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The Magnes-C™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

The Magnes-C™ Anterior Cervical Plate System components are intended for anterior screw fixation and stabilization of the cervical spine during the development of cervical interbody spinal fusion. The Magnes-C™ Anterior Cervical Plate System consists of one through three-level plates and fixed and variable screws, in a variety of sizes to accommodate individual patient anatomy. The Magnes-C components are provided nonsterile. Instruments to facilitate unilateral anterior fixation are included.

The provided text describes a medical device, the Magnes-C Anterior Cervical Plate System, and its clearance by the FDA. However, it does not include information about acceptance criteria for an AI/ML powered device, nor a study proving meeting such criteria. Instead, it details the indications for use, device description, materials, and mechanical testing results to demonstrate substantial equivalence to predicate devices for a spinal implant.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study for an AI-powered device based on the given text.

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The SpineNet SSP System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

The SpineNet SSP System is an anterior cervical plate and screw system which includes fixed and variable self-tapping screws and one- through four level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided document is a 510(k) Premarket Notification from the FDA regarding the SpineNet SSP System. It confirms the device's clearance and substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML powered device.

The document primarily focuses on the mechanical testing of the implant device itself (spinal intervertebral body fixation orthosis), confirming its mechanical performance is substantially equivalent to predicate devices.

Therefore, it is not possible to complete the requested table or answer the questions related to AI/ML device performance and validation based on the provided text. The document refers to "Performance Data" which states: "Mechanical testing of the worst case SpineNet SSP System construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion. The mechanical test results demonstrate that the SpineNet SSP System device performance is substantially equivalent to the predicate devices." This clearly indicates a physical device, not a software or AI/ML product that would require the type of performance evaluation outlined in your request.

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The Curiteva Midline Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.

The Curiteva Midline Anterior Cervical Plate System consists of screws and plates. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy. All implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136 and are provided non-sterile.

The provided text is a 510(k) summary for the Curiteva Midline Anterior Cervical Plate System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical performance data. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, particular performance metrics, details of a study that proves the device meets those criteria, sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies (MRMC or standalone AI performance).

Therefore, I cannot fulfill the request as the essential information is not present in the provided document.

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through mechanical testing for implantable devices like the one described. It typically does not involve clinical studies with human readers or AI algorithms in the way the prompt's questions suggest.

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