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The AccuFit® Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (TI-LS) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiosy, scollosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The AccuFit® Lateral 2-Hole Plate consists of non-sterile, single use, titanium alloy (Ti-6AI-4V ELI per ASTM F136) rigid plates and screws of varying sizes. The plate attaches by means of screws to the lateral portion of the vertebral body. The AccuFit® Lateral 2-Hole Plate (Subject Device) will be implanted using the instruments cleared with the AccuFit® Lateral Plate System (K162211), however a new inserter and tray will be introduced to the system that is to be used with the AccuFit® Lateral 2-Hole Plate (Subject Device). The AccuFit® Lateral 2-Hole Plate is to be provided non-sterile. They require sterilization prior to use.

The provided text describes a medical device (AccuFit® Lateral 2-Hole Plate) and its 510(k) clearance by the FDA based on substantial equivalence to predicate devices. It does not present information related to the performance of an AI/ML-enabled device, nor does it detail a study involving human readers or expert ground truth establishment for a diagnostic algorithm.

Therefore, I cannot extract the information required in your request about acceptance criteria, device performance, sample sizes, ground truth establishment, or human reader studies. The document pertains to a physical spinal implant, not an AI-based diagnostic tool.

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The NexGen Anterior Cervical Plate System is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; deformity (defined as kyphosis, lordosis, or scoliosis); spinal stenosis; pseudoarthrosis; and failed previous fusions.

The NexGen Anterior Cervical Plate System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The NexGen Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws (available in self-drilling or self-tapping configurations), and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

The provided document is a 510(k) summary for the NexGen Anterior Cervical Plate System. It describes the device and its equivalence to predicate devices, but it does not contain information about acceptance criteria for a device performance study or the results of such a study in terms of metrics like sensitivity, specificity, or AUC.

Instead, the document details a non-clinical test summary focused on mechanical properties to demonstrate substantial equivalence to predicate devices. It explicitly states: "No clinical studies were performed."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used for performance evaluation, as this information is not present in the provided text.

The closest relevant information is the Non-clinical Test Summary, which describes the testing performed for the device's mechanical integrity.

Here's what can be extracted from the document regarding the non-clinical testing:

Device Meeting Acceptance Criteria (Non-Clinical Mechanical Testing):

Missing Information (Not provided in the document):

• Sample size used for the test set and the data provenance: Not applicable as no clinical study or test set for performance was conducted.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

• Non-clinical Test Summary: Static and dynamic compression and torsion testing per ASTM F1717.
• Conclusion: The device is "as strong or stronger than the predicate devices."
• Clinical Test Summary: "No clinical studies were performed."

This device's clearance is based on substantial equivalence to predicate devices primarily through mechanical performance testing and similarity in design, materials, and intended use, rather than a clinical performance study with human subjects or AI algorithm evaluations.

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