This anterolateral/anterior system consists of several vertebral screws, locking Inis allectuateraliances system of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5). This amerolateral verteoral boures of unilization during the development of a solid spinal fusion.

When used as an anterolateral/anterior spine plate and rod system, the MaCs™ 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
Spillar schools
Deformities (i.e., scoliosis, kyphosis, lordosis, whether neuromuscular or related to deficient . posterior elements)
Tumors (neoplastic disease) .
Pseudarthrosis .
Failed previous fusion surgery

Device Description

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 eyetype 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "macsTL modular anterior construct system," a spinal intervertebral body fixation orthosis. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way a clinical study with performance metrics would.

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the cornerstone of the 510(k) pathway for medical device approval. This means the device is considered safe and effective because it is similar to other devices already on the market.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be found in a clinical study for software or diagnostic devices. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices, focusing on:

Intended Use and Indications for Use: The macsTM system must have the same or similar indications as the predicate devices.
Material Composition: It must be made of the same implant alloy.
Design and Function: It must have similar form, function, components, instruments, dimensions, geometry, and features.
Biomechanical Performance: It must demonstrate comparable performance (stiffness, fatigue endurance) to the predicate devices and existing standards.

Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (macsTL modular anterior construct system)
Same Intended Use and Indications for Use	SAME as Centaur™ Spinal System (K994347) and BodyForm® (K983622): - Degenerative disk disease - Spondylolisthesis / Spondylolysis - Fracture - Spinal stenosis - Deformities (scoliosis, kyphosis, lordosis) - Tumors - Pseudarthrosis - Failed Previous Fusion Surgery
Same Material Composition	SAME as Centaur™ Spinal System and BodyForm®: Titanium alloy (ASTM F-136-96 titanium alloy [Ti6Al4V] mentioned for Centaur™).
Similar Design, Form, Function, Components, Geometry	Similar to Centaur™ Spinal System and BodyForm®: Plate, rod, nuts & cancellous bone screws. Profile <10mm (Equivalent). Attachment: Anterior - Thoraco/lumbar spine. Surgical Approach: Open, endoscopic, or mini-surgical (Centaur and BodyForm: Open or mini-surgical).
Comparable Biomechanical Performance (Stiffness, Fatigue)	Satisfactory in compression-bending and torsion tests. Satisfactory fatigue endurance of rod and plate constructs. Equivalent stiffness to rod system; comparable and within required specifications. Comparable and within required specifications for fatigue performance. These results show that the performance of the macs " system is comparable to other systems on the market when the published data are reviewed. (Referenced relevant standards: ASTM F-1717-96 testing, ASTM F-136, 92 and ISO 5832-3)

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

The document primarily describes biomechanical testing of the device components and constructs, not a clinical "test set" of patient data in the sense of a diagnostic algorithm.
The sample sizes for these biomechanical tests are not specified in the provided text.
There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because this submission is based on engineering and material testing, and comparison to existing devices, not a new clinical study with patient data.

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

This question is not applicable as there is no "test set" in the context of clinical images or patient data requiring expert consensus for ground truth. The evaluation is based on engineering specifications, material standards, and comparison to predicate devices, which would involve engineering and medical device regulatory experts, but not in the way requested for a diagnostic study.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of clinical images or patient data to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted or described. This type of study is typically performed for diagnostic or AI-assisted devices to assess human-in-the-loop performance. The macsTL system is an implantable surgical device, not a diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone "algorithm only" study was not done. The device is a physical implant, not a software algorithm. The "standalone" performance here refers to the biomechanical integrity and material properties of the device itself, which are evaluated through engineering tests, not an algorithm's performance.

7. Type of Ground Truth Used

For the biomechanical testing, the "ground truth" (or reference against which performance is measured) is the established performance standards (e.g., ASTM, ISO standards) and the published data/known performance of the predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic or clinical trial.

8. Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI/ML algorithm requiring a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

In summary:

This 510(k) submission for the macsTL modular anterior construct system relies on demonstrating substantial equivalence through:

Comparison of intended use, indications, materials, and design features to legally marketed predicate devices.
Biomechanical testing to ensure its material and structural performance (stiffness, fatigue strength) are satisfactory and comparable to those of existing, approved devices and relevant industry standards.
Compliance with manufacturing quality systems (QSR/CGMP) and material standards (ASTM, ISO).

