The Shoreline ACS device is a stand-alone device interior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease of the cervical spine at a single level (C2-T ). The Shoreline ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had at least six (0) weeks of nonoperative treatment. The cervical device is to be used with Shoreline bone screw fixation and the Shoreline locking cover.

Device Description

The SeaSpine Shoreline™ ACS (Anterior Cervical Standalone) System consists of the implant assembly, associated instrumentation as well as caddies and trays that may be used for storage and organization. The implant assembly is 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. Shoreline ACS is offered in a variety of footprints and heights to accommodate variations in patient anatomy and is generally box-shaped with surface teeth and a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The system is implanted via an anterior approach.

The system offers spacers in low profile and no profile versions. Low profile versions have minimal profile anterior to the disc space (1.6mm), while no profile versions have zero profile. Both low profile and no profile spacers are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene® (NM). Alternatively, the no profile spacer is available without a NanoMetalene® coating. Both low profile and no profile versions of the spacers are available in a standard lordotic angle. The Low Profile spacer will also be offered in multiple lordosis versions. The SeaSpine Shoreline™ ACS spacers include radiographic markers manufactured from either titanium alloy (ASTM F136) or tantalum (ASTM F560).

No profile implant versions are offered in a two-screw construct and the low profile versions in two. three, and four-screw constructs to accommodate a range of surgeon preference. For all spacer, plate and screw variations, the locking cover attaches to the device and physically blocks the screw heads to prevent screw back out from the construct.

AI/ML Overview

The provided text refers to a 510(k) premarket notification for the SeaSpine Shoreline™ ACS - Anterior Cervical Standalone System, an intervertebral body fusion device. The focus of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria as you might find for a novel AI/software device.

Therefore, many of the requested sections related to acceptance criteria, ground truth, expert opinions, and AI performance studies are not applicable to this particular document. This is a medical device approval based primarily on mechanical testing and material equivalence to existing devices.

Here's an analysis based on the information provided and what is not present:

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

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance equivalent to predicate device per ASTM standards	Demonstrated equivalent performance to the Globus predicate through static and dynamic compression shear, and torsion testing per ASTM F2077, subsidence testing per ASTM F2267, and wear particle analysis per ASTM F1877.
Intended Use	Single level cervical spinal fusion via anterior approach for skeletally mature patients with Degenerative Disc Disease (DDD) (Matches predicate)
Materials	Equivalent or similar materials: PEEK-OPTIMA per ASTM 2026, Titanium alloy (ASTM F136), Tantalum, (ASTM F560), CP Titanium Surface (ASTM F67) (Matches or similar to predicate)
Design	Equivalent or similar spacer height, footprint, lordotic angle, and screw/plate dimensions (Matches or similar to predicate)

Notes:

The document explicitly states that the device demonstrated equivalent performance to the predicate device in specific mechanical tests. The "acceptance criteria" here are implicitly that the device performs at least as well as the predicate device in these tests, adhering to the specified ASTM standards. Specific numerical thresholds for acceptance are not detailed in this summary but would be part of the underlying test reports.

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

This information is not provided in the document. Mechanical testing typically involves a set number of samples of the device components, but the specific quantity is not mentioned here. Data provenance (country, retrospective/prospective) is not relevant for this type of mechanical comparison testing.

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. This study is not evaluating expert interpretation or diagnostic performance. It's focused on the physical and mechanical properties of the device.

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

Not applicable. There is no "test set" requiring adjudication in the context of expert review or diagnostic outcomes.

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 a medical device, not an AI/software product that assists human readers. No MRMC study was performed.

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

Not applicable. This is a physical medical implant, not an algorithm.

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

For mechanical testing, the "ground truth" is defined by the ASTM standards (e.g., F2077, F2267, F1877) themselves, which specify the methodology and expected performance characteristics against which the device is measured. There is no expert consensus or pathology involved in establishing this ground truth for a mechanical test.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. No training set was used.

Summary

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

September 14, 2016

SeaSpine Orthopedics Corporation Ms. Jenny Fam Sr. Director, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008

Re: K161081

Trade/Device Name: SeaSpine Shoreline™ ACS - Anterior Cervical Standalone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: August 12, 2016 Received: August 15, 2016

Dear Ms. Fam:

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 Parts 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/ResourcesforYou/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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161081

Device Name

SeaSpine Shoreline™ ACS - Anterior Cervical Standalone System

Indications for Use (Describe)

The Shoreline ACS device is a stand-alone device interior cervical interbody fusion procedures in sketally mature patients with degenerative disc disease of the cervical spine at a single level (C2-T ). The Shoreline ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had at least six (0) weeks of nonoperative treatment. The cervical device is to be used with Shoreline bone screw fixation and the Shoreline locking cover.

