The SeaSpine® Shoreline™ ACS 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 non-operative treatment. The cervical device is to be used with bone screw fixation and a locking cover.

Device Description

The SeaSpine® Shoreline™ ACS - Anterior Cervical Standalone System consists of the implant assembly composed of a single use 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 versions. Both low profile and no profile spacers are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM).

The no profile versions of the spacers are available in a standard lordotic angle, while the low profile spacer is offered in multiple lordosis versions. The 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.

The no profile and low profile NanoMetalene cervical spacers will be provided in gamma sterilized packaging: the bone screws, plate, and locking cover will be provided non-sterile for subsequent sterilization at the healthcare facility.

The instruments included with the Shoreline™ ACS system facilitate the placement, adjustment, and final locking of the interbody spacers, and removal if necessary. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "SeaSpine® Shoreline™ ACS – Anterior Cervical Standalone System." This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to legally marketed predicate devices.

Crucially, this document does not describe a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to existing devices, primarily through non-clinical (mechanical) testing.

Therefore, many of the requested points regarding acceptance criteria for performance, sample sizes for test/training sets in clinical studies, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for a diagnostic or AI device cannot be directly answered from the provided text. This document is for a traditional medical device (an implant), not a diagnostic or AI-driven system that would typically undergo such rigorous performance evaluation.

However, I can extract information related to the non-clinical testing performed to demonstrate equivalence to a predicate device, which serves as a form of "acceptance criteria" in the context of a 510(k) submission for this type of device.

Here's an interpretation based on the provided text, focusing on what is present and noting what is absent:

Device: SeaSpine® Shoreline™ ACS – Anterior Cervical Standalone System (an intervertebral body fusion device)

Purpose of Submission: Premarket Notification (510(k)) to demonstrate substantial equivalence to legally marketed predicate devices.

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

The "acceptance criteria" here are based on meeting the performance of predicate devices or relevant ASTM standards for mechanical properties. There isn't a table of specific numerical criteria and reported values in the provided summary, but rather a statement of successful demonstration of equivalence.

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance (demonstrate equivalent performance to predicate Shoreline system)	Demonstrated equivalent performance to the predicate Shoreline™ ACS system through engineering analysis. This included:
- Static Compression (per ASTM F2077)	Performed, equivalence demonstrated.
- Dynamic Compression (per ASTM F2077)	Performed, equivalence demonstrated.
- Compression Shear (per ASTM F2077)	Performed, equivalence demonstrated.
- Torsion (per ASTM F2077)	Performed, equivalence demonstrated.
- Subsidence (per ASTM F2267)	Performed, equivalence demonstrated.
- Wear Particle Analysis (per ASTM F1877)	Performed, equivalence demonstrated.
- Screw Push Out Testing	Performed, equivalence demonstrated.
Sterility Assurance	Validated a Sterility Assurance Level (SAL) of 10⁻⁶.
Packaging & Shipping Integrity	Ensured maintenance of a sterile barrier.
Bacterial Endotoxin Testing	Conducted in accordance with ANSI/AAMI ST-72:2011.

2. Sample sizes used for the test set and the data provenance

Test Set Sample Size: Not specified for the non-clinical mechanical tests. These tests typically involve a defined number of samples per test type according to the ASTM standards, but specific numerical sample sizes are not provided in this summary.
Data Provenance: The tests are "Non-Clinical Testing" and "engineering analysis," implying laboratory testing of the device itself, not human subject data. Therefore, notions of country of origin or retrospective/prospective data do not apply in the context of this 510(k) submission for an implantable device.

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

Not Applicable: This type of information is relevant for diagnostic devices or AI systems that interpret medical images/data, where human expert consensus often forms the ground truth. For this mechanical implant device, the "ground truth" is established by adherence to engineering standards and comparison to a predicate device's measured mechanical properties. There's no mention of experts establishing a "ground truth" in the diagnostic sense.

4. Adjudication method for the test set

Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are for reconciling differences in expert interpretations, typically in diagnostic studies. This is not pertinent to the mechanical testing described.

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 PEEK/titanium implant, not an AI software or a diagnostic reading device. No MRMC study was performed or is relevant.

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

Not Applicable: As above, this is a physical implant, not an algorithm. Standalone performance as an algorithm is not relevant.

7. The type of ground truth used

For the non-clinical mechanical testing, the "ground truth" is defined by the established mechanical properties of the predicate device and the requirements of the specified ASTM standards (e.g., F2077, F2267, F1877). The goal was to show that the new device's mechanical behavior was "equivalent" to the predicate.

