The SeaSpine WaveForm A System Interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine WaveForm A Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

No-Profile Implants w/ Screws:

The SeaSpine WaveForm A System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

No-Profile Implants w/ Inline Fixation Anchors:

The SeaSpine WaveForm A System No-Profile Interbody, when used with Inline Fixation Anchors and a No Profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, 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 A No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The SeaSpine WaveForm A Interbody assembled with the Anterior Plate, when used with Screws and an Anterior Plate Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, 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. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

Device Description

The Seaspine WaveForm A System are additively manufactured intervertebral fusion devices with 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. The implants are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001 and are provided sterile-packed. The WaveForm A interbodies have the ability to accept an anterior faceplate and offer various configurations that can be used with bone screws or inline fixation anchors, locking covers and an optional spin plate. The instruments included with the 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

Please note: The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "SeaSpine WaveForm™ A Interbody System." This type of document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing for mechanical performance, not a clinical study involving human patients or complex AI-driven diagnostic accuracy.

Therefore, the information typically found in a clinical study report regarding acceptance criteria for diagnostic accuracy, sample sizes for AI training/testing, expert adjudication, or MRMC studies for AI devices is not present in this document. The "study" referenced in this document refers to non-clinical mechanical and sterilization testing of the interbody fusion device itself.

Based on the provided text, here's an attempt to answer your questions, highlighting what information is not available in this specific document:

Description of Acceptance Criteria and Proving Device Meets Criteria (Based on Non-Clinical Testing)

The SeaSpine WaveForm™ A Interbody System is an intervertebral fusion device. Its acceptance criteria and proof of meeting them, as described in this 510(k) submission, primarily revolve around non-clinical mechanical performance and sterilization validation, demonstrating its safety and effectiveness are at least equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Specific Test	Acceptance Criteria (Implied from equivalence claim)	Reported Device Performance
Mechanical Performance	Compression (ASTM F2077)	Equivalent to legally marketed predicate devices.	Demonstrated equivalent mechanical performance to the predicate system in accordance with requirements.
	Compression-Shear (ASTM F2077)	Equivalent to legally marketed predicate devices.	Demonstrated equivalent mechanical performance to the predicate system in accordance with requirements.
	Subsidence (ASTM F2267)	Equivalent to legally marketed predicate devices.	Demonstrated equivalent mechanical performance to the predicate system in accordance with requirements.
	Wear Testing (F1877)	Equivalent to legally marketed predicate devices.	Demonstrated equivalent mechanical performance to the predicate system in accordance with requirements.
	Expulsion	No unacceptable expulsion when tested.	Performed; determined to be equivalent.
	Static Screw Push Out	No unacceptable screw push out when tested.	Performed; determined to be equivalent.
Sterilization & Packaging	Sterility Assurance Level (SAL) Validation	Achieve a SAL of 10^-6.	Validated to a SAL of 10^-6.
	Maintenance of Sterile Barrier	Ensure barrier integrity post-packaging and shipping.	Ensured.
	Bacterial Endotoxin (BET) (ANSI/AAMI ST-72:2011)	Meets endotoxin limits.	Conducted in accordance with ANSI/AAMI ST-72:2011; results implied to be acceptable.
	Packaging & Shipping Tests	Maintain product integrity and sterility.	Conducted and results implied to be acceptable.

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

Sample Size: The document does not specify exact sample sizes for each non-clinical mechanical test (e.g., number of devices tested for compression, expulsion, etc.). These are typically described in detailed test reports referenced by such a submission but not usually included in the summary letter itself.
Data Provenance: The data provenance is from non-clinical laboratory testing of the device itself. It is not patient or human data, so concepts like country of origin or retrospective/prospective do not apply in the context of this 510(k) summary.

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

Not Applicable. For a medical device 510(k) clearance based on non-clinical mechanical testing, "ground truth" as it relates to human diagnosis or outcome is not established by medical experts for the test set. Ground truth for mechanical testing would be defined by the physical actual measurements and observations during laboratory experiments, compared against established engineering standards (e.g., ASTM standards).

