The MSD SiLo™ System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the MSD SiLo™ components are 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 MSD SiLo™ Spinal System consists of a variety of rods, hooks, screws, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The MSD SiLo™ Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The MSD SiLo™ Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the MSD SiLo™ Spinal System. These components include CD HORIZON® rods and CROSSLINK® plates.

MSD SiLo™ hooks are intended for posterior use only.

AI/ML Overview

This document does not contain information about acceptance criteria, device performance metrics, or any study design that would typically be used to prove a device meets acceptance criteria.

The document is a 510(k) premarket notification summary and an FDA clearance letter for the MSD SiLo™ Spinal System. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (CD HORIZON® Spinal System components cleared in K041030).

Here's what the document does provide and why it doesn't fit the requested criteria:

Substantial Equivalence (Section VI): It explicitly states that "Documentation, including test reports, was provided which demonstrated the MSD SiLo™ Spinal System to be substantially equivalent to CD HORIZON® Spinal System components previously cleared in K041030." This means the device met the regulatory requirement for substantial equivalence to a predicate, not that it underwent a specific performance study against defined acceptance criteria (e.g., sensitivity, specificity for an AI algorithm).
Device Description and Indications for Use: These sections describe what the device is and what it's intended to treat, but not its performance.

Therefore, I cannot populate the requested table or answer the study-related questions based on the provided text.

To answer your specific questions, information about a performance study (clinical or in-vitro) with defined acceptance criteria for the MSD SiLo™ Spinal System would be needed. This document indicates the device was cleared through the 510(k) pathway, which oftentimes relies on demonstrating equivalence rather than requiring extensive new clinical performance studies against specific endpoints, especially for mechanical devices like spinal systems.

Summary

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NOV - 4 2004

MSD SiLo™ Spinal System Summary of Safety and Effectiveness August 2004

Medtronic Sofamor Danek, Inc. USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Richard W. Treharne, PhD Contact: Sr. Vice President, Regulatory Affairs
Proposed Proprietary Trade Name: MSD SiLo™ Spinal System II.
Classification Name: Spinal Interlaminal Fixation and Spinal Intervertebral Fixation III. Orthosis and/or Pedicle Screw Spinal System (per 21 CFR Section 888.3050, 888.3060 and/or 888.3070)

IV. Product Description

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the MSD SiLo™ Spinal System. These components include CD HORIZON® rods and CROSSLINK® plates.

MSD SiLo™ hooks are intended for posterior use only.

V. Indications

The MSD SiLo™ Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, MSD SiLo™ components are 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) turnor resection, and/or (8) failed previous fusion.

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Substantial Equivalence VI.

Documentation, including test reports, was provided which demonstrated the MSD SiLo™ Spinal System to be substantially equivalent to CD HORIZON® Spinal System components previously cleared in K041030.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2004

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

K042210 Re:

Trade/Device Name: MSD SILO Spinal System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: III Product Code: MNI, MNH, KWP, KWQ, NKB Dated: September 30, 2004 Received: October 1, 2004

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 10 use sualed in the entroduce) is stgmay and ment 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). and Cosmeter fore, 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.

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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. This letter will allow you to begin marketing your device as described in your Section 5 10(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/dsma/dsmamain.html

Sincerely vours,

Mark A Milliken

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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Page 1 of 1 August 2004

510(k) Number (if known):K042210

MSD SiLo™ Spinal System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millken

Division of General, Restorative, and Neurological Devices

510(k) Number K042210

Regulation Number and Section

N/A