Search Results

The Idys® PLIF cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L3 to S1. The Idys® PTLIF, Idys® TLIF cages are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a posterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The Idys®-LIF cages, which have various widths and heights, are designed for use as a lumbar interbody fusion device. The device has to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device can contain one or more slots to receive the autologous bone graft to promote the fusion process between the endplates. The superior and inferior surfaces of the implant are designed with a rough surface which interact with the surface of the vertebral endplates and help in resisting back out. The Idys®-LIF cages are made of compliant ASTM F2026 polyetheretherketone (PEEK) with markers made of compliant ASTM F560 Tantalum for PLIF and PTLIF, made of compliant ASTM F560 Tantalum and made of compliant ASTM F136 Titanium alloy for TLIF. It is essential to insert implants with instrumentation specifically designed for this purpose.

The provided text describes a 510(k) premarket notification for a medical device called "Idys® LIF," an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical studies with acceptance criteria for device performance as would be seen in a de novo or PMA submission for a novel device or software.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/software performance.

Here's a breakdown of why the requested information is absent and what is provided:

Why the requested information is not present:

• No AI/Software Component: The device is a physical intervertebral body fusion cage. There is no mention of any AI or software component in its design, operation, or intended use that would require the types of performance studies (e.g., diagnostic accuracy, reader study) implied by your prompt.
• Submission Type: A 510(k) demonstrates substantial equivalence. For physical devices like this, performance testing typically involves bench testing (mechanical, biocompatibility) against recognized standards to ensure the device performs as intended and is comparable to predicate devices. It does not involve human reader studies or ground truth establishment in the way AI/software performance studies would.
• Focus of Performance Data: The "Performance Data" section explicitly states that testing was "conducted per ASTM F2077 and ASTM F2267," which are standards for intervertebral body fusion devices, involving "static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, and wear testing." These are all mechanical and material property tests.

What information is available in the document related to "performance":

• Acceptance Criteria and Reported Performance (Table): Not applicable for the type of performance evaluation conducted here. The 'acceptance' is based on meeting the ASTM standards and demonstrating comparable mechanical properties to the predicate.
• Sample Size for Test Set and Data Provenance: Not applicable in the context of diagnostic accuracy/AI performance. The "test set" would be the manufactured devices undergoing mechanical testing. The provenance is from the manufacturer's testing.
• Number of Experts, Qualifications, and Adjudication Method for Ground Truth: Not applicable. Ground truth as typically understood for AI or diagnostic studies (e.g., diagnoses, disease presence) is not established through expert consensus for this physical device.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not a diagnostic device or AI software.
• Standalone Performance: The "Performance Data" describes mechanical standalone performance (device in isolation, under simulated physiological loads).
• Type of Ground Truth: For a physical implant, the "ground truth" would be engineering specifications and successful mechanical performance under stress, measured against industry standards.
• Sample Size for Training Set and How Ground Truth was Established for Training: Not applicable. This is not a machine learning model.

In summary, the provided document describes a physical medical device (intervertebral fusion cage) and its 510(k) submission, which relies on demonstrating substantial equivalence through mechanical performance testing against established standards, not through studies involving AI, human readers, or diagnostic accuracy.

Ask a specific question about this device