VEO is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. VEO is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine.

Device Description

VEO is a radiolucent PEEK interbody fusion implant comprised of various heights to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The lateral access technique allows a large cage to be implanted similar to marketed lateral lumbar interbody fusion sized cages. It is designed for use to provide structural stability in skeletally mature individuals.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the TranS1 VEO device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes a medical device, the TranS1 VEO, which is an intervertebral fusion device, and details its mechanical testing. The acceptance criteria are defined by various ASTM standards for mechanical testing. The reported device performance is that it met or exceeded these requirements.

Test	Standard	Acceptance Criteria	Reported Device Performance
Static Compression	ASTM F2077-11	Requirements established by ASTM F2077-11	Met or exceeded requirements
Static Compression Shear	ASTM F2077-11	Requirements established by ASTM F2077-11	Met or exceeded requirements
Static Torsion	ASTM F2077-11	Requirements established by ASTM F2077-11	Met or exceeded requirements
Subsidence	ASTM F2267-04	Requirements established by ASTM F2267-04	Met or exceeded requirements
Expulsion	ASTM Draft F04.25.02.02	Requirements established by ASTM Draft F04.25.02.02	Met or exceeded requirements
Dynamic Compression	ASTM F2077-11	Requirements established by ASTM F2077-11	Met or exceeded requirements

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

The document describes confirmatory mechanical testing and does not refer to clinical studies with patient data. Therefore, information regarding "sample size used for the test set" (in terms of patient numbers), "data provenance" (country of origin, retrospective/prospective) is not applicable in this context. The "test set" in this case refers to the physical devices undergoing mechanical tests. The specific number of devices tested for each mechanical test is not provided in the summary.

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

This information is not applicable as the study is a mechanical engineering test on a medical device, not a diagnostic or AI-driven evaluation that would require human expert ground truthing. The "ground truth" for these tests is the physical performance of the device against established engineering standards.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as above. Adjudication methods are typically relevant for clinical studies or image interpretation, not for mechanical device testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. The document describes mechanical testing of an intervertebral fusion device, not a diagnostic or interpretative AI system where human readers would be involved or assisted by AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not applicable. The device is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

The ground truth used for these tests is the established requirements and specifications within the referenced ASTM (American Society for Testing and Materials) standards. These are engineering benchmarks for material properties, structural integrity, and performance under various loads.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is not an AI/machine learning study or a clinical trial with a patient training cohort. The device's design and manufacturing are based on established engineering principles and materials science.

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

This information is not applicable for the same reasons as above. The "ground truth" for the device's design and manufacturing is derived from engineering principles and regulatory requirements for such implants.

Summary

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K123997

1 2013 APR

Premarket Notification [510(K)] Summary (per 21 CFR 807.92)

December 2012

Submitter:

Contact Person:

TranS1. Inc. 301 Government Center Drive Wilmington, NC 28403

Cheryl L Wagoner Director of Global Regulatory 910-332-1703 (phone), 910-233-1701 (fax)

Proprietary Name:

Classification:

888.3080: Intervertebral Fusion Device (MAX)

TranS1® Lateral Interbody Fusion Device or TranSI VEO

Legally Marketed Equivalent Device: TranS1 Lateral Interbody Fusion Device: K100210

Indications and Intended use:

VEO is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from 1.2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. VEO is designed to be used with autogenous graff and supplemental spinal fixation that is cleared for use in the lumbar spine.

Device Description

Technological Characteristics and Substantial Equivalence

Documentation was provided to demonstrate that the modified TranS1® Lateral Interbody Fusion Device (brand name VEO) is substantially equivalent to the TranS1® Lateral Interbody Fusion Device as cleared The Subject device is substantially equivalent in intended use, level of attachment, in K100210. materials, labeling, sterilization, and technological characteristics. These devices have the same intended use and indications and rely on the same fundamental scientific technology, therefore the Subject device is substantially equivalent to the Predicate device.

heet I of 2

Summary of Testing

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Confirmatory mechanical testing for the TranSI Interbody Fusion was performed per ASTM standards and included:

Test	Standard
Static Compression	ASTM F2077-11
Static Compression Shear	ASTM F2077-11
Static Torsion	ASTM F2077-11
Subsidence	ASTM F2267-04
Expulsion	ASTM Draft F04.25.02.02
Dynamic Compression	ASTM F2077-11

All static and dynamic testing met or exceeded the requirements as established by the test protocol and applicable ASTM standards. The results demonstrated that the subject VEO device presents no new worst case for performance testing and the Subject device was therefore found to be substantially equivalent to the Predicate.

Conclusion

Based on the indications for use, technological characteristics, and comparison to predicate device, the Subject VEO (TranS1 Interbody Fusion System) has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

sheet 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three overlapping human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: April 1, 2013

TranS1, Incorporated % Ms. Cheryl L. Wagoner Director of Global Regulatory 301 Government Center Drive Wilmington, North Carolina 28403

Re: K123997

Trade/Device Name: TranS1® Lateral Interbody Fusion Device or TranS1 VEO Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 11, 2013 Received: February 14, 2013

Dear Ms. Wagoner:

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 - Ms. Cheryl L. Wagoner

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark NMelkerson -S

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

Enclosure

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510(k) Number: K123997

Device Name: TranS1® Lateral Interbody Fusion Device or TranS1 VEO

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD 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.