The InTice™-C Porous Ti Cervical Interbody System is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks non-operative treatment with the InTice™-C Porous Ti Cervical Interbody System.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e. posterior cervical screw and rod systems and anterior cervical plate systems).

Device Description

The InTice™-C Porous Ti Cervical Interbody System is an intervertebral fusion device, generally box or oval-shaped, and available in a variety of shapes and sizes to accommodate the individual patient anatomy. The implants are made from highly porous commercially pure titanium (CP-TI Grade 2) that complies with ASTM F67. The material is formed into an integrated titanium scaffold, OsteoSync™ Ti (manufactured by Sites Medical), which assists in securing the implant in the intervertebral space. The formed titanium material has a porosity created by a designed hole pattern, and the superior and inferior surfaces of the implant have a tooth pattern to help resist implant dislodgement or expulsion once placed in its desired location. The hollow center of the implant allows the device to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The single use implants are provided sterile, and should not be reused under any circumstances.

The system does not contain software/firmware or electrical equipment.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the InTice™-C Porous Ti Cervical Interbody System. This type of submission aims to demonstrate that a new device is substantially equivalent to legally marketed predicate devices, rather than proving its safety and effectiveness through clinical trials designed to meet specific acceptance criteria for a novel technology.

Therefore, the document does not contain information about:

Acceptance criteria in the context of clinical performance metrics for an AI/device (e.g., sensitivity, specificity, accuracy). The "acceptance criteria" here are related to proving substantial equivalence to a predicate device.
A study that proves the device meets the acceptance criteria as would be done for a new device claiming improved clinical outcomes. Instead, it describes non-clinical testing to demonstrate performance equivalence to predicate devices.
Sample size for a test set and data provenance: There is no "test set" in the sense of a clinical validation dataset. The "testing" refers to biomechanical and material tests.
Number of experts and their qualifications, adjudication methods, MRMC studies, standalone performance, or type of ground truth used for a test set: These concepts are relevant to clinical or AI performance validation, which is not the focus of this 510(k) submission.
Sample size for training set or how ground truth for training set was established: These concepts are relevant for AI/machine learning models which are not part of this device submission.

What the document does describe in terms of "acceptance":

The "acceptance" in this context refers to the FDA's acceptance of the 510(k) premarket notification and the determination of substantial equivalence. The criteria for this acceptance are primarily based on demonstrating that the new device has "substantially equivalent" technological characteristics and performs comparably to legally marketed predicate devices, without introducing new safety or effectiveness concerns.

Here's a breakdown of the relevant information provided in the document, framed against the requested points, highlighting what is not applicable:

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

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence): The implicit acceptance criteria for this 510(k) submission are that the device's technical characteristics and performance must be "substantially equivalent" to predicate devices and not raise new questions of safety or effectiveness. This is demonstrated through non-clinical testing.
Reported Device Performance (Non-Clinical):

Test Performed	Acceptance (Reported Outcome)
ASTM F2077: Static and Dynamic Compression Testing	"Meets or exceeds the performance of the predicate devices."
ASTM-F2077: Static and Dynamic Torsion Testing	"Meets or exceeds the performance of the predicate devices."
ASTM F 2267: Subsidence	"Meets or exceeds the performance of the predicate devices."
Expulsion Testing	"Meets or exceeds the performance of the predicate devices."

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: This is a 510(k) submission for a physical medical device (interbody system), not an AI algorithm or a clinical study dataset for performance evaluation. The "testing" refers to mechanical and material property testing, not clinical data sets.

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

Not Applicable: Ground truth establishment by experts is relevant for clinical outcome or diagnostic accuracy studies, particularly for AI or image-based diagnostics. This is a submission for a spinal implant, relying on engineering and material standards for performance assessment relative to predicates.

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

Not Applicable: Adjudication methods apply to studies involving human interpretation or clinical endpoint assessments, which are not detailed in this 510(k) for a physical implant.

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: MRMC studies are specific to evaluating diagnostic performance, often for AI-assisted image interpretation. This submission is for a physical orthopedic implant.

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

Not Applicable: This criterion is for AI algorithms. The device described does not contain software/firmware or electrical equipment (Page extract 5).

