The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), posttraumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.

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

ABC extension plates MUST only be used with existing ABC plates and screws. They are NOT to be used with another manufacturers system.

Device Description

The ABC Cervical Extension Plate is used to extend the existing anterior stabilization plate (K974706) and Anterior Cervical Screw Spinal Fixation System (K000486).

The ABC E-Plates are exclusively used to extend an existing anterior stabilization plate on the cervical spine, which has been carried out using the ABC system. The E-Plate allows a mono-segmental or bi-segmental extension at the cranial or caudal end of the existing ABC plate.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "ABC Caudal and Cranial Extension Plate." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics typically associated with AI/ML device evaluations. Therefore, a direct response to your request for acceptance criteria and study details (like sample sizes, expert qualifications, etc.) for a performance study proving the device meets those criteria is not present in the document.

The document states:

"No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This explicitly indicates that there are no pre-defined performance standards or acceptance criteria that this device is being tested against in a formal performance study in the way an AI/ML device would be.
The entire submission hinges on demonstrating "SUBSTANTIAL EQUIVALENCE" to existing, legally marketed predicate devices.

Therefore, many of the requested fields cannot be filled as they pertain to a type of performance study that was not conducted or presented in this 510(k) submission.

Here's a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Not applicable.	Not applicable.
(No specific performance criteria or benchmarks are mentioned in this 510(k) for the extension plate; the focus is on substantial equivalence to predicate devices.)	(Performance is implied to be equivalent to the predicate devices based on design and material similarity, but no quantitative performance data is provided for the extension plate itself to compare against specific criteria.)

2. Sample sized used for the test set and the data provenance: Not applicable. No test set or clinical data of this nature is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert consensus is mentioned as part of a performance study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set.

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: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is discussed in the context of a performance study.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary based on the document:

This 510(k) submission successfully demonstrated that the ABC Caudal and Cranial Extension Plate is substantially equivalent to legally marketed predicate devices. The basis for this determination is:

Indications for Use: The device shares the same intended use as the predicate devices, which is for stabilizing the cervical spine due to conditions like degenerative disc disease, trauma, tumors, and failed fusions (C2-T1).
Technological Characteristics: The ABC Cervical Extension Plate is designed to extend existing anterior stabilization plates from the ABC system, indicating a similar mechanism of action and materials to the existing ABC plates and screws (K974706 and K000486), which were the primary predicate devices.
Performance Data: The document explicitly states "No performance standards have been promulgated... The new ABC System conforms with those and the Guidance for Spinal System 510(k)." This means a formal performance study with predefined acceptance criteria was not required or conducted as part of this 510(k) in the way a novel device or AI/ML product would need. Instead, the equivalence pathway relies on the safety and effectiveness profile of the predicate devices.

The FDA's decision letter confirms this, stating the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

Predicate Devices for Substantial Equivalence:

Aesculap's existing Anterior Cervical Spine Plates and Screws (K974706)
Aesculap's Anterior Cervical Screw Spinal Fixation System (K000486)
Osteonics Anterior Cervical Compression Plating System, Line Extension - Howmedica Osteonics Corp. (K992344)
Howmedica Osteonics Compression Plating System, Cortical Screws – Howmedica Osteonics Corp. (K993181)

Summary

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MAY 1 4 2004

K040017
Page 1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

ABC Caudal and Cranial Extension Plate

December 30, 2003

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034
CONTACT:	Joni Swoveland, Regulatory Affairs Assistant800-258-1946 (phone)610-791-6882 (fax)joni.swoveland@aesculap.com (e-mail)
TRADE NAME:	ABC Caudal and Cranial Extension Plate
COMMON NAME:	Anterior Cervical Spinal Stabilization System
DEVICE CLASS:	Class II
PRODUCT CODE:	KWQ
CLASSIFICATION:	888.3060 - Appliance, Fixation, Spinal Intervertebral Body
REVIEW PANEL:	Orthopedic

The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain inistablily rounting from degs confirmed by history and radiographic studies), with degoneration or or ures), post-traumatic kyphosis or lordosis, tumors, and retrauma (inoluling fractare); fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.

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

ABC extension plates MUST only be used with existing ABC plates and screws. They are NOT to be used with another manufacturers system.

DEVICE DESCRIPTION

The ABC Cervical Extension Plate is used to extend the existing anterior The ADO OUrloar Like was cleared through the Anterior Cervical Spine Plates Stablication plate (K974706) and Anterior Cervical Screw Spinal Fixation System (K000486).

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PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the No performance Standards nave boon promaignes. The new ABC System conforms Food, Drug and Cosmetic Aother those and the Guidance for Spinal System 510(k).

SUBSTANTIAL EQUIVALENCE

Aesculap believes that the ABC Extension is substantially equivalent to our Aesculap believes that the ABO Plates and Screws (K974706) and Anterior existing Antenor Oervical Opine Plater and Cordinal Collection predicate devices:

Osteonics Anterior Cervical Compression Plating System, Line Extension -Howmedica Osteonics Corp. (K992344). Howmediou Sotoonics Series (compression Plating System, Cortical Screws –

Howmedica Osteonics Corp. (K993181).

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Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center consists of three stylized lines that resemble a person with outstretched arms.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2004

Ms. Joni L. Swoveland Regulatory Affairs Assistant Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034

Re: K040017

Trade/Device Name: ABC Caudal and Cranial Extension Plate (e-Plate) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 5, 2004 Received: January 12, 2004

Dear Ms. Swoveland:

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

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Page 2 -- Ms. Joni Swoveland

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. production of the month of begin marketing your device as described in your Section 510(k) I mis lotter will and hy a very of substantial equivalence of your device to a legally premated 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 If you doon office of Compliance at (301) 594-4659. Also, please note the regulation entitled, ''Misbranding by reference to premarket notification'' (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Cly Witte

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

Enclosure

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Page 1 of 1

INDICATIONS FOR USE STATEMENT

K040017 510(k) Number (if known):

Device Name:

Indication for Use:

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

ABC extension plates MUST only be used with existing ABC plates and screws. They are NOT to be used with another manufacturers system.

Prescription Use	X
(per 21 CFR 801.109)
or Over-the-Counter Use
(Optional Format 3-10-98)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Restorative, Division of Gene and Neurological Devices

510(k) Number

k04 0017

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.