degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
spondylolisthesis
trauma (i.e., fracture or dislocation) .
spinal stenosis .
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
tumor .
pscudoarthrosis .
failed previous fusion .

Device Description

The ART Anterior Spinal System consists of a Plate that attaches to the anterior or antero-lateral vertebral body of the thoraco-lumbar and lumbar spine. One place on each vertebral body. The single size plate is attached to the vertebral body with two diverging Ø6.5mm Screws. The superior portion of the plate is U-shaned to receive a Ø6mm Rod. The inner surface of the U-shaped opening of the plate is threaded to receive a Locking Nut. When tightened the Locking Nut firmly secures the Rod to the Plate. In this manner the Rods connect two or more Plates. Sce schematic in Exhibit III.

A rod connector component, called a Domino, attaches two rods for use in multi-level fusions. Rods can be connected in series or parallel.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "ART Anterior Spinal System." It is a spinal intervertebral body fixation orthosis. However, the document does not contain any acceptance criteria, reported device performance data, details of a study on acceptance criteria, AI components, or human reader effectiveness studies.

The information provided focuses on:

Device Description: The physical components of the ART Anterior Spinal System.
Intended Use/Indications for Use: The medical conditions for which the device is designed (e.g., degenerative disc disease, spondylolisthesis, trauma).
Equivalency: Stating that the device is similar to previously cleared devices (Kaneda SR Anterior Spinal System and M-2 Anterior Plate).
Nonclinical Tests: A brief mention that "Testing was performed according to ASTM F1717." This refers to a standard for spinal implant testing, but no specific results or acceptance criteria from these tests are detailed.
Regulatory Information: Communication from the FDA confirming substantial equivalence to predicate devices, classification, and general regulatory requirements.

Therefore, requested information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone), and AI components cannot be extracted from this document, as it is not present.

To summarize, for the given input:

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

Not Available. The document states "Testing was performed according to ASTM F1717" but does not provide specific acceptance criteria or the results of these tests.

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

Not Available. No information on specific test sets, sample sizes, or data provenance is provided. The testing mentioned (ASTM F1717) is for mechanical properties, not clinical data sets.

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 Available. This information is for clinical studies, which are not described in this document.

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

Not Available. This information is for clinical studies, which are not described in this document.

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 document describes a physical medical device (spinal fixation system), not an AI-enabled diagnostic or therapeutic tool for which MRMC studies are typically performed. There is no mention of AI.

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

Not Applicable. This document describes a physical medical device, not an algorithm.

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

Not Available. This information is for clinical studies, which are not described in this document. The "ground truth" for a mechanical device would be its physical properties meeting engineering standards.

8. The sample size for the training set:

Not Applicable. No training set is mentioned as this is a physical medical device clearance, not an AI model.

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

Not Applicable. No training set is mentioned.

Summary

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K 0331 4 8

510(k) Summary

APR 1 2 2004

Date September 29, 2003

Submitter

Advanced Medical Technologies AG Kasteler Strasse 11 66620 Nonnweiler-Braunshausen Germany

Contact person

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

Common name

Anterior vertebral body fixation system

Classification name

Spinal Intervertebral Body Fixation Orthosis (per 21 CFR section 888.3060 )

Equivalent Device

The ART Anterior Spinal System is similar in material and indications as the Kaneda SR Anterior Spinal System (DePuy Acromed, K971248) and the M-2 Anterior Plate (DePuy Acromed, K972718).

Device Description

A rod connector component, called a Domino, attaches two rods for use in multi-level fusions. Rods can be connected in series or parallel.

Intended Use

The ART Anterior Spinal System is intended for anterolateral screw fixation of the T6-L5 spine.

Indications for use include:

· degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
· spondylolisthesis
trauma (i.e., fracture or dislocation) .
spinal stenosis .
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
tumor .
pscudoarthrosis .
failed previous fusion .

Summary Nonclinical Tests

Testing was performed according to ASTM F1717.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2004

Mr. J.D. Webb Advanced Medical Technologies 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K033148

Trade Name: ART Anterior Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: January 19, 2004 Received: January 21, 2004

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.

If your device is classified (see above) into cither 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.

{2}------------------------------------------------

Page 2 - Mr. J.D. Webb

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. 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours,

Mark N Milliken

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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510(k) number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

ART Anterior Spinal System Indications for Use

The ART Anterior Spinal System is intended for anterolateral screw fixation of the T6-L5 spine.

Indications for use include:

degenerative disc disease (ddd) defined as back pain of discogenic origin . with degeneration of the disc confirmed by history and radiographic studies
spondylolisthesis ●
trauma (i.e., fracture or dislocation) .
spinal stenosis .
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
. tumor
pseudoarthrosis ●
failed previous fusion �

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

Concurrence of CDRH, Office of Device Evaluation (ODE
)

Prescription Use ✓ (per 21 CFR 801.109)	OR	Over-the-Counter Use (Optional format 1-2-96)
-----------------------------------------	----	-----------------------------------------------

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

510(k) Number	(Division Sign-off) Division of General, Restorative, and Neurological Devices K033148
---------------	----------------------------------------------------------------------------------------------

Page iii 510(k) Number

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.