The KINETIC™ Anterior Cervical Plate is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with:

Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);
Spondylolisthesis
Trauma (including fractures or dislocations);
Spinal cord stenosis;
Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis);
Tumors;
Pseudarthrosis;
Failed previous fusions.

Device Description

The KINETIC™ Anterior Cervical Plate consists of various sizes of anterior cervical bone plates, screws and screw locking tabs. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. The KINETIC™ Anterior Cervical Plate components will be supplied clean and "NON-STERILE".

AI/ML Overview

This document is a 510(k) Summary for a medical device called the KINETIC™ Anterior Cervical Plate. It is not a clinical study report that would typically describe the detailed acceptance criteria and a study proving the device meets those criteria in terms of clinical performance (e.g., diagnostic accuracy, treatment efficacy).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for many Class II medical devices in the United States. In the context of a 510(k), "acceptance criteria" generally refer to the criteria for demonstrating substantial equivalence, often through engineering and bench testing rather than large-scale clinical trials.

Based on the provided text, here's an analysis of the requested information:

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

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance: Equivalent to predicate devices when tested per ASTM F1717 for Spinal Intervertebral Body Fixation Orthosis.	Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence. (Specific numerical performance metrics are not provided in this summary but would be in the underlying test report).
Material: Use of implant grade titanium alloy 6A1-4V ELI per ASTM F-136.	"Manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136."
Indications for Use: (Implied) Align with predicate device's indications.	Stated Indications for Use for KINETIC™ Anterior Cervical Plate, which were reviewed by the FDA as substantially equivalent to legally marketed predicate devices.
Design and Function: (Implied) Similar to predicate devices.	"The KINETIC™ Anterior Cervical Plate was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used."

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

Test Set Description: The "test set" in this context refers to the physical samples of the KINETIC™ Anterior Cervical Plate and its components that underwent biomechanical testing. The document does not specify the sample size (number of devices or constructs tested) for the ASTM F1717 biomechanical testing.
Data Provenance: Not explicitly stated, but typically, such biomechanical testing is conducted in a laboratory setting, likely in the country of manufacture or a contract testing facility. This would be considered prospective data generation for the purpose of demonstrating device performance.

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 question is not applicable in the context of this 510(k) summary. The "ground truth" for biomechanical testing is established by the specifications of the ASTM F1717 standard and the results of the physical tests performed on the device. It does not involve expert consensus in the way a diagnostic AI device would.

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

This question is not applicable. Adjudication methods like "2+1" are used in clinical studies or studies involving expert review of images or cases to establish ground truth. Biomechanical testing relies on objective measurements according to a standard protocol.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study applies to diagnostic devices, particularly those involving human interpretation of medical images, often with AI assistance. The KINETIC™ Anterior Cervical Plate is an implantable spinal fixation device, not a diagnostic tool requiring human reader interpretation in that manner.

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

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

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

The "ground truth" in this context refers to the established safety and effectiveness parameters for spinal fixation devices. This is primarily determined by:
- Benchtop biomechanical testing standards: Specifically, ASTM F1717, which dictates how spinal fixation devices should be tested for mechanical properties (e.g., strength, stiffness, fatigue). The "ground truth" is that the device must meet or exceed the performance of predicate devices under these standardized test conditions.
- Material standards: ASTM F-136 for titanium alloy 6A1-4V ELI, which ensures the material meets biocompatibility and mechanical requirements for implantable devices.
- Predicate device history: The regulatory history and known safety/effectiveness of the predicate device (NEO™ Anterior Cervical Plate System K040844 and others) serve as a baseline "ground truth" for substantial equivalence.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of developing this 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 as there is no training set.

In summary:

This 510(k) summary demonstrates compliance through demonstrating substantial equivalence to a predicate device, primarily relying on adherence to recognized material standards and biomechanical (bench) testing standards (ASTM F1717). It does not involve clinical trials or studies typically seen for diagnostic AI devices, and therefore many of the questions related to expert review, ground truth establishment, and training/test sets for AI are not applicable.

Summary

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K06243

Special 510(k) Summary of Safety and Effectiveness

	Special 510(k) Summary - KINETICTM Anterior Cervical Plate
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Submitted By:	Life Spine2400 Hassell Road, Suite 370Hoffman Estates, IL 60169	NOV 16 2006
	Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Erin MalloyLife Spine2400 Hassell Road, Suite 370Hoffman Estates, IL 60169
Date Prepared:	September 5, 2006
Trade Name:	KINETIC™ Anterior Cervical Plate
Common Name:	Spinal Fixation System
Classification:	Spinal Invertertebral Body Fixation OrthosisCFR 888.3060Class II
Device Product Code:	KWQ
Predicate Device:	NEO™ Anterior Cervical Plate System K040844 and otherpredicate devices

Device Description:

Intended Use of the Device:

The KINETIC™ Anterior Cervical Plate is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with:

Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);

1. Spondylolisthesis
1. Trauma (including fractures or dislocations);

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Life

1. Spinal cord stenosis;
Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 5.
1. Tumors;
1. Pseudarthrosis;
1. Failed previous fusions.

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Material:

The KINETIC™ Anterior Cervical Plate is manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6AL-4V-ELI).

Performance Data:

Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.

Substantial Equivalence:

The KINETIC™ Anterior Cervical Plate was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 16 2006

Life Spine % Ms. Erin Malloy Project Engineer 2400 Hassell Road, Suite 370 Hoffman Estates, Illinois 60195

Re: K062643

Trade/Device Name: KINETIC™ Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 13, 2006 Received: October 17, 2006

Dear Ms. Malloy:

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 such 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); 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. Erin Malloy

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours.

POR
Mark N. Melkerson

Director Division of General, Restorative, and Neurologic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) number (if known): K062643

Device Name: KINETIC™ Anterior Cervical Plate

The KINETIC™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal cord stenosis; deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); tumors; pseudarthrosis; and / or failed previous fusions.

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Prescription Use x_ (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)

Poh

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k number K062643

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.