The Ellipse MAGEC Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (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 Ellipse Technologies, Inc. MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia fixation components (i.e. Pedicle screws, hooks and/or connectors). The system includes a non-sterile hand held External Remote Controller (ERC) that is used at various times after implant to non-invasively lengthen the implanted spinal rod. The implanted spinal rod is used to brace the spine during growth to minimize the progression of scoliosis. The titanium rod (Ti-6Al-4V ASTM F136) includes an actuator portion that holds a small internal magnet. The magnet in the actuator can be turned non-invasively by use of the ERC. Rotation of the magnet causes the MAGEC rod to be lengthened or shorten.

The hand held non-invasive ERC is electrically powered. The ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and either lengthen or shorten the rod. Periodic lengthening of the rod is performed to distract the spine and to provide adequate bracing during growth to minimize the progression of scoliosis. 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 sterilizable, single use device, which is used in the operating room to test the device prior to implantation. 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 describes the MAGEC® Spinal Bracing and Distraction System and its premarket notification (K140178) to the FDA. The submission focuses on establishing substantial equivalence to a predicate device, the Harrington Rod System, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the context of a diagnostic AI product.

Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with specific metrics like sensitivity/specificity, and detailed ground truth establishment for training) cannot be extracted from the provided document as it pertains to a mechanical medical device rather than a diagnostic AI.

However, I can extract information related to the device's performance evaluation.

Here's the information that can be extracted and a clear statement about what cannot:

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

The document does not provide a table of numerically defined acceptance criteria for a diagnostic AI product. Instead, it describes performance in terms of mechanical and clinical outcomes for a spinal bracing system.

Category	Acceptance Criteria (Not explicitly defined as numerical targets for a diagnostic device)	Reported Device Performance
Non-Clinical Testing	Equivalent mechanical performance to predicate devices (Harrington Rod System). Compliance with relevant mechanical, sterilization, biocompatibility, electrical safety, EMC/EMI, software, and magnetic field safety standards.	- Static and Dynamic Mechanical Testing (ASTM F1717, ASTM F2627): "Results of these tests demonstrate the MAGEC Spinal Bracing and Distraction System can be expected to perform in a manner substantially equivalent to the predicate devices."- Shelf Life Packaging Validation (ISO 11607-1): Performed.- Sterilization (ANSI/AAMI/ISO 11137-2): "Verification that the gamma radiation sterilization process provides a sterility assurance level of 10-6."- Biocompatibility (ISO 10993-1): Performed.- Device functionality and verification: Performed.- Electrical Safety (IEC 60601-1): Performed.- Electrical Interference and Compatibility (EMC/EMI) (EN 60601-1-2): Performed.- Magnetic Field Safety (ICNIRP 2009): Performed.- Software (FDA Guidance (May 11, 2005)): Performed.
In Vivo (Animal) Study	Safe and efficient non-invasive distraction of the spine in an animal model.	- Porcine Model (9 male Yucatan pigs): "Results of the in vivo porcine study demonstrates that the MAGEC System is safe and provides an efficient means of non-invasive distraction of the spine. No complications from distraction occurred." Attempted and actual distraction were recorded.
Clinical Performance	Safety and probable benefit, including deformity correction, continued growth, and reduced need for subsequent surgical procedures, similar to traditional growing rods.	- Retrospective clinical study (outside US): "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."- Specific endpoints assessed: Cobb angle correction, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in number of subsequent surgical procedures, and weight gain.- Demonstrated ability for non-invasive adjustment to lengthen the implanted rod, allowing continued spinal growth and increased Thoracic Spine Height.

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

Test Set Sample Size:
- In Vivo (Animal) Study: 9 male Yucatan pigs (randomly assigned to two groups: 1 (MAGEC rod) and 2 (sham)).
- Clinical Study: Not explicitly stated, but described as a "retrospective clinical study for children who had either a primary or revision spinal bracing procedure using the MAGEC System."
Data Provenance:
- In Vivo Study: Porcine model (animal study).
- Clinical Study: "evaluated outside the United States" (retrospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies performed were primarily in vivo animal studies and a retrospective clinical study focusing on device performance and clinical outcomes, not on establishing ground truth for a diagnostic AI.

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

This information is not provided as it is not relevant to the type of device and studies described.

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 information is not provided as it is not relevant to the type of device (spinal bracing system) and evaluation presented. It's a study design typically used for diagnostic imaging AI.

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

This information is not provided as it is not relevant to the type of device described, which is a physical, implantable medical device, not a standalone diagnostic algorithm.

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

Non-Clinical and In Vivo Studies: Ground truth was based on physical measurements, functional specifications, and observation of physiological responses (e.g., distraction achieved, lack of complications) in controlled experimental settings.
Clinical Performance Data: Ground truth or "probable benefit" was assessed based on clinical outcomes data such as 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.

8. The sample size for the training set

This information is not provided as there is no mention of a "training set" in the context of an AI/algorithm-based device. The device is mechanical with non-invasive magnetic actuation.

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

This information is not provided as there's no training set for an AI in this context.

