Search Results

The Curiteva Porous PEEK Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Porous PEEK Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The Curiteva Porous PEEK Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary.

All system components are manufactured from Titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026.

The Curiteva Porous PEEK Laminoplasty implants are sterile, single-use devices and available in a variety of different sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants have solid and porous PEEK regions.

The Curiteva Porous PEEK Laminoplasty implants are manufactured from implant-grade PEEK (per ASTM F2026). Each porous PEEK implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The provided text is a 510(k) Premarket Notification from the FDA regarding the Curiteva Porous PEEK Laminoplasty System. This document is a clearance letter for a medical device and does not contain information about an AI/ML (Artificial Intelligence/Machine Learning) device or its performance study.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves an AI/ML device meets those criteria, as the input document is not about such a device. The key information points requested (test set sample size, data provenance, expert panels, adjudication, MRMC studies, standalone performance, ground truth establishment, training set details) are specific to the validation of AI/ML models, which is not discussed in this medical device clearance document.

Ask a specific question about this device

The Curiteva Porous PEEK Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 - S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment with the device.

The Curiteva Porous PEEK Lumbar Interbody Fusion System implants are sterile, single-use devices and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally rectangle-shaped with an open central corridor to permit packing with bone graft to facilitate fusion. The implants have a dense outer ring with a porous structure lining the central graft corridor. The lateral sides of the implant may contain additional porous structures to allow for improved vascularization of the graft site to aid in fusion.

The Curiteva Porous PEEK Lumbar Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136). Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The provided document is a 510(k) premarket notification for a medical device called the "Curiteva Porous PEEK Lumbar Interbody Fusion System." This document does not pertain to an AI/ML powered device, and therefore, does not contain information about acceptance criteria, study details, or other parameters typically associated with the evaluation of AI/ML devices.

The document discusses the substantial equivalence of the new device to previously cleared predicate devices based on:

• Indications for Use: Treatment of degenerative disc disease (DDD) in the lumbar spine.
• Design Principles: Rectangle-shaped implants with an open central corridor for bone graft, a dense outer ring, and porous structures.
• Material Composition: Implant-grade PEEK with Titanium alloy markers and a hydroxyapatite (HA) coating.
• Performance Testing: Static and dynamic axial compression, static and dynamic compression-sheer, subsidence, expulsion, and particle characterization according to ASTM standards.

The document concludes that the Curiteva Porous PEEK Lumbar Interbody Fusion System is substantially equivalent to the predicate devices and is as safe, effective, and performs as well as, or better than, the predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the provided text.

Ask a specific question about this device