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TDM Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, who have had six months of non-operative treatment. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft. TDM Lumbar Interbody Fusion Cage System is to be used with supplemental fixation.

The TDM Lumbar Interbody Fusion Cage System (EVERGREEN PEEK PLIF Cage, LIME PEEK TLIF Cage, and PORTIA HYBRID TLIF cage) consists of intervertebral body fixation devices intended for use as an aid in spinal fixation. This system is fabricated and manufactured from PEEK as described by ASTM F2026. The Tantalum and Titanium marker used for this product is made to the voluntary standard of ASTM F560 and ASTM F136. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The EVERGREEN PEEK PLIF Cages are to be implanted via posterior approach. Two PLIF PEEK cages are placed on each side of the interbody space (right and left). The LIME PEEK TLIF Cages and PORTIA HYBRID TLIF cages are dedicated to transforaminal approach. TLIF technique involves placing only one bone graft spacer in the middle of the interbody space, without retraction of the spinal nerves.

The provided document is a 510(k) summary for the TDM Lumbar Interbody Fusion Cage System, a medical device used in spinal fusion procedures. It outlines the device's intended use, technological characteristics, and a comparison to predicate devices, focusing on non-clinical performance testing.

Crucially, this document does not contain information about a study proving that an AI/software device meets acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). The performance data section explicitly states: "Non-clinical testing was performed to demonstrate that the subject TDM Lumbar Interbody Fusion Cage System is substantially equivalent to the predicate device. The following testing was performed in accordance with the ASTM F2077, and ASTM F2267: - Static Axial Compression - Dynamic Axial Compression - Static Torsion - Static Shear - Dynamic Shear - Subsidence."

These are mechanical and biocompatibility tests for a physical implantable device, not performance studies for an AI/software as a medical device (SaMD) that would have diagnostic accuracy metrics.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria for an AI/software device based on the provided text. The document is for a physical orthopedic implant.

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The Goblin and Goblin LS Pedicle Screw Systems are intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications:

• · Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• · Spondylolisthesis;
• · Trauma (i.e., fracture or dislocation);
• Spinal stenosis;
• · Curvatures (i.e., scoliosis, kyphosis and/or lordosis);
• · Tumor and pseudarthrosis

The Goblin and Goblin LS Pedicle Screw Systems are top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, set screws, connectors, and transverse (cross) linking mechanisms. The implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F136. Various sizes of these implants are available.

The provided text is a 510(k) summary for the "Goblin and Goblin LS Pedicle Screw Systems." It describes a traditional medical device (pedicle screw systems for spinal fixation), not an AI/ML medical device. Therefore, the acceptance criteria and study information typically provided for AI/ML device validation (e.g., sample size for test/training sets, adjudication methods, expert qualifications, MRMC studies, standalone performance, ground truth establishment) are not applicable and are not present in this document.

The performance data section for this device focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices, specifically:

• Non-clinical testing performed in accordance with ASTM F1717:
  • Static compression
  • Dynamic compression
  • Static Torsion

This type of testing evaluates the mechanical integrity and performance of the physical implants, which is standard for pedicle screw systems.

Therefore, it is impossible to extract the requested information regarding acceptance criteria and studies that prove an AI/ML device meets those criteria from the provided document. The document concerns a hardware medical device.

Ask a specific question about this device