The TOMCAT™ Cervical Spinal System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients. The interbody is used with bone screws provided and requires no additional supplementary fixation. The interbody is inserted between the vertebral bodies into the disc space at one level from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies. The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, to facilitate fusion. The device is implanted by an anterior approach. The TOMCAT™ implant must be used with the screws included in the TOMCAT™ system. This device is to be used in patients who have had six weeks of non-operative treatment.

Device Description

The TOMCAT™ Cervical Spinal System is an anterior cervical spinal fixation system for an effective means of stabilizing the cervical vertebral column (C2-T1) as an adjunct to fusion of vertebral bodies. The TOMCAT™ System will provide an alternative to the more common cervical interbody spacer Anterior Cervical Discectomy & Fusion (ACDF) surgical procedure. The TOMCAT™ Cervical Spinal System is a radiolucent and radiopaque intervertebral body fusion device. The interbody is made from PEEK-OPTIMA® HA, PEEK per ASTM F2026 with Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136, Tantalum radiopaque markers per ASTM F560. This device accepts titanium (Ti-6Al-4V ELI) bone screws that are available in two diameters and multiple lengths.

The system will be composed of a cervical interbody spacer with a zero profile and a hybrid device is implanted anteriorly by inserting two screws, one screw into the anterior face of vertebral body and the other diagonally through the end plate. The zero profile device is implanted anteriorly and stabilized by two diagonally placed screws.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with detailed acceptance criteria for a new medical device. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, which would typically be found in a clinical or standalone performance study report, is not present in this document.

The document describes the regulatory process for the TOMCAT™ Cervical Spinal System, highlighting its indications for use and outlining performance standards it was tested against. However, it does not provide specific acceptance criteria values or detailed results of those tests.

Here's an analysis based on the provided text, indicating what information is available and what is not:

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

Acceptance Criteria: Not explicitly stated in terms of pass/fail values for each test. The document mentions that the device "has been tested by an independent laboratory in accordance to the following standard," implying that the testing met the requirements within those standards, but specific numerical acceptance criteria (e.g., "must withstand X MPa of compression") and the device's actual performance values against those criteria are not provided.
Reported Device Performance: No specific numerical performance metrics are reported. The document states that "The performance testing required is the equivalent for the predicate devices," which confirms that testing was done but omits the results.

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

Sample Size: Not specified. The document refers to "testing" against various ASTM standards, but does not state how many devices were tested for each.
Data Provenance: The document states that testing was done by "an independent laboratory," but does not specify the country of origin or if the tests were retrospective or prospective studies. Given the nature of mechanical testing, it would generally be prospective lab testing.

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

This information is not applicable to this document. This typically applies to clinical studies or studies involving interpretations (e.g., imaging diagnosis). The testing performed here (mechanical and material characterization) does not involve expert ground truth establishment in the same way. The "ground truth" for these tests are the physical measurements and material properties themselves.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. Mechanical testing results are objective measurements and do not require expert adjudication in the typical sense.

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

This information is not applicable. An MRMC study is relevant for AI/imaging interpretation devices. This device is an intervertebral body fusion device, not related to AI or diagnostic interpretation.

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

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

7. The type of ground truth used

The "ground truth" for the tests mentioned (Static/Dynamic Axial Compression, Torsion, Compression Shear, Subsidence, Expulsion) would be the physical properties and mechanical behavior of the device itself, measured objectively according to the specified ASTM standards. There is no expert consensus, pathology, or outcomes data used as "ground truth" in this context.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

Summary of available information regarding the study:

Study Type: Mechanical and material performance testing (physical device testing).
Standards Followed: ASTM F2077 (Static Axial Compression, Static Torsion, Static Compression Shear, Dynamic Axial Compression, Dynamic Torsion, Dynamic Compression Shear), ASTM F2267 (Static Testing in Subsidence), and ASTM Draft Standard F-04.25.02.02 (Static Testing in Expulsion).
Testing Body: An independent laboratory.
Purpose: To demonstrate that the device performs equivalently to predicate devices according to recognized performance standards, supporting a claim of substantial equivalence for regulatory clearance.

Summary

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

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" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles a human figure or a caduceus, composed of three curved lines.

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

December 18, 2015

Choice Spine, LP. Ms. Kim Finch Manager of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919

Re: K152515

Trade/Device Name: TOMCAT™ Cervical Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: December 8, 2015 Received: December 9, 2015

Dear Ms. Finch:

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

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

Page 2 - Ms. Kim Finch

forth in 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

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

Indications for Use

510(k) Number (if known) K152515

Device Name TOMCAT™ Cervical Spinal System

Indications for Use (Describe)

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

Prescription (Part 21 CFR 201.66) - Select Drug
Over-The-Counter - Select Drug

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}------------------------------------------------

8.0 510(k) Summary
Date Prepared:	December 8, 2015
Submitter Name:	Choice Spine, LP400 Erin Drive, Knoxville, TN 37919Tel: 865.246.3333 Fax: 865.246.3334
Regulatory Contact:	Kim Finch, Manager of Regulatory Affairs
Trade Name:	TOMCAT™ Cervical Spinal System
Product Class:	Class II
Regulation Number:	21 CFR 888.3080
Regulation Name:	Intervertebral body fusion device
Product Code:	OVE
Panel Code:	87 – Orthopedics Devices

Device Description:

Indications for Use:

The TOMCAT™ Cervical Spinal System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients. The interbody is used with bone screws provided and requires no additional supplementary fixation. The interbody is inserted between the vertebral bodies into the disc space at one level from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies. The device system is designed for use with autograft bone graft composed of cancellous and /or corticocancellous bone graft, to facilitate fusion. The device is implanted by an anterior approach. The TOMCAT™ implant must be used with the screws included in the TOMCAT™ system. This device is to be used in patients who have had six weeks of non-operative treatment.

Predicate Device(s):

The primary predicate is AVS Anchor-C, Stryker Inc., K102606. Other predicates are: Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device, SpineFrontier Inc., K142026 SpineSmith IN: C2 Spinal Fixation System, SpineSmith Partners LLP, K122630 STALIF C® & STALIF-C Ti™, Centinel Spine, Inc., K150053 BAK/Cervical Interbody System, Centerpulse Spine, PMA# P980048

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

Performance Standards:

The TOMCAT™ Cervical Spinal System has been tested by an independent laboratory in accordance to the following standard:

Static Axial Compression per ASTM F2077 Static Torsion per ASTM F2077 Static Compression Shear per ASTM F2077 Dynamic Axial Compression per ASTM F2077 Dynamic Torsion per ASTM F2077 Dynamic Compression Shear per ASTM F2077 Static Testing in Subsidence per ASTM F2267 Static Testing in Expulsion per ASTM Draft Standard F-04.25.02.02

The performance testing required is the equivalent for the predicate devices.

Substantial Equivalence:

The characteristics of the TOMCAT™ Cervical Spinal System are similar to the predicate devices Spine Frontier (K142026) Arena-C System, Stryker (K102606) AVS- Anchor-C, Spinesmith (K122630) IN:C2 and Centinel Spine (K150053) STALIF C & STALIF C -- Ti.

Equivalence is based on the similarities of the intended use, implant design, physical characteristics when compared to the predicates, and manufacturing materials. Choice Spine concludes that the TOMCAT™ Spinal System is substantially equivalent when compared to the predicate legally marketed 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.