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

Not Applicable (in the clinical/AI sense): The "ground truth" for this device's performance is based on established engineering standards (ASTM and other biomechanical properties) and comparison to the known characteristics of predicate devices. There is no clinical "ground truth" established in this document, as it focuses on substantial equivalence through non-clinical means.

8. The sample size for the training set

Not Applicable: There is no "training set" as this is not an AI/machine learning device.

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

Not Applicable: There is no "training set" for this device.

Summary

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May 17, 2018

X-Spine Systems, Inc. Charlene Brumbaugh Regulatory Affairs Manager 452 Alexandersville Rd. Miamisburg, Ohio 45342

Re: K173832

Trade/Device Name: InTice™ -C Porous Ti Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: April 13, 2018 Received: April 16, 2018

Dear Ms. Brumbaugh:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for

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)

K173832

Device Name

InTice™-C Porous Ti Cervical Interbody System

Indications for Use (Describe)

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

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

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510(K) SUMMARY

InTice™-C Porous Ti Cervical Interbody System

I. SUBMITTER/MANUFACTURER:	X-spine Systems, Inc.664 Cruiser LaneBelgrade, MT 59714Telephone (406) 388-0480FAX (406) 388-1354
	Establishment Registration Number: 3005031160

Official Contact:	Charlene BrumbaughRegulatory Affairs ManagerEmail: cbrumbaugh@xtantmedical.comTelephone (937) 847-8400, ext. 2192

II. DATE PREPARED:	May 17, 2018

III. OWNER/OPERATOR:	Xtant Medical Inc.664 Cruiser LaneBelgrade, MT 59714
	Owner/Operator Number: 10028385
	Official Correspondent: Stephen Smith, Vice PresidentRegulatory Assurance/ Quality AssuranceXtant Medical, Inc.Telephone (406) 388-0480

IV. DEVICE

Trade/Proprietary Name:	InTice™-C Porous Ti Cervical Interbody System
Device Common Name:	Intervertebral Fusion Device With Bone Graft
Regulation Number:	21 CFR §888.3080
Product Code:	ODP -- Intervertebral Fusion Device, Cervical

Regulatory Class:	Class II
Review Panel:	Orthopedic

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V. PURPOSE OF THE SUBMISSION

The purpose for this submission is to submit a new medical device for review.

VI. PRIMARY PREDICATE DEVICE

. Primary Predicate Device: X-spine, Inc.: Calix-C™ Cervical Interbody Spacer – K171075

VII. ADDITIONAL PREDICATE DEVICES

X-spine, Inc.: Irix-C™ Cervical Integrated Fusion System - K162944
· FortiCore™ -- K161485 [Cervical Intervertebral Body Fusion Device]

REFERENCE DEVICE VIII.

Arthrex BioSync Bone Wedge K151256

IX. INDICATIONS FOR USE

The InTice™-C Porous Ti Cervical Interbody System is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks non-operative treatment prior to treatment with the InTice™-C Porous Ti Cervical Interbody System.

X. DEVICE DESCRIPTION

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The system does not contain software/firmware or electrical equipment.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES XI.

The technological principle for both the subject and predicate devices is fixation in the cervical spine for skeletally mature patients with degenerative disc disease.

As was established in this submission, the subject device, InTice™-C Porous Ti Cervical Interbody System, is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices and reference device through comparison in areas including design, intended use, material composition, and function.

XII. PERFORMANCE DATA

Nonclinical testing was performed to demonstrate that the subject InTice™-C Porous Ti Cervical Interbody System is substantially equivalent to its predicate devices. The following testing was performed:

ASTM F2077: Static and Dynamic Compression Testing ●
ASTM-F2077: Static and Dynamic Torsion Testing
ASTM F 2267: Subsidence
Expulsion Testing

The results of these studies show that the subject device meets or exceeds the performance of the predicate devices and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices.

XIII. CONCLUSION

Based on assessment of the indications for use, technological characteristics, performance data, and comparison to the predicate and reference devices, the subject device, InTice™-C Porous Ti Cervical Interbody System has been shown to be substantially equivalent to 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.