The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft. for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.

The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.5mm to 6.5mm, including the PROTEX® or REVERE® or BEACON™ System, using corresponding parallel connectors.

Device Description

The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System consists of 3.5mm rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, occipital plates, and tapered rods. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), or stainless steel (per ASTM F138). Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be connected to stainless steel implants.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the ELLIPSE™ Occipito-Cervico-Thoracic Spinal System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a clinical trial with acceptance criteria for device performance as would be seen in a PMA.

Therefore, much of the requested information (acceptance criteria, details of a specific study proving it, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) is not typically present in a 510(k) submission for a spinal implant system. These submissions primarily rely on mechanical testing and comparison to predicate devices, not clinical studies in the way an AI/software device would.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is missing.

Acceptance Criteria and Device Performance Study for ELLIPSE™ Occipito-Cervico-Thoracic Spinal System (K090565)

The provided document describes a 510(k) premarket notification dossier for a medical device rather than a clinical study report with performance metrics. As such, the concept of "acceptance criteria" and "device performance" in the context of a new drug or advanced AI diagnostic device does not directly apply here. Instead, the "acceptance criteria" are the regulatory requirements for demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and comparison of technical characteristics and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (implied by 510(k) review)	Reported Device Performance / Method of Proof
Mechanical Performance	"Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." (Specific results are not provided in this summary, but the claim is that such testing was performed and met the guidance requirements.)
Material Composition	Implants composed of titanium alloy (per ASTM F136, F1472, or F1295), or stainless steel (per ASTM F138). (Conformity to these standards is an implicit acceptance criterion.)
Technical Characteristics	"The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System implants are similar to the predicate devices with respect to technical characteristics..."
Intended Use	"The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System implants are similar to the predicate devices with respect to... intended use." (The provided "Indications for Use Statement" details the intended use, and substantial equivalence implies this closely matches the predicate.)
Safety and Effectiveness (by equivalence)	Device is "substantially equivalent" to legally marketed predicate devices, implying comparable safety and effectiveness.
Biocompatibility	(Not explicitly mentioned in the provided text, but implied by regulatory requirements for implantable devices and compliance with material standards.)

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify a "test set" in the context of patient data or clinical samples. The "test" described is mechanical testing. The sample size for mechanical testing (i.e., number of devices or components tested) is not provided in this summary.
Data Provenance: Not applicable in the context of a clinical test set. The mechanical testing would have been conducted in a laboratory setting, likely in the US, given the company's location.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This information pertains to clinical studies often involving expert review of images or patient data to establish a 'ground truth' for diagnostic performance. A 510(k) for a spinal implant system does not typically involve this type of ground truth establishment. Mechanical testing relies on engineering standards and measurements, not human expert consensus for "ground truth."

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

Not Applicable. See explanation for #3.

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 system, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this device.

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

No. This is a spinal implant system, not an algorithm.

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

Engineering Standards and Specifications: For mechanical testing, the "ground truth" would be established by validated test methods, material specifications (e.g., ASTM standards), and engineering design criteria that define acceptable loads, fatigue life, and other mechanical properties. There is no biological "ground truth" in the sense of pathology or outcomes data for this specific submission's evidence.

8. The sample size for the training set

Not Applicable. This device did not involve a "training set" of data for an algorithm.

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

Not Applicable. See explanation for #8.

Summary

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K090565

510(k) Summary: ELLIPSE™ Occipito-Cervico-Thoracic Spinal System

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403(610) 415-9000
Contact:	Kelly J. Baker, Ph.DDirector, Clinical Affairs & Regulatory

JUN 3 0 2009

Device Name: ELLIPSE™ Occipito-Cervico-Thoracic Spinal System
Classification: Per 21 CFR as follows: $888.3050 Spinal Interlaminal Fixation Orthosis Product Code KWP. Regulatory Class II, Panel Code 87.
Globus PROTEX® CT K050391, K081906 Predicate(s): Stryker Oasys K032394

DEVICE DESCRIPTION:

INTENDED USE:

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation: thev are not intended for fixation of the posterior cervical spine.

The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.5mm to 6.5mm, including the PROTEX® REVERE® or BEACON™ Stabilization Systems, using corresponding parallel connectors.

pg 1 of 2

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K0905565

Basis of Substantial Equivalence:

The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System implants are similar to the predicate devices with respect to technical characteristics, performance, and intended use. Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Public Health Service

JUN 3 0 2009

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical Inc. % Kelly J. Baker, Ph.D 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K090565

Trade/Device Name: ELLIPSE™ Occipito-Cervico-Thoracic Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: June 2, 2009 Received: June 3, 2009

Dear Dr. Baker:

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 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 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.

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Page 2 - Dr. Kelly J. Baker

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Qbalora Buchus

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 Statement

510(k) Number:

K090565

Device Name:

ELLIPSE™ Occipito-Cervico-Thoracic Spinal System

Indications:

Prescription Use × (Per 21 CFR §801.109)

Over

Over-The-Counter Use

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K090565

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.