CAVUX™ Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

Device Description

The CAVUX™ Cervical Cage is a cervical intervertebral body fusion device. The system is comprised of a variety of implant sizes to accommodate various patient anatomies and pathology. All implantable components are manufactured from medical grade titanium alloy (6AI4V —ELI Ti). The center of the implant is hollow and is to be filled with autogenous bone material. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.

AI/ML Overview

This document pertains to the 510(k) premarket notification for the CAVUX™ Cervical Cage, an intervertebral body fusion device. The acceptance criteria and the study proving the device meets them are outlined in the "Performance Testing" section and the subsequent "Conclusions".

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Static and Dynamic Axial Compression	As per ASTM F2077-14 standards	"In all instances, the CAVUX™ Cervical Cage functioned as intended and met all pre-determined acceptance criteria. Bench testing results... exceeded those of the predicate PMT Cervical Cage."
Static and Dynamic Torsion	As per ASTM F2077-14 standards	"In all instances, the CAVUX™ Cervical Cage functioned as intended and met all pre-determined acceptance criteria. Bench testing results... exceeded those of the predicate PMT Cervical Cage."
Subsidence Testing	As per ASTM F2267-04 standards	"In all instances, the CAVUX™ Cervical Cage functioned as intended and met all pre-determined acceptance criteria. Bench testing results... exceeded those of the predicate PMT Cervical Cage."
Expulsion Testing	As per ASTM Draft Standard F-04.25.02.02 (Static Push-out Test Method)	"In all instances, the CAVUX™ Cervical Cage functioned as intended and met all pre-determined acceptance criteria. Bench testing results... exceeded those of the predicate PMT Cervical Cage."
Pyrogenicity Testing	In compliance with FDA Guidance Documents	"Pyrogenicity Testing was conducted and in compliance with FDA Guidance Documents listed below... In all instances, the CAVUX™ Cervical Cage functioned as intended and met all pre-determined acceptance criteria."

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

The document describes performance testing using the subject device (CAVUX™ Cervical Cage) and comparing its results to those of a predicate device (PMT Cervical Cage). However, it does not specify the exact sample sizes (number of devices tested) for each of the mechanical or pyrogenicity tests.

The data provenance is from bench testing, meaning it's laboratory-generated data rather than clinical data from human subjects. The country of origin of this testing is not explicitly stated, but the company is based in California, USA. The testing is prospective in the sense that the tests were conducted specifically to evaluate the device prior to its submission for market clearance.

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

This type of testing (mechanical and pyrogenicity) does not involve human experts establishing ground truth in the way clinical studies do. The "ground truth" is defined by the technical specifications of the ASTM standards and FDA guidance documents. Therefore, this question is not applicable in the context of this device's performance testing.

4. Adjudication Method for the Test Set

As the performance testing is based on objective, quantifiable measurements against established engineering and biological standards, there is no need for an adjudication method by human experts. The results are directly compared to the numerical limits and requirements set by the standards.

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 MRMC comparative effectiveness study was done. This device is a physical intervertebral fusion cage, not an AI-powered diagnostic or assistive tool. Therefore, this question is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No standalone performance evaluation was done. This question is not applicable as the device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

Engineering standards: ASTM F2077-14 (Static and Dynamic Axial Compression, Static and Dynamic Torsion), ASTM F2267-04 (Subsidence Testing), and ASTM Draft Standard F-04.25.02.02 (Expulsion Testing). These standards define the methodology and acceptance limits for mechanical performance.
Regulatory guidance: FDA Guidance Documents for Pyrogenicity Testing ("Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff" and "Pyrogen and Endotoxins Testing: Questions and Answers"). These define the acceptable levels of pyrogenic substances.

8. The Sample Size for the Training Set

There is no training set in the context of this device's performance testing. Training sets are relevant for machine learning algorithms, which are not involved here.

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

This question is not applicable as there is no training set for this type of device.

