The Mariner Cap System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
1. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
1. Spinal degenerative surgery, as an adjunct to spinal fusions.

The Mariner Cap System shall be used in conjunction with the SeaSpine Mariner Pedicle Screw System whenever "wiring" may help secure the attachment of other implants.

Device Description

The Mariner Cap is composed of three components: the Mariner Cap SP Connector, the Mariner Cap SP Locking Base, and the Locking Insert. The cap is designed to mate with the Mariner Pedicle Screw System screws. The Mariner Cap is added to the proximal end of the Mariner Screw and provides for an alternate method to attach the JAZZ Band and JAZZ Passer Band to skeletal structures as compared to the current method using a JAZZ connector (K171881).

AI/ML Overview

The provided FDA 510(k) summary (K201240) describes the Mariner Cap System, a device intended for temporary stabilization as a bone anchor. However, this document does not contain the detailed information required to describe the acceptance criteria and a study that proves the device meets those criteria in the context of device performance as typically understood for AI/ML devices.

The document is a regulatory submission for a medical device (a physical implant), not a software or AI/ML device. Therefore, the "acceptance criteria" and "study" mentioned primarily refer to non-clinical mechanical testing to demonstrate substantial equivalence to a predicate device, rather than performance metrics like sensitivity, specificity, or reader improvement, which are common for AI/ML studies.

Here's a breakdown based on the information available and why certain aspects of your request cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the "acceptance criteria" and "reported device performance" are related to mechanical testing for equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Similar performance to predicate system in dynamic compression (ASTM 1717)	Mariner Cap System demonstrated similar performance to the predicate system through dynamic compression testing.
Similar performance to predicate system in static compression	Mariner Cap System demonstrated similar performance to the predicate system through static compression testing.
Equivalent technological characteristics	The Mariner Cap System was shown to have equivalent technological characteristics to the cited predicate and reference device (components, description, intended use, operating principle, design, materials, sterility, manufacturing).

Note: This is a very different type of "performance" than what would be reported for an AI/ML device. There are no accuracy, sensitivity, or specificity metrics.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of mechanical testing. The testing would involve a certain number of manufactured devices for various mechanical tests, but this isn't a "test set" of patient data. The document does not specify the number of Mariner Cap Systems or components tested.
Data Provenance: Not applicable. The "data" refers to the results of mechanical tests performed on the physical device components, not patient data from a specific country or collected retrospectively/prospectively.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. Ground truth as typically understood for diagnostic AI/ML (e.g., radiologist reads) is not relevant for this type of mechanical device testing. The "ground truth" here would be the physical properties and mechanical behavior of the device under specific test conditions, as measured by standard engineering methods.
Qualifications of Experts: Not applicable. Engineering and quality assurance personnel would perform and analyze these tests, following recognized standards (like ASTM 1717).

4. Adjudication Method

Adjudication Method: Not applicable. This concept is relevant for disagreements among human readers or algorithm outputs in diagnostic studies. For mechanical testing, results are quantitative and compared against established benchmarks or predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This type of study is specifically for evaluating the impact of an AI algorithm on human reader performance. The Mariner Cap System is a physical implant, not an AI/ML diagnostic tool.

6. Standalone (Algorithm Only) Performance

Standalone Performance: No. The device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: For the mechanical testing, the "ground truth" would be the physical and mechanical properties of the device and its components, determined through standardized engineering tests (e.g., measuring forces, displacements, structural integrity, material properties) and compared against a predicate device.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no training set as the device is not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Established: Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary, the provided document describes a regulatory clearance for a physical medical implant (the Mariner Cap System) based on non-clinical mechanical testing demonstrating substantial equivalence to a predicate device. The questions posed in your request are largely tailored towards evaluating AI/ML-based medical devices, and thus many are not applicable to the context of this 510(k) submission.

Summary

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

August 5, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The words "U.S. FOOD & DRUG" are on the first line, and "ADMINISTRATION" is on the second line.

SeaSpine Orthopedics Corporation Alicia McArthur Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008

Re: K201240

Trade/Device Name: Mariner Cap System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: OWI Dated: May 6, 2020 Received: May 8, 2020

Dear Alicia McArthur:

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

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

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 (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 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/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,

Colin O'Neill, M.B.E. Acting 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) K201240

Device Name Mariner Cap System

Indications for Use (Describe)

The Mariner Cap System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
1. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
1. Spinal degenerative surgery, as an adjunct to spinal fusions.

The Mariner Cap System shall be used in conjunction with the SeaSpine Mariner Pedicle Screw System whenever "wiring" may help secure the attachment of other implants.

Type of Use (Select one or both , as applicable)
----------------------------------------------------------------

X 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 92008
Phone number:	(760) 216-5176
Fax number:	(760) 683-6874
Primary Contact:	Alicia McArthur, Regulatory Affairs Specialist
Secondary Contact:	Jesse Albright, Regulatory Affairs Specialist
Date Prepared:	July 29, 2020
Device Name
Trade Name:	Mariner Cap System
Common Name:	Bone Fixation Cerclage, Sublaminar
Classification Name:	Bone Fixation Cerclage (21 CFR 888.3010)

OWI Product Code:

Class:

Legally Marketed Predicate Devices

510(k) Number	Product Code	Trade Name	Manufacturer
PRIMARY PREDICATE Device
K182771	NKB, OWI	ISS-JAZZ ScrewSystem and JAZZ CAPSP	Implanet
REFERENCE Device
K173882	NKB	Mariner Pedicle ScrewSystem	SeaSpine OrthopedicsCorporation

Device Description

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

Indications for Use

The Mariner Cap System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
1. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis:
1. Spinal degenerative surgery, as an adjunct to spinal fusions.

The Mariner Cap System shall be used in conjunction with the SeaSpine Mariner Pedicle Screw System whenever "wiring" may help secure the attachment of other implants.

Summary of Technological Characteristics

The Mariner Cap System provides an alternate way to allow for braid attachment to the spine. The Mariner Cap System when used with the Mariner Pedicle Screw System, provides a more of ficient, lower profile method of adding the braid attachment to the fixation construct by attaching the JAZZ Passer Band to the Mariner Cap designed to attach to the proximal end of the screw. The locking mechanism used for the braid component in the Mariner Cap is identical to that already cleared in the JAZZ CAP (K182771).

The Mariner Cap System was shown to be substantially equivalent and have equivalent technological characteristics to the cited predicate and reference device in regard to components, device description, intended use/indications for use, technological characteristics (i.e., operating principle, design, materials, sterility, manufacturing, etc.) and performance (i.e., mechanical testing).

Non-Clinical Testing

The Mariner Cap System demonstrated similar performance to the predicate system through dynamic compression testing with reference to ASTM 1717 and static compression testing.

Clinical Testing

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

Conclusions

The submitted data demonstrates that the Mariner Cap System has been shown to be substantially equivalent to the legally marketed predicate device for its intended use.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.