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 (T3-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 " HMA Anterior Spinal Stabilization 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, lordosis, whether . neuromuscular or related to deficient posterior elements)
. Tumors (neoplastic disease)
Pseudarthrosis
Failed previous fusion surgery ●

Device Description

The MACS 1 HMA Anterior Spinal Stabilization System includes implantable metallic plates, rods, clamps, locking nuts and screws. The components are used in various combinations to form a construct for use during anterior spinal fusion surgery. The MACS" modular anterior construct system (K002824), which was cleared on May 8, 2001, consists of the twin screws, where as the MAC™ HMA Anterior Spinal Stabilization System consists of the HMA Polyaxial and Monoaxial Screws. Both of these systems are considered a part of each other. The stabilization plates, connection rods, fixation nut, locking screw, bone graft clamp and screw have been cleared under the MACS" modular anterior construct system (K002824).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MACS™ HMA Anterior Spinal Stabilization System:

This device is an anterior spinal stabilization system, a physical implant. The evaluation process for such devices differs significantly from software-based medical devices (like AI algorithms for image analysis) where performance metrics like sensitivity, specificity, and AUC are common. For implantable mechanical devices, the "acceptance criteria" and "study" revolve around mechanical integrity and biocompatibility, often demonstrated through laboratory testing and comparison to predicate devices, rather than clinical trials with human subjects focused on diagnostic accuracy.

Therefore, many of the requested points are not applicable to this type of device and the information provided in the 510(k) summary.

Acceptance Criteria and Study for MACS™ HMA Anterior Spinal Stabilization System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit in Document)	Reported Device Performance (from Section IV and Appendix I)
Mechanical Integrity	Fatigue Life: Ability to withstand repeated loading cycles without failure.	Fatigue testing of a "worst case" system configuration was conducted on samples of constructs made of titanium. (Specific numerical results are not provided in this summary but are stated to be in Section IV and Appendix I).
Material Properties	Stiffness, Strength: Mechanical properties suitable for spinal stabilization.	Conforms to applicable ASTM & ISO standards. (Specific numerical results are implied by conformity but not detailed here).
Biocompatibility	Materials (Titanium) are biocompatible and safe for implantation.	Not explicitly detailed in the provided text as a performance result, but implied by material choice and predicate device equivalence.
Design Equivalence	Similar design and basic operating principles to predicate devices.	"Substantially equivalent in their intended use, design, and basic operating principles to... K-Centrum Anterior Spinal Fixation System."
Manufacturing Standards	Compliance with Quality System Regulation (QS) for Medical Devices.	Assumed through FDA's substantial equivalence determination and ongoing compliance checks.

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

Sample Size for Test Set: The document mentions "samples of constructs made of titanium" for fatigue testing. It does not specify the exact number of samples used.
Data Provenance: The testing was laboratory-based mechanical testing, not human clinical data. Thus, "country of origin of the data" and "retrospective or prospective" do not apply in the typical sense. The testing was prospective in the sense that it was performed specifically for this submission.

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

This question is not applicable as the "test set" involves mechanical components (spinal implants) and not diagnostic data requiring expert interpretation. The "ground truth" for mechanical testing is established by engineering standards and measurements, not by human experts.

4. Adjudication Method for the Test Set

This question is not applicable. Mechanical testing does not involve adjudication by experts in the way clinical diagnostic studies do. The results are objective measurements from laboratory equipment.

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

This question is not applicable. This is a physical medical device (implant), not an AI diagnostic algorithm. Therefore, no MRMC study, AI assistance, or human reader improvement metrics are relevant.

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

This question is not applicable. This is a physical medical device (implant), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering standards and direct physical measurements (e.g., of load cycles for fatigue, stiffness, and strength) in a laboratory setting, as per applicable ASTM and ISO standards (e.g., ASTM F-1717-96 for the predicate device).

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of mechanical device testing for a 510(k) submission.

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

This question is not applicable. There is no "training set" or corresponding "ground truth" in the context of mechanical device testing for a 510(k) submission.

