The Medtronic Sofamor Danek PYRAMID® +4 ANTERIOR LUMBAR PLATE System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral lev :l below the bifurcation of the vascular structures or as an or anteriorly lateral placed supplemental fixation device for the 1.1 -L5 region.

When properly used, this system will ielp 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) Neo )lastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scolio is, lordosis, and/or kyphosis) associated with deficient posterior elements such as t at resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, and / or kyphosis) associated with pelvic obliquity.

The Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation of the vascular structures or laterally above 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 myelcmenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic or liquity.

Device Description

The subject device represents an expansion of the PYRAMID® ANTERIOR PLATE System. The prodicate system will be renamed the PYRAMID® +4 ANTERIOR LUMBAR PLATE System. Like its predicate counterpart, the subject device is intended for use as an ant rior fixation device to supplement an anterior lumbar interbody fusion. The variety of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System provides surgeons wit 1 options in the placement of the device to avoid interference with the vasculature, whil : still allowing for fixation. The PYRAMID® +4 ANTERIOR LUMBAR PLATE components are made of titanium alloy.

AI/ML Overview

The information provided describes the Medtronic Sofamor Danek PYRAMID® +4 Anterior Lumbar Plate System. This is a medical device, specifically an anterior lumbar plate system, and the provided document is a 510(k) summary for its premarket notification to the FDA.

Based on the provided text, the device's acceptance criteria are demonstrated through substantial equivalence to previously cleared devices rather than a performance study with specific metrics and thresholds. Therefore, a table of acceptance criteria and reported device performance in the traditional sense of diagnostic accuracy metrics cannot be fully generated.

However, I can extract the information to address the other points about the "study" that proves the device meets the acceptance criteria, which in this case is a comparative analysis for substantial equivalence.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated via Substantial Equivalence)	Reported Device Performance (as demonstrated by comparison)
Intended Use: As an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of vascular structures or an anteriorly lateral placed supplemental fixation device for the L1-L5 region, to provide temporary stabilization until a solid spinal fusion develops.	Demonstrated to be substantially equivalent in intended use to the predicate devices: PYRAMID® Anterior Plate Fixation System (K011665) and XANTUS® Anterior Lateral Supplemental Fixation System (K022070).
Indications for Use: (e.g., Degenerative disc disease, Pseudoarthrosis, Spondylolysis, Spondylolisthesis, Fracture, Neoplastic disease, Unsuccessful previous fusion, Lordotic deformities, Idiopathic thoracolumbar/lumbar scoliosis, Deformity associated with deficient posterior elements, Neuromuscular deformity)	Demonstrated to be substantially equivalent in indications for use to the predicate devices.
Material: Components made of titanium alloy.	Material confirmed as titanium alloy, consistent with predicate devices.
Design/Technology: Intended to provide options in placement to avoid vascular interference while allowing fixation.	Described as an "expansion of the PYRAMID® ANTERIOR PLATE System," implying similar core design principles and technology to the predicate. Documentation, including mechanical test results, further supported this.
Mechanical Properties/Performance: To provide necessary temporary stabilization.	Mechanical test results were provided to demonstrate performance and substantial equivalence to predicate devices. (Specific performance metrics of these tests are not detailed in the provided text).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not describe a clinical "test set" in terms of patient data. The "study" here is based on mechanical testing and a comparison to predicate devices. The sample size for these mechanical tests is not specified in the provided text.
Data Provenance: The data provenance is primarily from in-vitro mechanical testing performed by the manufacturer, Medtronic Sofamor Danek. It is not patient data from a specific country or retrospective/prospective study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This point is not applicable to this type of device submission. There was no "ground truth" established by human experts on a test set of data (e.g., medical images or patient outcomes). The assessment of substantial equivalence relies on the FDA's review team evaluating the provided documentation, including design specifications and mechanical test results, against predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring an adjudication method. The FDA's review process itself can be considered a form of adjudication but is not structured like a consensus-based ground truth establishment for a diagnostic device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done or described for this medical device submission. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to evaluate human performance with and without AI. The PYRAMID® +4 Anterior Lumbar Plate System is a physical implant, not an imaging or diagnostic tool.

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

This question is not applicable. The device is a physical implant (anterior lumbar plate), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on the established safety and effectiveness of the identified predicate devices (PYRAMID® Anterior Plate Fixation System and XANTUS® Anterior Lateral Supplemental Fixation System), as well as engineering principles and mechanical testing to demonstrate that the new device performs similarly and is safe for its intended use. There is no biological or clinical "ground truth" in the typical sense of a diagnostic study (e.g., pathology, outcomes data).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this physical device. The device's design is based on engineering principles, existing medical knowledge, and the established designs of predicate devices, not on data used for machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set. The "truth" for the design derives from engineering validation and comparison to established, legally marketed predicate devices.

