ELLIPSE posterior osteosynthesis system is intended to use in the non cervical spine. When use as a pedicle screw fixation system, ELLIPSE is Intended for patients: a) having severe spondylollsthesis (grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; b) who are receiving fusions using autogenous bone graft only; c) who are having the device fixed or attached to the lumbar and sacral spine and d) who are having the device removed after the development of a solld fusion mass.

When use as a pedicle screw fixation system, ELLIPSE is also 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 (T1- S1): degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scollosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Device Description

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

AI/ML Overview

The provided text describes a medical device, the ELLIPSE Lumbar posterior osteosynthesis system, and its premarket notification (510(k)) to the FDA. The information focuses on the device's design, intended use, and its substantial equivalence to predicate devices, supported by mechanical testing. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of diagnostic accuracy or clinical effectiveness in a human-in-the-loop or standalone AI context.

The document details the following regarding performance:

Acceptance Criteria and Reported Device Performance: This section is not applicable in the provided text as it refers to a medical device for surgical implantation, not a diagnostic or AI-driven decision support system. The "performance data" mentioned refers to the device conforming to special controls for pedicle screw spinal systems and mechanical testing per ASTM 1717.

Acceptance Criteria	Reported Device Performance
Not applicable	Conforms to special controls for Pedicle screw spinal system and "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on May 3, 2004. Mechanical testing was conducted per ASTM 1717.

Sample size used for the test set and the data provenance: Not applicable. The document discusses a physical medical device, not a software or AI-driven system that would involve test sets of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment is relevant for AI or diagnostic devices, not for a spinal osteosynthesis system.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating the impact of AI assistance on human reader performance, which doesn't apply to this physical medical device.
Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable. This applies to AI algorithms, not a physical medical implant.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable. The device is a surgical implant, not an AI model.
How the ground truth for the training set was established: Not applicable.

Summary of available performance information for the ELLIPSE Lumbar posterior osteosynthesis system:

The performance data provided relates to the mechanical properties and regulatory compliance of the implant, not to a diagnostic or AI-based system.

Conformance to Special Controls: The device conforms to special controls established for Pedicle screw spinal systems.
Guidance Compliance: It complies with the "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on May 3, 2004.
Mechanical Testing: Mechanical testing was conducted per ASTM 1717. This standard likely evaluates properties such as implant strength, fatigue characteristics, and resistance to various forces relevant to spinal fixation devices. The specific results of these tests (e.g., specific load capacities, fatigue life) are not detailed in the provided summary but are implied to have met acceptable standards for the device to be cleared.
Substantial Equivalence: The device is considered substantially equivalent to its predicate devices (SYNERGY (K011437) and XIA Spinal system (K013823)) in terms of intended use, material, design, mechanical properties, and function. This equivalence is based on the ASTM 1717 testing, suggesting its performance is comparable to already marketed devices.

Summary

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$\qquad K08//165$

DEC 1 7 2008

510(k) Summary of Safety and EFFECTIVENESS

As required by section 807.92(c)

Submitter	SPINEARTInternational 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	ELLIPSE Lumbar posterior osteosynthesis system
Common Name	Pedicle screw spinal system
Classification Name	Pedicle screw spinal system
Device classification	21 CFR 888.3070
Product code	MNI, MNH, KWP
Legally marketedpredicate devices	SYNERGY (K011437) and XIA Spinal system (numerous510k including K013823)
Description	ELLIPSE posterior osteosynthesis system includes
	pedicular screws, spondylolistesis screws longitudinal
	rods and transverse connector rods, connector and nut.
	All components of ELLIPSE posterior osteosynthesis
	system are made of TA6V4ELI conforming to ISO 5832.3
	and ASTM F 136.
	ELLIPSE components are supplied either sterile or not
	sterile and with a complete set of surgical instruments.
Intended Use	ELLIPSE Lumbar posterior osteosynthesis system is
	intended to provide immobilization and stabilization ofspinal 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).

Performance data	ELLIPSE Lumbar posterior osteosynthesis system
	conforms to special control established for Pedicle screw
	spinal system and to « Spinal System 510(k)s -
	Guidance for Industry and FDA Staff Document » issued
	on: May 3, 2004.Mechanical testing was conducted per ASTM 1717
Substantialequivalence	ELLIPSE Lumbar posterior osteosynthesis system is
	substantially equivalent to its predicate devices in terms
	of intended use, material, design, mechanical propertiesaccording to ASTM 1717 and function.

Revised December 16, 2008

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spineart % Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 Route de Pre-Bois CP1813 Geneva, Switzerland 1215

DEC 1 7 2008

Re: K081165

Trade/Device Name: ELLIPSE posterior osteosynthesis system Regulation Number: 21 CFR 888.2070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI, KWP Dated: December 8, 2008 Received: December 10, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Franck Pennesi

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

K081165 510(k) Number (if known): _ Device Name: ELLIPSE posterior osteosynthesis system Indications for Use:

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

(Division Sign-Off)

Division of General Restorative,

and Neurological Devices

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

510(k) Number	K081166
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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.