Summary of the Study:
The study performed was a laboratory-based mechanical fatigue test on "worst case" configurations of the MACS™ HMA Anterior Spinal Stabilization System constructs made of titanium. The purpose was to demonstrate the mechanical integrity and fatigue life of the device. The specific results of this testing are referenced as being available in Section IV and Appendix I of the full submission, but not summarized numerically in the provided text. The device's conformance to applicable ASTM and ISO standards is also stated, implying that its mechanical properties (stiffness, strength, fatigue life) meet recognized industry benchmarks that were likely used as performance acceptance criteria. The claim of "substantial equivalence" to predicate devices (like the K-Centrum Anterior Spinal Fixation System, which also underwent ASTM F-1717-96 testing) further supports that similar mechanical performance criteria and testing methodologies were applied.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In Accordance with SMDA of 1990

NOV 1 6 2001

MACS™ HMA Anterior Spinal Stabilization System

May 16, 2001

COMPANY:	Aesculap ®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034
CONTACT:	Lisa M. Millington, Regulatory Associate800-258-1946 (phone)610-231-3713 (fax)lisa.millington@aesculap.com (email)
TRADE NAME:	MACSTL HMA Anterior Spinal Stabilization System
COMMON NAME:	Anterior-Lateral Spinal Stabilization System
DEVICE CLASS:	Class II
PRODUCT CODE:	KWQ
CLASSIFICATION:	888.3060 – Spinal intervertebral body fixation orthosis
REVIEW PANEL:	Orthopedic and Rehabilitation Devices Panel

INTENDED 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, lordosis, whether . neuromuscular or related to deficient posterior elements)
. Tumors (neoplastic disease)
Pseudarthrosis
Failed previous fusion surgery ●

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DEVICE DESCRIPTION

K011556

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.

Fatigue testing of a "worst case" system configuration was conducted on samples of constructs made of titanium. A summary of this testing can be found in Section IV and the final reports are provided in Appendix I.

SUBSTANTIAL EQUIVALENCE

MACS" HMA Anterior Spinal Stabilization System is substantially equivalent in their intended use, design, and basic operating principles to the following predicate devices:

K-Centrum Anterior Spinal Fixation System .

By The Spineology Group (#K990959 & K002371) The K-Centrum® - Anterior Spinal Fixation System is cleared for marketing. K-Centrum® is an anterior spinal construct made up of one rod connected to two cage-like vertebral body screws. This system was tested using ASTM F-1717-96 recommendations. Properties of stiffness. strength and fatique life were determined. The K-Centrum® is intended to be used for the surgical treatment of vertebral body fractures and tumors. Equivalence can be seen in the design, material composition, surgical technique, testing methodologies and intended use.

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized eagle with three curved lines representing its wings. The eagle is facing to the right. The eagle is surrounded by text that is arranged in a circular pattern. The text is difficult to read due to the image quality.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2001

Ms. Lisa M. Millington Regulatory Associate Aesculap®. Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: KOI 1556 Trade/Device Name: MACST HMA Anterior Spinal Stabilization System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 24, 2001 Received: August 29, 2001

Dear Ms. Millington:

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 your 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 (QS) 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.

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Page 2 - Ms. Lisa M. Millington

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, 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,

Colie M. Witter, 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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NOV 1 6 2001

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Kollste

Device Name: MACS™ HMA Anterior Spinal Stabilization System

Indication for 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 (T3-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 " HMA Anterior Spinal Stabilization 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
. Spondvlolisthesis
. Spondvlolysis
Fracture ●
Spinal stenosis .
Deformities (i.e., scoliosis, kyphosis, lordosis, whether neuromuscular or . related to deficient posterior elements)
Tumors (neoplastic disease) ●
Pseudarthrosis ●
Failed previous fusion surgery .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (6

for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K011556
Prescription Use X or Over-the-Counter Use
(per 21 CFR 801.109) (Optional Format 3-10-98)

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.