The Endoskeleton TA® Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of nonoperative treatment prior to treatment with the device may be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

Device Description

The Endoskeleton TA® Interbody Fusion Device is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

AI/ML Overview

The provided text is a 510(k) summary for the Endoskeleton TA® Interbody Fusion Device. It details the device's indications for use, description, and predicate devices. However, it does not contain specific acceptance criteria, detailed study results, or information about AI/ML algorithm performance.

Here's a breakdown of why I cannot fulfill your request based on the provided text, and what information is present:

Missing Information (and why it's missing from a 510(k) summary of this type):

Acceptance Criteria and Reported Device Performance Table: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically doesn't include detailed performance criteria and results in the same way a clinical trial report or a PMA (Premarket Approval) application would. The summary states: "The pre-clinical testing performed indicated that the Endoskeleton TA® Interbody Fusion Device is adequate for the intended use," but no specific metrics are given.
Sample Size for Test Set and Data Provenance: This information is not typically part of a 510(k) summary for a spinal implant. The "testing" mentioned is likely mechanical/bench testing rather than clinical data involving a "test set" in the context of an AI/ML algorithm.
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable to this type of device and submission.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is an interbody fusion device, not a diagnostic imaging AI tool.
Standalone (algorithm only) Performance: Not applicable as it's not an AI/ML device.
Type of Ground Truth Used: Not applicable.
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set was Established: Not applicable.

Information that is present:

Device Name: Endoskeleton TA® Interbody Fusion Device
Indications for Use: For skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, with or without Grade I spondylolisthesis/retrolisthesis, who have received 6 months of nonoperative treatment. To be used with supplemental fixation and autograft bone.
Device Description: Comprised of various implant sizes manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and associated instrumentation.
Predicate Devices: BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), Ray Threaded Threaded Cage (Surgical Dynamics, P950019), and Titan Spine Endoskeleton TA® VBR (K032812).
Performance Testing (General Statement): "The pre-clinical testing performed indicated that the Endoskeleton TA® Interbody Fusion Device is adequate for the intended use."

Conclusion:

This 510(k) summary for the Endoskeleton TA® Interbody Fusion Device demonstrates substantial equivalence to predicate devices based on design, function, materials, and indications for use. It mentions pre-clinical testing, but does not provide the specific detailed performance metrics, acceptance criteria, or study methodologies that would be relevant for an AI/ML device as outlined in your request. The request's format (e.g., ground truth, training/test sets, experts, MRMC studies) is specifically tailored for AI/ML or diagnostic devices, which this interbody fusion device is not.

Summary

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

JUN 1 7 2008

7. 510(k) Summary according to 807.92(c)

Contact:	Kevin GemasPresident866-822-7800	Titan Spine, LLCMequon Technology Center10520 Baehr Rd., Suite AMequon, WI 53092
Trade Name:	Endoskeleton TA® Interbody Fusion Device
Product Class:	Class II
Classification:	21 CFR §888.3080 Orthosis, intervertebral fusion
Product Codes:	MAX
Panel Code:	87

Indications for Use:

The Endoskeleton TA® Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from 1.2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of nonoperative treatment prior to treatment with the device may be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

Device Description:

Predicate Device(s):

The Endoskeleton TA® Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The four predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015) and the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Titan Spine Endoskeleton TA® VBR (K032812).

Performance Testing:

The pre-clinical testing performed indicated that the Endoskeleton TA® Interbody Fusion Device is adequate for the intended use.

K080615
Page 1 of 1

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

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an emblem of an eagle with outstretched wings, stylized with thick, bold lines. The eagle faces to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2008

Titan Spinc, LLC % Silver Pine Consulting Mr. Richard Jansen President 13540 Guild Avenue Apple Valley, Minnesota 55124

Re: K080612

Trade/Device Name: Endoskeleton TA® Interbody Fusion Device Regulation Number: 21 CFR §888.3080 Regulation Name: Intervertebral body fusion device. Regulatory Class: Class II Product Code: MAX Dated: February 26, 2008 Received: April 22, 2008

Dear Mr. Jansen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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

Page 2 - Mr. Richard Jansen

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

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

Enclosure

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

K080615
Page 1 of 1

4. Statement of Indications for Use

510(k) Number (if known): _ Ko8 06 15

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Nihrol fx mxm

Division of General, Restorative, and Neurological Devices

510(k) Number K080615

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.