The MAGEC® Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal abnormalities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.

Device Description

The MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgiclly implanted using appropriate Stryker® Xia® fixation components (i.e. pedicle screws, hooks and/or connectors). The implanted MAGEC rod is used to brace the spine during growth to minimize the progression of scoliosis. The system includes a nonsterile hand held External Remote Controller (ERC or ERC 2) that is used periodically after implantation to non-invasively distract the implanted spinal rod. The titanium MAGEC rod includes an actuator portion that holds a small internal magnet. The actuator can be turned noninvasively by use of the ERC, which is electrically powered. The hand held non-invasive ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and distract the MAGEC rod. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted. Additional accessories for the MAGEC System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterile, single use device, which is used in the operating room to test the MAGEC rod prior to implantation. The MAGEC Manual Distractor used with the MAGEC System is made of Radel® and contains a rare-earth magnet. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC rod. The ERC is placed over this location on the child's back.

AI/ML Overview

The provided text is a 510(k) summary for the MAGEC® Spinal Bracing and Distraction System, focusing on a labeling revision from MR Unsafe to MR Conditional. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for software or AI-enabled medical devices.

Instead, the document details a comparison to a predicate device and non-clinical testing performed to establish MRI compatibility for the device itself. There is no mention of an algorithm or AI component in this specific submission.

Therefore, many of the requested categories about acceptance criteria, AI performance, ground truth, and human reader studies are not applicable to the information contained in this document.

However, I can extract the information relevant to the device's substantial equivalence and the testing related to its regulatory submission for the hardware component of the MAGEC System.

Based on the provided document, here is the information that can be extracted:

1. Table of Acceptance Criteria (for MRI Compatibility) and Reported Device Performance:

Test Description	Applicable Test Standard / Performance Metric	Reported Performance
Magnetically Induced Displacement Force	ASTM F2052	Evaluated for magnetically induced displacement force for MR Conditional labeling.
Magnetically Induced Torque	ASTM F2213	Evaluated for magnetically induced torque for MR Conditional labeling.
MR Image Artifact	ASTM F2119	Evaluated for MR image artifact for MR Conditional labeling.
Radiofrequency Induced Heating	ASTM F2182	Evaluated for radiofrequency induced heating for MR Conditional labeling.
Design Verification	None (Custom setups were developed and utilized)	Non-clinical testing indicated that, in accordance with relevant ASTM standards, MR Conditional labeling is appropriate.

Explanation: The "acceptance criteria" here are implicitly defined by the ASTM standards for MRI compatibility and the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment (12/11/2014)". The reported performance is that the testing indicated MR Conditional labeling is appropriate according to these standards and guidance.

2. Sample size used for the test set and the data provenance:

Test Set (for MRI compatibility): "Test samples were provided in the final manufactured condition." The exact number of samples is not specified, but it refers to manufactured units of the MAGEC rod.
Data Provenance: Not explicitly stated for the MRI compatibility testing, but it would be from in-house or contracted lab testing of the physical device.

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

Not applicable. This testing is for the physical device's MRI compatibility, not an AI or diagnostic algorithm requiring expert ground truth.

4. Adjudication method for the test set:

Not applicable. This testing is for the physical device's MRI compatibility, not an AI or diagnostic algorithm requiring adjudication.

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 submission concerns a physical medical device (spinal bracing system), not an AI or diagnostic algorithm.

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

Not applicable. This submission concerns a physical medical device (spinal bracing system), not an AI or diagnostic algorithm.

7. The type of ground truth used:

For MRI Compatibility: The "ground truth" is defined by the physical properties of the device and its interaction with an MRI environment, as measured against the specified ASTM standards and FDA guidance.
For Clinical Efficacy (referenced from predicate): The clinical study endpoints for the predicate device included: Cobb angle correction, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in subsequent surgical procedures, and weight gain. These are objective clinical measurements and patient outcomes.

8. The sample size for the training set:

Not applicable. This submission is about a physical medical device, not an AI model.

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

Not applicable. This submission is about a physical medical device, not an AI model.

Additional Information from the document:

Clinical Performance Data (referenced from predicate): A retrospective clinical study was conducted for the predicate MAGEC System outside the United States. This study evaluated children who had either a primary or revision spinal bracing procedure using the MAGEC System. The study showed benefits similar to traditional growing rods without the need for regular surgical lengthenings.
The current submission (K160352) is identical to the predicate device (K150885) in terms of indications for use, principles of operation, and technological characteristics. The only purpose of this specific premarket notification is to revise the labeling from MR Unsafe to MR Conditional based on the non-clinical MRI compatibility testing.

Summary

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July 29, 2022

NuVasive Specialized Orthopedics, Inc. Lance Justice Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656

Re: K160352

Trade/Device Name: MAGEC® Spinal Bracing and Distraction System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PGN

Dear Lance Justice:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 21, 2016. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation number, 21 CFR 888.3070.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ronald Jean, OHT6: Office of Orthopedic Devices, (301)796-5650, Ronald.Jean@fda.hhs.gov.

