The TranS1 Interbody Fusion System 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. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

Device Description

The TranS1® Interbody Fusion System is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The TranS1® Interbody Fusion System provides anterior, transforaminal or posterior approaches to the spine. The access techniques allow a large cage to be implanted similar to marketed anterior, transforaminal, or posterior lumbar interbody fusion devices. It is designed for use with supplemental fixation to provide structural stability in skeletally mature individuals.

AI/ML Overview

The provided document describes the 510(k) Pre-market Notification for the TranS1® Interbody Fusion System. This submission focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not involve a study related to AI or a software device, and therefore many of the requested criteria are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This device is a physical interbody fusion implant, not a software or AI-driven diagnostic device. Therefore, the "acceptance criteria" are related to mechanical performance for safety and effectiveness as defined by ASTM standards.

Test	Standard	Acceptance Criteria (Implied by Standard)	Reported Device Performance
Static Compression	ASTM F2077-11	Meets or exceeds standard requirements	Met or exceeded requirements
Static Compression Shear	ASTM F2077-11	Meets or exceeds standard requirements	Met or exceeded requirements
Static Torsion	ASTM F2077-11	Meets or exceeds standard requirements	Met or exceeded requirements
Subsidence	ASTM F2267-04	Meets or exceeds standard requirements	Met or exceeded requirements
Expulsion	N/A	N/A (Standard not specified)	Met or exceeded requirements
Dynamic Compression	ASTM F2077-11	Meets or exceeds standard requirements	Met or exceeded requirements

Note: The document states "All static and dynamic testing met or exceeded the requirements as established by the test protocol and applicable ASTM standards." This indicates that the device's performance satisfied the established benchmarks for mechanical integrity.

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

Test Set: The "test set" in this context refers to the samples of the TranS1® Interbody Fusion System that underwent mechanical testing. The document does not specify the exact number of units tested for each mechanical test.
Data Provenance: The mechanical testing was "performed per ASTM standards," implying controlled laboratory conditions. There is no information regarding country of origin for "data" in the sense of patient data, as this was not a clinical study. It was a pre-market submission based on engineering and materials testing. The study was not retrospective or prospective in the clinical sense, but rather a series of laboratory experiments.

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

Not Applicable (N/A): For mechanical testing of an implant, the "ground truth" is defined by the objective physical properties and performance against established ASTM standards. There are no human experts involved in establishing a "ground truth" for interpretive data in this type of submission. The standards themselves, and the engineers verifying compliance, serve this role.

4. Adjudication Method for the Test Set

Not Applicable (N/A): Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical readings or image analysis. This is not relevant for mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not Applicable (N/A): An MRMC study is a clinical study format involving multiple human readers interpreting cases, often with and without AI assistance, to assess diagnostic performance. This submission is for a physical medical implant and does not involve AI or diagnostic interpretation.

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

Not Applicable (N/A): This question pertains to AI algorithm performance. The TranS1® Interbody Fusion System is a physical device, not an algorithm.

7. The Type of Ground Truth Used

Mechanical Standards and Performance Metrics: The "ground truth" for the device's performance is adherence to the validated mechanical test standards (ASTM F2077-11, ASTM F2267-04, etc.) and meeting the predefined requirements within those standards. This is an objective and quantitative ground truth established by engineering principles.

8. The Sample Size for the Training Set

Not Applicable (N/A): There is no "training set" in the context of mechanical testing for a medical implant like this. Training sets are relevant for machine learning algorithms.

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

Not Applicable (N/A): As there is no training set, this question is not applicable.

Summary

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K12 0991

AUG 2 3 2012

Trant

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

July 2012

Submitter: Contact Person:

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

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

Proprietary Name: TranS1® Interbody Fusion System Classification: 888.3080: Intervertebral Fusion Device (MAX) Predicate Device: Life Spine Plateau Spacer System: K111569

Indications and Intended use:

The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiquous 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. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

Device Description

Technological Characteristics and Substantial Equivalence

Documentation was provided to demonstrate that the TranS1® Interbody Fusion System is substantially equivalent to the Predicate Life Spine Plateau Spacer System (K111569). The Subject device is substantially equivalent to the Predicate devices in intended use, level of attachment, materials, labeling, sterilization, and technological characteristic. These devices

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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 devices.

Summary of Testing

Mechanical testing for the TranS1 Interbody Fusion System 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	N/A
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 TranS1 Interbody Fusion System 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 TranS1 Interbody Fusion System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

Trans1 Incorporated % Ms. Cheryl L Wagoner Director of Regulatory 301 Government Center Drive Wilmington, North Carolina 28403

AUG 2 3 2012

Re: K120991

Trade/Device Name: TranS1® Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 23, 2012 Received: July 23, 2012

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For
N. Melkerson

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

Enclosure

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Statement of Indications for Use

510(k) Number: K120991

Device Name: TranS1® Interbody Fusion System

Indications for Use:

The TranS1 Interbody Fusion System 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 These DDD patients may also have up to Grade 1 spondylolisthesis or radiographic studies. retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

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)

Col-S
(Division Sign Off)

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

长120991 510(k) Number_

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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.