The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap Modulift VBR System may be used with bone graft.

Device Description

The AIS Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.

AI/ML Overview

The provided document is a 510(k) premarket notification for the AIS Modulift VBR System. This type of FDA submission is for medical devices seeking substantial equivalence to already legally marketed predicate devices, not typically for AI/ML-driven devices. Therefore, the information requested in the prompt, which is tailored for AI/ML device studies (e.g., acceptance criteria for algorithm performance, sample sizes for test sets, ground truth establishment by experts, adjudication methods, MRMC studies), is not relevant or applicable to this document.

The document primarily focuses on demonstrating the substantial equivalence of an adjustable vertebral body replacement system to existing predicate devices, focusing on design, intended use, material composition, function, and size.

However, I can extract information regarding the performance data mentioned in the document in the context of device safety and efficacy, which is a different type of performance than what is typically associated with AI/ML systems.

Based on the provided text, here's what can be extracted, acknowledging the mismatch with AI/ML specific questions:

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

Acceptance Criteria (Implied)	Reported Device Performance
Meet or exceed performance of predicate devices for expulsion.	The results of the testing showed that the subject AIS Modulift VBR System meets or exceeds the performance of the predicate devices.

Note: The document implies the acceptance criterion is performing at least as well as the predicate devices in the described tests. The specific quantitative acceptance thresholds are not provided in this summary.

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

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified in the provided text. The testing seems to be laboratory-based ("non-clinical testing").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. This is a mechanical device, and ground truth is typically established through engineering specifications and test protocols, not human expert consensus on medical images/data.
Qualifications of Experts: Not applicable.

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

Adjudication Method: Not applicable. This refers to consensus among human readers for AI/ML ground truth, which is not relevant here.

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:

MRMC Study: Not applicable. This type of study is for evaluating AI impact on human performance, which is not relevant for this mechanical device.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This refers to AI algorithm performance, not relevant for this device.

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

Type of Ground Truth: For this mechanical device, the "ground truth" or standard for evaluation would be established engineering principles, material science standards (e.g., ASTM F-136, ASTM F1537), and the performance characteristics of predicate devices in specific mechanical tests (like expulsion). This is distinct from clinical 'ground truth' defined by pathology or expert consensus for AI/ML systems.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning.

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

How Ground Truth for Training Set was Established: Not applicable, as there is no training set in the AI/ML sense.

Summary of Relevant Performance Data from the document:

The study referenced is "non-clinical testing" as recommended by the FDA Guidance for Spinal System 510(k)'s.

Test Performed: Expulsion per ASTM Draft Standard F-04.25.02.02.
Purpose: To demonstrate that the AIS Modulift VBR System is substantially equivalent to other predicate devices.
Results: The device "meets or exceeds the performance of the predicate devices."

This information confirms that the performance evaluation was based on mechanical testing relevant to physical device function and safety, not on AI/ML diagnostic or prognostic capabilities.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 29, 2014

Aesculap® Implant Systems, Incoporated Ms. Lisa M. Boyle Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K142150

Trade/Device Name: AIS Modulift VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP Dated: August 4, 2014 Received: August 5, 2014

Dear Ms. Boyle:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Lisa M. Boyle

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142150

Device Name AIS Modulift VBR System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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B. 510(k) SUMMARY (as required by 21 CFR 807.92)

Aesculap Implant Systems, LLC. (AIS) Modulift (Modulift) VBR System October 28, 2014

COMPANY:	Aesculap®Implant Systems, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311
CONTACT:	Lisa M. Boyle800-258-1946 (phone)610-791-6882 (fax)
TRADE NAME:	AIS Modulift VBR System
COMMON NAME:	Adjustable Vertebral Body Replacement Device
CLASSIFICATION NAME:	Spinal Vertebral Body Replacement Device
REGULATION NUMBER:	888.3060
PRODUCT CODE:	MQP

PURPOSE FOR PREMARKET NOTIFICATION

The AIS Modulift VBR System described in this submission introduces medium and large (15°) footplates that are used with the VBR's currently cleared in the existing product line under K133802 /K110864.

DEVICE DESCRIPTION

INDICATIONS FOR USE

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supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The AIS Modulift VBR System may be used with bone graft.

TECHNOLOGICAL CHARACTERISTICS(compared to Predicates)

As is established in this submission, the AIS Modulift VBR System is a mechanically adjustable vertebral body replacement device that is substantially equivalent to other predicate devices cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics to its predicate devices through comparison in design, intended use, material composition, function and range of sizes.

PERFORMANCE DATA

As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate that the AIS Modulift VBR System is substantially equivalent to other predicate devices. The following testing was performed:

Expulsion per ASTM Draft Standard F-04.25.02.02
The results of the testing showed that the subject AIS Modulift VBR System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.

PREDICATE DEVICE

Primary Predicate: Aesculap Modulift VBR System (K110864/K133802) .
Ulrich Obelisc VBR Systems (K060416) .

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.