The Shoreline Threaded TruProfile® Plate is intended for anterior cervical fixation (C2-T1) for the following indications: · Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),

· Spondylolisthesis,

· Trauma (i.e., fracture or dislocation),
· Spinal Stenosis,
· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
· Tumor,
· Pseudarthrosis.
· Failed previous fusion.

Device Description

The Shoreline Threaded TruProfile" Plate (referred to as the TruProfile Plate) is a spinal fixation system that consists of a variety of non-sterile, single-use plates, screws, and locking covers. Fixation is achieved by inserting bone screws through the openings in the vertebral bodies of the cervical spine. The Shoreline plates include locking covers that cover the heads of the bone screws to reduce the potential for screw back-out. The TruProfile Plate implant components are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The TruProfile Plate implant components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine (C2- T1) during the development of a cervical spinal fusion. Associated instruments are available to facilitate the implantation of the device. The instruments are placed in system-specific tray components for storage, protection, and organization prior to and during the steam sterilization process.

AI/ML Overview

The provided FDA 510(k) summary (K211903) for the Shoreline Threaded TruProfile® Plate describes a medical device, specifically a spinal fixation system. It does not describe an AI/ML powered medical device or a study involving such a device.

Therefore, the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device is not present in the provided text.

The document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical mechanical performance testing.

Here's a breakdown of what is present, in case there was a misunderstanding:

A table of acceptance criteria and the reported device performance:
- No formal table of "acceptance criteria" is presented in the context of an AI/ML device.
- The "performance" for this spinal plate device is mechanical performance testing.
- Reported Device Performance: "The TruProfile Plate has demonstrated equivalent mechanical performance to the predicate system through mechanical testing in static axial compression bending and torsion, and dynamic axial compression bending per ASTM F1717."
Sample size used for the test set and the data provenance:
- Not applicable as this is a mechanical device, not an AI/ML system tested with a data set of patient cases.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood for AI/ML devices involves expert annotations of medical images or other clinical data. For a mechanical device, performance is evaluated against engineering standards.
Adjudication method:
- Not applicable to a mechanical device.
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 as this is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable as this is not an AI/ML device.
The type of ground truth used:
- For the mechanical testing, the "ground truth" would be the specified mechanical limits and benchmarks set by the ASTM F1717 standard and the predicate device's performance.
The sample size for the training set:
- Not applicable as this is not an AI/ML device.
How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.

Summary

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August 30, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SeaSpine Orthopedics Corporation Kavita Chandrashekar Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008

Re: K211903

Trade/Device Name: Shoreline Threaded TruProfile® Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 18, 2021 Received: June 21, 2021

Dear Kavita Chandrashekar:

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/cdrl/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

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devices or postmarketing safety reporting (21 CFR 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 (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-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.

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality 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: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K211903

Device Name Shoreline Threaded TruProfile® Plate

Indications for Use (Describe)

· Spondylolisthesis,

· Trauma (i.e., fracture or dislocation),
· Spinal Stenosis,
· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
· Tumor,
· Pseudarthrosis.
· Failed previous 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

K211903

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:	5770 Armada Drive, Carlsbad CA
Phone number:	(858) 405-1276 (Kavita)
Fax number:	(760) 683-6874
Contact person:	Kavita Chandrashekar, Regulatory Affairs Specialist, Regulatory Affairs
Date Prepared:	June 18, 2021
Device Name
Trade Name:	Shoreline Threaded TruProfile® Plate
Device Classification Regulation:	888.3060
Common Name:	Cervical Plate
Classification Name:	Spinal Intervertebral Body Fixation Orthosis
Class:	II
Product Code:	KWQ

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Legally Marketed Predicate Devices

510(k) Number	ProductCode	Trade Name	Manufacturer
Primary Predicate Device
K202064	KWQ	SeaSpine Admiral AnteriorCervical Plate (ACP) System	SeaSpine Orthopedics Corporation
Additional Predicate Devices
K190885	OVE, ODP, KWQ	Elevation Spine Saber-CSystem	Elevation Spine
K173521	KWQ	SeaSpine Cabo ACP System	SeaSpine Orthopedics Corporation

Device Description

Intended Use/Indications for Use

The Shoreline Threaded TruProfile" Plate is intended for anterior cervical fixation (C2—T1) for the following indications:

. Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
Spondylolisthesis,
Trauma (i.e., fracture or dislocation),
. Spinal Stenosis,
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
Tumor,
Pseudarthrosis,
Failed previous fusion.

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Summary of Technological Characteristics

The TruProfile Plate is identical or similar to the cited predicate devices in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).

The plates are used to treat the same conditions, have essentially the same precautions and contraindications for use, and represent a basic design concept in terms of safety and effectiveness, and differ only in design details and not functionality.

Non-Clinical Testing

The TruProfile Plate has demonstrated equivalent mechanical performance to the predicate system through mechanical testing in static axial compression bending and torsion, and dynamic axial compression bending per ASTM F1717.

Conclusions

The submitted data demonstrates that the Shoreline TruProfile Plate is substantially equivalent to the cited legally marketed predicate.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.