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The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is an interbody fusion device system placed via a variety of open or minimally invasive approaches and indicated for use:

• · In skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1)
• · In patients having have received 6 months of nonoperative treatment prior to treatment
• With or without screws
• · With autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft

Standalone Use (with screws)
ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for stand-alone use in patients with DDD or with degenerative spondylolisthesis at one or two contiguous levels only when used with (1) at least three screws per implant (including at least one screw in each endplate) and (2) when ≤ 20° lordotic implants are used.

Use with Supplemental Fixation (with or without screws)
ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is intended for use with supplemental fixation in patients with Degenerative disc disease (DD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, Spinal deformity (degenerative scoliosis), Spondylolisthesis or retrolisthesis, or failed previous fusion (pseudoarthrosis).

When used at more than 2 contiguous levels, with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.

The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System is an integrated anterior lumbar interbody fusion device used to provide structural stability following discectomy.

The system consists of an interbody cage additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001, screws and locking mechanism manufactured from Titanium-6 Aluminum-4 ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899.

The ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System cages are offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.

I am sorry, but the provided text from the FDA 510(k) notification for the ANTARES 3DR™ Standalone Anterior Lumbar Interbody Fusion System does not contain any information regarding acceptance criteria or a study proving the device meets these criteria in the context of an AI/ML-driven medical device, as implied by the detailed questions about ground truth, expert readers, and training/test sets.

The document is a clearance letter for a physical medical device (an interbody fusion system), not an AI/ML software as a medical device (SaMD). The "Performance Data" section (Section IX on page 5) references mechanical testing standards for implants (ASTM F2077-18, ASTM F2267-04, ASTM Draft Standard F-04.25.02.02), which are standard for orthopedic implants to assess their structural integrity, compression, shear, and subsidence. These are not related to the performance of an algorithm or an AI model.

Therefore, I cannot extract the information required by your prompts regarding:

• Acceptance criteria for an AI/ML device and reported device performance
• Sample size and data provenance for a test set
• Number of experts and qualifications for ground truth establishment
• Adjudication method
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth (expert consensus, pathology, outcomes data)
• Sample size and ground truth establishment for a training set

To provide a response to your request, I would need a document detailing the validation of an AI/ML medical device, not a physical implant.

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