The SeaSpine® NewPort™ Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:

degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion,
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
spinal tumor,
pseudoarthrosis, and/or
failed previous fusion.

Device Description

The SeaSpine® NewPort™ Spinal System consists of pedicle screws, locking caps and rods, and is intended to act as a temporary or permanent posterior, non-cervical pedicle fixation implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The system also includes instruments to assist with implantation, and a tray for organization and storage.

AI/ML Overview

The provided document, a 510(k) premarket notification for the SeaSpine® NewPort™ Spinal System, does not contain information about a device that relies on AI/ML or image analysis with specific acceptance criteria and a study to prove it meets those criteria.

Instead, this document is for a traditional medical device: a spinal implant system (pedicle screws, rods, and locking caps). The "study" mentioned refers to non-clinical mechanical testing, not a clinical study involving human patients or a process for establishing ground truth from expert consensus.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them in the context of AI/ML performance, as this information is not present in the provided text.

Here's why the document doesn't fit your request:

Device Type: It's a spinal implant, not an AI/ML imaging or diagnostic device.
Testing: The testing performed is "Non-clinical Testing" for "mechanical safety" (Dynamic Axial Compression, Static Axial Compression, Static Axial Torsion). This is engineering validation of the implant's physical properties, not performance metrics for an AI algorithm.
No Clinical Testing: The document explicitly states, "No clinical testing was required to demonstrate equivalence." This means there was no study involving human patients to assess, for example, diagnostic accuracy or AI assistance.
No Reference to AI/ML: There is no mention of algorithms, image analysis, ground truth, expert readers, or any other concept related to AI/ML device performance.

If you are looking for an example of a 510(k) submission for an AI/ML device, you would need a different document.

Summary

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

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized representation of three human profiles. The profiles are stacked on top of each other, creating a sense of unity and connection. The seal is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.

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

September 8, 2016

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

Re: K161535

Trade/Device Name: SeaSpine® NewPort™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: June 16, 2016 Received: June 17, 2016

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 mav 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

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

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,

Mark N. Melkerson -S

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)

K161535

Device Name SeaSpine® NewPort™ Spinal System

degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion,
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
spinal tumor,
pseudoarthrosis, 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

1. Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:	5770 Armada Drive, Carlsbad, CA 92008
Phone number:	(760) 216-5136
Fax number:	(760) 683-6874
Contact person:	Gina Flores, Regulatory Affairs Specialist
Email address:	gina.flores@seaspine.com
Date Prepared:	August 30, 2016

2. Device Name

Trade Name:	SeaSpine® NewPort™ Spinal System
Common Name:	Pedicle Screw Spinal System
Classification Name:	Pedicle Screw Spinal System (21 CFR 888.3070)Product Code: NKB, Class IIIProduct Code: MNH, Class IIProduct Code: MNI, Class II

3. Legally Marketed Predicate Device(s)

510(k) Number	Product Code	Trade Name	Manufacturer
K083089(Primary Predicate)	NKB, MNH, MNI	NewPort™System	SeaSpine, Inc.
K053276(Additional Predicate)	NKB, MNH, MNI	ISTPedicleScrew System	SeaSpine, Inc.
K051663 K051942 K061342 K072605(Additional Predicate)	NKB, MNH, MNI	Malibu™ SpinalSystem	SeaSpine, Inc.

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

4. Device Description

The purpose of this submission is to add additional screw sizes, rods, locking cap and combination spinal cap and rod devices (cap/rod combos) for additional construct options.

5. Intended Use/Indications for use

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

severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion,

spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
spinal tumor,
pseudoarthrosis, and/or
failed previous fusion.

6. Substantial Equivalence Comparison

The SeaSpine® NewPort™ Spinal System is substantially equivalent to the cited

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

predicate devices with respect to intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).

7. Non-clinical Testing

The SeaSpine® NewPort™ Spinal System demonstrated equivalent performance to the predicate systems when the following mechanical tests were performed:

Dynamic Axial Compression ●
Static Axial Compression .
. Static Axial Torsion per ASTM F1717

8. Clinical Testing

No clinical testing was required to demonstrate equivalence.

9. Conclusions

The submitted data demonstrate that the SeaSpine® NewPort™ Spinal System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate devices.

Regulation Number and Section

N/A