EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE by DEPUY SPINE, INC.

The EXPEDIUM Spine System is intended for non-cervical, non-pedicle 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 failed previous fusion in skeletally mature patients.

The Expedium Spinous Process Fusion Plate is not intended for stand-alone use. When used with DePuy Spine VBR Spinal System components the Expedium Spinous Process Fusion Plate is intended for the following conditions:

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)
tumor

Device Description

The EXPEDIUM Spine System Spinous Process Fusion Plates are available in various lengths and spinous process heights. The EXPEDIUM Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. Manufactured from ASTM F-136 implant grade titanium alloy.

AI/ML Overview

The provided text is a 510(k) summary for the "EXPEDIUM™ Spine System Spinous Process Fusion Plates," a medical device. It does not contain information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, which is typically where such criteria and studies are relevant (e.g., for AI/ML devices).

Instead, this document is a premarket notification for a predicate device. It addresses its intended use, materials, and substantial equivalence to previously marketed devices. The phrase "Performance data were submitted to characterize the additional EXPEDIUM Spine System components" is present, but it does not detail the nature of these performance data or any specific acceptance criteria or study findings.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets or their data provenance.
Number and qualifications of experts for ground truth.
Adjudication methods.
MRMC comparative effectiveness study results.
Standalone performance.
Type of ground truth used (expert consensus, pathology, etc.).
Sample size for the training set.
How ground truth for the training set was established.

This document is from 2005, well before the widespread use of AI/ML in medical devices that necessitates the detailed performance studies you're asking about. The "performance data" mentioned likely refers to mechanical testing (e.g., fatigue, static strength) to ensure the implant's structural integrity, rather than diagnostic accuracy.

Summary

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K050675

APR 1 1 2005 510(k) Summary VII.

DePuv Spine, Inc. SUBMITTER: 325 Paramount Drive Raynham, MA 02780

CONTACT PERSON: Lisa Gilman

DATE PREPARED: February 25, 2005

CLASSIFICATION NAME: Appliance, Fixation, Spinal Interlaminar Orthosis, Spinal Intervertebral Body Fixation

EXPEDIUM Spine System Spinous Process Fusion PROPRIETARY NAME: Plates

PREDICATE DEVICES: EXPEDIUM Spine System K033901 Wilson Spinal Plate

DEVICE DESCRIPTION: The EXPEDIUM Spine System Spinous Process Fusion Plates are available in various lengths and spinous process heights.

The EXPEDIUM Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The EXPEDIUM Spine System is intended for non-INTENDED USE: cervical, non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed bv history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

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degenerative disc disease (defined as back pain of . discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
KOSO675

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spondvlolisthesis .
trauma (i.e., fracture or dislocation) .
tumor .
Manufactured from ASTM F-136 implant grade titanium MATERIALS: alloy.
Performance data were submitted to characterize the PERFORMANCE DATA: additional EXPEDIUM Spine System components.

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Image /page/2/Picture/1 description: The image shows the seal of 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 a stylized image of an eagle with its wings spread.

APR 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Gilman Senior Regulatory Affairs Associate DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K050675

Trade/Device Name: EXPEDIUM™ Spine System Spinous Process Fusion Plate Regulation Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWP Dated: March 24, 2005 Received: March 25, 2005

Dear Ms. Gilman:

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.

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. Lisa Gilman

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 (240) 276-4369. 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/industry/support/index.html.

Sincerely yours,

tipt Rhodes

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use III.

510(k) Number (if known):

EXPEDIUM™ Spine System Spinous Process Fusion Plate Device Name:

Indications For Use:

degenerative disc disease (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
. spondviolisthesis
trauma (i.e., fracture or dislocation) .
. tumor

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)

Stypt. Rwork

neral. Restorative. and Neurological Devices

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510(k) Number K050675

Regulation Number and Section

N/A