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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K161081 510(k) Summary

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:Phone number:Fax number:	5770 Armada Drive, Carlsbad, CA 92008(760) 216-5104(760) 683-6874
Contact person:Email address:	Jenny Fam, Sr. Director, Regulatory Affairsjenny.fam@seaspine.com
Date Prepared:	September 6, 2016
Device Name
Trade Name:	SeaSpine Shoreline™ ACS - Anterior Cervical Standalone System
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral fusion device with integrated fixation, cervical per 21 CFR888.3080
Product Code:	OVE
Class:	II

Legally Marketed Predicate and Reference Devices

510(k)Number	Product Code	Trade Name	Manufacturer
PREDICATE Device
K151939	OVE	Coalition	Globus Medical, Inc.
REFERENCE Devices
K150053	OVE	Stalif c; Stalif c-ti	Centinel Spine,Inc.
K092521	OVE	Zuma-C	SeaSpine, Inc.
K142488	ODP	Cambria NanoMetalene	SeaSpine, Inc.

Device Description

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without a NanoMetalene® coating. Both low profile and no profile versions of the spacers are available in a standard lordotic angle. The Low Profile spacer will also be offered in multiple lordosis versions. The SeaSpine Shoreline™ ACS spacers include radiographic markers manufactured from either titanium alloy (ASTM F136) or tantalum (ASTM F560).

Intended Use/Indications for Use

The Shoreline ACS device is a stand-alone device indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease of the cervical spine at a single level (C2-T1). The Shoreline ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had at least six (6) weeks of nonoperative treatment. The cervical device is to be used with Shoreline bone screw fixation and the Shoreline locking cover.

Comparison of Technological Characteristics

The SeaSpine Shoreline™ ACS is substantially equivalent to the cited predicate and reference devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).

	Intended Use	Materials	Design	Mechanical Testing
Subject Device:SeaSpine Shoreline™ACS	Single levelcervical spinalfusion via anteriorapproach forskeletally maturepatients withDegenerative DiscDisease (DDD)	Equivalent orsimilar materials:PEEK-OPTIMA perASTM 2026Titanium alloy(ASTM F136),Tantalum, (ASTMF560), CP TitaniumSurface (ASTMF67)	Equivalent orsimilar spacerheight,footprint,lordotic angleand screw/platedimensions	Mechanical testing:Static/Dynamic torsion(ASTM F2077),Static/Dynamic axialcompression (ASTM F2077),Static/Dynamic compressionshear (ASTM F2077),Subsidence (ASTM F2267),Wear evaluation (ASTMF1877)
Predicate/ReferenceDevices:Globus CoalitionSeaSpine Cambria NMSeaSpine Zuma-CCentinel Spine StalifC/C-Ti	Single levelcervical spinalfusion via anteriorapproach forskeletally maturepatients withDegenerative DiscDisease (DDD)	Some or all of thefollowing materials:PEEK-OPTIMA perASTM 2026Titanium alloy(ASTM F136),Tantalum, (ASTMF560), CP TitaniumSurface (ASTMF67)	Various spacerheight,footprint,lordotic angleand screw/platedimensions	Some or all of the followingtesting: Static/Dynamictorsion (ASTM F2077),Static/Dynamic axialcompression (ASTM F2077),Static/Dynamic compressionshear (ASTM F2077),Subsidence (ASTM F2267),Wear evaluation (ASTMF1877), Expulsion

Non-clinical Testing

The SeaSpine Shoreline™ ACS demonstrated equivalent performance to the Globus predicate through static and dynamic compression shear, and torsion testing per ASTM F2077, subsidence testing per ASTM F2267, and wear particle analysis per ASTM F1877.

Clinical Testing

No clinical testing was required to demonstrate equivalence.

Conclusions

The submitted data demonstrate that the SeaSpine Shoreline™ ACS is substantially equivalent to the cited legally marketed predicate devices; it is as safe, as effective, and performs at least as safely and effectively.

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.