This anterolateral / anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral / anterior spine plate and rod system, the MACST Modular Anterior Construct System is indicated for patients with:

Degenerative disk disease defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
Spondylolisthesis ●
Spondylolysis .
Fracture .
Spinal stenosis .
Deformities (i.e., scoliosis, kyphosis, whether neuromuscular or related . to deficient posterior elements)
Tumors (neoplastic disease) .
Pseudarthrosis .
Revision of previous surgery .

Device Description

The MACST Polyaxial Screw and Thoracic Line is an extension of the existing MACSTL implant system, cleared through 510(k) K002824 on May 8, 2001. The extension consists of a larger Polyaxial screw, as well as, a shorter Polyaxial screw for the Thoracic spine. The MACST Polyaxial screw with the larger diameter (10mm) is also designed to work as a rescue screw in poor bone quality.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the MACST Modular Anterior Construct System, a spinal stabilization system. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical or performance studies with acceptance criteria for a new device.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory document.

However, I can extract the available information and indicate where data is not provided or not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (If Applicable)	Reported Device Performance	Comments
Not specified for the device as a new product with new performance claims. This 510(k) relies on substantial equivalence.	"The new MACST System conforms to applicable ASTM and ISO standards."	This is a general statement of compliance, not a specific performance outcome with an acceptance value. No numerical performance metrics (e.g., strength, durability, fatigue life) are provided in this summary.

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

Sample Size (Test Set): Not applicable. No specific test set for performance evaluation is described as this is a substantial equivalence submission relying on prior device data and standard compliance.
Data Provenance: Not applicable. No clinical or comparative performance data from human or lab studies of the new device is presented. The submission focuses on design equivalence and material compliance.

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

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method for a test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not done, as this is a spinal implant, not an imaging or diagnostic device typically requiring reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (spinal implant), not a software algorithm.

7. The Type of Ground Truth Used

Not applicable. The submission does not describe a study involving "ground truth" as would be relevant for diagnostic or AI-based devices. The "truth" here is the device's adherence to design specifications and material properties, which are generally demonstrated through bench testing or material certifications, not clinical "ground truth" derived from patient outcomes or expert consensus for diagnosis.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is a physical medical device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided 510(k) summary, the "study" demonstrating the device meets acceptance criteria is a declaration of substantial equivalence to predicate devices and conformance to applicable ASTM and ISO standards.

The key points are:

Reliance on Predicate Devices: The MACST Polyaxial Screw and Thoracic Line is presented as an extension of the existing MACST implant system (K002824) and is deemed substantially equivalent to it and other predicate devices (K011556, K990959, K002371). This implies that if the predicate devices meet performance and safety criteria, the new device with similar design and materials also meets them.
Standards Conformance: The document states, "The new MACST System conforms to applicable ASTM and ISO standards." This indicates that the device has undergone testing (or its materials/design are known to comply) with recognized industry standards related to spinal implants, likely covering aspects like mechanical strength, fatigue, material biocompatibility, and sterilization. However, specific results from these tests are not included in this summary document. These standards themselves define the acceptance criteria for various physical and mechanical properties.

Summary

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JUL 25 2003

Image /page/0/Picture/1 description: The image shows the text "K032059" at the top. Below this text, the phrase "Page 1 of 2" is written. The text appears to be handwritten, and the image is a scan or photograph of a document. The page number indicates that this is the first page of a two-page document.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

in Accordance with SMDA of 1990

MACST - Modular Anterior Construct System

July 1, 2003

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034
CONTACT:	Georg Keller, Regulatory Affairs Manager800-258-1946 (phone)610-791-6882 (fax)georg.keller@aesculap.com (e-mail)
TRADE NAME:	MACSTL Modular Anterior Construct System
COMMON NAME:	Anterior Lateral Spinal Stabilization System
DEVICE CLASS:	Class II
PRODUCT CODE:	KWQ
CLASSIFICATION:	888.3060 - Appliance, Fixation, Spinal Intervertebral Body
REVIEW PANEL:	Orthopedic

INTENDED USE

This anterolateral / anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral / anterior spine plate and rod system, the MACS 16 Modular Anterior Construct System is indicated for patients with:

Degenerative disk disease defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
Spondylolisthesis ●
Spondylolysis .
Fracture .
Spinal stenosis .
Deformities (i.e., scoliosis, kyphosis, whether neuromuscular or related . to deficient posterior elements)
Tumors (neoplastic disease) .
Pseudarthrosis .
Revision of previous surgery .

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DEVICE DESCRIPTION

PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new MACST System conforms to applicable ASTM and ISO standards.

SUBSTANTIAL EQUIVALENCE

Aesculap believes that the MACST Modular Anterior Construct System Line Extension is substantially equivalent to the existing MACST Modular Anterior Construct System (K002824) and the following other predicate devices:

MACST HMA Anterior Spinal Stabilization System (K011556) .
K-Centrum Anterior Spinal Fixation System (K990959 & K002371) .

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 2003

Mr. Georg Keller Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K032059

Trade/Device Name: MACST Modular Anterior Construct System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 1, 2003 Received: June 2, 2003

Dear Mr. Keller:

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 - Mr. Georg Keller

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) 594-4639. 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 yours,

Sincerely, yours,

Mark McMullen

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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K032059

Device Name: MACST - Modular Anterior Construct System

Indication for Use:

Degenerative disk disease defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
Spondylolisthesis .
Spondylolysis .
Fracture .
. Spinal stenosis
Deformities (i.e., scoliosis, kyphosis, whether neuromuscular or related to . deficient posterior elements)
Tumors (neoplastic disease) .
Pseudarthrosis .
Revision of previous surgery ●

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

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

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

510(k) Number	K032059
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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.