The Shoreline Cervical Interbody RT System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone graft and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.

When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody Spacer Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels of the cervical spine (C3-C7).

When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.

Device Description

The SeaSpine Shoreline Anterior Cervical Standalone (ACS) System consists of the implant assembly composed of a PEEK cervical spacer (ASTM F2026) and a titanium alloy (ASTM F136) plate with titanium alloy variable angle or fixed bone screws, and a titanium alloy locking cover.

The Shoreline ACS System offers spacers in low profile (TruProfile) and no profile versions. Both TruProfile and no profile spacers are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM).

The subject Shoreline Cervical Interbody RT System is a NanoMetalene titanium bonded device offered in a variety of footprints and heights to accommodate variations in patient anatomy. The low-profile spacer is box-shaped with a central canal for receiving autograft bone and/or allogenic bone graft composed of cancellous, cortical and/or corticocancellous bone material.

The Shoreline Cervical Interbody RT System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with the Shoreline ACS bone screw fixation and locking cover.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Shoreline Cervical Interbody RT System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than a study proving the device meets specific acceptance criteria based on its performance in a clinical or standalone study.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not applicable or not provided in this specific regulatory submission.

Here's an breakdown based on the provided document:

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

Acceptance Criteria (Not explicitly stated in terms of performance metrics for the device itself, but rather engineering standards)	Reported Device Performance (Demonstrated Equivalence)
Mechanical Performance:	The Shoreline Cervical Interbody RT System demonstrated equivalent performance to the predicate Shoreline ACS system through:
* Static compression (per ASTM F2077)	* Equivalent performance to predicate
* Dynamic compression (per ASTM F2077)	* Equivalent performance to predicate
* Compression shear (per ASTM F2077)	* Equivalent performance to predicate
* Torsion (per ASTM F2077)	* Equivalent performance to predicate
* Subsidence (per ASTM F2267)	* Equivalent performance to predicate
Sterility & Packaging:
* Sterility Assurance Level (SAL) of 10-6	Validated at SAL of 10-6 through packaging, shipping, and sterilization tests.
* Maintenance of a sterile barrier	Ensured through packaging, shipping, and sterilization tests.
* Bacterial Endotoxin testing (BET) in accordance with ANSI/AAMI ST-72:2011	Conducted in accordance with ANSI/AAMI ST-72:2011.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This submission relies on substantial equivalence through non-clinical (bench) testing, not on clinical performance data or a test set of patient data.

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. See point 2.

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

Not applicable. See point 2.

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. This is not an AI/software device and no MRMC study was performed or required for this type of medical device (intervertebral body fusion device).

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

Not applicable. This device is a physical implant, not a standalone algorithm. The "standalone" mentioned in the "Indications for Use" refers to the device being used without supplemental fixation, but still as part of a surgical procedure involving a human surgeon.

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

Not applicable in the context of clinical "ground truth". The "ground truth" for this submission are the established mechanical testing standards (ASTM F2077, ASTM F2267) and sterility standards (ANSI/AAMI ST-72:2011). The "ground truth" for substantial equivalence is the performance of the legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning. The "training" here would refer to the design and development process based on established engineering principles and prior device knowledge, and validation against relevant standards.

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

Not applicable. See point 8. The "ground truth" for device development for this type of product is based on established biomechanical property requirements, material standards, and the performance characteristics of predicate devices.

Summary

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February 14, 2019

SeaSpine Orthopedics Corporation Gina Flores Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008

Re: K183083

Trade/Device Name: Shoreline Cervical Interbody RT System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: January 16, 2019 Received: January 17, 2019

Dear Ms. Flores:

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 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

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Katherine D. Kavlock -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) K183083

Device Name Shoreline Cervical Interbody RT System

Indications for Use (Describe)

When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.

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

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:Phone number:Fax number:	5770 Armada Drive, Carlsbad CA(760) 216-5136(760) 683-6874
Contact person:Email address:	Gina Flores, Sr. Regulatory Specialistgina.flores@seaspine.com
Date Prepared:	February 11, 2019
Device Name

Trade Name:	Shoreline Cervical Interbody RT System
Common Name:	Intervertebral Body Fusion Device
	Classification Name: Intervertebral fusion device with bone graft, cervical(21 CFR 888.3080)
Class:	II
Product Code:	OVE, ODP

Legally Marketed Predicate Devices

510(k) Number	Product Code	Trade Name	Manufacturer
PRIMARY PREDICATE Device
K170569	OVE	Shoreline ACS-Anterior CervicalSystem	SeaSpine OrthopedicsCorporation
Additional Predicate Device
K161081	OVE	Shoreline ACS-Anterior CervicalSystem	SeaSpine OrthopedicsCorporation
K162715,K171046	ODP, MAX	CambriaNanoMetalene Sterile	SeaSpine OrthopedicsCorporation
K172926, K111675,K101363, K050058,K032064	ODP, OVE	Vu c·POD	SeaSpine OrthopedicsCorporation(originally manufactured byIntegra LifeSciences, nowSeaSpine OrthopedicsCorporation)

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K173722	ODP	Patriot ColonialSpacer	Globus Medical Inc.
---------	-----	----------------------------	---------------------

Device Description

Intended Use/Indications for use

Shoreline Cervical Interbody RT System

The Shoreline Cervical Interbody RT System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical and/or corticocancellous bone.

When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.

When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.

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Summary of Technological Characteristics

The Shoreline Cervical Interbody RT System and predicate devices have the same operational principle; they act as a disc spacer and hold bone graft. The Shoreline Cervical Interbody RT System is substantially equivalent to the cited predicate devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).

The subject and predicate Shoreline ACS devices are based on the following similar technological elements:

Implant Spacer Heights
Spacer Footprints
Spacer Lordotic Angles ●
Screw Sizes and Lengths .

Non-Clinical Testing

The Shoreline Cervical Interbody RT System demonstrated equivalent performance to the predicate Shoreline ACS system through static and dynamic compression, compression shear, and torsion per ASTM F2077, and subsidence per ASTM F2267.

Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 106 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

Clinical Testing

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

Conclusions

The submitted data demonstrate that the Shoreline Cervical Interbody RT System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate.

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.

Indications for Use

Indications for Use (Describe)

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510(k) Summary

Contact Details

Legally Marketed Predicate Devices

Device Description

Intended Use/Indications for use

Shoreline Cervical Interbody RT System

Summary of Technological Characteristics

Non-Clinical Testing

Clinical Testing

Conclusions

§ 888.3080 Intervertebral body fusion device.

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