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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.

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