Cambria NanoMetalene is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.

Cambria is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.

Device Description

The Cambria System device is an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. The cervical spacers are manufactured from PEEK (ASTM F2026), with tantalum (ASTM F560) radiographic markers, and are generally box-shaped with a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The system is implanted via an anterior approach.

The Cambria System device is offered in a variety of heights and footprints to accommodate variations in patient anatomy. The cervical spacers are offered in all PEEK or with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM).

The Cambria NanoMetalene cervical spacers are provided in gamma sterilized packaging; the Cambria PEEK implants are provided non-sterile for subsequent sterilization at the healthcare facility.

The instruments included with the Cambria System facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

AI/ML Overview

The provided 510(k) summary for the SeaSpine Cambria System does not include acceptance criteria or a study demonstrating the device meets such criteria in the way typically found for AI/software-as-a-medical-device (SaMD) products. This document describes a medical device (an intervertebral fusion device) and its substantial equivalence to a predicate device, focusing on mechanical performance, materials, and sterility, rather than diagnostic accuracy or algorithmic performance.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this regulatory submission for a physical implantable device.

However, I can extract the relevant information regarding the non-clinical and clinical testing performed to support the device's substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device (intervertebral fusion device), the "acceptance criteria" and "device performance" are primarily related to its mechanical properties, material safety, and sterility, rather than diagnostic metrics like sensitivity or specificity. No explicit acceptance criteria values (e.g., "must withstand X force") are provided in this summary, but the types of tests performed imply compliance with relevant standards.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
- Withstand axial compression (ASTM F2077)	Engineering analysis verified that modifications did not create new worst cases. Conclusions from previously performed axial compression, compression shear, and torsion testing (ASTM F2077) remained valid.
- Withstand compression shear (ASTM F2077)	Engineering analysis verified that modifications did not create new worst cases. Conclusions from previously performed axial compression, compression shear, and torsion testing (ASTM F2077) remained valid.
- Withstand torsion (ASTM F2077)	Engineering analysis verified that modifications did not create new worst cases. Conclusions from previously performed axial compression, compression shear, and torsion testing (ASTM F2077) remained valid.
- Resist subsidence (ASTM F2267)	Engineering analysis verified that modifications did not create new worst cases. Conclusions from previously performed subsidence testing (ASTM F2267) remained valid.
- Resist expulsion (lab protocol)	Engineering analysis verified that modifications did not create new worst cases. Conclusions from previously performed expulsion testing (lab protocol) remained valid.
Sterility:
- Achieve Sterility Assurance Level (SAL) of 10⁻⁶	For Cambria NanoMetalene System implants, packaging, shipping, and sterilization tests were performed to validate a SAL of 10⁻⁶ and ensure maintenance of a sterile barrier.
- Meet bacterial endotoxin limits (ANSI/AAMI ST-72:2011)	Bacterial Endotoxin Testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Clinical Equivalence (for expanded indications, 2 contiguous levels):	An assessment of clinical literature data was completed to support the proposed indication for use of the Cambria System at 2 contiguous levels (C3-C7). The clinical data demonstrate that the Cambria System device performs comparably to the predicate device that is currently marketed for the same intended use. (Specific metrics or data from this assessment are not detailed in this summary.)

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

Test Set (Non-Clinical): Not explicitly stated, but mechanical testing typically uses a specific number of samples per test type as proscribed by the ASTM standards (e.g., ASTM F2077, F2267). The summary indicates "engineering analysis" and states that "conclusions from previously performed" tests remained valid, suggesting that a formal re-testing of a full set of samples might not have been performed if the modifications were deemed minor structurally.
Data Provenance (Clinical Literature): The summary mentions an "assessment of clinical literature data." This implies retrospective data collection from existing studies, but the specific country of origin or the nature of these studies is not detailed.

