The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.

When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

Device Description

The PYRAMID™ ANTERIOR PLATE Fixation System is a supplemental fixation construct consisting of a variety of shapes and sizes of plates, and screws, as well as ancillary products and instrument sets. The PYRAMID™ ANTERIOR PLATE Fixation System implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and titanium implant components must not be used together in a construct.

AI/ML Overview

The provided text describes a 510(k) submission for the Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System. This document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, not a study involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria for AI/human reader performance is not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device	Determined to be substantially equivalent to K013665 (PYRAMID™ ANTERIOR PLATE Fixation System).
Mechanical Functionality & Safety Tests	Mechanical testing was performed.
Compliance with Regulatory Standards	Implants made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission is for a medical device (spinal fixation system) and its substantial equivalence is demonstrated through mechanical testing, not a clinical study with a test set of human subjects or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth in the context of expert consensus is not relevant for this type of mechanical device submission. The "ground truth" here would be the performance of the predicate device against which the new device is compared.

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

Not Applicable. This is not a study requiring adjudication of expert opinions.

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 not an AI-assisted diagnostic or interpretive device.

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

No. This is a physical medical implant, not an algorithm.

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

The "ground truth" or benchmark here is the performance of the predicate device (K013665, PYRAMID™ ANTERIOR PLATE Fixation System) as established by its clearance and subsequent safety and effectiveness. The new device's mechanical performance is compared to this established predicate.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of mechanical testing for substantial equivalence.

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

Not Applicable. There is no "training set" or corresponding ground truth establishment in this context.

Summary

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KO21226e p½

MAY 1 3 2002

Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System 510(k) Summary April 2002

Submitter:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, TN 38132
Contact Person:	Richard Treharne
Trade Name:	PYRAMID™ ANTERIOR PLATE Fixation System
Classification Name:	Spinal Intervertebral Body Fixation Orthosis, Class II
Predicate Device(s):	The PYRAMID™ ANTERIOR PLATE Fixation System is substantiallyequivalent to K013665, Medtronic Sofamor Danek PYRAMID™ ANTERIORPLATE Fixation System, which was cleared on January 29, 2002.
Device Description:	The PYRAMID™ ANTERIOR PLATE Fixation System is a supplementalfixation construct consisting of a variety of shapes and sizes of plates, andscrews, as well as ancillary products and instrument sets. The PYRAMID™ANTERIOR PLATE Fixation System implant components can be locked into avariety of configurations, with each construct being tailor-made for theindividual case. The implant components are made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel andtitanium implant components must not be used together in a construct.
Intended Use:	The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE FixationSystem is indicated for use as an anteriorly placed supplemental fixationdevice for the lumbosacral level below the bifurcation of the vascularstructures.When properly used, this system will help provide temporary stabilization untila solid spinal fusion develops. Specific indications include: 1) Degenerativedisc disease (as defined by back pain of discogenic origin with degeneration ofthe disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3)Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7)Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9)Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis,lordosis, and/or kyphosis) associated with deficient posterior elements such asthat resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11)

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|COR1226 p2/

Neuromuscular deformity (i.e., scoliosis, and / or kyphosis) associated with pelvic obliquity.

Functionality & Safety Testing:

Mechanical testing was performed on the Subject PYRAMID™ ANTERIOR PLATE Fixation System, which determined it to be substantially equivalent to the Predicate PYRAMID™ ANTERIOR PLATE Fixation System

Conclusion:

The PYRAMID™ ANTERIOR PLATE Fixation System is substantially equivalent to K013665, the PYRAMID™ ANTERIOR PLATE Fixation System .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract shapes, possibly representing human figures or elements of health and well-being.

MAY 1 3 2002

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

Re: K021226

Trade/Device Name: PYRAMID™ Anterior Plate Fixation System Regulatory Number: 21CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 17, 2002 Received: April 18, 2002

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

This letter will allow you to begin marketing your device as described in your 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 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, (2017) 594-4639 - Radikens at (301) 594-4639. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsible (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N. Mibena

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): CO2 & LD2 & L

Device Name: PYRAMID™ ANTERIOR PLATE Fixation System

Indications for Use:

(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)

Mush N. Milkersen

ision of General, Restorative and Neurological Devices

510(k) Number K021226

Over-the-counter Use

Regulation Number and Section

N/A