The ALINE™ Anterior Cervical Plating System is designed to provide temporary stability to the cervical spine during the development of a solid spinal fusion in patients with degenerative disc disease (DDD), trauma (including fractures) and tumors. DDD is defined as neck and/or arm pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device is intended for anterior cervical intervertebral body screw fixation only.

Device Description

The ALINE TM Anterior Cervical Plating System is utilized to provide post-operative stabilization until fusion of the cervical spine has eventuated. Essentially, the plating system acts as an internal splint that carries a portion of the load until the process of healing is complete. The Aline Cervical Plating system consists of Ti-13-13 plates, bone screws, and locking screws.

AI/ML Overview

The provided text describes a medical device, the ALINE™ Anterior Cervical Plating System, and its clearance through the FDA's 510(k) process. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies of the kind requested in your prompt.

The document is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria as one would find for a de novo submission or a product requiring clinical trials for efficacy.

Therefore, I cannot fulfill your request for the specific details outlined, as a detailed study report with performance metrics is not present in the provided text.

The information I can extract and convey from the provided text is as follows:

Device Name: ALINE™ Anterior Cervical Plating System
Intended Use: To provide temporary stability to the cervical spine during the development of a solid spinal fusion in patients with degenerative disc disease (DDD), trauma (including fractures), and tumors. Intended for anterior cervical intervertebral body screw fixation only.
Predicate Device: ALINE™ Anterior Cervical Plating System (K943523) – This indicates that the current device (K984342) is considered substantially equivalent to a previously cleared device.
Regulatory Clearance: FDA 510(k) clearance (K984342) received on December 30, 1998, based on substantial equivalence to the predicate device.

To answer your request, if this were a study report, the following sections would typically contain the requested information:

A table of acceptance criteria and the reported device performance: This would be found in the results section of a clinical or non-clinical study.
Sample sized used for the test set and the data provenance: This would be in the methods section of a study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would be in the methods section, particularly for ground truth establishment.
Adjudication method for the test set: Details on how discrepancies were resolved would be in the methods section.
If a multi reader multi case (MRMC) comparative effectiveness study was done: This would be explicitly stated as a study type, with an effect size reported in the results.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This would be a specific study design and reported in the methods/results.
The type of ground truth used: This would be specified in the methods section (e.g., pathology, clinical follow-up, expert consensus).
The sample size for the training set: This would be detailed in the methods for algorithm development.
How the ground truth for the training set was established: This would be described in the methods for algorithm development.

Since none of this information is in the provided document, I cannot fill in the table or answer the specific questions about performance studies. The document only confirms that the device was deemed "substantially equivalent" to a previously cleared device, which typically relies on demonstrating similar technological characteristics and intended use, often without requiring new clinical performance studies for 510(k) clearance.

Summary

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BEC 30 1998

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Anterior Cervical Plating System

K9821342

United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856

Karen F. Jurczak CONTACT PËRSON:

Summary of Safety and Effectiveness

DATE PREPARED: December 1, 1998

CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis

COMMON NAME: Cervical Bone Plate System

PROPRIETARY NAME: ALINE 14 Anterior Cervical Plating System

PREDICATE DEVICES: ALINE™ Anterior Cervical Plating System (K943523)

DEVICE DESCRIPTION: The ALINE TM Anterior Cervical Plating System is utilized to provide post-operative stabilization until fusion of the cervical spine has eventuated. Essentially, the plating system acts as an internal splint that carries a portion of the load until the process of healing is complete.

The ALINE™ Anterior Cervical Plating System is designed INTENDED USE: to provide temporary stability to the cervical spine during the development of a solid spinal fusion in patients with degenerative disc disease (DDD), trauma (including fractures) and tumors. DDD is defined as neck and/or arm pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device is intended for anterior cervical intervertebral body screw fixation only.
MATERIALS: The Aline Cervical Plating system consists of Ti-13-13 plates, bone screws, and locking screws.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

DEC 30 1998

Ms. Karen F. Jurczak Associate. Corporate Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K984342

Trade Name: Aline™ Anterior Cervical Plating System Regulatory Class: II Product Code: KWO Dated: December 2, 1998 Received: December 4, 1998

Dear Ms. Jurczak:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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,

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Page 2 - Ms. Jurczak

permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours, Cussill a

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Anterior Cervical Plating System

K98 4342

Indications for Use

510(k) Number (if known):

ALINE™ Anterior Cervical Plating System Device Name:

Indications For Use:

The ALINE™ Anterior Cervical Plating System is designed to provide temporary stability to the cervical spine during the development of a solid spinal fusion in patients with degenerative disc disease (DDD), trauma (including fractures) and turnors. DDD is defined as neck and/or arm pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device is intended for anterior cervical intervertebral body screw fixation only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:	X	OR Over-The-Counter
Use:(Per 21 CFR 801.109)

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number	K984342
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Regulation Number and Section

N/A