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The Insignia™ Anterior Cervical Plate System is intended for anterior screw fixation to the C2-T1) for the following indications: degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The Insignia Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The Insignia Anterior Cervical Plate System consists of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to ASTM F136 and are offered non-sterile. The instruments in this system are intended for use in surgical procedures. This submission seeks clearance for redesigned Insignia plates and screws.

This is a 510(k) premarket notification for a medical device (Insignia™ Anterior Cervical Plate System), not an AI/ML medical device. Therefore, the information typically requested regarding acceptance criteria and performance studies for an AI/ML device (e.g., sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance) is not applicable or present in this document.

The provided document describes a spinal implant and its mechanical testing to demonstrate substantial equivalence to a predicate device. It explicitly states under "Clinical Information": "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document focuses on:

• Device Description: Spinal plates and screws made from titanium alloy.
• Intended Use: Anterior screw fixation to the cervical spine (C2-T1) for various spinal conditions.
• Technological Comparison: Demonstrating substantial equivalence to predicate devices in intended use, indications, design, function, and technology.
• Performance Data (Nonclinical): Mechanical testing (static compression, static torsion, dynamic compression, screw push-out) according to ASTM F1717 and FDA guidance for spinal plating systems.

No information about AI/ML algorithms, image analysis, diagnostic performance, or human-in-the-loop studies is present.

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The Insignia™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The Insignia Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The Insignia Anterior Cervical Plate System consists of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to ASTM F136 and are offered non-sterile. The instruments in this system are intended for use in surgical procedures.

The provided document, a 510(k) summary, describes a medical device called the "Insignia™ Anterior Cervical Plate System" and its substantial equivalence to predicate devices. However, this document does not contain the kind of information typically found in a study proving a device meets acceptance criteria for an AI/ML-based diagnostic or assistive technology.

The document is for a physical medical implant, a spinal fixation system, and the "performance data" section refers to nonclinical mechanical testing (e.g., static and dynamic compression, torsion testing) to demonstrate its physical performance and substantial equivalence to existing devices. It explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance (e.g., accuracy, sensitivity, specificity, reader improvement, ground truth methodology) because the document describes a purely mechanical device, not a diagnostic or AI-driven one.

The prompt's requirements (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the loop performance)," "type of ground truth used") are specific to AI/ML device evaluations, which are not relevant to this 510(k) submission for a spinal plate system.

Ask a specific question about this device