When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO 21th Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the COLORADO 2™ Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-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 (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the COLORADO 2™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracic/lumbar system, the COLORADO 2™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

Device Description

The COLORADO 2 The Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. COLORADO 2 114 implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. COLORADO 2™ Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the entire system may be made out of medical grade titanium or titanium alloy described by such standards as ASTM F67 or ISO 5832-3 or 5832-2.

The COLORADO 2TM Spinal System can be connected to only 5.5mm rods of the TSRH® Spinal System, CD HORIZON® Spinal System, GDLH®, and the TENOR™ Spinal Systems through 5.5mm axial rod connectors (i.e., CD Horizon Domino, COLORADO 2™ Connector for Sacral and Illio-Sacral Plates, TSRH® Offset and Axial Plates, etc.). Components from other systems may not be combined with components of the COLORADO 2™ Spinal System. When used with the COLORADO 2™ Spinal System components from the other systems may only be used for the COLORADO 2™ Spinal System indications.

AI/ML Overview

The provided text is a 510(k) summary for the COLORADO 2TM Spinal System. It details the product description, indications for use, and a statement of substantial equivalence to legally marketed predicate devices.

However, the document does not contain information regarding:

Acceptance criteria for device performance.
Any specific study that proves the device meets acceptance criteria.
Reported device performance metrics.
Sample sizes for test or training sets.
Data provenance.
Number or qualifications of experts.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone (algorithm only) performance studies.
Type of ground truth used.
How ground truth for training was established.

The 510(k) process for spinal systems primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices, focusing on materials, design, indications, and successful track record of the predicate. It does not typically involve the kind of performance studies with explicit acceptance criteria, ground truth, or expert review that would be found in submissions for diagnostic AI/ML devices or novel medical technologies without clear predicates.

Therefore, I cannot populate the table or answer the questions based on the provided text. The document states:
"The COLORADO™ 2 Spinal System is substantially equivalent to other legally marketed devices and Itself. A risk analysis was provided or referenced to demonstrate substantial equivalence."
This indicates that the primary "study" for this device was a demonstration of substantial equivalence, not a direct performance study against specific acceptance criteria.

Summary

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COLORADOT31 2 Spinal System JUL 2 2 2002 K020247 510(k) Summary June 2002

Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Proposed Proprietary Trade Name: COLORADO 27M Spinal System II.

III. Product Description

IV. Indications

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADOTM 2 Spinal System Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixat:on system, the COLORADOT™ 2 Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the COLORADOTA 2 Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and

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radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformuties (i.e., kyphosis, and/or lordosis). (5) fracture, (6) pseudarthrosis. (7) tumor resection, and/or (8) falled previous fusion.

When used as an anterolateral thoracic/lumbar system, the COLORADO™ 2 Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection. and/or (8) fa1led previous fusion.

Substantial Equivalence V.

The COLORADO™ 2 Spinal System is substantially equivalent to other legally marketed devices and Itself. A risk analysis was provided or referenced to demonstrate substantial equivalence.

The purpose of this submission was to add CD HORIZON® and TSRH® Spinal System 5.5mm rods and associated components to the existing COLORADO 2TM Spinal System.

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Image /page/2/Picture/0 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" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three overlapping profiles, suggesting a sense of unity and collaboration.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs · Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

JUL 2 2 2002

Re: K020247

Trade/Device Name: COLORADO 2™ Spinal System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050, 21CFR 888.3060 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI, KWP, KWQ Dated: April 29, 2002 Received: April 30, 2002

Dear Dr. Treharne:

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 mav 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 - Dr. Richard W. Treharne

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Mcllhenny

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: COLORADO 2TM Spinal System

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

Concurrence of CDRH Office of Evaluation (ODE)

Prescription Use		OR		Over-the-counter Use
(Per 21 CFR 801.109)
(Optional 1-2-96)

for (Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number	K020247
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Regulation Number and Section

N/A