This indicates that the acceptance criteria are based on mechanical performance standards and equivalence to predicate devices in those mechanical aspects.

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

Acceptance Criteria	Reported Device Performance
Mechanical Performance: - Static compression bending - Static torsion - Dynamic mechanical testing	Conforms to ASTM F1717-10 standards. "additional components perform as safely and effectively as their predicate devices." "as safe, as effective, and performs as safely and effectively as their predicate devices."
Substantial Equivalence: - Intended use - Material - Design - Mechanical properties - Function	"ROMEO posterior osteosynthesis system additional Substantial - agently and inter predicate device in terms of interms of intended use, material, design, mechanical properties and function."
Special Controls: - Conformance to "Spinal System Special - Suidance for Industry and FDA Staff Document" issued on May 3, 2004.	Device "conforms to special control established for Pedicle screw spinal system."

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

Not provided. The document describes mechanical testing, not a clinical or imaging study with a "test set" of patient data.

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)

Not applicable. This information is relevant for clinical or imaging studies involving human interpretation or assessment, which is not described here.

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

Not applicable. This information is relevant for clinical or imaging studies involving human interpretation or assessment, which is not described here.

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 pertains to a mechanical spinal implant system, not an AI or imaging diagnostic device.

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

Not applicable. This document pertains to a mechanical spinal implant system, not an AI or imaging diagnostic device.

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

For mechanical testing, the "ground truth" would be the standards themselves (e.g., ASTM F1717-10 specifications) and the performance of the predicate devices as a benchmark for equivalence. There isn't a "ground truth" in the sense of clinical disease diagnosis or pathology.

8. The sample size for the training set

Not applicable. This document describes mechanical testing for a spinal implant, not a machine learning model that requires a training set. If "sample size" refers to the number of devices or components tested, that specific number is not provided, only that "Mechanical testing including static compression bending, static torsion, dynamic Mcchanical testing moraing performed..."

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

Not applicable. As above, this is not a machine learning context.

Summary

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AUG 19 2011

510(k) SUMMARY

As required by section 807.92

Submitter	SPINEARTInternational Center Cointrin 20 route de pré-bois CP18131215 GENEVA 15SWITZERLAND
Contacts	Franck PENNESI Director of Industry & QualityPhone : +41 22 799 40 25Fax : +41 22 799 40 26Mail : fpennesi@spineart.chRegulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)idrubaix@nordnet.fr
Trade Name	ROMEO posterior osteosynthesis system
SPECIAL 510k	Modification to ROMEO posterior osteosynthesis system(Extension of range of products)
CFR section	888.3070 and 888.3050
Classification Name	Pedicle screw spinal system / Spinal interlaminal fixation orthosis
Class	II
Product Codes	KWP Spinal interlaminal fixation orthosisMNH orthosis, spondylolisthesis spinal fixationMNI orthosis, spinal pedicle fixation
Device panel	ORTHOPEDIC
Legally marketedpredicate devices	ELLIPSE posterior osteosynthesis system (K081165) andROMEO posterior osteosynthesis system (K093170 and K101678) manufactured by SPINEART

Description: The modifications to ROMEO posterior osteosynthesis system (K081165, K093170, K101678) manufactured by SPINEART consist of addition of addition of R093170, 11010707 manufacturers - Public Public and pedicle hooks and pedicle hooks (angled, Ma These components are supplied either sterile or not sterile.

Intended Use ROMEO posterior osteosynthesis system is intended to provide Intended - 35 - 10 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 1 infinobilization and beautinent of the following acute and chronic instabilities or aujunct to tasion in the increases and sacral spine: severe spondylolisthesis (grades aelormities of the therefora; degenerative spondylolisthesis with objective evidence 9 und 17 of the 20 02 76; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and or nearonogie infpaintinosis). When used as a posterior, non-cervical, nonpedicle screw fixation system, ROMEO posterior osteosynthesis system is intended for pealcie screw indications for the following indications: degenerative disc disease(DDD) the following marcations discogenic origin with degeneration of the disc confirmed by (i.e., e. b.a. pan. ban pan. studies); spondylolisthesis; trauma (i.e., fracture or mistory and rainosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

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Performance data ROMEO posterior osteosynthesis additional components conforms to special control established for Pedicle screw spinal system and to « Spinal System Special - Suidance for Industry and FDA Staff Document » issued on: May 3, 2004. Mechanical testing including static compression bending, static torsion, dynamic Mcchanical testing moraing performed according to ASTM F1717-10. Results compression that additional components perform as safely and effectively as their predicate devices.

Substantial equivalence ROMEO posterior osteosynthesis system additional Substantial - agently and inter predicate device in terms of interms of intended use, material, design, mechanical properties and function.

ass, matther, performance testing according to special control demonstrate that Non- ellined. Ponents are as safe, as effective, and performs as safely and effectively as their predicate devices.

Preparation date, July 18, 2011

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle symbol, with three overlapping wing shapes, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

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

Spineart % Mr. Franck Pennesi International Center Cointrin 20 Route de pre bois CP1813 1215 Geneva 15 Switzerland

AUG 1 9 2011

Re: K112108

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, KWP Dated: June 21, 2011 Received: June 22, 2011

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

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Page 2 - Mr. Franck Pennesi

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Eil Keith

-fr Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

· Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K112108
Device Name: ROMEO posterior osteosynthesis system
Indications for Use:

Over-The-Counter Use _ Prescription Use > AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OD

(Divisio Division of Surgical, Orthopedic, and Restorative Devices

KII2108 510(k) Number __

Page 1 of 1

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.