(237 days)
ELLIPSE posterior osteosynthesis system is intended to use in the non cervical spine. When use as a pedicle screw fixation system, ELLIPSE is Intended for patients: a) having severe spondylollsthesis (grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; b) who are receiving fusions using autogenous bone graft only; c) who are having the device fixed or attached to the lumbar and sacral spine and d) who are having the device removed after the development of a solld fusion mass.
When use as a pedicle screw fixation system, ELLIPSE is also 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 (T1- S1): degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scollosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
ELLIPSE posterior osteosynthesis system includes pedicular screws, spondylolistesis screws longitudinal rods and transverse connector rods, connector and nut. All components of ELLIPSE posterior osteosynthesis system are made of TA6V4ELI conforming to ISO 5832.3 and ASTM F 136. ELLIPSE components are supplied either sterile or not sterile and with a complete set of surgical instruments.
The provided text describes a medical device, the ELLIPSE Lumbar posterior osteosynthesis system, and its premarket notification (510(k)) to the FDA. The information focuses on the device's design, intended use, and its substantial equivalence to predicate devices, supported by mechanical testing. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of diagnostic accuracy or clinical effectiveness in a human-in-the-loop or standalone AI context.
The document details the following regarding performance:
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Acceptance Criteria and Reported Device Performance: This section is not applicable in the provided text as it refers to a medical device for surgical implantation, not a diagnostic or AI-driven decision support system. The "performance data" mentioned refers to the device conforming to special controls for pedicle screw spinal systems and mechanical testing per ASTM 1717.
Acceptance Criteria Reported Device Performance Not applicable Conforms to special controls for Pedicle screw spinal system and "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on May 3, 2004. Mechanical testing was conducted per ASTM 1717. -
Sample size used for the test set and the data provenance: Not applicable. The document discusses a physical medical device, not a software or AI-driven system that would involve test sets of data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment is relevant for AI or diagnostic devices, not for a spinal osteosynthesis system.
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Adjudication method for the test set: Not applicable.
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Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating the impact of AI assistance on human reader performance, which doesn't apply to this physical medical device.
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Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable. This applies to AI algorithms, not a physical medical implant.
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Type of ground truth used: Not applicable.
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Sample size for the training set: Not applicable. The device is a surgical implant, not an AI model.
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How the ground truth for the training set was established: Not applicable.
Summary of available performance information for the ELLIPSE Lumbar posterior osteosynthesis system:
The performance data provided relates to the mechanical properties and regulatory compliance of the implant, not to a diagnostic or AI-based system.
- Conformance to Special Controls: The device conforms to special controls established for Pedicle screw spinal systems.
- Guidance Compliance: It complies with the "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on May 3, 2004.
- Mechanical Testing: Mechanical testing was conducted per ASTM 1717. This standard likely evaluates properties such as implant strength, fatigue characteristics, and resistance to various forces relevant to spinal fixation devices. The specific results of these tests (e.g., specific load capacities, fatigue life) are not detailed in the provided summary but are implied to have met acceptable standards for the device to be cleared.
- Substantial Equivalence: The device is considered substantially equivalent to its predicate devices (SYNERGY (K011437) and XIA Spinal system (K013823)) in terms of intended use, material, design, mechanical properties, and function. This equivalence is based on the ASTM 1717 testing, suggesting its performance is comparable to already marketed devices.
§ 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.