The Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.

This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine.

This device is intended to be used in patients who have had six weeks of non-operative treatment.

Device Description

The Vusion® CS Plus system is designed for cervical intervertebral body fusion. The implant is a non-sterile PEEK Optima LT1 (ASTM F2026) implant body and two tantalum (ASTM F560) marker pins and is provided in multiple footprints, lordotic angles, and heights to match patient's anatomy. The implant includes machined fixation teeth on the superior and inferior surfaces, a graft window passing between the superior and inferior surfaces, and an insertion hole for implant placement.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Vusion® CS Plus," an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance data, rather than clinical study data showcasing diagnostic or predictive accuracy. Therefore, information typically found in studies for AI/algorithm-based devices (like acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone performance) is not applicable here.

This submission relies on engineering and material testing to prove its safety and effectiveness.

Here's an analysis based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Measure)	Description	Reported Device Performance
Material Equivalence	Vusion® CS Plus uses the same basic design, material (PEEK Optima LT1 and Tantalum marker pins), and sizes (widths, lengths, heights within the range offered by predicate systems) as previously cleared predicate devices.	The Vusion® CS Plus system uses PEEK Optima LT1 (ASTM F2026) for the implant body and two tantalum (ASTM F560) marker pins. Its dimensions are described as "multiple footprints, lordotic angles, and heights to match patient's anatomy" and are within the range offered by predicate systems. This establishes technological similarity.
Intended Use Equivalence	The intended use of Vusion® CS Plus is the same as the predicate devices.	The Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease of the cervical spine, to be implanted via an open, anterior approach with autogenous bone and used with a supplemental internal fixation system after six weeks of non-operative treatment.
Mechanical Performance	The device's mechanical performance, specifically static and dynamic compression, static shear, static and dynamic torsion, and subsidence, should be comparable or superior to predicate devices when tested under worst-case configurations according to specified ASTM standards.	Results: The mechanical test results demonstrated that Vusion® CS Plus devices perform as well as or better than the predicate devices. (Specific quantitative values are not provided in this summary, but the conclusion states equivalence or superiority.)

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

Sample Size for Test Set: Not applicable. This submission relies on mechanical testing of the device itself, not a clinical test set of patient data. The "worst case configurations" of the device were tested. The exact number of units or configurations tested is not specified in this summary.
Data Provenance: Not applicable. The data comes from laboratory mechanical testing of the device's physical properties, not from patient data (e.g., country of origin, retrospective/prospective are irrelevant here).

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

Not applicable. There is no "ground truth" derived from expert consensus on patient data in this submission type. The "ground truth" for mechanical testing is established by the ASTM F2077 and ASTM F2267 standards against which the device performance is measured, and comparison to predicate device performance.

4. Adjudication Method for the Test Set

Not applicable. As there is no "test set" of patient data or corresponding expert ground truth, adjudication methods (like 2+1, 3+1, none) are not relevant here. The evaluation is based on engineering and material standards compliance.

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. This device is an intervertebral body fusion device (physical implant), not an AI or imaging system requiring human interpretation or an MRMC study.

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

Not applicable. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this regulatory submission is based on established engineering and material standards (ASTM F2077, ASTM F2267) and the performance characteristics of legally marketed predicate devices. The goal is to demonstrate "substantial equivalence" to these predicates in terms of safety and effectiveness, primarily through mechanical performance.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical testing for a physical implant. The design and manufacturing process would involve internal development and validation, but not a "training set" as understood for AI/machine learning.

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

Not applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply. The "ground truth" for the device's design and manufacturing is based on engineering principles, material science, and compliance with relevant industry standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Ortho Development. The logo consists of a stylized symbol resembling concentric arcs emanating from a solid circle, followed by the word "ORTHO" in bold, sans-serif capital letters. Below "ORTHO" is the word "DEVELOPMENT" in smaller, sans-serif capital letters with an asterisk at the end.

K122588
Page 1 of 2

JUN 1 2 2013

510(k) Summary

NAME OF SPONSOR:

Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020

510(k) CONTACT:

Tom Haueter Regulatory Affairs Manager Telephone: (801) 553-9991 Facsimile: (801) 553-9993 Email: thaueter@orthodevelopment.com

DATE PREPARED:

PROPRIETARY NAME:

COMMON NAME:

CLASSIFICATION:

DEVICE PRODUCT CODE:

PREDICATE DEVICES:

DEVICE DESCRIPTION:

Vusion® CS Plus 510(k)

July 11, 2012

Vusion® CS Plus

Intervertebral Body Fusion Device

21 CFR 888.3080, Intervertebral Body Fusion Device.

ODP

LDR Spine Cervical Interbody Fusion System (K091088) LDR Spine

ROI-C Cervical Cage (K113559) LDR Spine

Aesculap CeSpace PEEK Spinal Implant System (K083311) Aesculap® Implant Systems

Aleutian IBF System (K113138) K2M, Inc.

Crystal™ Intervertebral Body Fusion Device (K073351) Spinal Elements

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Image /page/1/Picture/1 description: The image shows the logo for "Ortho Development". The logo consists of a circular icon with three curved lines emanating from the right side, followed by the word "ORTHO" in bold, sans-serif font. Below the word "ORTHO" is the word "DEVELOPMENT" in a smaller, sans-serif font.

fixation teeth on the superior and inferior surfaces, a graft window passing between the superior and inferior surfaces, and an insertion hole for implant placement . INTENDED USE: The Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. . This device is intended to be used in patients who have had six weeks of non-operative treatment. TECHNOLOGICAL Vusion® CS Plus has the same technological characteristics as the CHARACTERISTICS: predicate devices. These include: t Intended use (as described above) . Basic design Material (PEEK) . . Sizes (widths, lengths, heights are within range(s) offered by the predicate systems) Therefore the fundamental scientific technology of Vusion® CS Plus is the same as previously cleared devices. The following non-clinical mechanical tests were conducted on the PERFORMANCE DATA: worst case configurations of Vusion® CS Plus: . Static and dynamic compression testing per ASTM F2077 . Static shear testing per ASTM F2077 Static and dynamic torsion testing per ASTM F2077 . . Subsidence testing per ASTM F2267

The mechanical test results demonstrate that Vusion® CS Plus devices perform as well as or better than the predicate devices. Therefore, Vusion® CS Plus is as safe and effective as the predicates.

Based on similarities in intended use, design, materials, manufacturing methods, and packaging, Vusion® CS Plus is substantially equivalent to the previously cleared predicate devices. Mechanical test results demonstrate that the proposed Vusion® CS Plus is substantially equivalent to the predicate devices.

Vusion® CS Plus 510(k)

CONCLUSIONS:

Section 5, 510(k) Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper portion of the logo.

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

Letter Dated: June 12, 2013

Ortho Development Corporation % Mr. Tom Haueter Regulatory Affairs Manager 12187 South Business Park Drive Draper, Utah 84020

Re: K122588

Trade/Device Name: Vusion® CS Plus Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 28, 2013 Received: May 29, 2013

Dear Mr. Haueter:

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 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

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Page 2 - Mr. Tom Haueter

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Laurence D. Coyne -A

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

Enclosure

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Indications for Use

510(k) Number (if known): K122588

Device Name: Ortho Development Vusion® CS Plus

Indications for Use:

This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine.

This device is intended to be used in patients who have had six weeks of non-operative treatment.

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(Part 21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, RhD Division of Orthopedic Devices

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.