(84 days)
The ARx Modular Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scollosis. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When used as a posterior spine thoracic/lumbar system, the ARx Modular Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.
In order to achieve additional levels of fixation in skeletally mature patients, the ARx Modular Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.
The ARx Modular Spinal System consists of an assortment of rods, modular tulips, and offset connectors. The tulip head and taper lock are assembled during manufacturing to create the modular tulip assembly. The ARx Modular Spinal System implant components are made from titanium alloy (Ti- 6Al-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) per ASTM F1537.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the ARx Modular Spinal System components with components from any other system or manufacturer.
The provided text describes a 510(k) premarket notification for a medical device called the "ARx Modular Spinal System." This submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices based on design, materials, indications for use, and mechanical performance testing.
Crucially, this document does NOT describe the acceptance criteria or a study proving that an AI/algorithmic device meets these criteria. The device in question is a physical spinal implant system, not an AI or software as a medical device (SaMD).
Therefore, I cannot answer the requested questions about acceptance criteria for an AI/algorithmic device, sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these concepts are not applicable to the information provided in the document.
The document discusses:
- Device: ARx Modular Spinal System (spinal implant).
- Purpose: Posterior pedicle screw fixation for the spine.
- Materials: Titanium alloy and cobalt chrome.
- Testing: Mechanical performance testing (e.g., Static Axial Compression Bending Testing, Dynamic Compression Bending Testing) according to ASTM standards (F1717, F1798 & F5436-01) to demonstrate substantial equivalence to predicate devices.
- Conclusion: The device is substantially equivalent to predicate devices.
To answer your request, the provided input does not contain the information needed regarding acceptance criteria and performance studies for an AI/algorithmic medical 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.