The Manta Ray TDF Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

The Manta Ray TDF Spacer is intended for use with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

Device Description

The Manta Ray TDF Spacer features a cervical interbody cage that engages the entire disc space, including the uncovertebral joints, during the fusion process. This engagement between the lateral wings and the uncovertebral joints is intended to further reduce subsidence by increasing the mating surface area. The interbody spacer is manufactured from polyetheretherketone (PEEK) (per ASTM F2026), tantalum (per ASTM F560) markers for radiographic visualization, and NanoMetalene®, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. Each spacer has a central graft window for receiving autograft and/or allogenic bone graft material and is offered in a variety of footprints, and lordotic options to accommodate variations in pathology and patient anatomy. The Manta Ray TDF Spacer is intended for use with supplemental fixation.

The instruments provided with the Manta Ray TDF Spacer facilitate the placement, adjustment, and removal, if necessary, of the interbody spacer. The spacer is provided sterile packaged, whereas the instruments are provided in system-specific trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

AI/ML Overview

This FDA 510(k) premarket notification for the Manta Ray TDF Spacer does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a diagnostic or AI/ML-driven device.

Instead, this document is for a medical device (an intervertebral body fusion device) where the "acceptance criteria" for clearance are based on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through non-clinical mechanical testing. Clinical trials or studies with performance metrics like sensitivity, specificity, or reader improvement are generally not required for this type of device unless new and different technological characteristics are introduced that raise new questions of safety and effectiveness.

Here's the breakdown based on the provided text:

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

Since this is a substantial equivalence submission for a mechanical implant, there isn't a direct "acceptance criteria" table with performance metrics like accuracy or error rates as would be seen for a diagnostic device. The "acceptance criteria" here implicitly refers to meeting or exceeding the performance established by the predicate devices in various mechanical tests.

Acceptance Criteria (Implicit from Substantial Equivalence and ASTM Standards)	Reported Device Performance (Manta Ray TDF Spacer)
Equivalent mechanical performance to predicate devices in static compression	Demonstrated equivalent mechanical performance to predicate devices per ASTM F2077.
Equivalent mechanical performance to predicate devices in dynamic compression	Demonstrated equivalent mechanical performance to predicate devices per ASTM F2077.
Equivalent mechanical performance to predicate devices in static torsion	Demonstrated equivalent mechanical performance to predicate devices per ASTM F2077.
Equivalent mechanical performance to predicate devices in dynamic torsion	Demonstrated equivalent mechanical performance to predicate devices per ASTM F2077.
Equivalent mechanical performance to predicate devices in subsidence	Demonstrated equivalent mechanical performance to predicate devices per ASTM F2267.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable in the context of clinical test sets. The "test set" here refers to the specimens used for non-clinical mechanical testing. The exact number of samples for each mechanical test (e.g., number of constructs tested for compression, torsion, subsidence) is not provided in this summary. ASTM standards (F2077, F2267) typically specify minimum sample sizes for such tests.
Data Provenance: Not applicable in the context of clinical patient data. The tests are laboratory-based mechanical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in the sense of expert clinical diagnosis is not established for this type of mechanical device submission. The "ground truth" for mechanical testing is derived from the physical properties and performance metrics measured according to established ASTM standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for expert review of clinical data, which is not part of this submission.

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

No. This type of study is not relevant for an interbody fusion device that does not involve AI or human interpretation of diagnostic images.

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

No. This device is a passive implantable medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the clinical sense. The "ground truth" for mechanical testing is adherence to and performance measurements against established ASTM (American Society for Testing and Materials) standards for spinal implants.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary

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February 3, 2023

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

Re: K220296

Trade/Device Name: Manta Ray TDF Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 23, 2023 Received: January 24, 2023

Dear Ms. 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

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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,

Brent Showalter -S

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) K220296

Device Name Manta Ray TDF Spacer

Indications for Use (Describe)

The Manta Ray TDF Spacer is intended for use with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone and 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)

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510(k) Summary

Contact Details

Device Class:

Applicant Name:Address:Phone number:Fax number:Contact Person:Date Prepared:	SeaSpine Orthopedics Corporation5770 Armada Drive, Carlsbad, CA 92008(760) 216-5176(760) 683-6874Jesse Albright, Associate Manager, Regulatory AffairsFebruary 1, 2023
Device Name
Trade Name:Common Name:Classification Name:Product Code(s):	Manta Ray TDF SpacerIntervertebral Body Fusion DeviceIntervertebral Fusion Device With Bone Graft, Cervical (21 CFR 888.3080)ODP

Legally Marketed Predicate Devices

510(k) Number	Product Code(s)	Trade Name	Manufacturer
Primary Predicate Device
K183083	OVE, ODP	Shoreline CervicalInterbody RT System	SeaSpine OrthopedicsCorporation
Additional Predicate Device(s)
K212904	OVE, ODP	SeaSpine WaveForm CInterbody System	SeaSpine OrthopedicsCorporation
K101363	ODP	Vu cPOD IntervertebralBody Fusion Device	SeaSpine OrthopedicsCorporation
K151496	ODP	Latitude-C CervicalInterbody Spacer System	DeGen Medical

Device Description

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allogenic bone graft material and is offered in a variety of footprints, and lordotic options to accommodate variations in pathology and patient anatomy. The Manta Ray TDF Spacer is intended for use with supplemental fixation.

Intended Use/Indications for Use

The Manta Ray TDF Spacer is intended for use with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

Summary of Technological Characteristics

The Manta Ray TDF Spacer and the cited predicate devices have the same operational principle; they act as a disc spacer and hold bone graft. The subject device is also similar to the cited predicate devices in regard to intended use/indications for use, device description, technological characteristics (e.g., design, components, materials, manufacturing, labeling, sterility, etc.), and non-clinical performance (i.e., mechanical testing).

Compared to the predicate counterparts, the Manta Ray TDF Spacer is used to treat the same conditions, has essentially the same precautions and contraindications for use, and represents a basic design concept in terms of safety and effectiveness, differing only in design details and not functionality.

The subject and predicate devices are based on the following similar technological elements:

. Spacer Heights
Spacer Footprints
. Spacer Lordotic Angles

Non-Clinical Testing

The Manta Ray TDF Spacer has demonstrated equivalent mechanical performance to the predicate devices through mechanical testing in static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, and subsidence per ASTM F2267.

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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 Manta Ray TDF Spacer is substantially equivalent to the cited legally marketed predicates.

Regulation Number and Section

N/A