Sincerely,

Ronald P. Jean -S

Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

October 21, 2016

NuVasive Specialized Orthopedics, Inc. Mr. Lance Justice Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo. California 92656

Re: K160352

Trade/Device Name: MAGEC® Spinal Bracing and Distraction System Regulatory Class: Unclassified Product Code: PGN Dated: September 8, 2016 Received: September 9, 2016

Dear Mr. Justice:

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 devicerelated adverse events) (21 CFR 803); 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. 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

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or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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,

Mark N. Melkerson -S

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) K160352

Device Name

MAGEC® Spinal Bracing and Distraction 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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510(k) Summary

MAGEC® Spinal Bracing and Distraction System

Premarket Notification Number: K160352

NuVasive Specialized Orthopedics, Inc. 1. Company: 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
Contact: Lance Justice Regulatory Affairs Specialist Phone: (949) 544-6540 Fax: (949) 837-3664

Date Prepared: September 8, 2016

1. Proprietary Trade Name: MAGEC® Spinal Bracing and Distraction System
1. Common Name: Non Fusion Growing Rod System
Unclassified (Product Code PGN, Growing Rod System Magnetic 4. Classification Name: Actuation)
Product Description: The MAGEC Spinal Bracing and Distraction System is comprised of a sterile 5. single use spinal rod that can be surgiclly implanted using appropriate Stryker® Xia® fixation components (i.e. pedicle screws, hooks and/or connectors). The implanted MAGEC rod is used to brace the spine during growth to minimize the progression of scoliosis. The system includes a nonsterile hand held External Remote Controller (ERC or ERC 2) that is used periodically after implantation to non-invasively distract the implanted spinal rod. The titanium MAGEC rod includes an actuator portion that holds a small internal magnet. The actuator can be turned noninvasively by use of the ERC, which is electrically powered. The hand held non-invasive ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and distract the MAGEC rod. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted. Additional accessories for the MAGEC System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterile, single use device, which is used in the operating room to test the MAGEC rod prior to implantation. The MAGEC Manual Distractor used with the MAGEC System is made of Radel® and contains a rare-earth magnet. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC rod. The ERC is placed over this location on the child's back.
Indications for Use: The MAGEC Spinal Bracing and Distraction System is intended for skeletally 6. immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle

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of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.

1. Substantial equivalence: Documentation that includes mechanical test results, design verification and detailed comparison to the predicate device demonstrates that the MAGEC System is substantially equivalent to the following 510(k) cleared device:
- MAGEC Spinal Bracing and Distraction System (K150885) ●

Substantial equivalence to the predicate device is based on indications for use, principles of operation, technological characteristics, and pre-clinical testing performed.

The MAGEC System that is the subject of this premarket notification is identical to the predicate device and has the same indications for use. All design and technological characteristics remain the same. The purpose of the premarket notification is only to revise the labeling from MR Unsafe to MR Conditional.

Non-clinical testing on the MAGEC System was performed to evaluate MRI compatibility in 1.5T clinical scanners. Due to the presence of a permanent magnet in the device. the ASTM standards were applied where possible and custom setups were developed and utilized in order to conduct the evaluations. Test samples were provided in the final manufactured condition and were evaluated for magnetically induced displacement force and torque. MR image artifact, radiofrequency induced heating, and design verification. Results of these testing indicated that, in accordance with relevant ASTM standards, MR Conditional labeling is appropriate.

The FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment (12/11/2014)" was utilized to determine the specific non-clinical tests required to establish the labeling revision from MR Unsafe to MR Conditional:

Test Description	Applicable Test Standard
Magnetically Induced Displacement Force	ASTM F2052
Magnetically Induced Torque	ASTM F2213
MR Image Artifact	ASTM F2119
Radiofrequency Induced Heating	ASTM F2182
Design Verification	None

Additional non-clinical tests that were performed on the predicate MAGEC System are also applicable to the subject MAGEC System with the MR Conditional labeling change. There are no changes being made to the ERC, the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator as a result of this submission, therefore all testing that was performed on the predicate MAGEC System for those components are applicable to the MAGEC System subject of this premarket notification.

8. Clinical Performance Data:

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Previous clinical performance data for the predicate MAGEC System are applicable to this MAGEC System. The safety and probable benefit of the predicate MAGEC System was evaluated outside the United States in a retrospective clinical study for children who had either a primary or revision spinal bracing procedure using the MAGEC System. In assessing probable benefit, the endpoints chosen in the study included Cobb angle correction in the coronal plane, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in the number of subsequent surgical procedures, and weight gain.

The results of the clinical study showed the MAGEC System provides the benefits of spinal deformity correction and continued growth, similar to that for traditional growing rods, without the need for regular surgical lengthening procedures in these children. As with traditional growing rods, the MAGEC System provides direct bracing to the spine. This bracing provides for correction and maintenance of the scoliotic curve as defined by the Cobb Angle. In addition, a return to a more normal symmetry of the thoracic cavity is provided as demonstrated by the space available for lung (SAL). While implantation of the MAGEC System shares many of the same risks and hazards associated with those of traditional growing rods, the MAGEC System offers the benefit of non-invasive adjustment to lengthen the implanted rod without the need to perform another surgery. The ability of the device to be adjusted non-invasively in length provides the ability of the spine to continue growing in these subjects and for the Thoracic Spine Height to increase with this growth.

9. Conclusion:

Conclusions can be drawn from these tests that the MAGEC System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.