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The Proficient® Posterior Cervical Spine System is intended to immobilize the spine as an adjunct to fusion for cervical (C1-C7) and thoracic (T1-T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies and degenerative disease of the facets with instability. The Proficient® Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient® Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient® transition rods.

The modified Proficient® Posterior Cervical Spine System consists of a selection of non-sterile, single-use polyaxial screws, locking screws, rods, and connectors manufactured from titanium per ASTM F136 and ASTM F67 and cobalt-chrome alloys per ASTM F1537 and ASTM F1058. The rods, screws, and connectors are attached to the cervicothoracic spine of skeletally mature patients to stabilize the spine during fusion of vertebral bodies.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Proficient® Posterior Cervical Spine System." This document primarily focuses on establishing substantial equivalence to a predicate device based on material composition, design, and mechanical performance testing.

Crucially, this document does NOT describe the acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device.

The questions you've asked (about sample size, expert ground truth, MRMC studies, standalone performance, etc.) are highly relevant to the validation of AI/ML-driven medical devices, especially for image analysis or diagnostic support. However, this FDA submission pertains to a physical orthopedic implant, specifically a spinal fixation system. Its "performance data" refers to mechanical testing (e.g., dynamic axial compression bend testing, dynamic torsional testing, and axial grip testing) to ensure the physical device can withstand anticipated forces in the human body, not to the performance of an algorithm or diagnostic accuracy.

Therefore, I cannot extract the information requested from the provided text as it does not contain the type of study design and performance metrics relevant to an AI/ML medical device.

To answer your request, if this were an AI/ML medical device submission, the provided information would be insufficient. Based on the document, here's what can be inferred:

• Type of Device: Physical spinal implant (Proficient® Posterior Cervical Spine System).
• Purpose of Submission: To gain clearance for the addition of new components and a modification to instrumentation for an already cleared device.
• Key Clearance Mechanism: Substantial Equivalence to a predicate device (K172594 - Proficient® Posterior Cervical Spine System by Spine Wave, Inc.).
• Performance Data Mentioned: Dynamic axial compression bend testing, dynamic torsional testing, and axial grip testing. These are mechanical tests for the implant's structural integrity.

Therefore, a direct answer to your specific questions, as if this were an AI/ML device, cannot be provided from this document.

Ask a specific question about this device

The Proficient® Posterior Cervical Spine System is intended to immobilize the spine as an adjunct to fusion for cervical (C1-C7) and thoracic (T1- T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radios and degenerative disease of the facets with instability. The Proficient® Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient® Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient® transition rods.

The subject Proficient® Posterior Cervical Spine System consists of a selection of non-sterile, single-use polyaxial screws, locking screws, rods, and connectors manufactured from titanium per ASTM F136 and ASTM F67 and cobalt-chrome allovs per ASTM F1537 and ASTM F1058. The rods, screws, and connectors are attached to the cervicothoracic spine of skeletally mature patients to stabilize the spine during fusion of vertebral bodies.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device (e.g., an AI-powered medical device) meets those criteria.

The document is a 510(k) premarket notification for a medical device called the "Proficient® Posterior Cervical Spine System," which is a spinal implant. It describes the device, its intended use, comparison to predicate devices, and mechanical performance testing to demonstrate substantial equivalence, such as:

• Dynamic axial compression bend testing
• Dynamic torsional testing
• Static and axial grip testing

This type of testing is to ensure the mechanical integrity and performance of the physical implant, not to validate criteria for an AI or software-based medical device as your request implies.

Therefore, I cannot extract the information required in your request, such as sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, or training set details, because this document is about a surgical implant and not a software/AI device.

Ask a specific question about this device