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

This section is not applicable as the document describes a physical medical device, not an AI/SaMD product requiring expert-derived ground truth for diagnostic or interpretative tasks. The "ground truth" for mechanical testing is compliance with physical standards. For clinical equivalence, it relies on literature established via clinical trials for similar predicate devices.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above.

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

This section is not applicable as the device is not an AI product.

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

This section is not applicable as the device is not an AI product.

7. The Type of Ground Truth Used

Non-Clinical (Mechanical): Ground truth is based on established engineering and materials science principles, and adherence to recognized standards such as ASTM F2077, ASTM F2267, and ANSI/AAMI ST-72:2011.
Clinical: For supporting the expanded indications, the ground truth was derived from "clinical literature data," implying established clinical outcomes and efficacy data for similar devices from published studies or historical clinical trials.

8. The Sample Size for the Training Set

This section is not applicable as the device is not an AI product and therefore does not have a "training set" in the machine learning sense. Its design and manufacturing are based on established engineering principles and materials.

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

This section is not applicable for the reasons stated above.

Summary

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

July 7, 2017

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

Re: K171046

Trade/Device Name: SeaSpine Cambria System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: April 6, 2017 Received: April 7, 2017

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 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 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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,

Vincent J. Devlin -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171046

Device Name

SeaSpine Cambria NanoMetalene 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.

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

510(k) Number (if known) K171046

Device Name SeaSpine Cambria System

Indications for Use (Describe)

Cambria is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.

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

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:	5770 Armada Drive, Carlsbad CA
Phone number:	(760) 216-5136
Fax number:	(760) 683-6874
Contact person:	Gina Flores, Sr. Regulatory Specialist
Email address:	gina.flores@seaspine.com
Date Prepared:	July 5, 2017
Device Name
Trade Name:	SeaSpine Cambria System
Common Name:	Intervertebral Fusion device with bone graft, cervical
Classification Name:	Intervertebral fusion device with integrated fixation, cervical(21 CFR 888.3080)
Class:	II
Product Code:	ODP

Legally Marketed Predicate Devices

510(k) Number	Product Code	Trade Name	Manufacturer
PRIMARY PREDICATE Device
K082309	ODP	Cambria System	SeaSpineOrthopedicsCorporation
Additional PREDICATE Devices
K162715	ODP	Cambria NanoMetalene Sterile	SeaSpineOrthopedicsCorporation
K142488	ODP	Cambria NanoMetalene	SeaSpineOrthopedicsCorporation
K151322	MAX, ODP	Zeus-C-Amendia InterbodyFusion Device	Amendia, Inc.

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Device Description

The Cambria NanoMetalene cervical spacers are provided in gamma sterilized packaging; the Cambria PEEK implants are provided non-sterile for subsequent sterilization at the healthcare facility.

Intended Use/Indications for use

Cambria

Cambria NanoMetalene

Cambria NanoMetalene is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.

Summary of Technological Characteristics

The Cambria System and predicate devices have the same operating principle; they act as a disc spacer and hold bone graft to promote fusion in the cervical spine. The Cambria System is substantially equivalent to the cited predicate devices in areas including intended use/indications

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for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).

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

Spacer Heights
Spacer Footprints
Spacer Lordotic Angle ●
Implant Materials ●

Non-Clinical Testing

Engineering analysis verified that the device modifications did not create any new worst cases with respect to mechanical performance; conclusions from the previously performed axial compression, compression shear, and torsion testing (ASTM F2077), subsidence testing (ASTM F2267), and expulsion testing (lab protocol) remained valid.

For the Cambria NanoMetalene System implants, packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 10° and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

Clinical Testing

An assessment of clinical literature data was completed to support the proposed indication for use of the Cambria System at 2 contiguous levels (C3-C7).

Conclusions

The submitted data demonstrate that the SeaSpine Cambria System are substantially equivalent to the cited legally marketed predicate. The clinical data demonstrate that the Cambria System device performs comparably to the predicate device that is currently marketed for the same intended use.

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.