The Cogent Mcd-LIF XL is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

Device Description

The Cogent Med-LIF XL includes additional sizes to the Cogent Med-LIF system. The Cogent Med-LIF XL is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF XL consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular antimigration teeth, and tantalum x-ray markers.

The Cogent Med-LIF XL is available in various sizes to accommodate varying patient anatomy. The implants come in two lordotic options. 0° (parallel) and 6° (lordotic). The parallel implants are available in heights ranging from 8mm to 16mm and the lordotic implants are available in heights ranging from 10mm to 16mm. All implants are 15mm wide and are available in three lengths; 28, 30 and 32mm.

The Cogent Med-LIF XL implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space.

The Cogent Med-LIF XL implants are non-sterile and are to be sterilized by the end user.

AI/ML Overview

The document provided is a 510(k) premarket notification from the FDA for a medical device called Cogent Med-LIF XL, an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria with specific performance metrics. As such, much of the requested information regarding acceptance criteria, study design, and human reader performance is not available in the provided text.

Based on the available information, here's a breakdown:

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

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide a direct comparison of the Cogent Med-LIF XL's performance against specific numerical benchmarks. Instead, it relies on demonstrating substantial equivalence through bench testing to a legally marketed predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical performance comparable to predicate device for intervertebral body fusion devices.	"Mechanical and non-clinical testing of the Cogent Med-LIF XL device indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate."
Compliance with ASTM F2077 (Static Shear Compression and Dynamic Shear Compression).	Bench tests were conducted per ASTM F2077, indicating successful completion of these tests.
Biocompatibility of materials.	Manufactured from polyetheretherketone (PEEK) as per ASTM F2026, titanium alloy (Ti-6Al-4V) per ASTM F1472, and tantalum per ASTM F560, all standard biocompatible materials.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided because no clinical studies were performed. The submission relies solely on non-clinical (bench) testing. Therefore, there is no test set in the context of clinical data, and no data provenance from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable as no clinical studies were performed, and thus no ground truth based on expert review of patient data was established for a test set. The evaluation was limited to bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as no clinical studies were performed to generate a test set requiring adjudication.

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

This information is not applicable as this is a mechanical intervertebral body fusion device, not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC study or assessment of AI assistance for human readers was conducted or is relevant.

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

This information is not applicable as this is a mechanical intervertebral body fusion device, not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The 'ground truth' for this submission is based on engineering standards and performance established by the predicate device. For the bench tests, the "ground truth" would be the fulfillment of the specified ASTM F2077 mechanical testing requirements, and the "truth" that the device performs comparably to the predicate.

8. The sample size for the training set

This information is not applicable as no machine learning or AI models were used. The device is a physical implant, not a software algorithm requiring a training set.

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

This information is not applicable as no machine learning or AI models were used, and therefore no training set was established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" conducted for the Cogent Med-LIF XL device was exclusively non-clinical bench testing.

Tests Performed:
- ASTM F2077 - Static Shear Compression
- ASTM F2077 - Dynamic Shear Compression
Purpose: To demonstrate mechanical performance and substantial equivalence to the predicate device (Cogent Med-LIF System, K132738).
Outcome: The non-clinical testing "indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate."
Materials Testing: The materials (PEEK, Ti-6Al-4V, Tantalum) were specified to conform to their respective ASTM standards (F2026, F1472, F560), implying their suitability and established performance.
Absence of Clinical Data: The submission explicitly states, "No clinical studies were performed." The FDA's 510(k) clearance in this case is based on the device having the same indications for use, technological characteristics, and comparable performance through non-clinical testing as a legally marketed predicate device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines connecting them. The profiles are rendered in black, and the background is white.

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

October 15, 2014

Cogent Spine, LLC % Mr. Jude Paganelli Cor Medical Ventures, LLC 101 North Acacia Avenue, Suite 106 Solana Beach, California 92075

Re: K142193

Trade/Device Name: Cogent Med-LIF XL Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 15, 2014 Received: September 16, 2014

Dear Mr. Paganelli:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Jude Paganelli

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 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. 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 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.

RonaldFD/Jean -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K142193

Device Name Cogent Med-LIF XL

Indications for Use (Describe)

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)

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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

SUBMITTER:

Submitted By:

Company Name:	Cogent Spine
Address:	101 N. Acacia, Suite 106Solana Beach, CA 92075
Telephone:	(858) 774-7891

CONTACT PERSON: Jude Paganelli

DATE PREPARED: July 30, 2014

TRADE NAME: Cogent Med-LIF XL

COMMON NAME: Intervertebral Body Fusion Device

CLASSIFICATION NAME: Intervertebral Body Fusion Device (21 CFR 888.3080)

PRODUCT CODE: MAX

SUBSTANTIALLY EQUIVALENT TO:

The Cogent Med-LIF XL is substantially equivalent to the predicate, Cogent Med-LIF System (K132738) in all facets including: indications, technology, method of use and performance.

DESCRIPTION of the DEVICE:

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The Cogent Med-LIF XL implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space.

The Cogent Med-LIF XL implants are non-sterile and are to be sterilized by the end user.

MATERIALS:

The Cogent Med-LIF XL is manufactured from polyetheretherketone (PEEK) as per ASTM F2026 and contains titanium alloy (Ti-6Al-4V) per ASTM F1472 and tantalum per ASTM F560.

INDICATIONS FOR USE:

The Cogent Med-LIF XL is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

NON-CLINICAL TEST SUMMARY:

Cogent Spine conducted the following bench tests:

ASTM F2077
- . Static Shear Compression
- · Dynamic Shear Compression

In summary, mechanical and non-clinical testing of the Cogent Med-LIF XL device indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.

CLINICAL TEST SUMMARY:

No clinical studies were performed.

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CONCLUSIONS:

The Cogent Med-LIF XL device has shown to be substantially equivalent to a legally marketed predicate based on indications for use, technological characteristics, performance testing and comparison to predicate devices.

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.