(256 days)
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.
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.
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.
§ 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.