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple human readers. This document describes non-clinical engineering and biological safety tests where "adjudication" is not a relevant concept.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is a clinical study design used to evaluate the impact of a diagnostic device (often AI-assisted) on human reader performance. This document pertains to a structural interbody fusion device, not a diagnostic imaging or AI device. Therefore, no MRMC study was done, and there is no discussion of human readers improving with AI assistance.

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

No. This device is a physical implant, not a software algorithm. Therefore, "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used:

Engineering Standards and Laboratory Measurements. The "ground truth" for the non-clinical tests described (mechanical performance, sterilization) is established by adherence to recognized ASTM F-series standards (e.g., ASTM F2077, F2267, F1877), ANSI/AAMI standards (e.g., ST-72:2011), and internal protocols for physical and chemical testing. These standards define the methods and expected performance characteristics for such implants.

8. The Sample Size for the Training Set:

Not Applicable. The concept of a "training set" is relevant to machine learning/AI models. This document describes a manufactured physical medical device, not a data-driven model. The device's design and manufacturing processes are developed through engineering and materials science, not by training on a data set.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. As there is no "training set" in the context of this physical device, there is no ground truth established for it in that sense. The "truth" for the device's design and functionality is based on established biomechanical principles, material science, and regulatory requirements.

Summary

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June 2, 2021

SeaSpine Orthopedics Corporation Aly Alvarez Associate Manager, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008

Re: K210583

Trade/Device Name: SeaSpine WaveForm™ A Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: May 3, 2021 Received: May 5, 2021

Dear Aly Alvarez:

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.

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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 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.

for 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

510(k) Number (if known) K210583

Device Name SeaSpine WaveForm™ A Interbody System

Indications for Use (Describe)

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The SeaSpine WaveForm A System Interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine WaveForm A Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) months of non-operative treatment.

No-Profile Implants w/ Screws:

No-Profile Implants w/ Inline Fixation Anchors:

TruProfile Interbody 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)

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510(k) Summary

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:	5770 Armada Drive, Carlsbad CA
Phone number:	(619) 884-4342 (Aly) or 760-271-6804 (Alicia)
Fax number:	(760) 683-6874
Contact person:	Aly Alvarez, Associate Manager, Regulatory Affairs
Additional contact:	Alicia McArthur, Regulatory Affairs Specialist, Regulatory Affairs
Date Prepared:	May 4, 2021

Device Name

Trade Name:	SeaSpine WaveForm™ A Interbody System
Device Classification Regulation:	888.3080
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral body fusion device with bone graft, lumbar; Intervertebral body fusion device with integrated fixation, lumbar
Class:	II
Product Code:	MAX, OVD

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Legally Marketed Predicate Devices

510(k) Number	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K201193	MAX, OVD	SeaSpine Meridian System	SeaSpineOrthopedicsCorporation
Additional Predicate Device
K101310	OVD	SeaSpine Vu a•PODIntervertebral Body FusionDevice	SeaSpineOrthopedicsCorporation(previously ThekenSpine)
Additional Predicate Device
K201755	MAX	SeaSpine WaveForm TOSystem	SeaSpineOrthopedicsCorporation

Device Description

Intended Use/Indications for Use

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

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No-Profile Implants w/ Screws:

No-Profile Implants w/ Inline Fixation Anchors:

The SeaSpine WaveForm A System No-Profile Interbody, when used with Inline Fixation Anchors and a No Profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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 A No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The SeaSpine WaveForm A Interbody assembled with the Anterior Plate, when used with Screws and an Anterior Plate Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

Summary of Technological Characteristics

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

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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

Mechanical Performance in compression and compression-shear (ASTM F2077), subsidence (ASTM F2267), wear testing (F1877), expulsion, and static screw push out was performed. Packaging, shipping and sterilization tests were also conducted to validate a Sterility Assurance Level (SAL) of 10 -6 and ensure maintenance of a sterile barrier. Bacterial Endotoxin (BET) was conducted in accordance with ANSI/AAMI ST- 72:2011. The SeaSpine WaveForm A System has demonstrated equivalent mechanical performance to the predicate system in accordance with these requirements.

Conclusions

The submitted data demonstrates that the SeaSpine WaveForm A System performs 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.