The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damage or unstable vertebral body due to tumor or trauma. The Spinal Edge ATLAS Spinal Cage is intended to be used with supplemental spinal fixation system(s) that have been labeled for use in the thoracic and/or lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer may if indicated be packed with bone grafting material. The Spinal Edge ATLAS Spinal Cage is designed to provide anterior spinal column support for a prolonged period of time even in the absence of fusion.

Device Description

The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow optional grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the cortical endplates of the adjacent vertebrae to resist expulsion

AI/ML Overview

The provided text describes a medical device, the "Spinal Edge ATLAS Spinal Cage," and its premarket notification (510(k)) to the FDA. The document outlines the device's description, intended use, and substantial equivalence to predicate devices. It briefly mentions performance testing but does not provide specific acceptance criteria or detailed study results directly comparable to such criteria.

Therefore, I cannot fully answer your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance. The document focuses on regulatory compliance through substantial equivalence, primarily through material and functional similarity to existing devices and general performance testing against a standard.

Here's what can be extracted based on the provided text, while highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated for specific performance metrics (e.g., strength, durability thresholds).	General compliance with standards: The document states, "Testing to demonstrate with FDA's Guidance for Spinal System 510(k) May 3, 2004 was completed for the Spinal Edge ATLAS Spinal Cage." It also mentions, "The testing was conducted to validate the ATLAS Spinal Cage in accordance with MTI Protocol PR465-0001 and ASTM F2077-03, 'Test Methods for Intervertebral Body Fusion Devices' demonstration compliance."

Acceptance Criteria

Reported Device Performance

Not Explicitly Stated for specific performance metrics (e.g., strength, durability thresholds).

General compliance with standards: The document states, "Testing to demonstrate with FDA's Guidance for Spinal System 510(k) May 3, 2004 was completed for the Spinal Edge ATLAS Spinal Cage." It also mentions, "The testing was conducted to validate the ATLAS Spinal Cage in accordance with MTI Protocol PR465-0001 and ASTM F2077-03, 'Test Methods for Intervertebral Body Fusion Devices' demonstration compliance."

Missing Information: The document states that testing was completed and demonstrated compliance with a specific FDA guidance and an ASTM standard. However, it does not detail the specific acceptance criteria (e.g., "device must withstand X Newtons of compression for Y cycles") or the actual test results (e.g., "device withstood Z Newtons for W cycles") that would allow for a direct comparison as typically presented in such a table for software or diagnostic devices. This is common for predicate device submissions where the focus is often on demonstrating comparable mechanical properties to legally marketed devices rather than establishing new performance benchmarks.

Missing Information from the Provided Text for all other points:

The provided document does not contain any information regarding:

Sample sized used for the test set and the data provenance: This information is not present. The testing described is physical, mechanical testing of the device, not a study involving patient data or a "test set" in the context of AI/diagnostic device evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as the testing described is mechanical, not involving expert interpretation of data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the type of device and testing described.
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 device is a physical implant, not an AI or diagnostic software.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" would be the measured physical properties against the specified standard requirements. The document only states compliance with ASTM F2077-03 and FDA guidance.
The sample size for the training set: Not applicable. There is no "training set" for physical device testing in this context.
How the ground truth for the training set was established: Not applicable.

Summary of Device-Related Information:

Device Name: ATLAS Spinal Cage
Sponsor: Spinal Edge, LLC
Intended Use: Thoracolumbar spine (T1-L5) vertebral body replacement due to tumor or trauma. To be used with supplemental spinal fixation systems. Provides anterior spinal column support for a prolonged period, even without fusion.
Materials: Same as predicate devices (specific material not detailed, but implies biocompatibility and appropriate mechanical properties).
Performance Testing Standard: MTI Protocol PR465-0001 and ASTM F2077-03, "Test Methods for Intervertebral Body Fusion Devices."
FDA Determination: Substantially equivalent to predicate devices K990148 (Stackable Cage System - DePuy AcroMed, Inc.) and K040284 (Sustain Radiolucent Spacer - Globus Medical, Inc.).

The provided text focuses on the regulatory submission process for a physical medical implant based on substantial equivalence, rather than a detailed performance study with explicit acceptance criteria and corresponding results for a diagnostic or AI-driven device.

Summary

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5.0 510(k) Summary

1. Sponsor

JUN - 8 2006

Spinal Edge, LLC 780 W Army Trail Road # 218 Carol Stream, Illinois 60188-9297

Primary Contact:	Yashdip Pannu M.D.
Telephone:	630.903.4364
Date Prepared:	April 5, 2006 (Revised May 23, 2006)

2. Device Name:

Proprietary Name:	ATLAS Spinal Cage
Common/Usual Name:	Spinal Vertebral Body Replacement Device
Classification Name:	Spinal Vertebral Body Replacement Device
	(21 CFR 888 3060) Class II

3. Predicate Devices

K990148 - Stackable Cage System - DePuy AcroMed, Inc. K040284 - Sustain Radiolucent Spacer - Globus Medical, Inc.

4. Device Description

5. Intended Use

Spinal Edge, LLC ATLAS Spinal Cage - 510(k)

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K060916

be packed with bone grafting material. The Spinal Edge ATLAS Spinal Cage is designed to provide anterior spinal column support for a prolonged period of time even in the absence of fusion.

6. Technological Characteristics and Substantial Equivalent

The ATLAS Spinal Cage and its predicate devices have the same indications for use and are made of the same materials. Testing to demonstrate with FDA's Guidance for Spinal System 510(k) May 3, 2004 was combleted for the Spinal Edge ATLAS Spinal Cage.

7. Performance Testing

The testing was conducted to validate the ATLAS Spinal Cage in accordance with MTI Protocol PR465-0001 and ASTM F2077-03, "Test Methods for Intervertebral Body Fusion Devices" demonstration compliance.

ge 2 of 2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2006

Spinal Edge, LLC c/o Ms. Christina Vacca 25125 Detroit Road Westlake, Ohio 44145

Re: K060916

Trade/Device Name: ATLAS Spinal Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: April 4, 2006 Received: April 4, 2006

Dear Ms. Vacca:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced above and have a no legally marketed predicate devices marketed in interstate for use stated in the encreases) is the enactment date of the Medical Device Amendments, or to continer to provision to ridge 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 I ou may, diereleve, mains 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 If your de rice is elassinon 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 (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 – Ms. Christina Vacca

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Herbert Simonus

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 Statement 4.0

10609 in 510(k) Number (if Known): __

Indications For Use:

The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damage or unstable vertebral body due to tumor or trauma. The Spinal Edge ATLAS Spinal Cage is intended to be used with supplemental spinal fixation system that have been labeled for use in the thoracic and/or lumbar spine(i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer may if indicated be packed with bone grafting material. The Spinal Edge ATLAS Spinal Cage is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period of time.

Prescription Use: X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use: (Part 21 CFR 807 Subpart C)

Herbert Lemmer

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

1-06 0916 510(k) Number_

Spinal Edge, LLC ATLAS Spinal Cage - 510(k) April 5, 2006 Company Confidential

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.