The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle 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.

Device Description

The EXPEDIUM® 4.5mm Spine System is a rod-hook-screw system. The EXPEDIUM 4.5mm Spine System proposed single and dual diameter rods are offered in titanium, stainless steel, and cobalt-chromiummolybdenum. They are available in various geometries and sizes to accommodate patient anatomy.

AI/ML Overview

The provided text describes a 510(k) summary for the EXPEDIUM Spine System, which is a medical device for spinal fixation. It details the device's characteristics, intended use, and comparison to predicate devices, but it does not contain any information about a study that would establish acceptance criteria for device performance based on clinical or AI-driven evaluation, nor does it provide performance data in the context of diagnostic accuracy or expert consensus.

The "Performance Data" section specifically states:
"Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification. Specifically, static and dynamic compression testing as well as static torsion testing were performed."

This indicates that the performance data submitted relates to mechanical testing of the device components (e.g., strength, durability), not to a study assessing the device's diagnostic or clinical performance in comparison to a ground truth or human experts. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in the provided document.

Here's an attempt to address the points based on the available information, highlighting what is not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Type of Performance)	Reported Device Performance
Mechanical Performance (ASTM F 1717)	Passed (Implied by conclusion of substantial equivalence)
- Static Compression	Performed
- Dynamic Compression	Performed
- Static Torsion	Performed
Clinical Performance (e.g., diagnostic accuracy, human reader improvement)	Not Applicable/Not Provided

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

Not Provided. The document refers to mechanical testing data, not clinical test set 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/Not Provided. The study described is mechanical testing, not a study involving expert assessment of a test set.

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

Not Applicable/Not Provided.

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

Not Applicable/Not Provided. This document describes a traditional medical device (spine system), not an AI-driven or diagnostic device.

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

Not Applicable/Not Provided.

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

For the mechanical performance, the "ground truth" or standard would be the requirements of ASTM F 1717 for spinal implant testing. The document states that performance data per ASTM F 1717 was submitted, implying compliance with the test standards.

8. The sample size for the training set

Not Applicable/Not Provided. There is no mention of a "training set" as this is not an AI/ML device or a diagnostic performance study.

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

Not Applicable/Not Provided.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence for a physical spinal implant device based on its design, materials, intended use, and mechanical performance testing according to ASTM F 1717 standards. It does not describe any studies related to clinical diagnostic performance, expert evaluations, or AI system performance, which are the typical contexts for the requested information.

Summary

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K110551

510(K) SUMMARY

A.	Submitter Information	DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767
	Contact Person:	Daphney Germain-KolawoleRegulatory Affairs Associate
	Voice:	(508) 880-8395
	Fax:	(508) 828-3797
	E-Mail:	dgermain@its.jnj.com
B.	Date Prepared	2/25/2011
C.	Device Class	Class III
D.	Device Name
	Trade/Proprietary Name:	EXPEDIUM Spine System
	Common/Usual Name:	Pedicle Screw Spinal System
	Classification Name:	Spinal interlaminar fixation orthosisper 21 CFR §888.3050Spinal intervertebral body fixation orthosisper 21 CFR §888.3060Pedicle screw spinal fixationper 21 CFR §888.3070
	Classification Panel:	Orthopaedics
	FDA Panel Number:	87

DePuy Spine, Inc., a Johnson & Johnson Company

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K110551

E. Product Code(s)

NKB, MNI, MNH, KWQ , KWP

F. Predicate Device Name

Trade name: DePuy Spine EXPEDIUM® Spine System (K063772) DePuy Spine EXPEDIUM® Spine System (K090230) DePuy Spine EXPEDIUM® Spine System (K092473) DePuy Spine MOSS MIAMI Spine System (K011182) DePuy Spine MOSS MIAMI Spine System (K023804)

E. Device Description

F. Intended Use

The EXPEDIUM Spine System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The EXPED!UM PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from L1-S1 in skeletally mature patients.

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F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

The proposed modifications to the DePuy Spine EXPEDIUM® 4.5mm Spine System are identical to the predicate devices except that the dual diameter rods are offered in cobalt-chromium-molybdenum alloy and in additional sizes. Also, the labeling limitation indicating the minimum screw diameter size no longer applies and is removed from the instructions for use. The design, materials, and technology remain identical to the predicate systems.

G. Materials

Manufactured from ASTM F 1537 implant grade cobalt-chromiummolybdenum alloy, ASTM F 138 implant grade stainless steel, and ASTM F 136 implant grade titanium alloy.

H. Performance Data

Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification. Specifically, static and dynamic compression testing as well as static torsion testing were performed.

l. Conclusion

Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

DePuy Spine, Inc., a Johnson & Johnson Company

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 6 2011

DePuy Spine, Inc. % Mr. Frank Jurczak Sr. Regulatory Affairs Associate 325 Paramount Drive Raynham, Masschusetts 02767

Re: K110551

Trade/Device Name: EXPEDIUM Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: September 30, 2011 Received: October 03, 2011

Dear Mr. Jurczak:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 not 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

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Page 2 - Mr. Frank Jurczak

CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedi and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: EXPEDIUM® Spine System

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

(Diysion Sign-Off Division of Surgical Orthopedic, and Restorative Devices

5 ' 0(k) Number_K 110551

DePuy Spine, Inc., a Johnson & Johnson Company

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.