It is not a submission for a diagnostic device or a device involving AI, and therefore, the questions related to clinical study design, reader performance, and AI-specific metrics are not addressed in this document.

Summary

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MAY = 82001

Summary of Safety and Effectiveness Information	AESCULAP® INC.
Premarket Notification, Section 510(k)	DECEMBER 5, 2000

Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:

Device Name:
Trade Name:	macsTL modular anterior construct system
Common Name(s):	Anterior thoraco-lumbar spine plates
Classification Name(s):	Spinal intervertebral body fixation orthosis

Establishment Name & Registration Number:

Name:	Aesculap® Inc.
Number:	2916714

Classification(s):

$ 888.3060 Spinal intervertebral body fixation orthosis.

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 eyetype 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.

Classification. Class II.

Device Class:	Class II for all requested indications
Classification Panel:	Orthopaedic and Rehabilitation Devices Panel
Product Code(s):	KWQ

Applicant Name & Address:

Aesculap® Inc. 1000 Gateway Blvd. South San Francisco, CA 94080-7028 650.876.7000 voice - 650.876.0266 fax

Company Contact:

Wilson Constantine, M.D. Aesculap® Inc. 1000 Gateway Blvd. South San Francisco, CA 94080-7028 650.876.7000 voice - 650.876.0266 fax

Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C -100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

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Performance Standards (Section 514 compliance):

Performance Standards (Section 314 compliance).
Food and Drug Administration mandated Performance standards for anterior spine plates are not in effect. rood and Drug Ammilistiation manance Performance Standards applicable to the mass AESCOLAF® INC. Intends to compy mathe present time, various performance standards such as ASTM, ISO, QSR/CGMP and in-house SOP standards are used. In addition, AESCULAR® INC. complies with the ISO, QSNCONI and in-nouse SOF standards are are are are are and 520 of the Food, Drug, and Cosmetic Act.

Special Controls:

Special Controls.
All Class II devices are subject to Special Controls. No FDA mandated special controls are in effect at the present time.

Labeling:

The macs" modular anterior construct system discussed in this premarket notification will be manufactured for AESCULAR® INC. and labeled as such. The system will be marketed exclusively to healthcare facilities and physicians.

Surgical Technique. The surgical approach of the macs™ modular anterior construct system is similar to other anterior thoraco-lumbar plate spinal systems.

Warning: Federal (United States) Law restricts this device to sale by or on the order of a physician only.

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

CAUTION: Mixing of dissimilar metals can accelerate the corrosion process. The components of this system must NOT be used with implants of other material in building a construct. Components of the macs ... modular anterior construct system should NOT be used with components from any other system or manufacturer.

"Precaution: The implantation of the macs" - modular anterior construct system should be performed only by experienced spinal surgeons with specific training in the use of such spinal devices because the technique is a technically demanding procedure presenting a risk of serious injury to the patient."

Preamendments Device (legally marketed comparison device):

AESCULAP® Inc. believes that the macs" modular anterior construct system is substantially equivalent to the following spinal device system marketed by Theken Surgical.

BodyForm® - Thoraco-Lumbar Fixation System, K983622 - Theken Surgical, LLC.

Centaur™ Spinal System - K994347 - Howmedica/Osteonics/Stryker

The BodyForm® - Thoraco-Lumbar Fixation System is cleared for marketing. BodyForm® is a spinal construct made up of one plate contoured to match the lateral profile of the thoraco-lumbar vertebral bodies, four Morse taper headed screws, and two locking set screws. The plates are sized and designed in such a way that they will accommodate particular bone graft heights. The BodyForm® is intended to be used for the surgical treatment of spinal instability or deformity. Equivalence can be seen in the design, material composition, surgical technique, testing methodologies and intended use.

The Centaur™ Spinal System is cleared for marketing. Used anteriorly, the Centaur™ System is a spinal construct manufactured from ASTM F-136-96 titanium alloy (Ti6Al4V). The system is comprised of primary and secondary bone screws, rods, lateral connectors, plates and accessories. The Centaur™ Spinal System is intended to treat deformities of curvature, fracture, tumor, spinal stenosis, spondylosisthesis, failed previous spine surgery and degenerative disk disease. Equivalence can be seen in the design, material composition, surgical technique, testing methodologies and intended use.

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

To facilitate comparison of the macs™ modular anterior construct system to the systems identified above, a 1 0 facilitate comparison table is located at the end of the document.

