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ARTFX SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as an anterior anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the ARTFX SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

-Degenerative dise disease (DDD) (defined as back pain of discogenic origin with degeneration of the dise confirmed by history and radiographic studies): .

-Spondylolisthesis;

• Trauma (i.e. fi acture or dislocation);
  -Spinal stenosis:

• -Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)

• Tumor:

• -Pseudoarthrosis; and Failed previous fusion

The Proposed system is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated screws , rods (Straight and pre-bent) , connectors , hooks and setscrews. The Artfx Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

ARTFX SPINAL FIXATION SYSTEM is supplied non-sterile, single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

The provided text describes the 510(k) premarket notification for the ArtFX Spinal Fixation System. It details the device's design, materials, indications for use, and performance testing relative to predicate devices. However, this document does not contain any information about an AI/ML-driven device, nor does it present any studies that involve acceptance criteria, performance metrics, ground truth establishment, or human reader studies typically associated with AI/ML medical devices.

The document primarily focuses on demonstrating substantial equivalence for a physical medical device (spinal fixation system) based on material properties, mechanical testing (ASTM F1717, F1798), and similarity in design and intended use to existing predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them for an AI/ML context using the provided text. The information required for your request (AI/ML performance, ground truth, sample sizes for AI training/testing, expert review, human-in-the-loop studies) is not present in this FDA clearance letter for a spinal implant.

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The Venus Cervical Plate System is intervertebral screw fixation of the cervical spine at levels C2-T 1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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

-Deformities or curvatures (including kyphosis, lordosis, or scoliosis)

-Pseudarthrosis

-Failed previous fusion

-Decompression of the spinal cord following total or partial cervical vertebrectomy

-Spondylolisthesis

-Spinal stenosis.

The Venus Cervical Plate System is supplied non-sterile, single use and are fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available. The Venus Cervical Plate System configurations ranging in lengths from 17 mm to the one-level plates, 27 mm to 40 mm for the two-level plates, 45 mm for the three-level plates, , and 70 mm to 90 mm for the four -level plates. All of the plate levels incorporate blocking mechanism to aid in prevention of bone screw back-out. The bone screws are provided with fixed angles available in self- tapping design. The fixed bone screws are inserted at a defined angle. The bone screws are offered in 3.5 mm, 4.0 mm and 4.50 mm diameters in lengths of 12 mm – 22 mm. The implants (bone screws and cervical plates) are provided as single-use, non-sterile devices manufactured from implantable grade titanium alloy (TI6Al4V-ELI).

The Venus Cervical Plate System is intended for use as an aid in cervical spinal fusion .

The Venus Cervical Plate System is supplied non-sterile, single use and are fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available.

The provided text is a 510(k) summary for the Venus Cervical Plate System, a medical device for spinal fixation. It details the device's indications for use, description, non-clinical testing, and comparison to predicate devices.

However, the document does not describe:

• Acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy.
• A study proving the device meets such acceptance criteria.
• Any information regarding a test set, data provenance, expert panels, adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment for diagnostic or clinical evaluation.
• Sample sizes for training sets or how ground truth for training sets was established.

The document focuses on the mechanical and material performance of the device, not its AI/software performance or diagnostic accuracy. The "Non-Clinical Testing" section describes engineering tests (e.g., Pull-out Test, Fatigue Test) to ensure the device's physical integrity and equivalence to predicate devices, which is typical for implantable orthopedic devices.

Therefore, I cannot fulfill your request for information related to AI/software performance, diagnostic accuracy, or clinical study methodologies (like MRMC studies, expert adjudication, etc.) based on the provided text. The information you're asking for would be relevant to software as a medical device (SaMD) or AI-enabled medical devices that involve image analysis, diagnosis, or prognostication, which is not what this document addresses.

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