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 non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft (autograft) and supplemental fixation.

Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (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, and used with autogenous bone and supplemental fixation, such as an anterior plating system.

Device Description

The SeaSpine® Spacer System (Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®), and the Cambria NanoMetalene® are intervertebral fusion devices manufactured from polyetheretherketone (PEEK OPTIMA LT1 per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6AI-4V ELI per ASTM F136) for radiographic visualization. The implants have a one-micron thick surface coat of commercially pure (CP) titanium. The devices have a central canal for receiving autogenous bone graft and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this 510(k) is to receive clearance to offer the interbody devices of the noted systems gamma sterilized in individual packaging.

AI/ML Overview

The provided text does not describe acceptance criteria for a medical device's performance, nor does it detail a study proving specific performance metrics. Instead, it is an FDA 510(k) clearance letter for the SeaSpine® Spacer System, which focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving new performance criteria.

Here's an analysis based on the information provided, specifically addressing the points in your request:

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

This information is not provided in the document. The document focuses on demonstrating substantial equivalence to predicate devices, not on setting or meeting specific performance acceptance criteria for a new device's functionality. The "Performance Testing" section under "Summary of Technological Characteristics" states "No new testing required," indicating that performance was largely inferred from the predicate devices.

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

This information is not provided. The document explicitly states "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This means there was no clinical test set in the traditional sense for assessing device performance.

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)

This information is not provided. As no clinical testing was performed for the device's efficacy or safety to establish a ground truth, there were no experts used for this purpose in the context of a performance study.

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

This information is not provided. There was no test set or clinical study requiring an adjudication method.

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 information is not provided. The device is an intervertebral body fusion device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not applicable.

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

This information is not provided. The device is a physical implant, not an algorithm. The concept of "standalone performance" for an algorithm is not relevant here.

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

This information is not explicitly stated as no clinical performance data was assessed for the subject device to establish a "ground truth." The determination of safety and effectiveness for substantial equivalence relies on the established performance characteristics and indications for use of the predicate devices, not on new ground truth established for the subject device itself.

8. The sample size for the training set

This information is not provided. As no AI/algorithm is involved, the concept of a "training set" is not applicable.

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

This information is not provided. As no AI/algorithm is involved, the concept of a "training set" and its ground truth is not applicable.

Summary of Device and Approval Process (based on the document):

The document is an FDA 510(k) clearance for the SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®, and SeaSpine® Cambria NanoMetalene®.

Type of Device: Intervertebral Body Fusion Device
Purpose of 510(k): To receive clearance to offer the interbody devices gamma sterilized in individual packaging, rather than being sterilized by the end-user as with the predicate devices.
Key Argument for Clearance: Substantial equivalence to legally marketed predicate devices (K102026 and K142488).
Evidence for Substantial Equivalence:
- Intended Use/Indications for Use: The subject devices have substantially equivalent indications and intended use as the cited predicates.
- Technological Characteristics: Similar operating principle, design, materials (PEEK-OPTIMA with titanium alloy/tantalum markers and CP titanium surface), manufacturing.
- Performance (Mechanical Safety): No new mechanical testing was required because the design and materials are essentially the same as the predicate devices, which underwent analysis and static & dynamic testing (ASTM F2027), wear evaluation (ASTM F1877), and subsidence (ASTM F2267).
- New Element Justified: The change to pre-sterilized packaging required non-clinical testing, including packaging, shipping, sterility validation (SAL 10⁻⁶), and bacterial endotoxin testing (BET) in accordance with ANSI/AAMI ST-72:2011.
Clinical Testing: Not applicable; the determination of substantial equivalence was not based on an assessment of clinical performance data.

