The nv is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment with an intervertebral body fusion device. The ny' devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.

Device Description

The nv is an intervertebral body fusion device used in the cervical spine following discectomy. All devices are manufactured from PEEK Optima® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization.

The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow centre to accommodate bone graft. The devices are implanted via an anterior (ACIF) surgical approach. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability and prevent back out.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "nvC," an intervertebral body fusion device. This type of regulatory submission typically focuses on demonstrating "substantial equivalence" to a predicate device, rather than conducting a full clinical study with specific acceptance criteria as might be seen for novel technologies or PMA applications. As such, the document details mechanical testing to support substantial equivalence rather than a study against a pre-defined performance acceptance criteria for a diagnostic or AI-driven device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets acceptance criteria (as would be typical for an AI/diagnostic device) are not directly applicable or available in this submission. This 510(k) primarily demonstrates the device's mechanical performance is comparable to an existing device, implying it meets the safety and effectiveness standards already established for such devices.

Here's an attempt to address your request based on the available information, noting where information is not present in the document.

Description of Acceptance Criteria and Proving Study for the nvC Intervertebral Body Fusion Device

The nvC device, a PEEK Optima® LT1 intervertebral body fusion device, established its substantial equivalence to predicate devices through a series of mechanical performance tests, rather than a clinical study with traditional acceptance criteria for diagnostic accuracy or clinical outcomes. The "acceptance criteria" here are implicitly the performance levels demonstrated by the predicate devices in the same standardized mechanical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicitly from Predicate Devices)	Reported nvC Device Performance
Static Axial Compression: Performance comparable to predicate device per ASTM F2077	Passed; results demonstrated substantial equivalence to the predicate device
Dynamic Axial Compression: Performance comparable to predicate device per ASTM F2077	Passed; results demonstrated substantial equivalence to the predicate device
Static Torsion: Performance comparable to predicate device per ASTM F2077	Passed; results demonstrated substantial equivalence to the predicate device
Dynamic Torsion: Performance comparable to predicate device per ASTM F2077	Passed; results demonstrated substantial equivalence to the predicate device
Subsidence: Performance comparable to predicate device per ASTM F2267	Passed; results demonstrated substantial equivalence to the predicate device
Expulsion: Performance comparable to predicate device (no specific standard cited for this)	Passed; results demonstrated substantial equivalence to the predicate device

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

Sample Size: The document does not specify the exact number of test samples (e.g., individual device units) used for each mechanical test. Mechanical testing typically uses a specific number of samples (e.g., n=5 or n=6) per test condition.
Data Provenance: The tests were conducted internally or by a testing laboratory as part of the regulatory submission process. There is no information regarding country of origin or whether the data is retrospective or prospective, as these terms are not applicable to material mechanical testing.

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

This information is not applicable to mechanical testing of an intervertebral body fusion device. Ground truth and expert consensus are relevant for diagnostic devices or those involving interpretation of medical images/data. The "ground truth" for mechanical testing is established by the test standards themselves and measured physical properties.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, not in standardized mechanical testing.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret results, and an AI's impact on their performance is evaluated. The nvC is a physical implant, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study of an algorithm was done. This device does not involve an algorithm or AI. The tests performed are for the physical properties of the implant itself.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on engineering and material science standards, specifically the mechanical performance requirements outlined in ASTM F2077 and ASTM F2267, as well as general expectations for expulsion resistance. The performance of the predicate devices in these tests serves as the benchmark for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the context of data-driven models. The device's design is likely based on engineering principles and prior experience with similar implants.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

Summary of the Study:

The study conducted for the nvC device was a series of non-clinical mechanical performance tests. These tests were performed in accordance with recognized ASTM standards (F2077 for axial compression and torsion; F2267 for subsidence) and also included an expulsion test. The purpose of these tests was to demonstrate that the mechanical properties and performance of the nvC device were substantially equivalent to those of its predicate devices: X-Spine Calix™ Cervical Interbody Spacer (K083637) and Genesys Spine Apache™ Cervical Interbody System (K103034). The conclusion of the submission is that the device's technological characteristics and performance are comparable to the predicate devices, thereby supporting its substantial equivalence for the stated indications for use.

Summary

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

December 23, 2014

Nvision Biomedical Technologies, LLC % Ms. Jennifer Palinchik JALEX Medical, LLC 27881 Clemens Road, Suite 2 Westlake, Ohio 44145

Re: K142328

Trade/Device Name: nv Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 25, 2014 Received: November 26, 2014

Dear Ms. Palinchik:

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, Lori A. Wiggins -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) K142328

Device Name nv C

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Submitted By:	Nvision Biomedical Technologies, LLC18618 Tuscany Stone, Suite 120
	San Antonio, TX 78258
Date:	October 29, 2014
Contact Person:	Jennifer Palinchik
	Regulatory Consultant
Contact Telephone:	(440) 930-2015
Device Trade Name:	nvC
Classification Name:	Intervertebral Body Fusion Device
Device Classification:	Class II
Reviewing Panel:	Orthopedic
Regulation Number:	888.3080
Product Code:	ODP
Predicate Device:	Primary Predicate: X-Spine Calix™ Cervical Interbody
	Spacer (K083637)
	Other Predicate: Genesys Spine Apache™ Cervical
	Interbody System (K103034)
	These predicates have not been subject to a design-relatedrecall.

Device Description:

Intended Use:

The nv is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The ny

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devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.

Comparison of Technological Characteristics:

The technological characteristics of the nv device, including materials, size, shape and usage were compared to a predicate device. The comparison of information provided in this Premarket Notification supports the substantial equivalence, material information, and analysis of data.

Mechanical Testing:

Performance testing was conducted in accordance with the following standardized tests:

Static and Dynamic Axial Compression per ASTM F2077 ●
Static and Dynamic Torsion per ASTM F2077 ●
Subsidence per ASTM F2267 ●
Expulsion

The results of the performance testing demonstrate substantial equivalence of the nv to the predicate device.

Conclusion:

Non-clinical data presented in this Premarket Submission supports the substantial equivalence of the subject device to the predicate. Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.

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.