Summary

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

October 7, 2016

Providence Medical Technology, Inc. Mr. Edward Liou Chief Operating Officer 1331 North California Boulevard, Suite 320 Walnut Creek, California 94596

Re: K161642

Trade/Device Name: CAVUX™ Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 7, 2016 Received: September 9, 2016

Dear Mr. Liou:

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,

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) K161642

Device Name CAVUX™ Cervical Cage

Indications for Use (Describe)

CAVUX™ Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenc pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment with the device. Devices are intended to be used with autogenous bone graft 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)

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510(k) SUMMARY

Providence Medical Technology, Inc.'s CAVUX™ Cervical Cages

Date Prepared: September 7, 2016
Company: Providence Medical Technology, Inc. 1331 N. California Blvd., Suite 320 Walnut Creek, CA 94596
Contact Person: Edward Liou ed@providencemt.com Phone: 415.923.9376 Facsimile: 415.923.9377
CAVUX™ Cervical Cage Trade Name:
Common Name: Cervical Cage

Classification Name: Intervertebral Fusion Device With Bone Graft, Cervical

Regulation Number: 21 CFR 888.3080

ODP Product Code: Class: Class II
Predicate Devices:

Primary Predicate: PMT Cervical Cage (K122801, Cleared 5/24/13) (This device has not been subject to recall.)

Reference Device: Titan Spine, LLC: Endoskeleton® TC (K100889, Cleared 7/29/10)

Device Description:

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Indications for Use:

Technological Characteristics:

The CAVUX™ Cervical Cage consists of the following:

CAVUX™ Cervical Cage Implant .
. Delivery Instrument packaged with the Implant

The CAVUX™ Cervical Cage implants are manufactured from Titanium-6AL-4V ELI alloy, which conforms to ASTM F136 and are available in a variety of sizes and lordotic angles to accommodate patient anatomy. Superior and inferior surfaces of the implant feature teeth that provide bony contact with the endplates while a box shape in the center of the implant with fenestrations (windows) is intended to house autogenous bone. The superior and inferior surfaces of the implant are grit blasted and acid etched to improve fixation to adjacent bone.

The CAVUX™ Cervical Cage is held within the delivery instrument which facilitates insertion of the implant into the interbody space. The delivery instrument features a physical stop to prevent over-insertion.

Devices are supplied sterile and single use only.

Performance Testing

The following testing was performed using the subject device and results were compared to those of the predicate device:

Static and Dynamic Axial Compression Testing

ASTM F2077-14 Standard Test methods for Intervertebral Body Fusion Devices .

Static and Dynamic Torsion Testing

ASTM F2077-14 Standard Test methods for Intervertebral Body Fusion Devices .

Subsidence Testing

. ASTM F2267-04 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

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Expulsion Testing

ASTM Draft Standard F-04.25.02.02 Static Push-out Test Method for Intervertebral . Body Fusion Devices

Pyrogenicity Testing

. Pyrogenicity Testing was conducted and in compliance with FDA Guidance Documents listed below:
- "Submission and Review of Sterility Information in Premarket Notification o (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff"
- "Pyrogen and Endotoxins Testing: Questions and Answers" O

In all instances, the CAVUX™ Cervical Cage functioned as intended and met all pre-determined acceptance criteria. Bench testing results of the CAVUX™ Cervical Cage exceeded those of the predicate PMT Cervical Cage. Therefore, the performance characteristics of the CAVUX ™ Cervical Cage are substantially equivalent to those of the PMT Cervical Cage.

Conclusions

The CAVUX™ Cervical Cage has the same indication for use, technological characteristics, and principles of operation as the predicate device. The differences between the subject and predicate devices are that the subject device includes a surface treatment and is available in different sizes than the predicate device. These minor differences between the CAVUX™ Cervical Cage and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the CAVUX™ Cervical Cage is as safe and effective as the PMT Cervical Cage. Thus, the CAVUX™ Cervical Cage is substantially equivalent to the PMT Cervical Cage.

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.