The SeaSpine WaveForm L™ System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L 1 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cortical, cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The SeaSpine WaveForm L™ System is intended for use as an adjunct to fusion in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc hermiation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The SeaSpine WaveForm L System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The SeaSpine WaveForm L System is intended for use with supplemental fixation.

When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous and/or corticocancellous bone and supplemental fixation.

Device Description

The Seaspine WaveForm Lumbar Systems are additively manufactured intervertebral fusion devices that feature a sodium hydroide (NaOH) surface treatment which results in a microroughened surface over the entirety of the implant. The devices include both NaOH treated and non-treated versions and have large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation. WaveForm Lumbar System includes 3 different implants:

A straight, rectangular-shaped cage, intended for lateral surgical placements, and referred to as WaveForm L
. A straight, rectangular-shaped cage, intended for posterior and transforaminal surgical placements, and referred to as WaveForm TO, and
. A curved, banana-shaped cage, intended for transforaminal surgical placements, and referred to as WaveForm TA

The implants are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001 and are provided sterile-packed. The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. 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 document is a 510(k) summary for the SeaSpine WaveForm Lumbar Systems. It describes the device, its intended use, and a summary of non-clinical testing. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of diagnostic performance or AI effectiveness.

Specifically, the document focuses on the mechanical performance and substantial equivalence of the intervertebral body fusion device to predicate devices, as required for FDA 510(k) clearance.

Therefore, I cannot provide the requested information regarding acceptance criteria for diagnostic performance or AI, as this type of information is not present in the given text.

The closest relevant information, which pertains to device performance in a mechanical sense (not diagnostic or AI performance), is:

Non-Clinical Testing:
"The SeaSpine WaveForm Lumbar Systems have demonstrated equivalent mechanical performance to the predicate system in accordance with requirements outlined in ASTM F2077, ASTM F2267, ASTM F1877, and Expulsion."

The document concludes that the device performs at least as safely and effectively as the predicate based on these non-clinical mechanical tests, implying these standards serve as the "acceptance criteria" for mechanical performance and safety for this type of medical device.

To directly answer your numbered points based only on the provided text, many will be marked as "Not Applicable" or "Not Provided" due to the nature of this regulatory document:

Table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit for non-clinical mechanical performance): Adherence to standards ASTM F2077, ASTM F2267, ASTM F1877, and successful Expulsion testing, demonstrating equivalent mechanical performance to the predicate device (K082310: SeaSpine Spacer System - Pacifica).
- Reported Device Performance: "The SeaSpine WaveForm Lumbar Systems have demonstrated equivalent mechanical performance to the predicate system in accordance with requirements outlined in ASTM F2077, ASTM F2267, ASTM F1877, and Expulsion."
Sample size used for the test set and the data provenance: Not applicable. This document describes mechanical testing, not a diagnostic test with a "test set" in the sense of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review process for a "test set" (related to diagnostic or AI performance) is mentioned.
Adjudication method for the test set: Not applicable.
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 document does not concern AI or human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not concern an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to diagnostic or AI performance. For the mechanical tests, the "ground truth" would be the established testing parameters and results of the predicate device.
The sample size for the training set: Not applicable. This document does not describe AI development or training.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains 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, "U.S. Food & Drug Administration," written out next to it.

May 4, 2022

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

Re: K213420

Trade/Device Name: WaveForm™ L System, WaveForm™ TO System, WaveForm™ TA System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM Dated: April 18, 2022 Received: April 19, 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

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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,

Brent Showalter, Ph.D. 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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

K213420 Page 1 of 3

510(k) Number (if known)

K213420

Device Name SeaSpine WaveForm LTM System

Indications for Use (Describe)

The SeaSpine WaveForm L™ System is intended for use with supplemental fixation.

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."

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

K213420

Page 2 of 3

510(k) Number (if known) K213420

Device Name

SeaSpine WaveForm™ TO Interbody System

Indications for Use (Describe)

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.

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."

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

K213420

Page 3 of 3

510(k) Number (if known)

K213420

Device Name SeaSpine WaveForm™ TA Interbody System

Indications for Use (Describe)

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.

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."

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510(k) Summary

K213420

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:Phone number:Fax number:	5770 Armada Drive, Carlsbad CA(760) 271-6804(760) 683-6874
Primary Contact:Previous Contact:	Jesse Albright, Associate Manager, Regulatory AffairsAlicia McArthur, Specialist, Regulatory Affairs
Date Prepared:	April 15, 2022
Device Name
Trade Name:	1. SeaSpine WaveForm™ L Interbody System2. SeaSpine WaveForm™ TO Interbody System3. SeaSpine WaveForm™ TA Interbody System
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Body Fusion Device (21 CFR 888.3080)
Class:	II
Product Code:	MAX, PHM

Subject and Predicate Devices

510(k)Number	Device	Purpose ofSubmission	Applicability to SubjectDevice
K213420	SeaSpine WaveForm LumbarSystems	Introduction ofsystem	Subject Devices SeekingClearance

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K082310	SeaSpine Spacer System - Pacifica	Introduction of system (primary predicate)	Testing from K082310 was compared to subject device
K201755	SeaSpine WaveForm L System	Introduction of systems (additional predicates)	Identical indications; identical manufacturing method; similar or identical implant sizes and shapes
	SeaSpine WaveForm TO System
	SeaSpine WaveForm TA System
K172064	Ti-Diagon Oblique TLIF	Clearance of system (additional predicate)	SeaSpine is seeking similar surface treatment language

Device Description

A straight, rectangular-shaped cage, intended for lateral surgical placements, and referred to as WaveForm L
. A straight, rectangular-shaped cage, intended for posterior and transforaminal surgical placements, and referred to as WaveForm TO, and
. A curved, banana-shaped cage, intended for transforaminal surgical placements, and referred to as WaveForm TA

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Intended Use/Indications for Use

WaveForm L Interbody System

The SeaSpine WaveForm L System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cortical cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The SeaSpine WaveForm L System is intended for use as an adjunct to fusion in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The SeaSpine WaveForm™ L System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The SeaSpine WaveForm L System is intended for use with supplemental fixation.

WaveForm TO Interbody System

WaveForm TA Interbody System

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autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous and/or corticocancellous bone and supplemental fixation.

Summary of Technological Characteristics

The SeaSpine WaveForm Lumbar Systems are 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, etc.) and performance (mechanical safety).

The implants 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 SeaSpine WaveForm Lumbar Systems have demonstrated equivalent mechanical performance to the predicate system in accordance with requirements outlined in ASTM F2077, ASTM F2267, ASTM F1877, and Expulsion.

Conclusions

The submitted data demonstrates that the SeaSpine WaveForm Lumbar Systems perform at least as safely and effectively as 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.