Summary

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July 29, 2022

Ellipse Technologies, Incorporated John McIntyre Vice President, Regulatory, Quality, and Clinical Affairs 13900 Alton Parkway Suite 123 Irvine, California 92618

Re: K140178

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 John McIntyre:

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 February 27, 2014. 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 903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

· February 27, 2014

Ellipse Technologies, Incorporated John McIntyre Vice President, Regulatory, Quality, and Clinical Affairs 13900 Alton Parkway Suite 123 Irvine, California 92618 US

Re: K140178

Trade/Device Name: MAGEC® Spinal Bracing and Distraction System Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: PGN Dated: January 23, 2014 Received: January 24, 2014

Dear Mr. McIntyre:

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 - Mr. John McIntyre

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 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" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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.

Sincerely yours,

Vincent J. Devlin -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140178

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (1/14)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

. . . . . . . . . .

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13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com

510(k) Summary

MAGEC® Spinal Bracing and Distraction System

Premarket Notification Number: K140178

Ellipse Technologies, Incorporated 1. Company: 13900 Alton Parkway, Suite 123 Irvine, CA 92618

Contact:

Date Prepared:

John McIntyre Vice President. RA/QA/CA Phone: (949) 837-3600 x203 Fax: (949) 837-3664 February 25. 2014

Proprietary Trade Name: MAGEC® Spinal Bracing and Distraction System

Non Fusion Growing Rod System 3. Common Name:

Classification Name: Unclassified (Product Code PGN, Growing Rod System -4. Magnetic Actuation)

Harrington Rod System, Preamendment 5. Predicate Device:

Product Description: The Ellipse Technologies, Inc. MAGEC Spinal Bracing and 6. Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia fixation components (i.e. Pedicle screws, hooks and/or connectors). The system includes a non-sterile hand held External Remote Controller (ERC) that is used at various times after implant to non-invasively lengthen the implanted spinal The implanted spinal rod is used to brace the spine during growth to minimize the rod. progression of scoliosis. The titanium rod (Ti-6Al-4V ASTM F136) includes an actuator portion

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13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com

that holds a small internal magnet. The magnet in the actuator can be turned non-invasively by use of the ERC. Rotation of the magnet causes the MAGEC rod to be lengthened or shorten.

Intended Use: The Ellipse MAGEC Spinal Bracing and Distraction System is 7. intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (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.

Substantial equivalence: Substantial equivalence to the preamendment Harrington Rod System is based on similar indications for use, technological characteristics, and on pre-clinical testing and clinical data.

Technological Characteristics: 9.

Both the MAGEC System and the predicate are spinal rods that have adjustable length, and are implanted on the posterior spine using hooks or screws. Both systems are manufactured of biocompatible metals and supplied sterile. The difference in the technological characteristics of the predicate device and the MAGEC System is the non-invasive distraction technology, which was previously cleared in Ellipse Orthopedic devices, K101997, K113695, K113219, K131677

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K140178 - Page 3 of 5 13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com

and K133289. This technological difference does not raise new types of issues of safety and effectiveness.

10. Non-Clinical Performance Data:

Non-clinical testing on the MAGEC System included Static and Dynamic Mechanical testing according to the methods outlined in the standard ASTM F1717 and ASTM F2627. Results of these tests demonstrate the MAGEC Spinal Bracing and Distraction System can be expected to perform in a manner substantially equivalent to the predicate devices.

In addition to mechanical testing, design functionality and verification, shelf life testing, validation of the gamma radiation sterilization cycle in accordance with the VDmar 20 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 106, and biocompatibility in accordance with ISO 10993-1 for the intended use of the device was performed.

The specific non-clinical tests that have been performed in order to establish equivalence to the predicate devices:

Test Description	Applicable Test Standard
Static Mechanical Testing	ASTM F1717
Dynamic Mechanical Testing	ASTM F2624
Shelf Life Packaging Validation	ISO 11607-1
Sterilization of healthcare products -- Radiation - Part 2:Establishing the sterilization dose	ANSI/AAMI/ISO 11137-2
Biocompatibility	ISO 10993-1
Device functionality and verification	None
Electrical Safety	IEC 60601-1
Electrical Interference and Compatibility (EMC/EMI)	EN 60601-1-2
Magnetic Field Safety	ICNIRP 2009
Software	FDA "Guidance for the Content of PremarketSubmissions for Software Contained in MedicalDevices" Issued May 11, 2005

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K140178 - Page 4 of 5

13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 Fax: 949-837-3664 www.ellipse-tech.com

In vivo animal studies were performed in the porcine model to evaluate the performance of the MAGEC System and verify that the MAGEC rod is safe and is able to perform per functional specifications. Nine male Yucatan pigs of similar age (mean of 7.2 mo.) were randomly assigned an identifying number and were assigned to one of two test groups designated Group 1 (MAGEC rod) and Group 2 (sham). All animals were of similar weight. Both groups were checked once each weeks for ten weeks to follow growth progress utilizing Fluoroscopy. For seven weeks post implantation, under sedation, attempted and actual distraction of the Ellipse implantable device (actuator) was recorded in Group I using the fluoroscopy images. X-ray and CT were performed post instrumentation implantation (before initial distraction), pre-implant removal, and prior to sacrifice. Results of the in vivo porcine study demonstrates that the MAGEC System is safe and provides an efficient means of non-invasive distraction of the spine. No complications from distraction occurred.

Clinical Performance Data: 11.

The safety and probable benefit of the 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 to those of traditional growing rods, the MAGEC System offers the

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K140178 - Page 5 of 5

13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com

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.

Conclusion: 12.

Conclusions can be drawn from these non-clinical and clinical 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.