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The DeGen Medical Cyclop™ Anterior Cervical Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™ Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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)
• · Spinal Stenosis
• · Trauma (i.e. fracture or dislocation)
• · Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
• Spinal Tumors
• Pseudoarthrosis or failed previous fusion
• · Spondylolisthesis
• · Decompression of the spinal following total or partial cervical vertebrectomy

The DeGen Medical Cyclops™ Anterior Cervical Plate Systems (CACP) consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The CACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options. The system is provided non-sterile and is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The purpose of this submission is to add additional two-level plate lengths to the Cyclops™ Anterior Cervical Plate System

The provided document does not contain information regarding a study that proves a device meets acceptance criteria related to AI or algorithm performance.

Instead, this document is an FDA 510(k) clearance letter for a medical device called the "Cyclops™ Anterior Cervical Plate System." This system is described as an implantable device used for spinal fusion and stabilization in the cervical spine.

The document discusses:

• Device Name: Cyclops™ Anterior Cervical Plate System
• Regulation Number and Name: 21 CFR 888.3060, Spinal intervertebral body fixation orthosis
• Regulatory Class: Class II
• Indications for Use: Aid in cervical spinal fusion, temporary stabilization of the anterior spine for various conditions (Degenerative Disc Disease, Spinal Stenosis, Trauma, Deformity, Spinal Tumors, Pseudoarthrosis, Spondylolisthesis, Decompression).
• Substantial Equivalence: The clearance is based on the device being substantially equivalent to previously cleared predicate devices (K191786 Cyclops™ Anterior Cervical Plate System and K150759 DeGen Medical Hyper-C Anterior Cervical Plate System). The equivalence is established through comparison of design, intended use, material composition, function, and range of sizes.
• Non-Clinical Performance Testing: A risk review was conducted on existing verification and validation data for the Cyclops™ Anterior Cervical Plate System regarding the addition of two-level plates. The conclusion was that no impacts to safety or effectiveness would result.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/algorithm-based device as this document is for a physical implantable medical device, not a software or AI product.

The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are relevant for evaluating AI/ML-based medical devices, but not for the type of device described in this 510(k) summary.

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The DeGen Medical Cyclops™ Anterior Cervical Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™ Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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)
• Spinal Stenosis .
• Trauma (i.e. fracture or dislocation) .
• Deformity or curvatures (including scoliosis, kyphosis, or lordosis) .
• . Spinal Tumors
• Pseudoarthrosis or failed previous fusion .
• Spondylolisthesis .
• Decompression of the spinal following total or partial cervical vertebrectomy .

The DeGen Medical Cyclops™ Anterior Cervical Plate Systems (CACP) consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The CACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options. The system is provided non-sterile and is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The provided text is a 510(k) summary for a medical device, the DeGen Medical Cyclops™ Anterior Cervical Plate System. It describes the device's intended use, technological characteristics, and non-clinical performance testing. However, this document does not contain information about an AI/ML-based medical device. Therefore, it is not possible to describe acceptance criteria or a study proving an AI/ML device meets those criteria from this text.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, function, and mechanical performance rather than clinical performance or AI algorithm assessment.

Therefore, I cannot fulfill the request as the core information regarding an AI/ML device's acceptance criteria, performance study details, ground truth establishment, or human-in-the-loop analysis is absent from the provided text.

Ask a specific question about this device