When used as a cervical intervertebral body fusion device, the Medical Concepts Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

When used as a lumbar intervertebral body fusion device, the Medical Concepts Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

When used as a vertebral body replacement device, the Medical Concepts System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device system is intended to be used with autograft or allograft bone.

Device Description

The Medical Concepts Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

1. Medical Concepts cervical interbody fusion device(s), which may be implanted as a single device via an anterior approach.
1. Medical Concepts lumbar interbody fusion device(s), which may be implanted
- bi-laterally via a posterior (PLIF) approach; i
- as a single device via a transforaminal (TLIF) approach; or -
- as as a single device via an anterior/anterolateral (ALIF) or direct lateral (DLIF) approach.
1. Medical Concepts vertebral body replacement device(s), which may be implanted in the thoracic and/or thoracolumbar spine (T1-L5).

The Medical Concepts Interbody Fusion System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The Medical Concepts Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

AI/ML Overview

The Medical Concepts Interbody Fusion System is a medical device for spinal fusion procedures. The study conducted to demonstrate its substantial equivalence to predicate devices focused on non-clinical mechanical testing, rather than a clinical study involving human patients or complex AI diagnostic performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Basis for Substantial Equivalence)	Reported Device Performance (Summary of Non-Clinical Testing)
Same intended use as predicate devices	Demonstrated by device indications for cervical, lumbar, and vertebral body replacement applications, mirroring predicate devices.
Primary implant design similar to predicate devices	Stated as having similar design.
Equivalent material of manufacture (PEEK Optima LT1 with tantalum markers)	Confirmed to conform to ASTM F2026 (PEEK) and ASTM F560 (tantalum).
Substantially equivalent results for static and dynamic compression testing (per ASTM F2077-03)	Non-clinical test results indicate substantial equivalence.
Substantially equivalent results for static and dynamic torsion testing (per ASTM F2077-03)	Non-clinical test results indicate substantial equivalence.
Substantially equivalent results for subsidence testing (per ASTM F2267-04)	Non-clinical test results indicate substantial equivalence.
Substantially equivalent results for expulsion testing (per ASTM Draft Standard F-04.25.02.02)	Non-clinical test results indicate substantial equivalence.

2. Sample Size for Test Set and Data Provenance

Sample Size: Not applicable. The study was non-clinical and involved physical testing of the device, not a test set of patient data.
Data Provenance: Not applicable. The data came from laboratory mechanical testing, not a country of origin for clinical or imaging data. The testing was conducted in accordance with recognized ASTM standards.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

Number of Experts: Not applicable. Ground truth for mechanical testing is established by the specifications in the ASTM standards themselves and the objective measurements derived from the tests.
Qualifications: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. As this was non-clinical mechanical testing, there was no need for expert adjudication of results in the way it would be required for clinical or image-based studies. The results are based on objective measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical implant, and the approval was based on demonstrating substantial equivalence through non-clinical mechanical testing, not on comparative effectiveness with human readers or AI assistance.

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

Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth used for this premarket notification was the performance specifications and methodologies defined by established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices. The device's performance was measured against these objective, standardized criteria.

8. The Sample Size for the Training Set

Sample Size: Not applicable. There was no "training set" in the context of machine learning or AI as this was physical device testing. The tests involved specific numbers of devices or samples as dictated by the ASTM standards for each mechanical test, but this is not analogous to a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable. As there was no training set for an AI/algorithm, there was no ground truth for a training set to be established. The "ground truth" for the device's performance was inherently defined by the ASTM standards it was tested against.

Summary

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K110659

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Medical Concepts Interbody Fusion System

・ .

