The Camber Spine Technologies Ti-Diagon® Oblique TLIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Camber Spine Technologies Ti-Diagon® Oblique TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. Camber Spine Technologies Ti Diagon Oblique TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The Camber Spine Technologies Ti-Diagon Oblique TLIF is an interbody fusion device with a hollow chamber to permit packing of autologous bone graft in order to facilitate fusion. The inferior and superior surfaces of the Ti-Diagon Oblique TLIF have a rough texture, as the result of a photochemical etching process, to help prevent movement of the device.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Ti-Diagon Oblique TLIF), which primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance. It does not contain information about studies involving human readers, AI, or clinical ground truth in the way a diagnostic device submission might. Therefore, many of the requested fields cannot be populated from the provided document.

Here's an analysis of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Static Compression Shear	Defined by predicate device performance (not explicitly stated in quantitative terms)	Met accepted criteria (implied to be comparable to predicate devices)
Dynamic Compression	Defined by predicate device performance (not explicitly stated in quantitative terms)	Met accepted criteria (implied to be comparable to predicate devices)
Dynamic Compression Shear	Defined by predicate device performance (not explicitly stated in quantitative terms)	Met accepted criteria (implied to be comparable to predicate devices)
Expulsion	Defined by predicate device performance (not explicitly stated in quantitative terms)	Met accepted criteria (implied to be comparable to predicate devices)
Subsidence	Defined by predicate device performance (not explicitly stated in quantitative terms)	Met accepted criteria (implied to be comparable to predicate devices)

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

The document refers to "Performance Testing Summary" which included mechanical tests per ASTM F2077-14 and F2267-04. These standards are for in vitro mechanical testing of intervertebral body fusion devices.
Sample Size: Not specified in the provided text.
Data Provenance: The data provenance for this type of testing is generally lab-generated data from mechanical testing setups, not human or clinical data. Not explicitly stated where the tests were performed.
Retrospective/Prospective: Not applicable for mechanical bench testing.

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

Not applicable. The "ground truth" for mechanical testing is derived from quantitative measurements of physical properties, not expert opinion.

4. Adjudication method for the test set:

Not applicable. Mechanical testing results are typically compared against pre-defined engineering specifications and predicate performance, not adjudicated by human experts.

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 document does not pertain to an AI-assisted diagnostic device or any study involving human readers.

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

No. This document does not describe an algorithm or AI device.

7. The type of ground truth used:

For the mechanical testing, the "ground truth" is the quantitative measurement of the device's physical properties and mechanical performance, compared against the performance of predicate devices and relevant ASTM standards (ASTM F2077-14 and F2267-04).

8. The sample size for the training set:

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

Not applicable. There is no mention of a "training set" or "ground truth" in the context of AI/ML.

Summary of what cannot be answered from the provided text:

The document describes a 510(k) submission for a spinal implant (intervertebral body fusion device). The "acceptance criteria" and "study" refer to mechanical performance testing to demonstrate the device is as mechanically sound as its predicate devices. The information requested regarding AI performance, human readers, clinical ground truth, and specific sample sizes for such studies is not present because this device is a physical implant, not a diagnostic or AI-powered tool.

Summary

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September 15, 2017

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

Camber Spine Technologies % Mr. Justin Eggleton Senior Director, Spine Regulatory Affairs

Re: K172064

MCRA, LLC

1050 K Street NW, Suite 1000

Washington, District of Columbia 20001

Trade/Device Name: Ti-Diagon Oblique TLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 5, 2017 Received: July 7, 2017

Dear Mr. Eggleton:

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

Image /page/0/Picture/10 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 image of three human profiles facing to the right, stacked on top of each other.

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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 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 contact the Division of Industry and Consumer Education (DICE) 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 (DICE) 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.

Katherine D. Kavlock -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K172064

Device Name Ti-Diagon Oblique TLIF

Indications for Use (Describe)

Camber Spine Technologies Ti-Diagon® Oblique TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Device Trade Name:	Ti-Diagon Oblique TLIF
Manufacturer:	Camber Spine Technologies418 E. Lancaster Ave.Wayne, PA 19087
Contact:	Mr. Daniel A. PontecorvoCEOPhone: 484.427.7060
Prepared by:	Justin EggletonMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: 202.552.5800jeggleton@mcra.com
Date Prepared:	September 7, 2017
Classifications:	21 CFR §888.3080, Intervertebral body fusion device
Class:	II
Product Codes:	MAX
Primary Predicate:	Camber Spine Technologies TLS 5.0 Interbody Cage(K121254)
Additional Predicate(s):	Camber Spine Technologies Diagon Oblique Cage (K134038), andAurora Spine Interbody Fusion System (K133967)
Reference Device:	Rhausler Plage™ Anterior Cervical Fusion System (K111272)

Indications For Use:

The Camber Spine Technologies Ti-Diagon Oblique TLIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Camber Spine Technologies Ti-Diagon Oblique TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. Camber Spine Technologies Ti

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Diagon Oblique TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description:

Predicate Device:

The subject Ti-Diagon Oblique TLIF device is substantially equivalent to predicates Camber Spine Technologies TLS 5.0 Interbody Cage (K121254), Camber Spine Technologies Diagon Oblique Cage (K134038), and Aurora Spine Interbody Fusion System (K133967) with respect to indications, design, materials, function, manufacturing, and/or performance. Additional comparisons were made to the reference device Rhausler Plage™ Anterior Cervical Fusion System (K111272).

Performance Testing Summary:

Testing performed indicates that the Ti-Diagon Oblique TLIF is as mechanically sound as predicate devices. Testing included static compression shear, dynamic compression, dynamic compression sheat, expulsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met.

Substantial Equivalence:

The subject Ti-Diagon Oblique TLIF device was demonstrated to be substantially equivalent to predicates Camber Spine Technologies TLS 5.0 Interbody Cage (K121254), Camber Spine Technologies Diagon Oblique Cage (K134038), and Aurora Spine Interbody Fusion System (K133967) with respect to indications, design, materials, function, manufacturing, and/or performance. Additional comparisons were made to the reference device Rhausler Plage™ Anterior Cervical Fusion System (K111272).

Conclusion:

Camber Spine Technologies provided sufficient information to demonstrate the Ti-Diagon Oblique TLIF is substantially equivalent to predicates Camber Spine Technologies TLS 5.0 Interbody Cage (K121254). Camber Spine Technologies Diagon Oblique Cage (K134038). and Aurora Spine Interbody Fusion System (K133967) with respect to indications, design, materials, function, manufacturing, and/or performance. Additional comparisons were made to the reference device Rhausler Plage™ Anterior Cervical Fusion System (K111272).

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.