Summary

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K071416

NOV - 1 2007

MEDTRONIC Sofamor Danek PYRAMID® +4 Anterior Lumbar Plate System 510(k) Summary May 2007

I.	Company:	Medtronic Sofamor Danek, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132(901) 396-3133
	Contact:	Christine Sciert, Regulatory Affairs Group Director
II.	Product Name:	PYRAMID® +4 Anterior Lumbar Plate System
	Classification Name:	Spinal Interaminal Fixation Orthosis
	Class II	Product Code: KWQ
	21 CFR:	888.3060

III. Description: The subject device represents an expansion of the PYRAMID® ANTERIOR PLATE System. The prodicate system will be renamed the PYRAMID® +4 ANTERIOR LUMBAR PLATE System. Like its predicate counterpart, the subject device is intended for use as an ant rior fixation device to supplement an anterior lumbar interbody fusion. The variety of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System provides surgeons wit 1 options in the placement of the device to avoid interference with the vasculature, whil : still allowing for fixation. The PYRAMID® +4 ANTERIOR LUMBAR PLATE components are made of titanium alloy.
IV, Indications for Use: The Medtronic Sofamor Danek PYRAMID® +4 ANTERIOR LUMBAR PLATE System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral lev :l below the bifurcation of the vascular structures or as an or anteriorly lateral placed supplemental fixation device for the 1.1 -L5 region.

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Substantial Equivalence: Documents tion, including mechanical test results, provided V. has demonstrated that the PYRAMID® +4 Anterior Lumbar Plate System is substantially equivalent to similar previously cleared devices such as the PYRAMID® Anterior Plate Fixation System (K01:665, 12/29/2002) and the XANTUS® Anterior Lateral Supplemental Fixation System (K022070, SE 07/22/02).

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PYRAMID® +4 ANTERIOR I UMBAR PLATE System 510(k) APPLICATION

NOTICE

The enclosed materials and descriptions contain information, which is trade secure or confidential under 21 CFR 20,61 and not disclosable to the public under the Freedom of Information Act (FOIA). If you are not able to assure us that the enclosed information will not be disclosed to the public, we request that this submission be handled by FDA in accordance with 21 CFR 20.44 relating to presubmission reviews. Consequently, until you hear otherwise from us, we ask that you keep our application for this device confidential. We consider this premarket notification confidential information. If we disclose this application to anyone except consultants or employe es, we will notify the FDA.

Submitter Information I .

Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: 901-396-3133 Telefax: 901-346-9738 Contact; Christine Scifert Director, Regulatory Affairs

Manufacturing Facilities

Warsaw Orthopedic, Inc. (also known as) Medtronic Sofamor Danek Manufacturing, Inc. 2500 Silveus Crossing Warsaw, Indiana 46582 Telephone: 219-267-6826

Medtronic Puerto Rico Operations Co., med Rel Road 909, KM.0.4 Barrio Mariana Humacao, PR 00792

Device Name

Common or Usual Name: Metallic B< ne Fixation Appliance Proposed Proprietary or Trade Name: PYRAMIC™ +4 ANTERIOR LUMBAR PLATE System Classification Name: Spinal Interlaminal Fixation Orthosis

Establishment Registration Number

1030489	Medtronic Sofamor Danek USA, Inc.
1824199	Warsaw Orthopedic (also known as) Medtronic Sofamor DanekManufacturing (For reference onl/)
2647346	Medtronic Puerto Rico Operation: Co.

Classification

Class II - 21 CFR 888.3060 (Orthopedic OR 87) Product Code - KWQ

Performance Standards (FD&C Act Section 514)

We are unaware of any performance standards for this device.

000008

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek, Inc. % Ms. Christine Scifert Regulatory Affairs Group Director 1800 Pyramid Place

Re: K071416

Memphis, TN 38132

Trade/Device Name: Pyramid® +4 Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 25, 2007 Received: September 26, 2007

Dear Ms. Scifert:

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.

NOV - 1 2007

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 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 – Ms. Christine Scifert

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Mark N. Millikan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 3 -

Indications for Use

510(k) Number (if known): K071416

Device Name: Pyramid +4 Anterior Lumbar Plate System

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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number	K071416

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.