(57 days)
The Ellipse MAGEC 2 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.
The MAGEC 2 Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia9 fixation components (i.e. Pedicle screws, hooks and/or connectors). The implanted MAGEC 2 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 or ERC 2) that is used periodically after implantation to noninvasively distract the implanted spinal rod. The titanium MAGEC 2 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 distract the MAGEC 2 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 2 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 2 rod prior to implantation. The MAGEC Manual Distractor used with the MAGEC 2 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 2 rod. The ERC is placed over this location on the child's back.
The provided document describes the FDA 510(k) clearance for the MAGEC 2 Spinal Bracing and Distraction System. This is a medical device designed to treat severe progressive spinal deformities in skeletally immature patients. The document focuses on demonstrating substantial equivalence to an existing predicate device (MAGEC Spinal Bracing and Distraction System, K140613), rather than outlining explicit acceptance criteria with numerical thresholds. Therefore, the "acceptance criteria" presented are implied by the comparison to the predicate and the general requirements for safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a medical device (spinal rod) and not a software algorithm with quantitative performance metrics like accuracy, sensitivity, or specificity, the "acceptance criteria" are related to mechanical performance, sterilization, and biocompatibility, as compared to the predicate device. The document states that the MAGEC 2 System is substantially equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in the document) |
|---|---|
| Mechanical Performance (Static & Dynamic) | "Non-clinical testing on the MAGEC 2 System included Static and Dynamic Mechanical testing according to the methods outlined in the standard ASTM F1717..." |
| "The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include: |
- Static Mechanical Testing (ASTM F1717-14)
- Dynamic Mechanical Testing (ASTM F1717-14)"
"Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
| Wear Testing | "wear testing and particulate analysis according to the methods in the standards ASTM F2624 and ASTM F1877."
"The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include: - Wear Testing (ASTM F2624-12)"
"Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
| Particulate Analysis | "wear testing and particulate analysis according to the methods in the standards ASTM F2624 and ASTM F1877."
"The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include: - Particulate Analysis (ASTM F1877-05)"
"Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
| Sterilization Efficacy | "validation of the gamma radiation sterilization cycle in accordance with the VDmag 22 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 10-6."
"The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include: - Sterilization Validation (ANSI/AAMI/ISO 11137-2)"
"Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
| Biocompatibility | "The performance testing on the predicate device includes... biocompatibility in accordance with ISO 10993-1 for the intended use of the device." (Implied to be met for the new device as well due to material similarity and predicate equivalence.) |
| Design Verification | "design verification and validation."
"The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include: - Design Verification" (Standard not specified for Design Verification itself, but related to other standards.)
"Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
| Indications for Use Equivalence | "The MAGEC 2 System that is subject of this premarket notification and the predicate device have the same indications for use."
"Substantial equivalence to the predicate device is based on indications for use..." |
| Principles of Operation Equivalence | "Both the MAGEC 2 System and the predicate device are spinal rods that have adjustable length, and are implanted on the posterior spine using hooks or screws. Both devices operate on the same non-invasive distraction technology using the Ellipse External Remote Controller (ERC or ERC 2)."
"Substantial equivalence to the predicate device is based on... principles of operation..." |
| Technological Characteristics Equivalence | "The technological characteristics of the subject device and the predicate device are similar. Both systems are manufactured of the same biocompatible metals and supplied sterile by the same methods of gamma radiation. The differences between the two systems include the addition of a 6.0 mm diameter rod to the product offering, design modifications to remove structural welds and new design features."
"Substantial equivalence to the predicate device is based on... technological characteristics..."
"Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
| Similar Safety and Probable Benefit as Predicate Device | "Previous clinical performance data for the predicate MAGEC System is applicable to the MAGEC 2 System."
"The safety and probable benefit of the predicate MAGEC System was evaluated outside the United States in a retrospective clinical study..." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a new test set sample size for the MAGEC 2 System for clinical performance. Instead, it relies on the clinical performance data of the predicate MAGEC System.
- Sample Size: Not specified for the predicate device's clinical study beyond "children."
- Data Provenance: "evaluated outside the United States in a retrospective clinical study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The clinical study for the predicate device is described as a "retrospective clinical study," which would typically involve reviewing patient records, imaging, and outcomes. The "ground truth" for success in this context would be based on objective measurements (Cobb angle, thoracic spine height, SAL) and patient outcomes. It does not mention expert adjudication for establishing ground truth in the same way an AI diagnostic device would.
4. Adjudication Method for the Test Set
Not applicable/not specified. The clinical study was retrospective, relying on medical records and measurements.
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 device is a surgically implanted spinal rod system, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the predicate device's clinical study, the ground truth for "safety and probable benefit" was based on:
- Outcomes Data: Cobb angle correction, 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.
- Expert Clinical Assessment (Implied): While not explicitly stated as "expert consensus," the evaluation of these parameters and overall patient outcomes would inherently involve clinical expertise.
For the non-clinical tests of the MAGEC 2 System, the "ground truth" was established by conformance to established ASTM and ISO standards for mechanical performance, wear, particulate analysis, and sterilization.
8. The Sample Size for the Training Set
Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as above.
§ 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.