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 I spondylolisthesis or retrolisthesis at the involved level(s). The TranS1 Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autograft and/or allograft comprised of cancellous and/or coricocancellous 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 used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. The devices are designed to be used in conjunction with supplemental spinal fixation instrumentation. The subject devices are multiple component systems comprised of single-use implants designed to treat the lumbar spine.

The TranS1 Interbody Fusion System lumbar implants are fabricated from PEEK (ASTM F2026) with Tantalum (ASTM F560) x-ray markers. The TranS1 Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

AI/ML Overview

I am sorry, but the provided text only discusses the FDA's 510(k) clearance for the TranS1 Interbody Fusion System, which is a medical device used for spinal fusion procedures. It specifies the intended use, material composition, and references performance testing conducted according to ASTM standards for static and dynamic mechanical properties, as well as subsidence and expulsion.

However, the text does not contain any information about an AI/ML powered device, acceptance criteria related to AI/ML performance metrics (e.g., accuracy, sensitivity, specificity), or any study details proving an AI/ML device meets such criteria.

Therefore, I cannot fulfill your request for information about:

A table of acceptance criteria and reported device performance for an AI/ML device.
Sample sizes and data provenance for a test set for an AI/ML device.
Number and qualifications of experts for AI/ML ground truth.
Adjudication method for an AI/ML test set.
MRMC study for an AI/ML device.
Standalone performance for an AI/ML algorithm.
Type of ground truth used for an AI/ML device.
Sample size for the training set for an AI/ML device.
How ground truth was established for the training set for an AI/ML device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 25, 2019

TranS1 Ms. Kristen Allen Director of Compliance and Regulatory Affairs 3804 Park Avenue, Suite C Wilmington, North Carolina 28403

Re: K191791

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: September 10, 2019 Received: September 11, 2019

Dear Ms. Allen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Ronald P. Jean. PhD Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191791

Device Name TranS1 Interbody Fusion System

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
----------------------------------------------------------

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for TRAN 1. The logo is in blue and green. The word "TRAN" is in blue, followed by the number "1" in blue. To the right of the number "1" is a green design that looks like a series of vertical lines.

510(k) Summary TranS1 Interbody Fusion System Submitter: TranS1. Inc. 3804 Park Avenue, Suite C Wilmington, NC 28403 Contact Person: Kristen Allen Director of Compliance and Regulatory Affairs 910-612-4153 (P) Kristen@trans1.com (e-mail) Date Prepared: September 10, 2019 Trade Name: TranS1 Interbody Fusion System Common Name: Intervertebral body fusion device Device Product Code and Classification: Regulation Number: 21 CFR 888.3080 MAX, Class II, Intervertebral Fusion Device with Bone Graft, Lumbar Primary Predicate: TranS1 Interbody Fusion Devices (K120991) Life Spine Plateau Spacer System (K111569) Additional Predicates: Amendia Interbody Fusion Device (K151310) Choice Spine Lumbar Spacer System (K162103) K2M Cascadia Interbody System (K172009)

Device Description:

Indications and Intended use:

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for TRAN1. The logo is in blue and green. The word "TRAN" is in blue, and the number "1" is in green. There are also some green lines next to the number "1".

retrolisthesis at the involved level(s). The TranS1 Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

Summary of Technological Characteristics:

The subject devices are substantially equivalent to the predicate devices as well as other similar devices cleared by FDA for commercial distribution in the United States. The Subject Device was shown to have the same technological characteristics as its predicate devices through comparison of characteristics including design, intended use, material composition, performance specifications and function. Both the subject and predicate lumbar devices are interbody devices designed to contain graft material and facilitate fusion between two vertebral bodies in the lumbar region of the spine.

Summary of Performance Testing:

The worst-case device was tested in static compression, static torsion, static shear compression and dynamic compression (ASTM F2077), Subsidence (ASTM F2267) and Expulsion. An engineering analysis was presented to characterize all configurations of the Subject Device to confirm the worst-case device.

Conclusion:

Based on the comparison to predicate device, the Subject Device has been shown to be substantially equivalent to the legally marketed predicate 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.