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 consists of a variety 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) premarket notification for the PYRAMID® ANTERIOR PLATE Fixation System, specifically to include modified screws.

Based on the provided text, there is no study described that demonstrates the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity for an AI/ML powered device.

This document is a regulatory submission for a medical device (a spinal fixation system), not a study report for an AI/ML algorithm. The "acceptance criteria" and "device performance" in this context refer to manufacturing, material specifications, and substantial equivalence to a previously cleared predicate device, rather than the performance of an AI model.

Therefore, many of the requested categories for AI/ML device studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

However, I can extract information relevant to the regulatory approval process and the broader context of device "performance" in a non-AI sense.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by 510(k) Process)	Reported Device Performance (Implied by 510(k) Clearance)
Substantial Equivalence: Device (including modified screws) is as safe and effective as a legally marketed predicate device.	The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices.
Material Compatibility/Safety: Components made of suitable biocompatible materials.	Implied by the use of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3.
Intended Use Compatibility: Device's design and materials support its specified indications for use.	The system is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level and helps provide temporary stabilization until solid spinal fusion develops.
Manufacturing Quality: Adherence to General Controls provisions (e.g., GMP requirements, labeling).	FDA states the device is subject to general controls provisions of the Act, including requirements for annual registration, listing, good manufacturing practice, and labeling.

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 document is not about a study involving a test set for an AI/ML algorithm. The 510(k) process relies on demonstrating substantial equivalence to a predicate device, which typically involves engineering testing, material testing, and potentially clinical literature review, rather than a "test set" in the AI sense.

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. No explicit "ground truth" establishment for a test set is described in the context of an AI/ML device. The "experts" involved would be regulatory reviewers at the FDA (Celia M. Witten, Ph.D., M.D., Director, Division of General, Restorative and Neurological Devices Office of Device Evaluation) assessing the submission.

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

Not Applicable. No test set or adjudication method for AI/ML performance is described.

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. An MRMC study is not mentioned as this relates to an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

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

Not Applicable in the AI/ML sense. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate device (K013665), to which the current device is deemed substantially equivalent.

8. The sample size for the training set

Not Applicable. No training set is involved for an AI/ML algorithm.

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

Not Applicable. No training set is involved for an AI/ML algorithm.

In summary, this document is a regulatory clearance for a physical medical device (spinal fixation system) based on substantial equivalence, not a performance study of an AI/ML powered device.

Summary

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PYRAMID® ANTERIOR PLATE Fixation System Summary of Safety and Effectiveness January 2005

Medtronic Sofamor Danek, Inc. USA Company: I. 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
- Richard W. Treharne, PhD Contact: Sr. Vice President, Regulatory Affairs
Proposed Proprietary Trade Name: PYRAMID® ANTERIOR PLATE Fixation II. System
Classification Name: Spinal Intervertebral Body Fixation Orthosis, Class II III.

Regulation Number: 21 CFR Sections 888.3050

Code: KWQ

Product Description IV.

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

The purpose of this 510(k) submission is to include modified screws to the PYRAMID® ANTERIOR PLATE Fixation System.

V. Indications

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) anoogento engin >> Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) I bouccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida,

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or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity

Substantial Equivalence VI.

Documentation was provided which demonstrated the PYRAMID" ANTERIOR PLATE Fixation Documentation was provided with the PYRAMID® ANTERIOR PLATE Fixation System components previously cleared in K013665.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Public Health Service

FEB 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050117

K050117
Trade Name: PYRAMID™ Anterior Plate Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: January 14, 2005 Received: January 18, 2005

Dear Dr. Treharne:

We have reviewed your Section 510(k) premarket notification of intent to market the device in indicati we have reviewed your bection 9 ro(if) premium is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosary to tegans actment date of the Medical Device Amendments, or to commerce program to May 20, 1978, the encordance with the provisions of the Federal Food, Drug. devices that have occh recuire approval of a premarket approval application (PMA). and Cosmetic 71ct) that to neviews subject to the general controls provisions of the Act. The r ou may, merciore, market the act include requirements for annual registration, listing of general controls provisions 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 device to such additional controls. Existing major regulations affecting your device can thay be subject to saterial Regulations, Title 21, Parts 800 to 898. In addition, FDA may ov loand nrther announcements concerning your device in the Federal Register.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri 3 ibsudited by our device complies with other requirements of the Act that I DA has made a acterimistions administered by other Federal agencies. You must of any I cut al statures and regulations and limited to: registration and listing (21 Compry with an the Hot 6 requirements) 01); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant) by sound of Sections 531-542 of the Act); 21 CFR 1000-1050. product thanation control po begin marketing your device as described in your Section 510(k) I mis ictier with anow you to ogin mailing of substantial equivalence of your device to a legally premaince notineation. The 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 If you desire specific as not any and (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 other general informational 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,

Mark A. Mellarson

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 __ of _ January 2005

510(k) Number (if known): K050117

Device Name:

PYRAMID® ANTERIOR PLATE Fixation System

Indications for Use

Prescription Use (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)

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

K050117

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.