(76 days)
The MAGEC® 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.
The MAGEC System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® Reline® 4.5-5.0 (Reline Small Stature) or Armada® 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 non-sterile hand held External Remote Controller (ERC) 1 or 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 magnet in the actuator can be turned non-invasively 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 either distract or retract the 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, MAGEC Rod Template, 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 Rod Template is a sterile, single-use accessory used for intraoperative planning of the surgical procedure. 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 previously implanted in a patient.
The provided documents describe the MAGEC® System, a non-fusion growing rod system for pediatric spinal deformities. The information included focuses on the FDA 510(k) submission for this device, which aims to demonstrate substantial equivalence to previously cleared predicate devices.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments by AI |
|---|---|---|
| Pyrogenicity Test (LAL Kinetic Turbidimetric Assay) | "Pyrogen testing was performed on the subject device to ensure it meets the pyrogen limit specifications for sterile implant devices." | The documentation explicitly states that the device meets pyrogen limit specifications. This suggests a pass/fail criterion for pyrogen levels, but the specific numerical limits are not provided. |
| Static Compression Bending (ASTM F1717-15) | "The results demonstrate that the subject MAGEC System is substantially equivalent to the predicate." | While the general conclusion is given, the specific loads, displacements, or failure modes, and how they compare numerically to the predicate device or a defined threshold, are not detailed. |
| Static Torsion (ASTM F1717-15) | "The results demonstrate that the subject MAGEC System is substantially equivalent to the predicate." | Similar to static compression bending, specific numerical performance metrics are not provided. |
| Dynamic Compression Bending (ASTM F1717-15) | "The results demonstrate that the subject MAGEC System is substantially equivalent to the predicate." | Again, specific numerical performance metrics and their comparison to a predicate or standard are not included in this summary. |
| Mechanical Performance (overall) | "Nonclinical testing was performed to demonstrate that the subject MAGEC System is substantially equivalent to the predicate device." | This is a general statement. Substantial equivalence for mechanical properties implies that the new device's performance is either similar to or better than the predicate's, and does not raise new questions of safety or effectiveness. The specific threshold for "similar" is not defined here. |
Important Note: The provided document is a 510(k) summary, which is typically a high-level overview. It often summarizes the conclusions of testing rather than providing detailed raw data or specific numerical acceptance limits for each test. For a full understanding of the acceptance criteria, one would need to review the complete testing protocols and reports submitted to the FDA, which are not included here.
Study Information
Based on the provided text, the following information can be extracted or inferred:
-
Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample sizes (number of devices or tests performed) for the mechanical (static and dynamic) or pyrogenicity tests. It only lists the types of tests.
- Data Provenance: The studies were nonclinical (bench testing) performed by the manufacturer, NuVasive Specialized Orthopedics, Incorporated. The country of origin for the data is not explicitly stated but would presumably be the US where NuVasive is located. These are not clinical studies with human subjects or retrospective/prospective human data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was a nonclinical, bench-testing study to evaluate mechanical and biological safety (pyrogenicity) properties, not a study involving human readers or expert evaluation of images/data for ground truth establishment.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically relevant for clinical studies where multiple experts assess cases and their agreement or disagreement needs to be resolved. This document describes nonclinical engineering and safety testing.
-
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:
- No. An MRMC study was not done. This device is a surgical implant system, not an AI-powered diagnostic or assistive tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This device is a physical medical device (implant and external controller), not an algorithm or AI system.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Standards and Safety Limits. The "ground truth" for the nonclinical tests were the specifications and criteria defined by the relevant ASTM and ANSI/AAMI standards (e.g., ASTM F1717-15 for spinal implant constructs, ANSI/AAMI ST72 for bacterial endotoxins). For "substantial equivalence," the performance of the device was compared directly to that of the predicate device, implying the predicate's performance served as a benchmark for acceptable "truth."
-
The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device, so there is no "training set."
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML algorithm.
§ 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.