The Vault-C Standalone Cervical Interbody Fusion System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Vault-C implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C-3 to T-1 disc levels. Patients should have at least six weeks of non-operative treatment with an intervertebral fusion device.

Device Description

The Vault-C consists of a spacer assembly including a PEEK cage with a titanium alloy plate and titanium bone screws for intervertebral body fusion. Screws are available in a variety of diameter-length combinations. The titanium and PEEK spacers are available in a variety of depths, widths and heights. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine.

AI/ML Overview

The provided text describes the Spinal USA Vault-C Standalone Cervical Interbody Fusion System, a medical device, and the testing conducted to support its 510(k) premarket notification. The study described is a non-clinical performance study, not an AI-based study or a clinical trial involving human data analysis. Therefore, many of the requested categories related to AI performance, human readers, sample sizes for training/test sets, and ground truth establishment for AI models are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Mode)	Reported Device Performance (Summary)
Static Axial Compression	Strength is sufficient for intended use; substantially equivalent to predicates
Static Compression-Shear	Strength is sufficient for intended use; substantially equivalent to predicates
Static Torsion	Strength is sufficient for intended use; substantially equivalent to predicates
Dynamic Axial Compression	Strength is sufficient for intended use; substantially equivalent to predicates
Dynamic Compression-Shear	Strength is sufficient for intended use; substantially equivalent to predicates
Dynamic Torsion	Strength is sufficient for intended use; substantially equivalent to predicates
Subsidence	Strength is sufficient for intended use; substantially equivalent to predicates

The acceptance criteria implicitly refer to performance thresholds defined within the ASTM standards (ASTM F-2077 and ASTM F-2267) which the device was tested against and found to meet. The specific quantitative values for these thresholds or the Vault-C's measured performance are not explicitly stated, but the conclusion is that the device's strength is sufficient and comparable to predicate devices.

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

Sample Size for Test Set: Not specified in the document. Non-clinical mechanical testing standards typically involve a defined number of samples, but the exact count is not mentioned here.
Data Provenance: The data is from non-clinical mechanical testing of the device itself. It is not patient data from a specific country, nor is it retrospective or prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a mechanical performance study of a physical device, not an AI or diagnostic study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable. This was a mechanical performance study.

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 was a non-clinical mechanical performance study of a physical implant. It did not involve human readers or AI assistance.

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

Not applicable. This device is a physical intervertebral fusion system, not an algorithm.

7. The type of ground truth used

For this type of study, the "ground truth" is established by the specified ASTM standards (ASTM F-2077 and ASTM F-2267). The device's mechanical properties are measured and compared against the requirements and, implicitly, the performance of predicate devices as defined by these industry-recognized test methods.

8. The sample size for the training set

Not applicable. This is not an AI study, so there is no "training set."

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

Not applicable. There is no training set for this type of non-clinical mechanical performance study.

Summary

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5.510(K) SUMMARY

Submitter's Name:	Spinal USA, Inc.
Submitter's Address:	2050 Executive DrivePearl. MS 39208
Submitter's Telephone:	601-420-4244
Contact Person:	Meredith L. May, MSEmpirical Testing Corp.719.337.7579
Date Summary wasPrepared:	28 June 2013
Trade or Proprietary Name:	Vault-C Standalone Cervical Interbody Fusion System
Common or Usual Name:	Intervertebral body fusion device.
Classification:	Class II per 21 CFR §888.3080
Product Code:	OVE
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate Devices:	Centinel Spine Stalif C System (K120819)Biomet Spine. Solitaire-C System (K113796)LDR Spine ROI-C (K091088, K113559)Life Spine, Inc. Pro-Link Stand-Alone Cervical System (K121151)Globus Medical. Inc COALITION Spacer (K083389)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The Vault-C Standalone Cervical Interbody Fusion System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-TI) at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Vault-C implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C-3 to T-1 disc levels.

Spinal USA Vault-C Standalone Cervical Interbody Fusion System

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Patients should have at least six weeks of non-operative treatment with an intervertebral fusion device.

The indication for use for the Spinal USA Vault-C is similar to that of the Centinel Spine Stalif C System (K120819). Biomet Spine Solitaire-C System (K113796). LDR Spine ROI-C (K091088, K 113559), Life Spine, Inc. Pro-Link Stand-Alone Cervical System (K121151) and Globus Medical. Inc. COALITION Spacer (K083389).

TECHNICAL CHARACTERISTICS

The spacers are manufactured from PEEK-OPTIMA® (ASTM F2026), titanium alloy (ASTM F136), and tantalum (ASTM F560-05). The predicate devices are manufactured from the same or similar materials. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

. Indications for Use
Materials of manufacture �
t Structural support mechanism

PERFORMANCE DATA

The Vault-C has been tested in the following test modes:

Static Axial Compression (ASTM F-2077) .
. Static Compression-Shear (ASTM F-2077)
Static Torsion (ASTM F-2077) . ●
Dynamic Axial Compression (ASTM F-2077) ●
Dynamic Compression-Shear (ASTM F-2077) .
. Dynamic Torsion (ASTM F-2077)
Subsidence (ASTM F-2267 and ASTM F-2077)

The results of this non-clinical testing show that the strength of the Vault-C 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 Vault-C is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, superimposed over three horizontal bars. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 25, 2013

Spinal USA % Ms. Meredith May Partnership Manager Empirical Testing Corporation 4628 Northpark Drve Colorado Springs, Colorado 80918

Re: K132029

Trade/Device Name: Vault-C Standalone Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: October 8, 2013 Received: October 18, 2013

Dear Ms. May:

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

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Page 2 - Ms. Meredith May

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 Nielkerson -S

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

Enclosure

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	DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: December 31, 2013
	Indications for Use	See PRA Statement on last page.
510(k) Number (if known)
K132029
Device NameVault-C Standalone Cervical Interbody Fusion System
Indications for Use (Describe)
intervertebral fusion device	The Vault-C Standalone Cervical Interbody Fusion System is a standalone cervical interbodythe disc confirmed by history and radiographic studies. The Vault-C implants are used with twotitanium alloy screws and filled with autogenous bone graft material to facilitate fusion in thecervical spine. The device is placed via an anterior approach at the C-3 to T-1 disc levels.Patients should have at least six weeks of non-operative treatment with an	device intended for use in skeletally mature patients with degenerative disc disease (DDD) of thecervical spine (C3-T1) at one disc level. DDD is defined as discogenic pain with degeneration of














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)
	PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
	Anton E. Dmitriev, PhD

	Division of Orthopedic Devices



FORM FDA 3881 (9/13)	Page 1 of 2	PSC Publishing Bervices (301) 443-8

Spinal USA Vault-C Standalone Cervical Interbody Fusion System

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.