(312 days)
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.
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 or shorten 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 includes an actuator portion that holds a small internal 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 shortened.
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 during a distraction procedure.
The provided document is a 510(k) summary for the Ellipse MAGEC® Spinal Bracing and Distraction System, focusing on the inclusion of a second-generation External Remote Controller (ERC 2). The submission aims to demonstrate substantial equivalence to a previously cleared MAGEC System (K140178).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or precision). Instead, it relies on demonstrating that the ERC 2 performs equivalently to its predicate device through design functionality, safety, and compatibility testing. The "reported device performance" is essentially the successful completion of these tests, showing the ERC 2 meets the standards set for medical devices of its type and performs as intended.
| Test/Document Description | Applicable Test Standard / Performance Demonstrated |
|---|---|
| Risk Management Report | EN ISO 14971: Non-clinical performance data indicates "no new risks identified with the ERC 2." |
| Electrical Safety | IEC 60601-1 (3rd edition): Testing performed to demonstrate electrical safety. The results of testing demonstrate that the ERC 2 meets the intended use and performance specifications. |
| Electromagnetic Compatibility and Interference | IEC 60601-1-2: Testing performed to demonstrate electromagnetic compatibility. The results of testing demonstrate that the ERC 2 meets the intended use and performance specifications. |
| Design Verification Testing | N/A (in-house developed test methodologies): Testing performed to demonstrate "suitability of the device for its intended use" and that it "meets the intended use and performance specifications." The ERC 2 was designed to improve ergonomic handling and user interfaces while maintaining the same methods and principles of operation as the first generation ERC. |
| Software Validation | FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: Validation performed to ensure software functionality and safety. The results of testing demonstrate that the ERC 2 meets the intended use and performance specifications. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "in vitro evaluations" and "non-clinical testing" for the ERC 2. It does not specify a "test set" in the context of patient data or clinical trials with a defined sample size. The testing described is primarily engineering and performance verification of the device components.
For the clinical performance data, the document states: "The retrospective clinical study performed on the MAGEC System and previously submitted is also applicable to the ERC 2 and this submission."
- Sample Size: Not specified in the provided text.
- Data Provenance: Retrospective, as explicitly stated. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable and not provided. The non-clinical testing for the ERC 2 focuses on engineering specifications and safety standards, not on diagnostic accuracy requiring expert interpretation of results. The previous retrospective clinical study supporting the MAGEC system (not the ERC 2 specifically) would have involved clinical assessments, but details on ground truth establishment and expert involvement are not in this document.
4. Adjudication Method for the Test Set:
Not applicable and not provided, as the testing described for the ERC 2 doesn't pertain to diagnostic accuracy where adjudication of expert opinions would be relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study is not mentioned in the context of this 510(k) submission. This submission focuses on the safety and performance of a device component (ERC 2) and its substantial equivalence to a predicate, not on the comparative effectiveness of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable to the device described. The MAGEC system is a physical implant and an external controller (ERC 2), not a standalone algorithm. The ERC 2 is a human-operated device used to interact with the implanted rod.
7. The Type of Ground Truth Used:
For the non-clinical testing of the ERC 2 (electrical, EMC, design verification, software validation), the "ground truth" is defined by the relevant engineering standards (EN ISO 14971, IEC 60601-1, IEC 60601-1-2) and FDA guidance for software. The device's performance against these established benchmarks serves as the "truth." For the retrospective clinical study mentioned, the type of ground truth used is not specified in this document, but would typically involve clinical outcomes or expert diagnoses.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. The ERC 2 is a hardware device with embedded software, not a machine learning model that requires a "training set" in the conventional sense of AI development.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" in the context of an AI/ML model for this device.
§ 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.