When used with the bone screws, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material.

When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.

The Theken Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws, is a stand alone device. If the Theken Spine Vu aPod Intervertebral Body Fusion Device is used with the SpinPlate then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. The SpinPlate and bone screws are not intended to be used together. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

Device Description

The Vu aPOD Intervertebral Body Fusion Device consists of lumbar spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu aPOD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026 while the bone screws and SpinMate are comprised of Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu aPOD Intervertebral Body Fusion Device is for lumbar spinal use at one or two contiguous levels from the L2-L3 to L5-S1 disc levels.

AI/ML Overview

This document pertains to the 510(k) summary for the Theken Spine Vu aPOD Intervertebral Body Fusion Device, a spinal implant, not an AI/ML powered device. As such, concepts like "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (e.g., sensitivity, specificity, F1 score) are not directly applicable.

The document describes the preclinical testing performed to demonstrate the device's substantial equivalence to predicate devices, focusing on mechanical performance.

Here's an interpretation of the requested information based on the provided text, re-framing "acceptance criteria" to refer to the mechanical performance standards:

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

Acceptance Criteria (Performance Standards per ASTM)	Reported Device Performance
ASTM F2077: Static Axial Compression	Met (indicating substantial equivalence to predicate devices)
ASTM F2077: Static Compression-Shear	Met (indicating substantial equivalence to predicate devices)
ASTM F2077: Static Torsion	Met (indicating substantial equivalence to predicate devices)
ASTM F2077: Dynamic Axial Compression	Met (indicating substantial equivalence to predicate devices)
ASTM F2077: Dynamic Compression-Shear	Met (indicating substantial equivalence to predicate devices)
ASTM F2077: Expulsion	Met (indicating substantial equivalence to predicate devices)
ASTM F2267: Static Subsidence	Met (indicating substantial equivalence to predicate devices)

Explanation: The document states that "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 aPOD Intervertebral Body Fusion Device is substantially equivalent to predicate devices." This implies that the device successfully met the performance requirements outlined in these ASTM standards, thus proving its mechanical integrity and equivalence to existing, cleared devices.

Regarding the remaining points (2-9), these are relevant to AI/ML device evaluations and are not applicable to this physical medical device. The document does not contain information on:

Sample size used for a test set (as there is no "test set" in the AI/ML sense)
Data provenance for a test set
Number of experts used to establish ground truth or their qualifications
Adjudication method for a test set
Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone (algorithm only) performance
Type of ground truth (e.g., pathology, outcomes data) for an AI/ML model
Sample size for a training set
How ground truth for a training set was established

This 510(k) summary focuses on demonstrating mechanical and material equivalence of a surgical implant to previously cleared devices through preclinical bench testing, rather than evaluating the performance of an AI/ML algorithm.

Summary

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510(k) Summary

Manufacturer:	Theken Spine, LLC	SEP 02 2010
	1800 Triplett BlvdAkron, OH 44306	14101310
Device Trade Name:	Theken Spine Vu aPOD 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:	August 5, 2010
Classification:	§888.3080, Intervertebral body fusion device
Class:	II
Product Code:	MAX

Indications For Use:

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The Theken Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws, is a stand alone device. If the Theken Spine Vu aPod Intervertebral Body Fusion Device is used with the SpinPlate then additional supplemental fixation, which has been cleared by the FIDA for use in the lumbar spine, must be used to augment stability. The SpinPlate and bone screws are not intended to be used together. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

Device Description:

Predicate Device(s):

The Vu aPOD Intervertebral Body Fusion Device was shown to be substantially equivalent to previously cleared devices, including the Theken Spine Vu aPOD System (K080822), Titan Spine Endoskeleton TA (K080615), Spinal Elements Lucent Magnum + (K083475), and I.DR Spine ROI-A (K082262), and has the same indications for use, design, and function.

Performance Standards:

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

Conclusion:

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

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

SEP 12 2011

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

Re: K101310

Trade/Device Name: Vu a·POD Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: August 12, 2010 Received: August 13, 2010

Dear Mr. Stiegman:

This letter corrects our substantially equivalent letter of September 2, 2010.

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 (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.

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

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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, by ont rot 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 photifics: " now (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. Millbern

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

Enclosure

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Indications for Use

SEP 02 2010

510(k) Number (if known): K101310

Vu aPOD Intervertebral Body Fusion Device Device Name:_

Indications For Use:

AND/OR -Prescription Use x (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
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Division of Surgical. Orthopedic. and Restorative Devices

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KIDI310 510(k) Number_

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.