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InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients.
InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

The InFill® V2 Lateral is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient.

The InFill® V2 Lateral is provided sterile, for single use only.

The provided text describes a 510(k) premarket notification for an intervertebral body fusion device and does not contain information about the acceptance criteria and study proving device performance in the context of an AI/ML powered medical device. The document pertains to a physical medical implant (InFill® Interbody Fusion Device) and its substantial equivalence to a predicate device based on material, design, and mechanical testing (Finite Element Analysis).

Therefore, I cannot extract the information required for the provided questions as they are specific to AI/ML device performance studies, which are not present in this document.

The document discusses:

• Device Name: InFill® Interbody Fusion Devices
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral body fusion device
• Regulatory Class: Class II
• Product Code: MAX
• Predicate Device: InFill® Interbody Fusion Device (K151184)
• Device Description: Radiolucent implantable device manufactured from PEEK and tantalum, available in various sizes.
• Indications for Use: Intervertebral body fusion of the spine in skeletally mature patients (L2 to S1), used with autogenous bone graft and supplemental internal spinal fixation systems, for degenerative disc disease (DDD) with up to Grade I spondylolisthesis.
• Technical Characteristics: Comparison showing minor changes in lengths, widths, and marker diameter compared to the predicate device, but similar shape, surface features, bone graft support, primary material, surgical approach, and surface geometry.
• Performance Data: A Finite Element Analysis (FEA) was performed to assess the new device. It evaluated axial compression, static subsidence, and fatigue failure. The analysis concluded that the new device (InFill® V2 Lateral) showed lower principal stresses compared to the predicate and met specified criteria, demonstrating substantial equivalence without raising new safety or performance questions.

None of the questions about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, ground truth type, training set size, training set ground truth) are applicable to the information provided in this document, as it is not about an AI/ML medical device.

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