TranS1® AxiaLIF® 2-LEVEL System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2-LEVEL System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectorny, or for assistance in the performance of L4-S1 interbody fusion.

The AxiaLIF® 2-LEVEL System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2-LEVEL System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.

Device Description

The Trans1® AxiaLIF® II System is made of medical grade titanium alloy conforming to such standards as ASTM F-136.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for a medical device called the "TranS1® AxiaLIF® II System." It primarily focuses on demonstrating substantial equivalence to a predicate device and specifying the indications for use.

Crucially, this document does NOT describe specific acceptance criteria and a study demonstrating the device meets those criteria, as typically found in clinical trials or performance studies that assess a device's accuracy or efficacy.

Instead, the submission is focused on regulatory clearance by demonstrating substantial equivalence to an already legally marketed device (TranS1® AxiaLIF® System). This means the FDA found the new device to be as safe and effective as the predicate device, based on shared technological characteristics and indications for use.

Therefore, many of the requested details such as sample sizes for test and training sets, expert qualifications, ground truth establishment, or specific performance metrics (like accuracy, sensitivity, specificity for diagnostic devices, or specific outcome measures for therapeutic devices) are not present in this type of regulatory submission. This document is a summary of the 510(k) application, not a detailed study report.

Here's an attempt to answer the questions based only on the provided text, while acknowledging its limitations:

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

This document does not provide a table of acceptance criteria or reported device performance in the context of a study demonstrating numerical compliance to those criteria. The primary "acceptance criterion" for this 510(k) submission was to demonstrate substantial equivalence to a predicate device.

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 / Not provided. This document does not describe a test set or data from a study designed to evaluate performance metrics. The submission focuses on substantial equivalence based on technological characteristics and intended use.

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 concept of "ground truth" for a test set, as it relates to accuracy or performance assessment, is not detailed in this regulatory summary.

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

Not applicable / Not provided. Adjudication methods are relevant for studies that require expert review of cases to establish ground truth, which is not the type of study described here.

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. The TranS1® AxiaLIF® II System is an anterior spinal fixation system, not a diagnostic device involving human readers or AI assistance. Therefore, an MRMC comparative effectiveness study is not relevant to this device's regulatory submission as described.

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

Not applicable. As a spinal fixation system, this device is a surgical implant and does not involve an "algorithm only" performance.

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

Not applicable / Not provided. This document does not detail a study that uses a "ground truth" for evaluating device performance as would be relevant for diagnostic or AI-driven systems. For a surgical implant, "ground truth" might refer to clinical outcomes, but no such study is presented here.

8. The sample size for the training set

Not applicable / Not provided. This document does not describe a training set, as it is not a machine learning or AI device.

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

Not applicable / Not provided. This question is irrelevant for the type of device and regulatory submission described in the provided text.

Summary of what IS stated in the document regarding "acceptance" for regulatory purposes:

Substantial Equivalence: The primary "acceptance criterion" for the 510(k) process is demonstrating substantial equivalence to a legally marketed predicate device.
Predicate Device: The TranS1® AxiaLIF® II System was deemed substantially equivalent to the TranS1® AxiaLIF® System.
Regulatory Action: The FDA issued a letter allowing the device to be marketed, signifying that it met the requirements for substantial equivalence.

The provided text is a regulatory filing summary, not a scientific study report describing performance against acceptance criteria.

Summary

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Premarket Notification [510(k)] Summary

Prepared: March 31, 2008

APR 2 8 2008

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807, and in particular 807.92, the following summary of information is provided:

Submitter Information

TranS1 Incorporated 411 Landmark Drive Wilmington, NC 28412

Application Contacts:

Robert Sheridan	Bill Jackson
Senior Advisor to TranS1 Inc.	Vice President of Regulatory, Clinical, and Quality
Same address and fax as above	Same address and fax as above,
Phone: 910-509-0403	Phone: 910-332-1727
rsheridan@ec.rr.com	bjackson@trans1.com

Device Names

Proprietary Name:	TranS1® AxiaLIF® II System
Common/Usual Name:	Anterior spinal fixation system
Classification Name:	Spinal Intervertebral Body Fixation Orthosis(21 CFR 888.3060)
Regulatory Classification	Class II
Product Code:	KWQ
FDA Panel Code:	87 Orthopedics

Device Description

The Trans1® AxiaLIF® II System is made of medical grade titanium alloy conforming to such standards as ASTM F-136.

Intended Use and Indications for Use

Tran 1"

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Tran - "

Substantial Equivalence

Documentation was provided to demonstrate that the TranS1® AxiaLIF® II System is substantially equivalent to the TranS1® AxiaLIF® System.

Page 2 of 2

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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 features a stylized eagle with three stripes extending from its back, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TranS1 Incorporated % Mr. Robert Sheridan Senior Advisor to TranS1 Inc. 411 Landmark Drive Wilmington, NC 28412

APR 2 8 2008

K073643 Re: Trade/Device Name: TranS1® AxiaLIF II Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 22, 2008 Received: April 23, 2008

Dear Mr. Sheridan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 -- Mr. Robert Sheridan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Miller

Mark N. Melkerson · Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Tranti

Statement of Indications for Use

510(k) Number: K073643

Device Name: TranS1® AxiaLIF II

Indications for Use:

TranSI® AxiaLIF® 2-LEVEL System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2-LEVEL System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectorny, or for assistance in the performance of L4-S1 interbody fusion.

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)

Nil hp Oylm for mxm
(Division Sign-Off) Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number K073643

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.