The INTESS™ Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

Device Description

The INTESS™ Cervical Cage was developed as implants for the stabilization of the cervical column. The INTESS™ implants have graft windows which help facilitate bony integration. The INTESS™ implants have ridges on both their inferior and superior surfaces. X-ray markers are integrated for visualization of the implants during and after surgery.

Materials:
Zeniva ZA500 PEEK conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:
Maintain adequate disc space until fusion occurs.

AI/ML Overview

The provided document is a 510(k) Summary for the INTESS™ Cervical Cage. This type of document is a premarket notification to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device.

It's important to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with defined performance metrics like a typical AI/software device. For a traditional medical device like the INTESS™ Cervical Cage, "acceptance criteria" are usually met by demonstrating that the device's functional and safety characteristics are comparable (substantially equivalent) to already approved devices.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device (with details like sample sizes, expert ground truth, MRMC studies, etc.) does not directly apply to this 510(k) submission for a physical implant.

However, I can extract the information relevant to the equivalence demonstration for the INTESS™ Cervical Cage:

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

Since this is a 510(k) to demonstrate substantial equivalence, "acceptance criteria" are implied by the performance of the predicate devices. The "reported device performance" is a demonstration that the INTESS™ Cervical Cage performs comparably to these predicates in non-clinical tests.

Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (INTESS™ Cervical Cage)
Static and dynamic compression performance (ASTM F2077)	Testing indicates equivalence to predicate devices.
Static and dynamic torsion performance (ASTM F2077)	Testing indicates equivalence to predicate devices.
Subsidence performance (ASTM F2267)	Testing indicates equivalence to predicate devices.
Material properties (Zeniva ZA500 PEEK, Tantalum)	Conforms to ASTM F2026 and ASTM F560, respectively, demonstrating equivalence to predicates.
Function: Maintain adequate disc space	Achieved, as demonstrated by materials and mechanical testing, similar to predicate devices.

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

Sample Size for Test Set: Not applicable in the context of human data. For mechanical testing, the "sample size" refers to the number of physical devices tested. This information is typically detailed in the test reports referenced by the ASTM standards, but not usually in the 510(k) summary itself. The document states "The following tests were conducted," implying a sufficient number of devices were tested to meet the ASTM standards.
Data Provenance: Not applicable for a non-clinical mechanical test summary.

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):

Not applicable. Ground truth from human experts is not used for mechanical testing of a physical implant. The "ground truth" for mechanical performance is established through adherence to recognized ASTM standards and the associated testing methodologies.

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

Not applicable. This device's evaluation did not involve human adjudication of test results in the way an AI/software device would. The mechanical tests have pass/fail criteria based on engineering specifications.

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 is a physical implant, not an AI/software device. No MRMC study was performed.

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

No. This is a physical implant.

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

The "ground truth" for the non-clinical tests is based on established engineering and materials standards (ASTM F2077, ASTM F2267, ASTM F2026, ASTM F560) and the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. There is no training set for a physical implant.

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

Not applicable. There is no training set for a physical implant.

Summary of the Study (Equivalence Demonstration):

The study conducted to support the INTESS™ Cervical Cage was a series of non-clinical bench tests designed to demonstrate the device's mechanical integrity and material properties.

Tests Performed:
- Static and dynamic compression per ASTM F2077
- Static and dynamic torsion per ASTM F2077
- Subsidence per ASTM F2267
Materials Conformance: Zeniva ZA500 PEEK conforming to ASTM F2026 and Unalloyed tantalum conforming to ASTM F560.
Conclusion: The results of this testing indicated that the INTESS™ Cervical Cage is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.
Clinical Studies: No clinical studies were performed.

In essence, for this device, "acceptance criteria" are met by demonstrating that its physical and mechanical properties, as measured by standard engineering tests, are comparable to those of already approved predicate devices.

Summary

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APR 1 6 2014

510(k) Summary for the INTESS™ Cervical Cage

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the INTESS™ Cervical Cage

1. GENERAL INFORMATION

Date Prepared:	April 10, 2014
Trade Name:	INTESS™ Cervical Cage
Common Name:	intervertebral body fusion device
Classification Name:	Intervertebral body fusion device - cervical
Class:	II
Product Code:	ODP
CFR section:	21 CFR section 888.3080
Device panel:	Orthopedic
Legally Marketed	Spinal Elements, Crystal Cervical Cage (K073351)
Predicate Device:	Zimmer, BAK/C Vista Interbody Fusion (P980048 S3)LDR Spine Cervical Interbody Fusion System (K091088)Daytona Anterior Cervical Cage System (K110733)
Submitter:	Kalitec Direct, LLC618 E. South Street, Suite 500Orlando, FL 32801W (407) 545-2063
Contact:	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net

2. DEVICE DESCRIPTION

Materials:

Zeniva ZA500 PEEK conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:

Maintain adequate disc space until fusion occurs.

SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES 3.

The INTESS™ Cervical Cage is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

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4. INTENDED USE

5. NON-CLINICAL TEST SUMMARY

The following tests were conducted:

. Static and dynamic compression per ASTM F2077
. Static and dynamic torsion per ASTM F2077
Subsidence per ASTM F2267 .

The results of this testing indicate that the INTESS™ Cervical Cage is equivalent to predicate devices.

6. CLINICAL TEST SUMMARY

No clinical studies were performed

7. CONCLUSIONS NONCLINICAL AND CLINICAL

Kalitec Direct, LLC considers the INTESS™ Cervical Cage to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.

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Image /page/2/Picture/0 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 logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 16, 2014

Kalitec Direct, LLC % The OrthoMedix Group, Incorporated Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K133815

Trade/Device Name: INTESS™ Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 21, 2014 Received: January 23, 2014

Dear Mr. Webb:

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. J.D. Webb

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/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/Resourcesfor You/Industry/default.htm.

Sincercly yours.

Ronald P. 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)

K133815

Device Name

INTESS™ Cervical Cage

Indications for Use (Describe)

The INTESS™ Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-TI). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY ----------

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

E Blogh de

Division of

FORM FDA 3881 (9/13)

.. : :

PSC Publishing Services (301) +43-6740

Form Approved: OMB No, 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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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.