The Vy Spine™ ClariVy™ Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used supplemental spinal fixation cleared for the implanted level.

The Vy Spine™ ClariVy™ Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerate disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Vy Spine™ ClariVy™ Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

Device Description

The Vy Spine™ ClariVy™ Cervical IBF System is comprised of implants components. The implant component, the Vy Spine™ ClariVy™ Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Vy Spine™ ClariVy™ Cervical IBF System may also include Titanium alloy bone screws to secure the device to the vertebral body.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vy Spine™ ClariVy™ Cervical IBF System:

Based on the provided text, the device does not involve artificial intelligence or algorithms, and therefore, the typical acceptance criteria and study design elements requested (such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable.

The submission is for an intervertebral body fusion (IBF) device, which is a physical implant. The "Non-Clinical Testing" section describes mechanical testing to assess the device's physical properties, not its diagnostic or predictive performance.

Therefore, many of the specific questions cannot be answered from the provided document as they pertain to AI/software device evaluation, not a physical implant.

Acceptance Criteria and Reported Device Performance

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

Since this is a physical medical device (intervertebral body fusion system), the "acceptance criteria" are related to mechanical performance, material properties, and biocompatibility, rather than diagnostic accuracy metrics like sensitivity or specificity. The text describes the testing performed but does not explicitly state numerical acceptance criteria in a table. It implies that meeting the standards outlined in the ASTM protocols demonstrates acceptable performance.

Acceptance Criteria Category	Reported Device Performance / Assessment Method
Mechanical Performance	- Tested per ASTM F-2077 (Standard Test Methods for Intervertebral Body Fusion Devices)
	- Tested per ASTM F-2267 (Standard Test Method for Measuring Load Displacement of Spinal Implants Under Static and Dynamic Compression and Transverse Load)
	- Tested per ASTM Draft F-04.25.02.02 standards (specifications not fully detailed in the document, but implies relevant mechanical tests for spinal implants)
	- Mechanical tests included: static axial compression, dynamic axial compression, static axial torsion, dynamic axial torsion, static compressive shear, dynamic compressive shear, expulsion, and subsidence.
Material Composition	- The subject device has the "same material" (PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers) as the predicate devices, which is presumed to be acceptable.
Biocompatibility	- The subject device has the "same... biocompatibility" as the predicate devices, implying it meets established biocompatibility standards.
Design and Sizes	- The subject device has the "same... design, sizes" as the predicate devices, indicating substantial equivalence in these aspects.
Intended Use	- The subject device has the "same... indication of use" as the predicate devices, affirming its suitability for the specified clinical application (intervertebral body fusion of the cervical spine for DDD).
Function	- The subject device was shown to have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. (This implies functional equivalence based on mechanical and material properties compared to a legally marketed predicate).
Substantial Equivalence	- The device is considered substantially equivalent to the predicate device (Reliance Cervical IBF K173102) in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation, based on the non-clinical testing and comparison of technological characteristics. This is the primary "acceptance criterion" for 510(k) clearance, rather than a quantifiable performance metric for a diagnostic AI device.

Unavailable Information (Due to Device Type)

The following information is not applicable or available in the provided document because the Vy Spine™ ClariVy™ Cervical IBF System is a physical implant, not an AI/software device. The questions are structured for AI/diagnostic product evaluations, which is not what this FDA clearance describes.

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 pertains to clinical data for diagnostic/AI devices. For this physical implant, the "test set" would be physical samples of the device undergoing mechanical testing. The document refers to "various ASTM Standards" and testing "at a third party facility," but does not detail the number of physical units tested or their "provenance."

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. Ground truth, in this context, usually refers to clinically confirmed diagnoses or outcomes for evaluating AI/diagnostic performance. For a mechanical device, performance is evaluated against engineering standards and material properties, not expert-adjudicated clinical "ground truth."

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

Not Applicable. Adjudication methods are used to establish a consensus ground truth for diagnostic studies, typically with human readers. This concept does not apply to the mechanical testing of 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 for evaluating the performance of diagnostic systems (often AI) with and without human interaction, which is irrelevant for an intervertebral body fusion implant.

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

Not Applicable. This device does not contain any algorithms or software. The document explicitly states: "This device does not contain software or electrical equipment."

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

Not Applicable. For mechanical testing, the "ground truth" is defined by the physical behaviors and measurements against established engineering standards (e.g., how much load a device can withstand before deformation or failure), not clinical diagnostic truths.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/software device that learns from data.

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

Not Applicable. As there is no training set, there is no ground truth establishment for it.

Summary regarding the device:

The Vy Spine™ ClariVy™ Cervical IBF System is a Class II physical medical device intended for intervertebral body fusion. Its clearance (K212715) relies on demonstrating substantial equivalence to a previously cleared predicate device (Reliance Cervical IBF K173102) through:

Comparison of technological characteristics (material, design, size, intended use).
Non-clinical mechanical testing performed according to ASTM standards to ensure its safety and effectiveness are comparable to the predicate.

The document very clearly states: "This device does not contain software or electrical equipment." This is why the questions related to AI/software performance evaluation are not relevant.

Summary

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December 20, 2021

Vy Spine, LLC Jordan Hendrickson Operations Manager 2236 Capital Circle NE, Suite 103-1 Tallahassee. Florida 32308

Re: K212715

Trade/Device Name: Vy Spine™ ClariVy™ Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, OVE Dated: November 16, 2021 Received: November 18, 2021

Dear Mr. Hendrickson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212715

Device Name Vy SpineTM ClariVyTM Cervical IBF System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 Telephone: 866-489-7746 Fax: 850-597-8571

Contact: Jordan Hendrickson Operations Manager

510(k) Number:	K212715
Common or Usual Name:	Intervertebral Body Fusion Device
Proposed Proprietary or Trade Name:	Vy Spine™ ClariVy™ Cervical IBF System
Classification Name:	Intervertebral Body Fusion Device
Regulation Number:	21 CFR 888.3080
Product Code:	ODP, OVE
Regulatory Classification:	Class II

Substantial Equivalence

The Vy Spine™ ClariVy™ Cervical IBF System is substantially equivalent to the primary predicate device Reliance Cervical IBF (K173102). The Vy Spine™ ClariVy™ Cervical IBF System is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.

Device Description

Intended Use/Indications for Use

The Vy Spine™ ClariVy™ Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

7 December 2021

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studies). The Vy Spine™ ClariVy™ Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

Non-Clinical Testing

The Reliance Cervical IBF System (K173102) has undergone Non-Clinical Testing using various ASTM Standards at a third party facility. Mechanical testing was performed on the Reliance Cervical IBF System following ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02 standards. These mechanical tests included static axial compression, dynamic axial compression, static axial torsion, dynamic axial torsion, static compressive shear, dynamic compressive shear, expulsion, and subsidence. The subject Vy Spine™ ClariVy™ Cervical IBF System has the same material, design, sizes, indication of use & biocompatibility as the predicate devices.

Technological Characteristics

The subject Vy Spine™ ClariVy™ Cervical IBF 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 have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.

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.