8. The sample size for the training set

Not Applicable: As this is a physical medical device and its performance was assessed through non-clinical mechanical testing and comparison to a predicate, there is no "training set" in the context of machine learning. There was "No clinical testing required to demonstrate equivalence."

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

Not Applicable: See point 8. No training set was used.

Summary of what was reported in the 510(k) in relation to proving the device meets criteria:

The primary method for demonstrating the device meets the necessary criteria for FDA clearance via 510(k) was to show substantial equivalence to a legally marketed predicate device (SeaSpine® Shoreline™ ACS - K161081) through:

Non-Clinical Mechanical Testing: This involved engineering analyses of static and dynamic compression, compression shear, torsion (per ASTM F2077), subsidence (per ASTM F2267), and wear particle analysis (per ASTM F1877), as well as screw push out testing. The results of these tests demonstrated "equivalent performance" to the predicate.
Performance Testing for Sterility and Packaging: This included packaging, shipping, and sterilization tests to validate a Sterility Assurance Level (SAL) of 10⁻⁶ and ensure maintenance of a sterile barrier. Bacterial Endotoxin Testing (BET) was also conducted per ANSI/AAMI ST-72:2011.
Comparison of Technological Characteristics: The submission highlighted that the device shared similar technological elements with predicate devices, such as implant spacer heights, footprints, lordotic angles, screw sizes and lengths, and anterior plates.

Crucially, the document explicitly states: "No clinical testing was required to demonstrate equivalence." This means that the "acceptance criteria" and "proof" were entirely based on non-clinical, laboratory-based demonstrations of mechanical and material equivalence to a device already deemed safe and effective by the FDA.

Summary

{0}------------------------------------------------

June 15, 2017

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a symbolic representation of a parent and child.

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

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

Re: K170569

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: May 12, 2017 Received: May 15, 2017

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. 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

{1}------------------------------------------------

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, Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K170569

Device Name

SeaSpine® Shoreline™ ACS - Anterior Cervical Standalone System

Indications for Use (Describe)

The SeaSpine® Shoreline ACS 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 non-operative treatment. The cervical device is to be used with bone screw fixation and a locking cover.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Contact Details

Applicant Name:	SeaSpine® Orthopedics Corporation
Address:	5770 Armada Drive, Carlsbad CA
Phone number:	(760) 216-5136
Fax number:	(760) 683-6874
Contact person:	Gina Flores, Regulatory Specialist
Email address:	gina.flores@seaspine.com
Date Prepared:	May 9, 2017
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(21 CFR 888.3080)
Class:	II
Product Code:	OVE

Legally Marketed Predicate Devices

510(k) Number	Product Code	Trade Name	Manufacturer
PRIMARY PREDICATE Device
K161081	OVE	Shoreline™ ACS- AnteriorCervical Standalone System	SeaSpine® OrthopedicsCorporation
Additional PREDICATE Devices
K151939	OVE, ODP,KWQ	Coalition™	Globus® Medical, Inc.
K162715	ODP	Cambria NanoMetalene Sterile	SeaSpine® OrthopedicsCorporation

{4}------------------------------------------------

Device Description

Intended Use/Indications for use

The SeaSpine® Shoreline™ ACS 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 non-operative treatment. The cervical device is to be used with Shoreline bone screw fixation and the Shoreline locking cover.

{5}------------------------------------------------

Summary of Technological Characteristics

The Shoreline™ ACS and predicate devices have the same operational principle; they act as a disc spacer and hold bone graft, and include integrated fixation to maintain stability by direct purchase into the bony vertebral endplates. The SeaSpine® Shoreline™ ACS 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 devices are based on the following similar technological elements:

Implant Spacer Heights
Spacer Footprints
o Spacer Lordotic Angles
Screw Sizes and Lengths
Anterior Plates ●

Non-Clinical Testing

The SeaSpine® Shoreline™ ACS System demonstrated equivalent performance to the predicate Shoreline system through engineering analysis of static and dynamic compression, compression shear, and torsion per ASTM F2077, subsidence per ASTM F2267, and wear particle analysis per ASTM F1877, as well as screw push out testing.

Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 10 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

Clinical Testing

No clinical testing was required to demonstrate equivalence.

Conclusions

The submitted data demonstrate that the SeaSpine® Shoreline™ ACS System is substantially equivalent to 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.