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GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.

GPS Advanced is a sterile, single use dispensing system for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The instrument system includes 1) a dispenser with a ratcheted plunger that advances with each squeeze of its handle and 2) two 5 cc GPS Advanced Cannulas which can be attached to the dispenser to deliver FIBERGRAFT™ BG Putty GPS. The 5 cc GPS Advanced Cannula (hereafter referred to as "GPS Advanced Cannula") is also available individually packaged. GPS Advanced and GPS Advanced Cannula are provided sterile via irradiation. GPS Advanced Cannulas are provided empty and need to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.

The provided document does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it relates to performance with AI.

The document is a 510(k) premarket notification for a medical device called "GPS Advanced; 5 cc GPS Advanced Cannula," which is a dispensing system for a bone graft substitute. The review focuses on the substantial equivalence of this device to legally marketed predicate devices, primarily regarding its mechanical and material characteristics, sterility, usability, and packaging.

The relevant section, "H. Performance Data," lists the following evaluations:

• Biological Risk Assessment
• Sterilization Validation
• Usability Engineering Evaluation
• Packaging and Shelf Life Testing, including functional evaluation

These are standard engineering and safety tests for a medical device that does not involve AI.

Therefore, I cannot provide the requested information regarding acceptance criteria for AI performance or a study demonstrating such performance.

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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.

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