The Stryker Spine AERO®-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-Tl disc.

DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.

The AERO®-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The AERO®-C Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. In addition, the device must be used with the included fixation anchors.

Device Description

The AERO®-C Cervical Cage is a hollow, ring-shaped PEEK Optima (per ASTM F2026) cage surrounded by a titanium alloy (per ASTM F136 and ISO 5832-3) jacket. It is intended for use as an interbody fusion device and is offered in a variety of heights, widths, depths, and lordotic angles to adapt to varying patient anatomies. The PEEK Optima cage portion consists of two closed pockets for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used with the internal supplemental fixation provided (AERO®-C Fixation Anchors). The AERO®-C Fixation Anchors are constructed from titanium alloy and possess rails that mate with dovetail channels located within the AERO®-C Cervical Cage. Once fully seated into the channels, the anchors are designed to lock into the titanium jacket.

AI/ML Overview

This document is a 510(k) premarket notification for the Stryker Spine AERO®-C Cervical Cage System. It primarily focuses on demonstrating substantial equivalence to predicate devices through design features, indications for use, technological characteristics, material use, and mechanical performance. It does NOT contain information about a clinical study involving human patients, human readers, or ground truth established by experts for classification performance.

Therefore, the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria through clinical performance metrics is largely absent because this document pertains to a premarket notification based on substantial equivalence and non-clinical (mechanical) testing, not clinical outcome studies measuring performance like sensitivity, specificity, or accuracy compared to a ground truth.

However, I can extract information related to the non-clinical testing performed:

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

The document states that "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AERO-C® implant system and demonstrated substantially equivalent performance to the identified predicate device systems."

While explicit numerical acceptance criteria are not detailed in this summary, the criteria are implicitly derived from the FDA's guidance document and the performance of the predicate devices. The reported performance is that the device demonstrated "substantially equivalent performance" to the predicates across the listed mechanical tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Compliance with FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" (June 12, 2007) and performance substantially equivalent to predicate devices for:	Demonstrated "substantially equivalent performance" to the identified predicate device systems for all listed mechanical tests.
Static Compression (per ASTM F2077)	Performance comparable to predicate devices.
Dynamic Compression (per ASTM F2077)	Performance comparable to predicate devices.
Static Compression Shear (per ASTM F2077)	Performance comparable to predicate devices.
Dynamic Compression Shear (per ASTM F2077)	Performance comparable to predicate devices.
Static Torsion (per ASTM F2077)	Performance comparable to predicate devices.
Dynamic Torsion (per ASTM F2077)	Performance comparable to predicate devices.
Expulsion (per ASTM F04-25-02-02 Draft)	Performance comparable to predicate devices.
Subsidence (per ASTM F2267)	Performance comparable to predicate devices.
Wear Debris Assessment	Performance comparable to predicate devices.
Fixation Anchor Engagement Evaluation	Performance comparable to predicate devices.
Dynamic Cadaveric Testing (fatigue performance under multiple loading modes)	Performance comparable to predicate devices; involved implantation into multiple functional spinal units and subsequent evaluation of fatigue performance under multiple loading modes.

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

The document describes non-clinical mechanical testing, primarily involving physical samples of the device and biological (cadaveric) material for a specific test. It does not refer to a "test set" in the context of clinical data for AI/algorithm performance.

Mechanical Tests (e.g., Static Compression, Dynamic Compression, etc.): The specific number of physical samples (devices) tested for each mechanical test is not provided in this summary but would typically be specified within the full test reports referenced by the ASTM standards.
Dynamic Cadaveric Testing: The summary mentions "the implantation of the AERO®-C device into multiple functional spinal units." The exact "multiple" number is not specified.
Data Provenance: Not applicable in the context of country of origin of patient data or clinical retrospective/prospective studies, as this is purely mechanical and cadaveric testing.

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. This document describes non-clinical mechanical testing for an implantable device, not an AI or diagnostic device that requires expert-established ground truth for its performance.

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

Not applicable. This document describes non-clinical mechanical testing, not a clinical study involving adjudication of clinical outcomes or decisions.

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

Not applicable. This document describes non-clinical mechanical testing for a spinal implant, not an AI or diagnostic device.

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

Not applicable. This document describes non-clinical mechanical testing for a spinal implant, not an AI or algorithm.

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

For the mechanical testing, the "ground truth" is defined by the acceptance criteria established by national and international standards (e.g., ASTM F2077, ASTM F2267) and FDA guidance documents, which quantify acceptable mechanical properties and behaviors of intervertebral body fusion devices. The performance of the predicate devices also serves as a benchmark for "substantial equivalence."

8. The sample size for the training set

Not applicable. This document describes non-clinical mechanical testing, not an AI/machine learning model where a "training set" would be relevant.

