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; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Device Description

ROMEO posterior osteosynthesis system includes pedicular screws, spondylolisthesis screws longitudinal rods and transverse connector rods, connector and nut. All components of ROMEO posterior osteosynthesis system are made of TA6V4ELI conforming to ISO 5832.3 and ASTM F 136. ROMEO components are supplied either sterile or not sterile and with a complete set of surgical instruments.

AI/ML Overview

This document is a 510(k) summary for the SPINEART ROMEO posterior osteosynthesis system. It details the device's characteristics, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain the specific information required to complete the table and answer all questions related to acceptance criteria and a study proving those criteria.

The 510(k) process for devices like this typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical performance studies to meet specific acceptance criteria in the same way an AI/ML software device would. The "Performance data" section refers to conformity with "special control established for Pedicle screw spinal system" and "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document," which primarily relate to mechanical properties, material biocompatibility, and sterilization, rather than performance metrics like sensitivity or specificity.

Therefore, many of the requested fields are not applicable or the information is not present in this document.

Here's an attempt to answer based only on the provided text, with clear indications where information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Conformity to special control established for Pedicle screw spinal system	ROMEO posterior osteosynthesis system conforms to special control.
Conformity to "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on May 3, 2004	ROMEO posterior osteosynthesis system conforms to the guidance document.
Substantial equivalence in terms of intended use, material, design, mechanical properties, and function to predicate devices (ELLIPSE posterior osteosynthesis system K081165 and ROMEO posterior osteosynthesis system K093170)	ROMEO posterior osteosynthesis system is substantially equivalent to its predicate device in terms of intended use, material, design, mechanical properties and function.

Study Information:

The provided document describes a 510(k) submission, which is a regulatory pathway to demonstrate substantial equivalence to a predicate device, not necessarily a study to prove novel acceptance criteria for device performance in the clinical sense (like AI/ML performance metrics). The "Performance data" section mentions conformity to established special controls and guidance documents for pedicle screw spinal systems. This implies that testing was conducted to meet the mechanical, material, and labeling requirements outlined in those documents, which are the "acceptance criteria" for this type of device within the 510(k) framework. However, the document does not detail specific study methodologies or results beyond the statement of conformity.

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

Sample size for test set: Not applicable and not provided. The 510(k) does not describe a clinical performance study with a "test set" in the context of diagnostic or AI/ML performance. The "performance data" refers to compliance with regulatory standards, likely involving mechanical testing of device components, not patient data sets.
Data provenance: Not applicable.

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. Ground truth as typically defined for AI/ML performance evaluation is not relevant to this 510(k) submission for a spinal implant.

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

Not applicable.

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. This is a spinal implant, not an AI/ML diagnostic or assistive device.

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

No. This is a spinal implant.

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

Not applicable. For a spinal implant, "ground truth" would relate to material properties, mechanical strength, biocompatibility, and clinical outcomes, evaluated through engineering tests and clinical follow-up (though no clinical study data is presented in this summary, as per the nature of the 510(k) process for this device type).

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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リット 1 2010

510(k) SUMMARY

As required by section 807.92(c)

Submitter	SPINEART
	International Center Cointrin 20 route de pré-bois
	CP1813
	1215 GENEVA 15
	SWITZERLAND
Contacts	Franck PENNESI Director of Industry & Quality
	Phone : +41 22 799 40 25
	Fax : +41 22 799 40 26
	Mail : fpennesi@spineart.ch
	Regulatory 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)
Classification Name	Pedicle screw spinal system
Class	II
Product Code	MNI orthosis, spinal pedicle fixation
Subsequentproduct	MNH orthosis, spondylolisthesis spinal fixation
codes	KWP Spinal interlaminal fixation orthosis
CFR section	888.3070
Device panel	Orthopedic
Legally marketedpredicate devices	ELLIPSE posterior osteosynthesis system (K081165)
	and ROMEO posterior osteosynthesis system
	(K093170) manufactured by SPINEART
Description	ROMEO posterior osteosynthesis system includespedicular screws, spondylolisthesis screws longitudinalrods and transverse connector rods, connector andnut.
	All components of ROMEO posterior osteosynthesis
	system are made of TA6V4ELI conforming to ISO
	5832.3 and ASTM F 136.
	ROMEO components are supplied either sterile or not
	sterile and with a complete set of surgical
	instruments.
Intended Use	ROMEO posterior osteosynthesis system is intended toprovide immobilization and stabilization of spinalsegments in skeletally mature patients as an adjunctto fusion in the treatment of the following acute andchronic instabilities or deformities of the thoracic,lumbar, and sacral spine: severe spondylolisthesis(grades 3 and 4) of the L5-S1 vertebra; degenerativespondylolisthesis with objective evidence of neurologicimpairment; fracture; dislocation; scoliosis; kyphosis;spinal tumor; and failed previous fusion(pseudarthrosis).
Performance data	ROMEO posterior osteosynthesis system conforms tospecial control established for Pedicle screw spinalsystem and to « Spinal System 510(k)s - Guidance forIndustry and FDA Staff Document » issued on: May 3,2004.
Substantialequivalence	ROMEO posterior osteosynthesis system issubstantially equivalent to its predicate device interms of intended use, material, design, mechanicalproperties and function.

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Preparation date, December 10, 2009

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, abstract design.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR 1 1 2010

SPINEART % Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 Route de Pre-bois – CP 1813 Geneva 1215, Switzerland

Re: K093936

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: February 04, 2010 Received: February 12, 2010

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

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Page 2 - Mr. Franck Pennesi

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 forth in the quality systems (OS) 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Aubare Buchrs

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): _ K093936 Device Name: ROMEO posterior osteosynthesis system Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 12 / 123

510(k) Number__K093936

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.