Summary of Biomechanical Testing:

In the compression-bending test the results are satisfactory. In the torsion test the ultimate torque of the plate and rods is satisfactory. The fatigue endurance of the rod and plate constructs is satisfactory. I he fallgar endarance of the plate and the pairs of rods are satisfactory.

Results and Conclusions:

The stiffness of the plate system is equivalent to that of the rod system.

The stimoss of the place is comparable and within the required specifications.

The fatigue performance is comparable and within the required specifications.
These results show that the performance of the macs " system is comparable to other systems on t market when the published data are reviewed.

Summary Basis for Equivalence and Comparison Table:

Summary Dasts for Equirated on the macs 14 modular anterior construct system implant constructs Biomechanical studies conductor on the macs - nocaliar for use as a spinal fixation device system. Based on the available information concerning the referenced comparison devices, these devices are similar in that:

The devices have the same intended use and indications for use. .
The devices are made of the same implant alloy. .
The devices have similar form, function, components, instruments, dimensions, geometry and features. .

The use of QSR based process controls, testing standards (ASTM F-1717 - 96 testing, materials standards (ASTM F-136, 92 and ISO 5832-3) and the similarities of the references comparison devices establish that (ASTM IFTS), 22 and 150 3052 3y and is substantially equivalent to available legally marketed anterior thoraco-lumbar spinal devices. It is believed that the anticipated clinical performance of the macs Tr modular anterior construct system is equivalent to the referenced systems.

FEATURE	macsTL modular anterior construct system	CentaurSystem	BodyForm	SE?
Indicationsfor Use:	degenerative disk disease defined as back pain ofdiscogenic origin with degeneration of the discconfirmed by history and radiographic studiesspondylolisthesisfracturespinal stenosisdeformities (i.e., scoliosis, kyphosis, lordosis)tumorspseudarthrosisFailed Previous Fusion Surgery	SAME	SAME	YES
Components:	Plate, rod, nuts & cancellous bone screws	SAME	SAME	YES
Sterility:	No. Steam sterilize on-site before use.	SAME	SAME	YES
Profile:	<10mm	EQUIVALENT	EQUIVALENT	YES
Materials:	Titanium alloy	SAME	SAME	YES
Attachment:	Anterior - Thoraco/lumbar spine	SAME	SAME	YES
Manufacturer:	Aesculap, Inc.	Howmedica	ThekenSurgical, LLC	YES
SurgicalApproach:	Open, endoscopic or mini-surgical	Open or mini-surgical	Open or mini-surgical	NO - YES
Product Code:	KWQ	SAME	SAME	YES
K - Number:	Pending	K994347	K983622	YES

Summary Comparison Table:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design with three curved lines representing the wings or feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 8 2001

AESCULAP, Inc. Mr. David W. Schlerf c/o Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523

Re: K002824

Trade Name: macs™ modular anterior construct system Regulation Number: 21 CFR 888.3060 Regulatory Class: Class II Product Code: KWQ Dated: December 5, 2000 Received: March 13, 2001

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave and we have determined the device is substantially equivalent (for the indications for use above and we have as a losses marketed in interstate commerce prior to May 28, 1976, the stated in the eneroune) to were Device Amendments, or to devices that have been reclassified in encordance 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, controls provisions or actice, 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 ( Femanel I pp 1 car) 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 mspootions, are 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, permits your device to proceed to the market.

{4}------------------------------------------------

Page 2 - Mr. David W. Schlerf

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Office of additionally 809.10 for in Vito diagnostic no nove, promotion and advertising of your device, (301) 594-4659. Additionally, for questions of the presentents of the regulation please contact the Office of Compilance at (301) - 1 - 1057 - 1039 - 10.07.97). Other general
entitled, "Misbranding by reference to premarket not any of transport Small entitled, "Misbranding by relective to premarket mary be obtained from the Division of Small
information on your responsibilities under the Act (201) /43-6597, or at is information on your responsionines uncer (800) 638-2041 or at (301) 443-6597, or at its
Manufacturers Assistance at its toll-free 11 its be Manufacturers "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

аттилешопр

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

510(k) Number : K002824

macs™ modular anterior construct system Device Name(s):

Indications for Use:

KWQ 888.3060 - Spinal Intervertebral Body Fixation Orthosis

When used as an anterolateral/anterior spine plate and rod system, the MaCs™ 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
Spillar schools
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 NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

D. Mutaelllro Mc Cunn

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

510(k) Number KOOZES24

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional format 1-2-96)

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.