The Hedgehog Cervical Interbody Fusion Device is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the cervical spine (C3-C7) and are placed via an anterior approach using autogenous bone as graft material for the interior graft window. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

Device Description

The proposed Hedgehog Cervical Interbody Fusion Device is a sterile, single use implant grade polyetheretherketone (PEEK) device, available in varied footprints and heights, designed for supplemental stabilization of the cervical spinal column in anterior cervical discectomy and fusion (ACDF) procedures.

The Hedgehog Cervical device is comprised of a single, continuous piece of PEEK Scoria™ formed into the final product shape. The Vertera device remains solid with a surface porous layer on the top surface of the implant body. This porous surface is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the cage assembly will have two marker bands, made from Tantalum, to enable visibility under xray.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Hedgehog Cervical Interbody Fusion Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the new device meets specific standalone performance criteria through extensive clinical trials for a novel technology. Therefore, the document does not contain information typically found in a study designed to prove a device meets acceptance criteria in the way an AI/ML device study would.

Specifically, the document states:

"Non-clinical testing has demonstrated substantially equivalent performance to predicate devices."
"Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices."

This means the "study" conducted for this device was a series of non-clinical tests (mechanical and material tests) to show that it performs similarly to an already approved device, not that it meets predefined performance metrics for a novel technology or that a clinical study was performed.

Therefore, many of the requested categories (like sample size for test set/training set, number of experts, adjudication methods, MRMC studies, or specific types of ground truth like pathology/outcomes data) are not applicable to this type of device submission and are not presented in the document.

However, based on the information provided, here's what can be extracted and inferred for the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Material Composition	Comprised of implant grade PEEK and Tantalum markers.
Sterility	Sterile
Single Use	Single use implant
Mechanical Performance	Substantially equivalent to predicate devices based on non-clinical testing per ASTM F2077-11 (static and dynamic compression and torsion) and ASTM F2267-04 (load-induced subsidence).
Particulate Characterization	Demonstrated substantially equivalent performance to predicate devices per ASTM F1877-05.
Expulsion Testing	Demonstrated substantially equivalent performance to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "non-clinical testing" and "functional performance testing" using ASTM standards. This implies laboratory testing of physical device samples, not a clinical test set of patient data.

Sample size: Not specified. Standard practice for these ASTM tests involves a defined number of samples, but the exact count is not given in this summary.
Data provenance: Laboratory-generated data from mechanical and material testing. Not applicable for retrospective/prospective patient data or country of origin in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in the context of this 510(k) for a physical implant device is established by the specifications and performance of the predicate device and the results of the non-clinical tests against established ASTM standards. No human experts were involved in establishing "ground truth" for a test set in the way they would be for diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to human interpretation of data, typically for clinical or diagnostic studies. The "test set" here refers to physical device samples undergoing engineering evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is a clinical study involving multiple human readers interpreting medical cases, often with and without AI assistance, to assess diagnostic performance. This device is a physical interbody fusion implant, not a diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a way that is applicable to a physical device. The "standalone" performance here relates to the device's intrinsic mechanical, material, and functional properties as assessed during non-clinical testing, without interaction with a human operator for diagnostic interpretation. The device's performance in these non-clinical tests is what was evaluated directly.

7. The Type of Ground Truth Used

For this physical medical device, the "ground truth" is intrinsically linked to:

Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate device (Spinal Elements, Crystal® K133218).
ASTM Standard Requirements: The acceptance criteria defined by the relevant ASTM standards for intervertebral body fusion devices (F2077-11, F2267-04, F1877-05). Adherence to these standards is an implicit "ground truth" for physical device performance.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a physical interbody fusion implant device. This term applies to machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable, for the same reason as point 8.

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 features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, flowing line style.

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

September 23, 2015

Vertera, Incorporated Mr. Stephen Laffoon Director of Engineering 311 Ferst Drive NW, Suite L1328 Atlanta, Georgia 30332

Re: K143685

Trade/Device Name: Hedgehog Cervical Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 21, 2015 Received: September 21, 2015

Dear Mr. Laffoon:

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 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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Indications for Use

K143685 510(k) Number:

Device Name: Hedgehog Cervical Interbody Fusion Device

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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510(k) Summary

Date Submitted: September 21, 2015

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(e).

A. Submitter: Vertera. Inc. 311 Ferst Drive NW, Suite L1328 Atlanta, Georgia 30332
B. Company Contact: Stephen Laffoon Director of Engineering (571) 758-3783 stephen.laffoon@verteraspine.com
C. Device Information: Trade Name(s): Hedgehog Cervical Interbody Fusion Device

Common Name(s): Cervical Interbody Fusion Device

D. Classification Name: Intervertebral Body Fusion Device, 888.3080
E. Product Code: ODP, Intervertebral Body Fusion Device, Cervical
F. Predicate Device(s): Spinal Elements, Crystal®, K133218
G. Physical Description:

H. Indications for Use:
The Hedgehog Cervical Interbody Fusion Device is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the

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cervical spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the cervical spine (C3-C7) and are placed via an anterior approach using autogenous bone as graft material for the interior graft window. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

l. Comparison of Technological Characteristics:
The Hedgehog Cervical Interbody Fusion Device is substantially equivalent in function and intended use to the following predicate device:

Spinal Elements, Crystal®K133218

All devices are comprised of implant grade PEEK and utilize tantalum markers. All devices have the same indications for use.

J. Non-Clinical Testing
In addition, functional performance testing has been conducted per applicable standards as recommended in the guidance document. These are (ASTM) F2077-11, Test Methods for Intervertebral Body Fusion Devices in static and dynamic compression and torsion, (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, and Expulsion Testing. Non-clinical testing has demonstrated substantially equivalent performance to predicate devices.

K. Conclusion

Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the 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.