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

Not applicable, as no training set for an AI/ML model is described.

Summary

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

December 18, 2015

Stryker Spine Ms. Sorava King Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K152532

Trade/Device Name: AERO®-C Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: November 23, 2015 Received: November 24, 2015

Dear Ms. King:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

Lori A. Wiggins -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) K152532

Device Name AERO®-C Cervical Cage 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)

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Section 10: 510k Summary
510(k) Summary: AERO®- C Cervical Cage System
Submitter:	Stryker Spine2 Pearl CourtAllendale, New Jersey 07401
Contact Person	Soraya KingRegulatory Affairs SpecialistPhone: 201-749-8296Fax: 201-962-4296Email: Soraya.King@Stryker.com
Date Prepared	November 23, 2015
Trade Name	AERO®-C Cervical Cage System
Proposed Class	Class II
Classification Nameand Number	Intervertebral body fusion device, 21 CFR 888.3080
Product Code	ODP
Predicate Devices	The AERO-C® Cervical Cage System was shown to besubstantially equivalent to the devices listed below:
	Primary Predicate
	• Stryker Spine AVS® AS PEEK Spacer, K142251 &K120486
	Additional Predicates
	• Stryker Spine AVS® Anchor-C Cervical Cage System,K102606
	• ORTHOVITA PEEK Cages, K072981
	• Surgicraft STALIF C®, K150053
	• Synthes Zero-P, K072981
	• LDR Spine ROI-C System, K091088
	Reference Devices
510(k) Summary: AERO®- C Cervical Cage System
	Stryker Spine AERO® -AL Lumber Cage System, K133328 Stryker Spine AERO®-LL Lumbar Cage System, K142066
Device Description	The AERO®-C Cervical Cage is a hollow, ring-shaped PEEKOptima (per ASTM F2026) cage surrounded by a titanium alloy(per ASTM F136 and ISO 5832-3) jacket. It is intended for useas an interbody fusion device and is offered in a variety ofheights, widths, depths, and lordotic angles to adapt to varyingpatient anatomies. The PEEK Optima cage portion consists oftwo closed pockets for graft containment and has serrations onthe superior and inferior surfaces of the cage. The implant isdesigned to be used with the internal supplemental fixationprovided (AERO®-C Fixation Anchors). The AERO®-CFixation Anchors are constructed from titanium alloy andpossess rails that mate with dovetail channels located within theAERO®-C Cervical Cage. Once fully seated into the channels,the anchors are designed to lock into the titanium jacket.
Indications for Use	The Stryker Spine AERO®-C Cervical Cage is indicated for usein cervical interbody fusion procedures in skeletally maturepatients with degenerative disc disease (DDD) at one level fromthe C2-C3 disc to the C7-T1 disc.DDD is defined as neck pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. These patients should be skeletally mature and have sixweeks of non-operative therapy.The AERO®-C Cervical Cage System is to be used withautogenous bone graft and/or allogenic bone graft comprised ofcancellous and/or corticocancellous bone graft, and is to beimplanted via an open, anterior approach.
510(k) Summary: AERO®- C Cervical Cage System
	The AERO®-C Cervical Cage System is intended to be usedwith supplemental spinal fixation systems that have been clearedfor use in the cervical spine. In addition, the device must be usedwith the included fixation anchors.
Summary of theTechnologicalCharacteristics	The subject AERO-C® implant system and the predicates sharesimilar design features:Graft windows for packing autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft Serrations on the superior and inferior surfaces Comparable heights, widths, depths, and lordotic angles Manufactured from PEEK and Titanium Alloy
510(k) Summary: AERO®- C Cervical Cage System
Summary of Non-Clinical Testing	Testing in compliance with FDA's June 12, 2007 "Class IISpecial Controls Guidance Document: Intervertebral BodyFusion Device" was performed for the AERO-C® implantsystem and demonstrated substantially equivalent performanceto the identified predicate device systems.The following mechanical tests were performed:• Static Compression (per ASTM F2077)• Dynamic Compression (per ASTM F2077)• Static Compression Shear (per ASTM F2077)• Dynamic Compression Shear (per ASTM F2077)• Static Torsion (per ASTM F2077)• Dynamic Torsion (per ASTM F2077)• Expulsion (per ASTM F04-25-02-02 Draft)• Subsidence (per ASTM F2267)• Wear Debris Assessment• Fixation Anchor Engagement Evaluation• Dynamic Cadaveric Testing involving the implantation of theAERO®-C device into multiple functional spinal units andsubsequent evaluation of fatigue performance under multipleloading modes.
Conclusion	Based upon a comparison of the design features, indications foruse, technological characteristics, the use of established well-known materials, and mechanical performance, the AERO®-CCervical Cage System has demonstrated substantial equivalenceto the identified predicate device systems.

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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.