The EXPEDIUM and VIPER Systems are 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 and VIPER Systems are 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.

When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

The subject EXPEDIUM and VIPER Spine System components consist of screws and are available in various geometries and sizes.

AI/ML Overview

The provided document is a 510(k) Summary for the DePuy Spine EXPEDIUM® and VIPER® Systems, which are spinal fixation devices. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials and detailed acceptance criteria for an AI/algorithm.

Therefore, the specific information requested about acceptance criteria, study design for proving device performance against those criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for AI/software-as-a-medical-device (SaMD) are not applicable to this submission.

Here's an explanation based on the provided document:

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

Not Applicable. This submission is for mechanical spinal implants, not an AI/software device. The "performance" is assessed through a comparison to predicate devices and mechanical testing, not against specific diagnostic or treatment accuracy acceptance criteria as would be expected for a SaMD.

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

Not Applicable. There is no "test set" in the context of an AI/software device. The performance was evaluated via non-clinical mechanical testing of the physical implants. The document does not specify the number of units tested, but mechanical tests typically involve a pre-determined number of samples to ensure statistical validity for the specific test (e.g., fatigue or static load).

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 AI/SaMD, refers to the verified correct output (e.g., diagnosis, measurement) for comparison with the algorithm's output. For mechanical implants, "ground truth" is typically defined by engineering specifications and material properties, verified through testing procedures against established standards (e.g., ASTM F1798). Experts involved would be engineers and material scientists.

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

Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert opinions when establishing ground truth for AI/SaMD. This is not pertinent to the mechanical testing of spinal implants.

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. MRMC studies are designed to evaluate the impact of an AI algorithm on human reader performance (e.g., radiologists, pathologists). This device is a physical implant, not an AI system.

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

Not Applicable. This concept applies to AI algorithms and not to physical medical devices like spinal implants.

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

For mechanical testing: The "ground truth" (or reference standard) for the nonclinical tests would be the established scientific and engineering principles outlined in the cited ASTM standards (F1798). Performance is measured against physical properties and failure points defined by these standards, not against biological or clinical outcomes or expert consensus on images.

8. The sample size for the training set

Not Applicable. There is no training set as this is not an AI/machine learning device.

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

Not Applicable. Since there is no training set, this question is not relevant.

Summary of what the document does provide regarding device performance:

The document states that "No clinical tests were performed."
Instead, the device's performance and safety were established through "Nonclinical Test Summary:"

Static Cantilever Beam in accordance with ASTM F1798
Dynamic Cantilever Beam in accordance with ASTM F1798
Axial Slip in accordance with ASTM F1798

These tests are designed to evaluate the mechanical properties and stability of the spinal implants and their interconnection mechanisms, ensuring they meet the requirements for their intended use and are comparable to predicate devices. The "acceptance criteria" here are implied to be the successful completion of these tests in accordance with the ASTM standards, demonstrating structural integrity and mechanical equivalence to the already cleared predicate devices. The specific results of these tests (e.g., actual load values, cycles to failure) are not detailed in this 510(k) summary but would have been submitted to the FDA in a more comprehensive report.

Summary

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DEC - 7 2010

5. 510(K) SUMMARY

Submitter: DePuy Spine, Inc. 325 Paramount Drive Raynham. MA 02767

Contact Person: Frank Jurczak Sr. Regulatory Affairs Associate Voice: (508) 828-3288 Fax: (508) 828-3797 E-Mail: fjurczak@its.ini.com

Date Prepared: October 6, 2010

Device Class: Class III

Classification Name: Spinal interlaminar fixation orthosis per 21 CFR §888.3050

Spinal intervertebral body fixation orthosis per 21 CFR §888.3060

Pedicle screw spinal fixation per 21 CFR §888.3070

Classification Panel: Orthopedics

FDA Panel Number: 87

Product Code(s):	NKB	KWQ	KWP	MNH	MNI
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Proprietary Name: EXPEDIUM® Spine System; VIPER® System

Predicate Devices: VIPER® System (K033901, K090648) EXPEDIUM® Spine System (K033901, K051024, K063156, K063741, K080313)

Device Description: The subject EXPEDIUM and VIPER Spine System components consist of screws and are available in various geometries and sizes.
The EXPEDIUM and VIPER Systems are intended to provide Intended Use: 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 and VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following

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October 6th, 2010

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.

Materials: Manufactured from ASTM F 138 implant grade stainless steel and ASTM F 136 implant grade titanium alloy

Comparison to

Predicate Device: The substantial equivalence of the subject devices to the predicates identified above is based upon the equivalence of intended use, design (fundamental scientific technology), materials, manufacturing methods, performance, sterility, biocompatibility, safety and packaging design.

Nonclinical Test Summary:

The following mechanical tests were conducted:

. Static Cantilever Beam in accordance with ASTM F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants".
Dynamic Cantilever Beam in accordance with ASTM . F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants".
Axial Slip in accordance with ASTM F1798 "Standard . Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants".

Clinical Test
Summary:

No clinical tests were performed.

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Conclusion: Based on the predicate comparison and testing, the subject modified screw components of the EXPEDIUM® and VIPER® Systems are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three stripes representing feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

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

DEC - 7 2010

Re: K101993

Trade/Device Name: EXPEDIUM® and VIPER® Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWQ, KWP, MNH, MNI Dated: November 16, 2010 Received: November 17, 2010

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 of the Act

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Page 2 - Mr. Frank Jurczak

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); medical device reporting (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/CDRHQffices/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,

A. B. R.
fr.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

DEC - 7 2010

Device Name: EXPEDIUM® and VIPER® Systems

Indications For Use:

When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

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 Surgical. Orthopedic, and/Restorative Devices

KI01993 510(k) Number_

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.