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The Aspida Anterior Lumbar Plating System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved.

The Aspida Anterior Lumbar Plating System is intended for anterior lumbar spine (L1-S1) fixation for the following indications:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
2. Pseudoarthrosis
3. Spondylolysis
4. Spondylolisthesis
5. Trauma (i.e., fracture or dislocation)
6. Spinal stenosis
7. Unsuccessful previous fusion surgery
8. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
9. Tumor

The Aspida Anterior Lumbar Plating System is a spinal fixation system that consists of a variety of non-sterile, single-use plates and screws. All implants are manufactured from titanium alloy conforming to ASTM F136. The system also contains Class I manual instruments. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.

The provided text describes the Aspida® Anterior Lumbar Plating System (K182808). However, it does not contain information about acceptance criteria or a study proving device meeting acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a traditional medical device (spinal intervertebral body fixation orthosis). The "performance data" section (page 5) refers to nonclinical testing of the physical device's mechanical properties (static compression, static torsion, dynamic compression per ASTM F1717) to demonstrate substantial equivalence to predicate devices, not performance evaluation of an AI/ML algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/ML device meets them based on the given text.

The bullet points below indicate what information is not present in the document based on the request's context for an AI/ML device:

• A table of acceptance criteria and the reported device performance: Not applicable; the document concerns a physical implant, not an AI/ML device with performance metrics like sensitivity or specificity.
• Sample sized used for the test set and the data provenance: Not applicable; no AI/ML test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no AI/ML test set or expert ground truth is described.
• Adjudication method: 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: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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