Premarket Notification

SUBMITTED BY	Medical Concepts, Inc11467 Huebner RdSuite 350San Antonio, TX 78230	SEP 13 2011
ESTABLISHMENTREGISTRATION NUMBER	Pending
OWNER/OPERATORNUMBER	Pending
CONTACT PERSON	Christopher T. CanisVice President, OperationsMedical Concepts, Inc.Phone: 210-344-1855Fax: 210-344-1846
SUBMISSION PREPARED BY	QA Consulting, Inc.Phone: 512-328-9404
DATE PREPARED	24 June 2011
CLASSIFICATION NAME	Intervertebral Fusion Device with Bone Graft, Lumbar (MAX)Intervertebral Fusion Device with Bone Graft, Cervical (ODP)Spinal Intervertebral Body Fixation Orthosis (MQP)
DEVICE CLASS	Class II
REGULATION NUMBER	888.3080 (Product Code: MAX)888.3080 (Product Code ODP)888.3060 (Product Code MQP)
COMMON NAME	Intervertebral Body Fusion Device (MAX, ODP)Vertebral Body Replacement Device (MQP)
PROPRIETARY NAME	Medical Concepts Interbody Fusion System
IDENTIFICATION OF PREDICATEDEVICE(S)	Predicate devices include various cleared interbody fusionand vertebral body replacement systems:- Eminent Spine System (K090064)

MC+ (K043479, K091088) ।
ﺗ

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DEVICE DESCRIPTION

The Medical Concepts Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

1. Medical Concepts cervical interbody fusion device(s), which may be implanted as a single device via an anterior approach.
1. Medical Concepts lumbar interbody fusion device(s), which may be implanted
- bi-laterally via a posterior (PLIF) approach; i
- as a single device via a transforaminal (TLIF) approach; or -
- as as a single device via an anterior/anterolateral (ALIF) or direct lateral (DLIF) approach.
1. Medical Concepts vertebral body replacement device(s), which may be implanted in the thoracic and/or thoracolumbar spine (T1-L5).

INDICATIONS

When used as a vertebral body replacement device, the Medical Concepts System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectorny) due to tumor or traumaffracture. The device system is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device system is intended to be used with autograft or allograft bone.

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this premarket notification is to obtain clearance to market the Medical Concepts Interbody Fusion System. The Medical Concepts Interbody Fusion System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.

The subject system has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:

Intended for use at either one level or two contiguous levels from L2-S1 for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Intended for use at one level from the C2-C3 disc to the C7-TI disc for the treatment of degenerative disc disease (DDD) of the cervical spine with accompanying radicular svmptoms.
Intended for use as a vertebral body replacement device (partial vertebrectomy) due to tumor or trauma/fracture.
Substantially equivalent results of non-clinical testing relative to static and dynamic testing -(per ASTM F2077-03), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)

DISCUSSION OF NON-CLINICAL TESTING

The following non-clinical tests were conducted:

Static and dynamic compression testing, conducted in accordance with ASTM F2077-03 -
-Static and dynamic torsion testing, conducted in accordance with ASTM F2077-03
Subsidence testing, conducted in accordance with ASTM F2267-04 -
-Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02

CONCLUSIONS

The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Medical Concepts Interbody Fusion System is substantially equivalent to the predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Medical Concepts, Inc. % Mr. Christopher T. Canis 11467 Huebner Road. Suite 350 San Antonio, Texas 78230

SEP 13 2011

Re: K110659

Trade/Device Name: Medical Concepts Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP, MQP Dated: September 01, 2011 Received: September 02, 2011

Dear Mr. Canis:

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. Iisting 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

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Page 2 - Mr. Christopher T. Canis

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 331-542 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/wcm115809.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/Safetv/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely vours Mark N. Melker

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

510(k) Number (if known): K110659

Medical Concepts Interbody Fusion System Device Name:

Indications for Use:

When used as a cervical intervertebral body fusion device, the Medical Concepts Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degeneralive disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Dission Sign-Off) Diffision of Surgical, Orthopedic, and Restorative Devices

510(k) Number_K 110659

The Forum 8000 IH-10 West, Suite 1140 San Antonio, TX 78230

Phone: 512-626-9599 Fax: 210-344-1846

Medical Concepts

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.