(192 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 MAGEC 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 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. 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.
The provided documentation does not contain detailed acceptance criteria or a comprehensive study that proves a device meets specific acceptance criteria in the typical format of a clinical or performance study for a diagnostic or AI-powered device.
Instead, the document is a 510(k) summary for the MAGEC® Spinal Bracing and Distraction System, which is a medical device for treating severe spinal deformities in skeletally immature patients. The purpose of this 510(k) submission is to demonstrate substantial equivalence to a previously cleared predicate device, not to establish performance against new, specific acceptance criteria for a novel device.
The "acceptance criteria" presented here are inferred from the need to show substantial equivalence, primarily through mechanical testing and a comparison of clinical outcomes to those expected from growing rods.
Here's an attempt to extract the requested information based on the provided text, recognizing that it may not perfectly fit the structure of a typical AI/diagnostic device performance study:
Acceptance Criteria and Device Performance Study for MAGEC® Spinal Bracing and Distraction System (K140613)
The device, the MAGEC® Spinal Bracing and Distraction System, is demonstrated to be substantially equivalent to a predicate device (MAGEC Spinal Bracing and Distraction System, K140178) by showing similar indications for use, principles of operation, technological characteristics, and comparable performance through non-clinical testing and a retrospective clinical study of the predicate device.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the performance of the predicate device and the new device's ability to meet those standards.
| Acceptance Criteria (Implied by Substantial Equivalence to K140178) | Reported Device Performance (MAGEC® Spinal Bracing and Distraction System, K140613) and/or Predicate (K140178) |
|---|---|
| Mechanical Performance: | |
| - Withstand static loads (Modified ASTM F1717) | - Demonstrated sufficient performance in Static Mechanical Testing (Modified ASTM F1717). |
| - Withstand dynamic loads (Modified ASTM F1717) | - Demonstrated sufficient performance in Dynamic Mechanical Testing (Modified ASTM F1717). |
| - Design Verification and Validation | - Successful design verification and validation. |
| Functional Safety: | |
| - Biocompatibility (ISO 10993-1) | - Demonstrated biocompatibility (tests performed on predicate, applicable to K140613). |
| - Sterility (Gamma radiation sterilization, SAL 10^-1, ISO 11137-2 VDmax 35) | - Sterilization process validated for predicate (applicable to K140613). |
| - Shelf life | - Shelf life testing performed on predicate (applicable to K140613). |
| In Vivo Performance (Safety & Efficacy): | |
| - Safe operation in vivo | - In vivo porcine study on predicate showed safety; no complications from distraction occurred. |
| - Ability to perform per functional specifications (e.g., non-invasive distraction of spine) | - In vivo porcine study on predicate showed efficient non-invasive distraction. |
| Clinical Outcomes (Probable Benefit - based on retrospective study of predicate in humans): | |
| - Cobb angle correction in coronal plane | - Clinical study on predicate showed spinal deformity correction and maintenance, similar to traditional growing rods. |
| - Thoracic spine height increase | - Clinical study on predicate showed continued growth and thoracic spine height increase. |
| - Improvement in Space Available for Lung (SAL) | - Clinical study on predicate showed improved thoracic cavity symmetry (SAL). |
| - Reduction in number of subsequent surgical procedures (implied by non-invasive adjustment) | - Non-invasive adjustment capability of MAGEC System (both predicate and K140613) reduces need for regular surgical lengthening. |
| - Coronal and sagittal balance improvement (not explicitly stated as outcome, but generally expected for spinal deformity correction) | - Not explicitly detailed as an outcome in the summary, but implied by overall spinal correction. |
| - Weight gain (as an indicator of overall health/growth in children with TIS) | - Considered as an endpoint in the clinical study of the predicate. |
2. Sample size used for the test set and the data provenance
- Test Set (Clinical Data for Predicate): The document mentions a "retrospective clinical study for children" that evaluated the predicate MAGEC System. The exact sample size (N) is not specified in the provided text.
- Data Provenance: The retrospective clinical study was conducted outside the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a clinical outcomes study, not a study requiring expert consensus for ground truth on an AI or diagnostic device. The outcomes (e.g., Cobb angle, TBH) are typically measured objectively based on medical imaging and patient records.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a clinical outcomes study, not a study requiring adjudication of expert interpretations.
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 is not an AI-assisted diagnostic device, but a physical medical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the human clinical performance portion (retrospective study of the predicate): Outcomes data (e.g., Cobb angle correction, thoracic spine height increase, SAL improvement, reduction in subsequent surgeries, weight gain) based on clinical measurements and patient records.
For the non-clinical testing: Physical measurements and engineering standards (e.g., ASTM F1717 for mechanical tests, ISO standards for biocompatibility and sterilization).
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI or machine learning 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.