When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO 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 fixation system, the COLORADO 2" Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of 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 (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 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, kyphosis, 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 2TM 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, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

Device Description

The COLORADO 2™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. COLORADO 2 ™ 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 2™ 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, the components from the other systems may only be used for the COLORADO 2™ Spinal System indications.

AI/ML Overview

This document is a 510(k) summary for the COLORADO 2™ Spinal System. It focuses on demonstrating substantial equivalence to pre-existing devices rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, many of the requested details about a study and its results cannot be extracted from this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not report specific acceptance criteria or quantitative device performance metrics in a study format. The entire submission is built around demonstrating "substantial equivalence" to predicate devices, meaning it aims to show the new device is as safe and effective as devices already on the market, rather than meeting predefined numerical performance targets from a direct device performance study.

Acceptance Criteria	Reported Device Performance
Not specified by this document as this is a 510(k) submission focused on substantial equivalence.	Not specified by this document as this is a 510(k) submission focused on substantial equivalence.

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

Sample size for test set: Not applicable. This document does not describe a performance study with a test set of data. It refers to a "risk analysis" and general information to demonstrate substantial equivalence, but not a study with a test set.
Data provenance: Not applicable. No data or test sets from a specific study are mentioned.

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

Number of experts: Not applicable. No test set requiring ground truth established by experts is mentioned.
Qualifications of experts: Not applicable.

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

Adjudication method: Not applicable. No test set requiring adjudication is mentioned.

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:

MRMC study: No. This document describes a spinal implant system and its components, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant here.
Effect size: Not applicable.

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

Standalone study: No. This document describes a physical medical device (spinal implant), not an algorithm or AI system. Therefore, a standalone algorithm study is not relevant.

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

Type of ground truth: Not applicable. There is no performance study where ground truth would be established. The basis for approval is "substantial equivalence" to legally marketed predicate devices, meaning the focus is on similarity in design, materials, and intended use to devices already deemed safe and effective.

8. The sample size for the training set:

Sample size for training set: Not applicable. This document describes a spinal implant system, not a machine learning model.

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

Ground truth for training set: Not applicable. This document describes a spinal implant system, not a machine learning model.

Summary based on the document:

The provided text is a 510(k) Summary for a spinal implant system called the COLORADO 2™ Spinal System. The purpose of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to perform a full-scale clinical trial or device performance study with quantifiable acceptance criteria in the manner requested.

The "study" referenced in the context of this document is the demonstration of substantial equivalence. This is achieved by comparing the new device to existing devices on the market (predicate devices) in terms of:

Product Description: Materials, components, and configurations.
Indications for Use: The medical conditions the device is intended to treat.
Technological Characteristics: How it functions and is constructed.
Risk Analysis: Assessing potential risks and mitigation strategies, often referencing existing standards or previous risk assessments for similar devices.

The approval letter confirms that the FDA reviewed the information and determined the device to be substantially equivalent to legally marketed predicate devices. This regulatory pathway does not typically involve the detailed performance studies with acceptance criteria, sample sizes, expert ground truth, and adjudication methods that would be seen for novel diagnostic algorithms or complex AI systems. The "acceptance criteria" here are essentially the FDA's regulatory requirements for demonstrating substantial equivalence based on the provided information.

Summary

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COLORADO 2™ Spinal System 510(k) Summary K030875 May 2003

Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: COLORADO 2TM Spinal System II. Regulation Numbers: 888.3050, 888.3060 and 888.3070

Regulation Names: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System, and Pedicle Screw Spinal System.

Codes: MNH, MNI, KWP, KWQ

III. Product Description

IV. Indications

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO 2TM 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).

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K030875

V. Substantial Equivalence

The COLORADO 2 110 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 a 6.35mm rod along with associated connecting CD HORIZON® and TSRH® Spinal System components to the existing COLORADO 2™ Spinal System.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2003

Richard W. Treharne, Ph.D. Sr. Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132

Re: K030875

Trade/Device Name: COLORADO® 2 Spinal System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; Spinal intervetebral body fixation orthosis; Spondylolisthesis spinal fixation device-system; Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, KWQ, MNH, MNI Dated: June 11, 2003 Received: June 12, 2003

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. Iisting 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

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Page 2 - Richard W. Treharne, Ph.D.

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. 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html

Sincerely yours.

l. Mark N. Melkers

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

Enclosure

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510(k) Number (if known): K030875

COLORADO 2Th1 Spinal System Device Name:

Indications for Use:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO 2™ Spinal System Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) dislocation, (4) scoliosis, (5) kyphosis, (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 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 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) spondylofisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)

OR Over-the-counter Use
for Mark A. Miltner
(Division Sign-Off)

of General, Restorative and Neurological Devices

510(k) Number K030875

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.