The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

Device Description

The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton® TCS IBD implants are intended for treatment in Cervical Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a large hollow region in the center to house bone graft material. The purpose of this submission is to change the surface treatment. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine. All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI). The only modification being made in this submission is the change to a new surface treatment which was previously cleared by the FDA for the Endoskeleton® System in K141953.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA regarding the Endoskeleton® TCS System, an intervertebral body fusion device. The focus of the submission is a change to the surface treatment of the device.

Since this document is a regulatory approval and not a study report, it does not contain the detailed information required to describe acceptance criteria, device performance, and study specifics in the format requested. The document states that the modified device is substantially equivalent to previously cleared devices based on a new surface treatment that was already validated. It explicitly says "no additional testing is needed."

Therefore, I cannot provide the requested information in the same way it would be presented for a study. However, I can extract the relevant statements from the document to answer some of your questions, and indicate where the information is not applicable or not provided.

Here's a breakdown of what can be extracted based on the document:

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

Acceptance Criteria: The document implies that the acceptance criterion for this submission is "substantial equivalence" to previously cleared predicate devices. Specifically, the key acceptance criterion is that the new surface treatment modification and the overall device "does not raise new questions regarding safety and effectiveness."
Reported Device Performance: The document states that the performance is considered substantially equivalent to the predicate devices and that the modification "presents no additional risk during implantation." The performance related to the surface treatment was previously validated with the Endoskeleton® System (K141953).

A table cannot be fully constructed as specific, quantifiable performance metrics for this particular submission are not provided, nor are explicit acceptance criteria beyond "substantial equivalence."

2. Sample size used for the test set and the data provenance

Sample size for the test set: Not applicable and not provided. The document states that "no additional testing is needed" for this submission because the modification (surface treatment) was previously cleared and validated.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable and not provided. This submission relies on the prior validation of the surface treatment and a comparison to predicate devices, not a new clinical test set requiring expert ground truth establishment.

4. Adjudication method for the test set

Not applicable and not provided.

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 is a medical device for spinal fusion, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI performance metrics are irrelevant to this submission.

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

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

7. The type of ground truth used

For this specific submission (K153122), the "ground truth" for demonstrating safety and effectiveness relies on the prior validation of the new surface treatment (NanoFIX™) in a previous submission (K141953) and comparative analysis to predicate devices. It also states that "all original design validations were supported" by the addition of the surface treatment.

8. The sample size for the training set

Not applicable and not provided. This is not an AI/machine learning device. The validation mentioned refers to engineering and biocompatibility testing for the surface treatment, not a "training set" in the context of data science.

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

Not applicable. As noted above, this is not an AI/machine learning device. The "ground truth" for the previously validated surface treatment (K141953) would have been established through relevant in-vitro and potentially in-vivo non-clinical studies to assess its mechanical properties, biocompatibility, and intended biological response, following established regulatory guidelines for medical device components and surface modifications. The document does not detail these prior studies.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 that resembles a caduceus or a staff with intertwined snakes, but in this case, it appears to be a more abstract representation of human figures or profiles.

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

December 14, 2015

Titan Spine, LLC % Christine Scifert Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133

Re: K153122

Trade/Device Name: Endoskeleton® TCS System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: October 28, 2015 Received: October 29, 2015

Dear Christine Scifert:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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 N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K153122

Device Name Endoskeleton(R) TCS System

$\frac{d}{dx}(f(x)+g(x)) = f'(x)+g'(x)$

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Expiration Date: January 31, 2017 See PRA Statement on last page.

K153122 Page 1 of 1

Form Approved: OMB No. 0910-0120

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510(k) Summary

Endoskeleton® TCS System December 9, 2015

Company:	Titan Spine, LLC6140 West Executive Drive, Suite AMequon, WI 53092, USA
EstablishmentRegistration:	3006340236
Primary Contact:	Christine ScifertPhone: 901-831-8053
Company Contact:	Jane RoddPhone: 866-822-7800Fax: 262-242-7802
Trade Name:	Endoskeleton® TCS Interbody Fusion Device
Common Name:	Intervertebral Body Fusion Device with Integrated Fusion CervicalIntervertebral Fusion Device with Bone Graft, Cervical
Classification:	Class II
Regulation Number:	21 CFR 888.3080 (Intervertebral body fusion device)
Panel:	87- Orthopedic
Product Code:	OVE, ODP
Primary Predicate:	Titan Spine Endoskeleton® TCS (K142940 S.E. 01/28/2015)
Additional Predicates:	Titan Spine Endoskeleton® TCS (K151596 S.E. 10/09/2015)Endoskeleton® System (K141953 S.E. 10/27/2014)

Device Description:

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The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.

All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI).

The only modification being made in this submission is the change to a new surface treatment which was previously cleared by the FDA for the Endoskeleton® System in K141953.

Indications for Use:

The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.

Substantial Equivalence:

The subject Endoskeleton® TCS IBD is substantially equivalent to Titan Spine's previously cleared Endoskeleton® TCS IBD (K142940; S.E. 01/28/2015 and K151596; S.E. 10/09/2015) and Endoskeleton® System with NanoFIX™ treatment (K141953; S.E. 10/27/2014).

The only modification being made in this submission is the change to a new surface treatment which was previously cleared by the FDA for the Endoskeleton® System in K141953. There are no changes to the device indications for use, design, dimensions, or materials. The predicate surface treatment was validated in the previous Endoskeleton® System (K141953). Results of that validation in addition to a design comparison of the surface treatments and devices indicated that the addition of the surface treatment presents no additional risk during implantation and all original design validations were supported. The subject Endoskeleton® TCS implant family has substantially equivalent geometry and features to predicate Endoskeleton® System devices and the geometry and features of the Endoskeleton® TCS implants are not altered by the previously cleared surface treatment, therefore it can be concluded that no additional testing is needed. Thus, it can be concluded that the subject does not raise new questions regarding safety and effectiveness.

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.