The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c·POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of nonoperative treatment. The Vu c POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Manta Ray or the Theken Tether systems.

Device Description

The Vu c POD Intervertebral Body Fusion Device consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu c POD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu c POD Intervertebral Body Fusion Device is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

AI/ML Overview

The provided text describes a medical device, the Vu c•POD Intervertebral Body Fusion Device, and its clearance process through the FDA's 510(k) pathway. This pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study to establish new performance criteria.

Therefore, the document does not contain details about acceptance criteria, clinical study designs, sample sizes for test or training sets, expert qualifications, or ground truth establishment in the way one would expect for a novel device undergoing a performance study against specific metrics. Instead, it relies on preclinical testing for substantial equivalence.

Here's an attempt to structure the information based on the request, reinterpreting "acceptance criteria" and "study" in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Equivalent to Predicate Device)	Reported Device Performance (Preclinical Testing)
Indications for Use: Same as predicate devices (anterior cervical interbody fusion for DDD at one level from C2-C3 to C7-T1, with autogenous bone graft and supplemental fixation).	Stated to have the "same indications for use" as predicate devices.
Design: Similar to predicate devices.	Stated to have the "same design" as predicate devices.
Material of Manufacture: Similar to predicate devices (PEEK OPTIMA LT1 polymer, tantalum radiographic markers).	Stated to have the "same material of manufacture" as predicate devices.
Function: Similar mechanical and functional properties to predicate devices.	Stated to have the "same function" as predicate devices.
Mechanical Performance (Static Axial Compression): Meets ASTM F2077 standards.	Preclinical testing performed per ASTM F2077, "indicating that the Vu c•POD Intervertebral Body Fusion Device is substantially equivalent to predicate devices."
Mechanical Performance (Static Compression-Shear): Meets ASTM F2077 standards.	Preclinical testing performed per ASTM F2077, "indicating that the Vu c•POD Intervertebral Body Fusion Device is substantially equivalent to predicate devices."
Mechanical Performance (Static Torsion): Meets ASTM F2077 standards.	Preclinical testing performed per ASTM F2077, "indicating that the Vu c•POD Intervertebral Body Fusion Device is substantially equivalent to predicate devices."
Mechanical Performance (Dynamic Axial Compression): Meets ASTM F2077 standards.	Preclinical testing performed per ASTM F2077, "indicating that the Vu c•POD Intervertebral Body Fusion Device is substantially equivalent to predicate devices."
Mechanical Performance (Dynamic Compression-Shear): Meets ASTM F2077 standards.	Preclinical testing performed per ASTM F2077, "indicating that the Vu c•POD Intervertebral Body Fusion Device is substantially equivalent to predicate devices."
Mechanical Performance (Expulsion): Meets ASTM F2077 standards.	Preclinical testing performed per ASTM F2077, "indicating that the Vu c•POD Intervertebral Body Fusion Device is substantially equivalent to predicate devices."
Mechanical Performance (Static Subsidence): Meets ASTM F2267 standards.	Preclinical testing performed per ASTM F2267, "indicating that the Vu c•POD Intervertebral Body Fusion Device is substantially equivalent to predicate devices."

Study Description (Preclinical Testing for Substantial Equivalence):

The "study" in this context refers to preclinical testing conducted to demonstrate substantial equivalence to previously cleared predicate devices, as required for a 510(k) submission.

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

Test Set Sample Size: Not applicable in the context of a clinical test set. The evaluation was based on preclinical mechanical testing and comparison of technological characteristics. The document does not specify the number of devices or samples used for the described preclinical tests (static axial compression, etc.).
Data Provenance: The preclinical testing was likely performed in a laboratory setting, indicated by adherence to ASTM standards. The document does not specify the country of origin of this data or if it was retrospective or prospective, as these terms are typically used for clinical data.

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 preclinical mechanical equivalency assessment, not a clinical study requiring expert assessment of patient data for ground truth. The "ground truth" was established by the specified ASTM standards which define acceptable mechanical performance parameters for intervertebral body fusion devices.

4. Adjudication method for the test set

Not applicable. No expert adjudication method (like 2+1, 3+1) was described as this was not a clinical or image-based diagnostic study. The assessment was based on whether the device's mechanical properties met established ASTM standards and were comparable to predicate devices.

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 device is an intervertebral body fusion device (an implant), not a diagnostic AI or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This device is a physical implant, not an algorithm or software.

7. The type of ground truth used

The "ground truth" (or basis for comparison) used was:

Established ASTM Standards: Specifically, ASTM F2077 for static and dynamic mechanical properties, and ASTM F2267 for static subsidence.
Technological Characteristics of Predicate Devices: The design, materials, function, and indications for use of the US Spine Phantom PLUS Cage System (K082801), Interbody Innovations Zeus Cervical Cage (K081614), LDR Spine MC+ (K080588), LDR Spine ROI-C Cervical Cage (K091088), Synthes Spine Zero-P Cervical Cage (K072981), and SpineArt Tryptik® Cervical Cage (K091873).

8. The sample size for the training set

Not applicable. The concept of a "training set" applies to machine learning algorithms, which is not relevant for this physical medical device.

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

Not applicable, for the same reason as above.

Summary

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

KIO13G3

DEC 1 6 2010

510(k) Summary

Manufacturer:	Theken Spine, LLC1800 Triplett BlvdAkron, OH 44306
Device Trade Name:	Theken Spine Vu c•POD Intervertebral Body Fusion Device
Contact:	Glenn StiegmanVice President, Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Office: 202.552.5800Fax: 202.552.5798
Date Prepared:	November 24, 2010
Classification:	§888.3080, Intervertebral body fusion device
Class:	II
Product Code:	ODP

Indications For Use:

Device Description:

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

K101363

Predicate Device(s):

The Vu c POD Intervertebral Body Fusion Device was shown to be substantially equivalent to previously cleared devices, including the US Spine Phantom PLUS Cage System (K082801), Interbody Innovations Zeus Cervical Cage (K081614), LDR Spine MC+ (K080588), LDR Spine ROI-C Cervical Cage (K091088), Synthes Spine Zero-P Cervical Cage (K072981), and SpineArt Tryptik® Cervical Cage (K091873).

Summary of Technological Characteristics:

The Vu c POD Intervertebral Body Fusion Device, in comparison to relevant predicate devices, has been shown to have the same indications for use, design, material of manufacture, and function.

Performance Standards:

Preclinical testing has been performed per ASTM F2077 (static axial compression, static compression-shear, static torsion, dynamic axial compression, dynamic compression-shear, expulsion) and ASTM F2267 (static subsidence) indicating that the Vu crPOD Intervertebral Body Fusion Device is substantially equivalent to predicate devices.

Conclusion:

Sufficient information, including extensive testing, has been presented to demonstrate the Vu c POD Intervertebral Body Fusion Device is substantially equivalent to predicate devices with the same indications, intended use, and technological features.

Pg 2 of 2

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.

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

Theken Spine, LLC % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Glenn Stiegman Vice President, Regulatory Affairs 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

DEC 1 6 2010

Re: K101363

Trade/Device Name: Vu c.POD Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: December 02, 2010 Received: December 03, 2010

Dear Mr. Stiegman:

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

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

Page 2 - Mr. Glenn Stiegman

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Milkus

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K101363

Device Name: Integra Spine Vu coPOD Intervertebral Body Fusion Device

The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of nonoperative treatment. The Vu c POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Integra Spine Manta Ray or the Integra Spine Tether systems.

V Prescription Use (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (29 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millhusan

Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K10/363

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.