In essence, the "study that proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which demonstrated substantial equivalence to predicate devices, thereby implying that existing acceptance criteria for similar devices are met without requiring new primary performance studies. The "acceptance criteria" here are aligned with the FDA's requirements for substantial equivalence to a predicate device, as opposed to specific clinical performance metrics for a novel technology.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

October 28, 2016

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

Re: K162715

Trade/Device Name: SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®; SeaSpine® Cambria NanoMetalene® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: September 28, 2016 Received: September 29, 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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

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Indications for Use

510(k) Number (if known) K162715

Device Name

SeaSpine® Spacer System - Hollywood NanoMetalene®, and Ventura NanoMetalene®

Indications for Use (Describe)

SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, and Ventura NanoMetalene®:

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.

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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) K162715

Device Name SeaSpine® Cambria NanoMetalene®

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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K162715 Page 1 of 4

Contact Details

Applicant Name:	SeaSpine® Orthopedics Corporation
Address:Phone number:Fax number:	5770 Armada Drive, Carlsbad CA(760) 216-5136(760) 683-6874
Contact person:Email address:	Gina Flores, Regulatory Specialistgina.flores@SeaSpine.com
Date Prepared:	October 27, 2016
Device Name
Trade Name:	SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®SeaSpine® Cambria NanoMetalene®
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral body fusion device(21 CFR 888.3080)
Class:	II
Product Code:	MAX, ODP

Legally Marketed Predicate Devices

510(k) Number	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K102026	MAX, MQP	SeaSpine® Spacer System-(Hollywood NanoMetalene®)	SeaSpine® OrthopedicsCorporation
Predicate Device
K142488	MAX, ODP	SeaSpine® Spacer System(Hollywood VI NanoMetalene®,Ventura NanoMetalene®)and Cambria NanoMetalene®	SeaSpine® OrthopedicsCorporation

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Device Description

Intended Use/Indications for use

The NanoMetalene® subject devices have substantially equivalent indications and intended use as the cited predicates:

SeaSpine® Spacer System (Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®):

Cambria NanoMetalene®:

Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (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 autogenous bone and supplemental fixation, such as an anterior plating system.

Summary of Technological Characteristics

The SeaSpine® Spacer System (Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®), and the Cambria NanoMetalene® devices are substantially equivalent to the cited predicate devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).

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	Subject Devices:	Predicate Devices:
	Hollywood NanoMetalene® System	Hollywood NanoMetalene® System
	Hollywood VI NanoMetalene® System	Hollywood VI NanoMetalene® System
	Ventura NanoMetalene® System	Ventura NanoMetalene® System
	Cambria NanoMetalene® System	Cambria NanoMetalene® System
Intended Use	Adjunct to spinal fusion procedures inskeletally mature patients withdegenerative disc disease (DDD)	Adjunct to spinal fusion procedures inskeletally mature patients withdegenerative disc disease (DDD)
Materials	PEEK-OPTIMA (ASTM 2026),Titanium alloy (ASTM F136),Tantalum, (ASTM F560),CP Titanium Surface (ASTM F67)	PEEK-OPTIMA (ASTM 2026),Titanium alloy (ASTM F136),Tantalum, (ASTM F560),CP Titanium Surface (ASTM F67)
Design	Varying footprints and heights with acentral channel to be filled withautogenous bone graft to allow forbone fusion.	Varying footprints and heights with acentral channel to be filled withautogenous bone graft to allow forbone fusion.
PerformanceTesting	No new testing required	Analysis and static & dynamictesting (ASTM F2027),Wear Evaluation (ASTM F1877),Subsidence (ASTM F2267)
Packaging	Implants will be double packaged inPETG trays with Tyvek lids.Components, accessories andinstruments are provided trays/caddiesintended for sterilization by the enduser	N/A - System implants, components,accessories and instruments areprovided in trays/caddies intended forsterilization by the end user
Sterilization	Implants will be provided in sterilepackaging validated to ensure aSAL 10-6Components, accessories andinstruments are sterilized by the enduser	System implants, components,accessories and instruments aresterilized by the end user

Non-Clinical Testing

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

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

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Conclusions

data demonstrate that the SeaSpine® Spacer System (Hollywood The submitted NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®), and Cambria NanoMetalene® devices are as safe, as effective, and perform at least as safely and effectively as the cited legally marketed predicates.

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.