The Cardo Medical Cervical Plate System components are intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with:

Degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
Trauma (including fractures) .
Tumor ●
Deformity (defined as kyphosis, lordosis or scollosis) .
Pseudoarthrosis .
Failed previous fusions. ●
The Cardo Medical Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.

Device Description

The Cardo Medical Cervical Plate System consists of titanium cervical plates and both self-tapping and self-drilling screw components. The surgeon uses the components to make a construct that is placed anteriorly for spinal fixation. The construct is used for temporary fixation which allows for fusion of the cervical spine. The modified system includes the addition of a fixed angle cervical screw as an option for the surgeon.

AI/ML Overview

The Cardo Medical Cervical Plate System is a medical device designed for anterior interbody fixation of the cervical spine. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on acceptance criteria with specific performance metrics.

Based on the provided text, here’s an analysis of the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "the device must withstand X force for Y cycles"). Instead, it references a standard and states equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ASTM F1717 (Static and Fatigue Testing)	The proposed device was equivalent to the predicate device for all testing performed.
Equivalence to Predicate Device (Vertebron Cervical Plate Systems) in terms of materials and safety/effectiveness impacts	The Cardo Medical Cervical Plate System consists of plates and screws manufactured from the same titanium alloy as the Vertebron, Inc. Cervical Plate Systems. Cardo Medical has determined that any differences in the proposed device will not impact the safety or effectiveness of the cervical plate system for its intended use.
Meeting requirements of "Spinal System 510(k)s" guidance document	Testing has shown that the proposed device meets the requirements of the current FDA Guidance document entitled "Spinal System 510(k)s" dated May 3, 2004.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the sample size (number of devices or tests performed) for the mechanical testing conducted according to ASTM F1717.
Data Provenance: The study is a prospective engineering test conducted on the Cardo Medical Cervical Plate System components. The location of the testing is not specified, but it would presumably be in a laboratory setting. There is no mention of clinical data or patient data.

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

This question is not applicable to this type of submission. The "ground truth" for mechanical testing is established by the specified standards (ASTM F1717) and engineering principles, not through expert consensus on medical images or clinical outcomes. The focus is on physical and mechanical properties.

4. Adjudication Method for the Test Set:

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or imaging studies, typically involving multiple expert readers reviewing cases. For mechanical testing, the results are objectively measured against defined criteria within the standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This question is not applicable. An MRMC study is relevant for evaluating diagnostic or screening devices where human readers interpret medical images or data, often with and without AI assistance. This submission is for a physical implant (cervical plate system), and its evaluation relies on mechanical testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This question is not applicable. This device is a physical implant, not an algorithm or AI-driven system. Therefore, "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used:

The "ground truth" for this device's evaluation is primarily established by engineering standards and specifications, specifically ASTM F1717. This standard dictates the test methods for evaluating static and fatigue performance of spinal implant constructs. The results are compared against the performance of a predicate device that is already deemed safe and effective.

8. Sample Size for the Training Set:

This question is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. Training sets are relevant for machine learning algorithms.

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

This question is not applicable for the same reasons as point 8.

Summary

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K091396

Cardo Medical Cervical Plate System Premarket Notification Submission - 510(k)

Summary of Safety and Effectiveness

AUG 05 2009

Submitter:	Denise DucheneCardo Medical Corporation1033 US Highway 46, Suite A204Clifton, NJ 07103
Date Prepared:	May 4, 2009
Device:	Cardo Medical Cervical Plate System
Classification:	87KWQ - Appliance, Fixation, Spinal Intervertebral Body, 21CFR 880.3060,Class II
Predicate Device:	Vertebron Cervical Plate Systems - K040003, K043181, K051815, K062110 andK081567. Cardo Medical Cervical Plate System K073530
Device Description:	The Cardo Medical Cervical Plate System consists of titanium cervical plates andboth self-tapping and self-drilling screw components. The surgeon uses thecomponents to make a construct that is placed anteriorly for spinal fixation. Theconstruct is used for temporary fixation which allows for fusion of the cervicalspine. The modified system includes the addition of a fixed angle cervical screwas an option for the surgeon.
Intended Use: The Cardo Medical Cervical Plate System is intended for anterior interbody fixation of the

Medical Cervical Plate System is intended for anterior interb cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (including fracture); tumor; deformity (defined as kyphosis, lordosis or scollosis): pseudoarthrosis: and/or failed previous fusions. The Cardo Medical Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.

Comparison to Predicates:

The Cardo Medical Cervical Plate System consists of plates and screws manufactured from the same titanium alloy as the Vertebron, Inc. Cervical Plate Systems. Therefore, the devices are equivalent to the Vertebron, Inc. Cervical Plate System.

Cardo Medical has determined that any differences in the proposed device will not impact the safety or effectiveness of the cervical plate system for its intended use. Testing has shown that the proposed device meets the requirements of the current FDA Guidance document entitled "Spinal System 510(k)s" dated May 3, 2004, and that the proposed device is equivalent to the predicate device.

Synopsis of Test Methods and Results:

Tests were performed on the cervical plate system. The testing was performed in accordance with ASTM F1717, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectorny Model. The proposed device was equivalent to the predicate device for all testing performed.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a modern, abstract design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Cardo Medical Corporation % Ms. Denise Duchene 1033 US Highway 46, Suite A204 Clifton, New Jersey 07103

AUG 0 5 2009

Re: K091396

Trade/Device Name: Cardo Medical Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: May 8, 2009 Received: May 10, 2009

Dear Ms. Duchene:

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 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 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.

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Page 2 -- Ms. Denise Duchene

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/ucm115809.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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director

Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Cardo Medical Cervical Plate System Premarket Notification Submission - 510(k)

Indications for Use Form

510(k) Number (if known):

Device Name: Cardo Medical Cervical Plate System

Indications for Use:

Degenerative disk disease (as defined by neck pain of discogenic origin with ● degeneration of the disc confirmed by history and radiographic studies);
Trauma (including fractures) .
Tumor ●
Deformity (defined as kyphosis, lordosis or scollosis) .
Pseudoarthrosis .
Failed previous fusions. ●

The Cardo Medical Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.

Prescription Use × (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K 091396

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.