The Tranquil-C™ Interbody System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 – T1. The Tranquil-CTM Interbody System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Tranquil-C™ Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Device Description

The Tranquil-C™ Interbody System is a cervical interbody fusion system. Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The implants are offered in various angles, widths, heights, and lengths to meet patient anatomy for the cervical spine. Implants are provided non-sterile or sterile via gamma irradiation. Instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The purpose of this special 510(k) is to gain clearance for modifications to existing cervical implants and the size range offered.

AI/ML Overview

The provided document is a 510(k) summary for the Nexus Spine Tranquil-C Interbody System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on clinical studies or performance objectives with measurable outcomes.

Therefore, the document does not contain the acceptance criteria or the study that proves the device meets specific acceptance criteria in the way you've described for a typical diagnostic or AI-driven device.

Here's why and what information is available:

Device Type: The Tranquil-C Interbody System is an implantable medical device (intervertebral body fusion device) for spinal fusion surgery. Its "performance" is primarily assessed through mechanical and biocompatibility testing, and its safety and effectiveness are established by demonstrating substantial equivalence to predicate devices that have already proven safe and effective.
510(k) Process: A 510(k) submission aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and materials. If significant differences exist, performance testing (e.g., mechanical, biocompatibility) is conducted to ensure the new device is as safe and effective as the predicate.
Lack of Clinical Study with Acceptance Criteria: The document explicitly states: "Engineering analysis has determined that the subject changes do not create a new worst case condition. Therefore, previously conducted testing remains applicable and no additional performance testing is required." This means no new performance study (e.g., a clinical trial comparing outcomes or an AI-specific validation study) was conducted for this specific 510(k) submission. The safety and effectiveness are inferred from the predicate devices and existing testing.

Consequently, I cannot fill out your requested table and information points as they are designed for a different type of device evaluation (e.g., diagnostic accuracy, AI performance).

However, I can extract what is relevant from the document regarding the device's assessment:

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied): The implied acceptance criterion for a 510(k) is "substantial equivalence" to the predicate devices in terms of safety and effectiveness. This is typically met by demonstrating that the new device has similar technological characteristics, materials, and intended use as the predicate, and any differences do not raise new questions of safety or effectiveness.
Reported Device Performance:
- Mechanical/Biocompatibility (Inferred from Predicate): The device is manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, indicating compliance with recognized standards for implantable materials. The document states "previously conducted testing remains applicable" from the predicate devices (Nexus Spine, LLC Tranquil Interbody System – K181483, K170297, Spinal Elements, Ventana™ C - K222833, Nexus Spine, LLC – Stable L and Stable C Interbody System – K232530). This implies the device, through its substantial equivalence, meets the mechanical and biocompatibility performance standards established by these predicate devices. The "performance" here refers to attributes like strength, fatigue resistance, and biological inertness, which are typically assessed through lab-based mechanical testing, not through diagnostic accuracy metrics of an AI.

2. Sample Size for Test Set and Data Provenance:

Not applicable. This is not an AI/diagnostic device and no "test set" in that context was used for this submission. The evaluation relies on engineering analysis and comparison to predicate devices, not patient data from a test set.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. Ground truth, in the context of expert consensus for diagnostic accuracy, is not relevant for this type of device submission. The "ground truth" for the device's safety and effectiveness is established through the regulatory clearance of its predicate devices and the robust engineering principles applied to its design and materials.

4. Adjudication Method:

Not applicable. No adjudication of expert opinions on a test set occurred.

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

Not applicable. This is not a diagnostic device or product involving human readers interpreting images with or without AI assistance.

6. Standalone Performance:

Not applicable. This is not an algorithm whose standalone performance would be evaluated.

7. Type of Ground Truth Used:

Regulatory/Engineering Equivalence: The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices, supported by engineering analysis that demonstrates the new device is as safe and effective despite minor modifications.

8. Sample Size for Training Set:

Not applicable. As this is not an AI/machine learning device, there is no "training set."

9. How Ground Truth for Training Set was Established:

Not applicable.

In summary: The provided FDA letter and 510(k) summary are for a traditional medical device (interbody fusion system) seeking market clearance via the substantial equivalence pathway, not a software-as-a-medical-device (SaMD) or AI-driven diagnostic. Therefore, the details about acceptance criteria and studies you've requested are not present because they are not typically required or relevant for this type of submission.

Summary

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March 12, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Nexus Spine, LLC Christine Scifert MRC Global 9085 East Mineral Circle, Suite 110 Centennial. Colorado 80112

Re: K240416

Trade/Device Name: Tranquil-C Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: February 7, 2024 Received: February 12, 2024

Dear Christine Scifert:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

Katherine D. Kavlock -S

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

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Indications for Use

510(k) Number (if known) K240416

Device Name Tranquil-C Interbody System

Indications for Use (Describe)

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

Tranquil-C Interbody System February 23, 2024

Company:	Nexus Spine, LLC2825 East Cottonwood Parkway Suite 330Salt Lake City, UT 84121
Primary/Secondary Contact:	Christine Scifert - PartnerMRC Global9085 E. Mineral Cir., Suite 110Centennial, CO 80112Phone: (901) 831-8053Email: christine.scifert@AskMRCGlobal.comJen McBride - Regulatory Consultant(901) 481-5902Email: jen.mcbride@askmcrglobal.com
Company Contact:	Jared CrockerVice President of Quality and Regulatory AffairsNexus Spine, LLCPhone: (801) 702-8592jared.crocker@nexusspine.com
Trade Name:	Tranquil-C Interbody System
Common Name:	Intervertebral Fusion Device With Bone Graft, Cervical
Classification:	Class II
Regulation:	21 CFR 888.3080 (Intervertebral Fusion Device)
Panel:	Orthopedic
Product Code:	ODP
Primary Predicate:	Nexus Spine, LLC Tranquil Interbody System – K181483

Device Description:

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sterile via gamma irradiation. Instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The purpose of this special 510(k) is to gain clearance for modifications to existing cervical implants and the size range offered.

Indications for Use:

The Tranquil-C™ Interbody System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 – T1. The Tranquil-C™ Interbody System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Tranquil-C™ Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Substantial Equivalence:

The subject Nexus Spine Tranquil-C™ Interbody System is substantially equivalent to the following predicate devices:

Primary Predicate:

Nexus Spine, LLC, Tranquil™ Interbody System - K181483

Additional Predicates:

. Nexus Spine, LLC, Tranquil Interbody System – K170297
. Spinal Elements, Ventana™ C - K222833
Nexus Spine, LLC – Stable L and Stable C Interbody System – K232530

There are insignificant differences between the subject Tranquil-C™ Interbody System and the predicate Tranquil-C devices (K181483; K170297). Materials and indications of the subject device are identical to those of the predicate devices. There are slight geometry differences between the subject and predicate devices but the extended size range of the subject device falls within the size range of the previously cleared devices. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.

Performance Testing:

Engineering analysis has determined that the subject changes do not create a new worst case condition. Therefore, previously conducted testing remains applicable an no additional performance testing is required.

Conclusion:

The subject device is determined to be 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.