CAVUX™ Cervical Cage-L SA System is indicated for standalone use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. 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 with the device.

CAVUX™ Cervical Cage-L is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

CAVUX™ Cervical Cage-L must be used with ALLY™ Bone Screw-L while serving as a standalone system, and as such requires no additional supplementary fixation systems.

Device Description

The Providence Medical Technology, Inc. CAVUX™ Cervical Cage-L SA System is supplied terminally sterilized and is single-use only. The subject device is manufactured from medical grade titanium and is available in various sizes. Subject device is a rectangular hollow box shape with space for allogenic and autogenous bone graft and teeth on the inferior and superior surfaces of the implant. Self-drilling and self-tapping screws are provided as part of the subject device.

AI/ML Overview

The provided text is a 510(k) Summary for the CAVUX™ Cervical Cage-L SA System. This document outlines the device's description, indications for use, and a summary of performance data used to demonstrate substantial equivalence to predicate devices. However, this type of document is primarily focused on demonstrating the mechanical and structural integrity of an orthopedic implant for its intended "use case" based on industry standards, rather than evaluating an AI/ML powered device's performance in terms of diagnostic accuracy or clinical effectiveness.

Therefore, many of the requested criteria related to AI/ML device studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission.

Here's the information that can be extracted or derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test Mode)	Reported Device Performance
ASTM F2077-14 Static Axial Compression	"strength...is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
ASTM F2077-14 Static Torsion	"strength...is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
ASTM F2077-14 Static Shear	"strength...is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
ASTM F2077-14 Dynamic Axial Compression	"strength...is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
ASTM F2077-14 Dynamic Shear	"strength...is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
ASTM Draft F-04.25.02.02 Static Expulsion	"strength...is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The testing described is mechanical/non-clinical, implying material and component-level testing rather than a patient-based test set.
Data Provenance: Not applicable in the context of 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:

Not applicable. Ground truth in this context would refer to material properties or mechanical failure points, established through standardized testing procedures, not expert interpretation of patient data.

4. Adjudication method for the test set:

Not applicable. Mechanical tests have objective pass/fail criteria based on physical measurements, not human adjudication.

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 is a submission for an orthopedic implant, not an AI/ML-powered diagnostic or assistive device.

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

No. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device would be established by the specifications and performance requirements defined by the ASTM standards for intervertebral body fusion devices, and the comparative performance data demonstrating substantial equivalence to predicate devices under those standards. This is a mechanical performance ground truth, not a clinical diagnostic ground truth.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of mechanical testing for an implant.

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

Not applicable.

Summary

{0}------------------------------------------------

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 symbol featuring three abstract 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

March 10, 2017

Providence Medical Technology, Inc. % Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K163474

Trade/Device Name: CAVUX™ Cervical Cage-L SA System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: February 10, 2017 Received: February 14, 2017

Dear Mr. Maxwell:

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

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K163474

Device Name CAVUX™ Cervical Cage-L SA System

Indications for Use (Describe)

CAVUX™ Cervical Cage-L is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

CAVUX™ Cervical Cage-L must be used with ALLY™ Bone Screw-L while serving as a standalone system, and as such requires no additional supplementary fixation systems.

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."

{3}------------------------------------------------

510(K) SUMMARY

Submitter's Name:	Providence Medical Technology, Inc.
Submitter's Address:	1331 N. California Blvd Suite 320Walnut Creek, CA 94596
Submitter's Telephone:	415.923.9376
Contact Person:	Kenneth C. Maxwell IIEmpirical Testing Corp.719.291.6874kmaxwell@empiricalconsulting.com
Date Summary was Prepared:	10 February 2017
Trade or Proprietary Name:	CAVUX™ Cervical Cage-L SA System
Common or Usual Name:	Intervertebral Fusion Device With Integrated Fixation,Cervical
Classification:	Class II per 21 CFR §888.3080
Product Code:	OVE

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

CAVUX™ Cervical Cage-L is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

CAVUX™ Cervical Cage-L must be used with ALLY™ Bone Screw-L while serving as a standalone system, and as such requires no additional supplementary fixation systems.

The indications for use for the CAVUX™ Cervical Cage-L SA System is similar to that of the predicates listed in Table 5-1.

{4}------------------------------------------------

510k Number	Trade or Proprietaryor Model Name	Manufacturer	PredicateType
K150053 K142079,K120819	STALIF C®	Centinel Spine	Primary
K102606	AVS® Anchor-CCervical Cage System	Stryker Spine	Additional
K152515	TOMCAT™ CervicalSpinal System	Choice Spine	Additional
K150765, K121103,K113559, K113559	ROI-C	LDR	Additional

Table 5-1: Predicate Devices

PERFORMANCE DATA

The CAVUX™ Cervical Cage-L SA System has been tested in the following test modes:

ASTM F2077-14 .
- o Static Axial Compression
- O Static Torsion
- o Static Shear
- o Dynamic Axial Compression
- o Dynamic Shear
. ASTM Draft F-04.25.02.02
- O Static Expulsion

The results of this non-clinical testing show that the strength of the CAVUX™ Cervical Cage-L SA System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the CAVUX™ Cervical Cage-L SA System is substantially equivalent to the predicate device.

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.