The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

· degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

· spondylolisthesis,
· trauma (i.e., fracture or dislocation),

· spinal stenosis,

· deformities or curvatures (i.e., scoliosis, and/or lordosis),
· spinal tumor,
pseudarthrosis, and/or
· failed previous fusion.

Device Description

The Mariner Pedicle Screw System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur.

The Mariner Pedicle Screw System includes a variety of non-sterile, single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of fixed, uni-axial, uni-planar, and polyaxial and motion-limiting modular pedicle screws, as well as connecting spinal rods, hooks, connectors, crossbars, and a separate locking element. The instruments included in the Mariner Pedicle Screw System facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants, and accessories to the system include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The Mariner RDX System provides additional implants and instruments to expand the functionality of the Mariner platform and provide surgeons with reduction-integrated implants to allow for implant-based reduction techniques with an open or minimally invasive approach. Additional implants include a locking cap and a variety of modular standard tab, and MIS screw heads, as well as additional instruments and accessories.

AI/ML Overview

The provided text describes a medical device, the Mariner RDX System, and its clearance by the FDA based on substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria for a new type of performance or diagnostic capability. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted.

However, I can provide the following:

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

The provided document describes the non-clinical testing for the Mariner RDX System as follows:

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent mechanical performance to predicate systems established via static and dynamic mechanical testing with reference to ASTM F1717.	The Mariner RDX System demonstrated equivalent mechanical performance to the predicate systems through static and dynamic mechanical testing with reference to ASTM F1717.

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

Not applicable. The clearance is based on non-clinical mechanical testing, not a clinical test set with patient data.

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

Not applicable. Ground truth from experts is not relevant for this type of mechanical testing.

4. Adjudication method for the test set

Not applicable. Adjudication methods are not relevant for this type of mechanical testing.

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. The document explicitly states: "Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data." This is a mechanical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" or standard for comparison was the mechanical performance of the predicate systems as defined by ASTM F1717.

8. The sample size for the training set

Not applicable. This is not an AI or algorithm-based device that requires a training set.

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

Not applicable.

Summary

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

Image /page/0/Picture/0 description: The image shows the date September 7, 2022. The month is spelled out, followed by the day and year. The text is in a simple, sans-serif font and is left-aligned. The date is likely part of a document or presentation.

Image /page/0/Picture/1 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SeaSpine Orthopedics Corporation Jesse Albright Associate Manager, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008

Re: K222110

Trade/Device Name: Mariner RDX System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: July 15, 2022 Received: July 18, 2022

Dear Jesse Albright:

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

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

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 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 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,

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

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

Indications for Use

510(k) Number (if known) K222110

Device Name Mariner RDX System

Indications for Use (Describe)

The indications for use are as follows:

· degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

· spondylolisthesis,
· trauma (i.e., fracture or dislocation),

· spinal stenosis,

· deformities or curvatures (i.e., scoliosis, and/or lordosis),
· spinal tumor,
pseudarthrosis, and/or
· 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)

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:Phone number:Fax number:	5770 Armada Drive, Carlsbad, CA 92008(760) 216-5176(760) 683-6874
Contact Person:	Jesse Albright, Associate Manager, Regulatory Affairs
Date Prepared:	July 15, 2022

Device Name

Trade Name:	Mariner RDX System
Common Name:	Thoracolumbosacral Pedicle Screw SystemSpinal Interlaminal Fixation SystemSpinal Intervertebral Body Fixation System
Classification Name:	Thoracolumbosacral Pedicle Screw System (21 CFR 888.3070)Appliance, Fixation, Spinal Interlaminal (21 CFR 888.3050)Appliance, Fixation, Spinal Intervertebral Body (21 CFR 888.3060)
Product Code(s):	NKB, KWP, KWQ
Device Class:	2

Legally Marketed Predicate Devices

510(k) Number	Product Code(s)	Trade Name	Manufacturer
Primary Predicate Device
K160902	NKB, KWP, MNH, MNI	Mariner Pedicle Screw System	SeaSpine Orthopedics Corporation
Additional Predicate Device(s)
K212692	NKB, KWP, KWQ	Mariner Pedicle Screw System	SeaSpine Orthopedics Corporation
K122571	NKB, KWP, MNI, MNH	Malibu Spinal System with the Daytona Deformity System	SeaSpine Orthopedics Corporation

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

Device Description

Intended Use/Indications for Use

The indications for use are as follows:

degenerative disc disease (DDD) as defined by back pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies,
. spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
spinal tumor,
pseudarthrosis, and/or
failed previous fusion.

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

Summary of Technological Characteristics

The Mariner RDX System is identical or similar to the cited predicate systems in regard to intended use/indications for use, device description, technological characteristics (e.g., operating principle, design, components, materials, manufacturing, labeling, sterility, etc.), and non-clinical performance (i.e., mechanical testing).

Non-Clinical Testing

The Mariner RDX System demonstrated equivalent mechanical performance to the predicate systems through static and dynamic mechanical testing with reference to ASTM F1717.

Clinical Testing

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

Conclusions

The submitted data demonstrate that the Mariner RDX System is substantially equivalent to the cited legally marketed predicates.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.