The IN:C2 Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. IN:C2 is a stand-alone device intended to be used with an anterior cover plate and a minimum two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. The implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The IN:C2 System consists of a 'U' shaped PEEK block in multiple footprint configurations and heights. The PEEK implants contain a titanium marker intended to verify position radiologically. The IN:C2 is a stand-alone system, intended for use with its cover plate assembly and two titanium bone screws provided. The IN:C2 implant is intended to be implanted via an open anterior approach.

The anterior cover plate assembly attaches to the anterior most portion of the device, and includes housing features for placement of two bone screws angled cephalad and caudal. The cover plate assembly and integrated screws are supplemental fixation.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA regarding the SpineSmith IN:C2 Spinal Fixation System. It focuses on demonstrating substantial equivalence to a predicate device rather than on the performance of an AI/ML powered device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and study details for an AI/ML medical device. Specifically:

Table of acceptance criteria and reported device performance: Not present, as this is for a physical medical device (spinal fixation system) and not an AI/ML device.
Sample size and data provenance for test set: Not present.
Number of experts and their qualifications for ground truth: Not present.
Adjudication method: Not present.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable and not present.
Standalone (algorithm only) performance: Not applicable and not present.
Type of ground truth used: Not applicable and not present.
Sample size for training set: Not applicable and not present.
How ground truth for training set was established: Not applicable and not present.

The document describes mechanical testing performed on the IN:C2 Spinal Fixation System to demonstrate its safety and effectiveness, conforming to ASTM standards for intervertebral body fusion devices. This mechanical testing served as the 'study' to prove the device met the criteria for substantial equivalence to its predicate.

The acceptance criteria for this physical device were its ability to perform comparably to the predicate device under specific mechanical stress tests, as outlined by the mentioned ASTM standards (e.g., F2077-11, F2267-04, F1877-05, and pull-off force testing). The reported device performance was that these tests demonstrated that "any minor differences, modification of the snap interface, do not impact device performance as compared to the predicates and demonstrate that the IN:C2 System is substantially equivalent to the predicate device."

Summary

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November 25, 2014

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

SpineSmith Partners, LLP Mr. Clifton Naivar Director, Quality and Regulatory Affairs 93 Red River Austin, Texas 78701

Re: K141537

Trade/Device Name: IN: C2 Spinal Fixation System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: October 2, 2014 Received: October 3, 2014

Dear Mr. Naivar:

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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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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.

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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INDICATIONS FOR USE

510(k) Number (if known): K141537

Device Name: IN:C2 Spinal Fixation System

Indications for Use:

x___________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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SpineSmith IN:C2 Spinal Fixation System

510(k) Summary

SUBMITTED BY	SpineSmith Partners, LLP93 Red RiverAustin, TX 78701
ESTABLISHMENTREGISTRATION NUMBER	3006404071
CONTACT PERSON	Clifton (Chris) NaivarDirector - Quality and Regulatory AffairsPhone: 512-637-2068Fax: 512-637-2096Email: cnaivar@spinesmithusa.com
SUBMISSION PREPARED BY	Clifton (Chris) NaivarDirector - Quality and Regulatory AffairsPhone: 512-637-2068
DATE PREPARED	September 17, 2014
CLASSIFICATION	OVE - intervertebral fusion device with integratedfixation, cervical
COMMON NAME	Intervertebral Body Fusion Device
PROPRIETARY NAME	IN:C2 Spinal Fixation System

IDENTIFICATION OF PREDICATE DEVICES:

The SpineSmith IN:C2 System, K122630, was determined to be substantially equivalent to the previously cleared Cimplicity System previous K073320, SpineSmith; Cleared 02/07/2008. K122630 is the primary predicate for this 510(k). The original design consisted of a titanium anterior plate which mates via a snap feature to a PEEK cage. The snap interface of the PEEK component is being replaced with a titanium insert. There are no additional changes in size, geometry, manufacturing methods, overall materials used or indications for use.

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DEVICE DESCRIPTION:

SpineSmith Partners LLP developed the IN:C2 Spinal Fixation System to be used during spinal fusion. IN:C2 serves to stabilize the spine while bony fusion develops.

INDICATIONS:

MECHANICAL TESTING:

The following non-clinical tests were conducted:

ASTM F2077-11, Test Methods for Intervertebral Body Fusion Devices. ●
. ASTM F2267-04. Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression.
ASTM F1877-05 Standard Practice for Characterization of Particles .
. Pull-off force testing was performed to determine the strength of the PEEK component and titanium anterior plate interface

CONCLUSIONS:

The subject and predicate device share the same intended use. There are no additional changes in size, geometry, manufacturing methods, overall materials used or indications for use. The non-clinical mechanical test results demonstrate that any minor differences, modification of the snap interface, do not impact device performance as compared to the predicates and demonstrate that the IN:C2 System is substantially equivalent to the predicate device.

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.