The Tranquil™ Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion.

The Tranquil™ Cervical Interbody System is intended for spinal fusion procedures at one level in the cervical spine (C3 to C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The cervical device is to be implanted via an open, anterior approach and packed with autogenous bone. The cervical device is to be used in patients who have had six weeks of non-operative treatment. This device system is intended for use with supplemental internal fixation systems.

The Tranquil™ Lumbar Interbody System is intended for use at either one level or two contiguous levels (12-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The patients may have had a previous nonfusion spinal surgery at the involved level(s). The device is intended to be used with supplemental internal fixation systems.

Device Description

The Tranquil Interbody System is made of Ti-6Al-4V ELI. The implant is offered in various angles, widths, heights, and lengths to meet patient anatomy for both cervical and lumbar spine. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

AI/ML Overview

This document is a 510(k) premarket notification for the "Tranquil Interbody System," a spinal implant, and primarily focuses on establishing substantial equivalence to previously cleared devices rather than providing a detailed study of its performance against specific acceptance criteria for a novel AI/software component. Therefore, much of the requested information regarding AI device performance metrics, sample sizes for training/test sets, expert qualifications, and ground truth establishment is not present in this regulatory submission.

However, based on the provided text, here's what can be extracted and inferred regarding performance data and acceptance criteria relevant to the physical device:

The document states that "Verification activities based on ASTM F2077, ASTM F2267 and expulsion testing were performed. The mechanical testing demonstrated the device can be expected to perform in a manner substantially equivalent to the predicates listed above."

This indicates that the acceptance criteria for this medical device are based on demonstrating mechanical equivalence to existing, legally marketed predicate devices, as per the specified ASTM standards and additional expulsion testing. The "reported device performance" is that it met these criteria, demonstrating substantial equivalence.

Here's a breakdown of the information you requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on standards/comparison)	Reported Device Performance
Mechanical performance as per ASTM F2077	Demonstrated substantial equivalence to predicate devices.
Mechanical performance as per ASTM F2267	Demonstrated substantial equivalence to predicate devices.
Expulsion resistance	Demonstrated substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified in the provided text. Mechanical testing typically involves a set number of physical samples, but the exact quantity is not detailed here.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. This refers to mechanical testing data, which is generated in a lab setting rather than clinical data from patients.

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

Not applicable / Not specified. For a physical device undergoing mechanical testing, "ground truth" as it pertains to expert consensus on clinical findings is not relevant. The "ground truth" would be the measured physical properties and performance against specified standards.

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

Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies to resolve discrepancies among human readers or evaluators of clinical data. Mechanical testing results are typically objective measurements.

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. This is a physical interbody fusion device, not an AI/software medical device. Therefore, MRMC studies and AI-assisted human reader performance improvements are not relevant here.

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

Not applicable. This document pertains to a physical medical device, not an algorithm or AI system.

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

For mechanical testing, the "ground truth" would be the objective measurements of material properties and structural integrity against defined engineering standards (ASTM F2077, ASTM F2267) and the performance of the predicate devices. There is no clinical "ground truth" like pathology or outcomes data presented for this specific premarket notification, as it focuses on substantial equivalence of the device's design and mechanical properties.

8. The sample size for the training set:

Not applicable / Not specified. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, no training set for an AI/ML algorithm is involved.

Key takeaway from the document:

The Nexus Spine Tranquil Interbody System established its acceptance criteria and met them by demonstrating substantial equivalence in its mechanical performance (material properties, design, and structural integrity via ASTM F2077, ASTM F2267, and expulsion testing) to existing predicate devices. This type of regulatory submission (510(k)) primarily relies on this comparison rather than extensive de novo clinical trials or AI/software performance studies.

Summary

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

Nexus Spine, LLC Mr. Jared Crocker Director of Quality and Regulatory Affairs 2825 East Cottonwood Parkway. Suite 330 Salt Lake City, Utah 84121

June 27, 2017

Re: K170297

Trade/Device Name: Tranquil Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: May 24, 2017 Received: May 25, 2017

Dear Mr. Crocker:

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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ResourcesforYou/Industry/default.htm. 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.

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,

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

510(k) Number (if known) K170297

Device Name

Tranquil Interbody System

Indications for Use (Describe)

The Tranquil™ Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion.

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

Submitter:	Nexus Spine, LLC
Contact Person:	Mr. Jared Crocker, Director of Quality and Regulatory Affairs2825 East Cottonwood Parkway, Suite 330Salt Lake City, UT 84121Telephone: (801) 702-8592Fax: (801) 702-8585
Date Prepared:	June 26, 2017
Trade Name:	Tranquil Interbody System
Classification, Nameand Number:	Class IIIntervertebral body fusion device21 CFR 888.3080
Product Code:	MAX, ODP

Product Code:

Predicate Device(s):

Manufacturer	Device	510(k)/PMA Number
Primary Predicate
K2M	Cascadia Interbody System	K160547
Other Predicates
Adaptive Specialty	Fusion Advantage Cervical CageFusion Advantage Lumbar Cage	K083425
K2M	Aleutian	K130699
Spinal Elements	Lucent	K071724/ K081968
Spinal Elements	Crystal Cervical Cage	K073351
LDR Spine	Cervical Interbody Fusion System	K091088
Meditech	Talos PLIF	K090707
Captiva Spine	PivoTEC Lumbar Interbody FusionDevice (LFID)	K092017

Device Description:

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	are provided clean and non-sterile for steam sterilization at the user'sfacility.
Intended Use:	The TranquilTM Interbody System is indicated for intervertebral bodyfusion of the spine in skeletally mature patients. The device system isdesigned for use with autograft to facilitate fusion.
	The TranquilTM Cervical Interbody System is intended for spinal fusionprocedures at one level in the cervical spine (C3 to C7) in skeletally maturepatients with degenerative disc disease (defined as neck pain of discogenicorigin with degeneration of the disc confirmed by history and radiographicstudies) of the cervical spine. The cervical device is to be implanted via anopen, anterior approach and packed with autogenous bone. The cervicaldevice is to be used in patients who have had six weeks of non-operativetreatment. This device system is intended for use with supplemental internafixation systems.
	The TranquilTM Lumbar Interbody System is intended for use at either onelevel or two contiguous levels (L2-S1) in skeletally mature patients withdegenerative disc disease (DDD). DDD is defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history andradiographic studies. DDD patients may also have up to Grade 1spondylolisthesis or retrolisthesis at the involved levels. The patients mayhave had a previous non-fusion spinal surgery at the involved level(s). Thedevice is intended to be used with supplemental internal fixation systems.
Statement ofTechnologicalComparison:	The Tranquil Interbody System is manufactured using additivemanufacturing, but the predicate devices are machined of the same material.This difference does not impact the substantial equivalence of the devices.The Tranquil Interbody System is substantially equivalent to the abovelisted predicate devices in terms of materials, design, indications for use andoperational principles.
Performance Data:	Verification activities based on ASTM F2077, ASTM F2267 and expulsiontesting were performed. The mechanical testing demonstrated the devicecan be expected to perform in a manner substantially equivalent to thepredicates listed above.
Conclusion:	Documentation provided demonstrates the Tranquil Interbody System issubstantially equivalent to 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.