The Curiteva Cervical Interbody Fusion is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2 - T1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Implants are intended to be used with autograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the cervical spine. Patients should receive at least six (6) weeks of non-operative treatment with the device.

Device Description

The Curiteva Cervical Interbody Fusion System implants are available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally box-shaped with an open central chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Curiteva Cervical Interbody Fusion System implants are manufactured from PEEK (per ASTM F2026) with Tantalum markers (per ASTM F560), or Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The PEEK implants are available with or without a medical grade commercially pure titanium (CpTi) plasma coating (per ASTM F1580) on the superior and inferior surfaces.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Curiteva Cervical Interbody Fusion System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving independent performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment cannot be found in the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

Cannot be provided directly. The document states that the device was "mechanically tested in the following test modes: static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, expulsion, and wear debris characterization per ASTM F1877." It then concludes that "the strength and performance... is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
However, the specific acceptance criteria (e.g., minimum compression strength, maximum subsidence) and the reported numerical performance values for the Curiteva device or the predicate devices are not detailed in this document. It only states that the device met the requirements for substantial equivalence.

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/Not mentioned. This was a non-clinical mechanical testing study, not a clinical study involving human patient data. Therefore, concepts like "test set," "data provenance," "country of origin," and "retrospective/prospective" do not apply. The "sample size" would refer to the number of devices tested, which is not specified but implicitly sufficient to meet ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This was mechanical testing, not a study requiring expert clinical assessment or ground truth establishment in a medical imaging context.

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

Not applicable. See point 3.

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:

No. An MRMC study is a clinical study typically used for diagnostic devices involving human interpretation of medical images, often with AI assistance. This document describes mechanical testing of an interbody fusion device, which is an implant, not an AI diagnostic tool.

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

Not applicable. This device is an implant, not an algorithm.

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

Not applicable. For mechanical testing, the "ground truth" is typically defined by the test standards (e.g., ASTM F2077, F2267, F1877) and the physical properties of the materials and device design. The results are quantitative measurements against these standards.

8. The sample size for the training set:

Not applicable. This refers to a dataset for training machine learning models, which is irrelevant for this mechanical testing submission.

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

Not applicable. See point 8.

Summary of available information related to performance:

The device's performance was evaluated through non-clinical mechanical testing based on established ASTM standards:

Test Modes:
- Static and dynamic compression (per ASTM F2077)
- Static and dynamic torsion (per ASTM F2077)
- Subsidence (per ASTM F2267)
- Expulsion
- Wear debris characterization (per ASTM F1877)
Conclusion: The results showed that the "strength and performance of the Curiteva Cervical Interbody Fusion System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The document focuses on establishing substantial equivalence, meaning the device performs as safely and effectively as a legally marketed predicate device, rather than defining novel acceptance criteria and demonstrating unique performance against them in a clinical study.

Summary

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Curiteva, LLC Eric Linder Chief Operating Officer 25127 Will McComb Drive Suite 100 Tanner, Alabama 35671

Re: K181261

Trade/Device Name: Curiteva Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: May 9, 2018 Received: May 11, 2018

Dear Eric Linder:

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 (QS) regulation (21 CFR Part 820);

July 9, 2018

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

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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)

K181261

Device Name Curiteva Cervical Interbody Fusion 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

A. Submitter Information

Submitter:	Curiteva, LLC25127 Will McComb Drive, Suite 100Tanner, AL 35671Phone: (256) 213-1057Fax: (256) 213-1058
Contact Person:	Eric Linderregulatory@curiteva.com
Date Prepared:	May 9, 2018

B. Device Information

Trade Name:	Curiteva Cervical Interbody Fusion System
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Fusion Device With Bone Graft, Cervical
Device Classification:	Class II (per 21 CFR 888.3080)
Product Code:	ODP
Classification Panel:	Division of Orthopedic Devices
Predicate Device(s):	Primary: Globus Medical PATRIOT Cervical Spacers, (includingCOLONIAL and COLONIAL TPS) -- K143578Additional: DeGen Medical Latitude-C Cervical InterbodySpacer System -- K151496Additional: Titan Spine Endoskeleton TC -- K100889

C. Device Description

The Curiteva Cervical Interbody Fusion System implants are manufactured from PEEK (per ASTM F2026) with Tantalum markers (per ASTM F560), or Titanium alloy (Ti-6Al-4V) that conforms to

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ASTM F136. The PEEK implants are available with or without a medical grade commercially pure titanium (CpTi) plasma coating (per ASTM F1580) on the superior and inferior surfaces.

D. Indications for Use

The Curiteva Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2 – T1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the cervical spine. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with the device.

E. Technological Characteristics

As was established in this submission, the subject Curiteva Cervical Interbody Fusion 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 to have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and range of sizes.

F. Performance Data

The Curiteva Cervical Interbody Fusion System was mechanically tested in the following test modes: static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, expulsion, and wear debris characterization per ASTM F1877.

The results of this non-clinical testing show that the strength and performance of the Curiteva Cervical Interbody Fusion System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

G. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Curiteva Cervical Interbody Fusion 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.