Search Results

The VertiFlex® Direct Decompression System is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.

The VertiFlex® Direct Decompression System consists of a group of instruments intended to assist in the performance of lumbar decompression through a minimallyinvasive approach. The instruments include both reusable, and single-use disposable devices. In combination, these instruments include dilators and a cannula through which the user may gain access to the site of decompression, and several specialized instruments with which both bony and soft tissue may be removed to decompress the neural elements. The single-use disposable devices will be provided sterile, and the reusable devices will be provided non-sterile for sterilization by the user before use.

The provided text is a 510(k) summary for the VertiFlex® Direct Decompression System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets these criteria in the context of clinical performance or diagnostic accuracy.

The summary explicitly states:

• "No clinical testing was conducted to support this submission." (Section 5.8)
• Non-clinical tests included "simulated decompression surgery in human cadavers, conducted to validate the performance of the subject System." (Section 5.7)

Therefore, based on the provided text, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or expert involvement as typically requested for studies evaluating diagnostic or clinical effectiveness. The submission focuses on substantial equivalence based on design characteristics, materials, and indications to existing predicate devices.

Here's what can be extracted from the document regarding testing and its purpose:

1. A table of acceptance criteria and the reported device performance

• No specific acceptance criteria related to clinical outcomes or diagnostic performance are presented.
• No reported device performance metrics (e.g., sensitivity, specificity, accuracy, clinical success rates) are provided. The submission focuses on demonstrating substantial equivalence to predicate devices through design and intended use comparisons.

2. Sample sized used for the test set and the data provenance

• The "test set" described is simulated decompression surgery in human cadavers. The sample size for this test set is not specified.
• The data provenance is non-clinical (cadaveric testing). The country of origin is not specified, and it is inherently prospective in that novel testing was conducted with the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided as the cadaveric testing was for "performance validation" of the system, not for establishing clinical ground truth for a diagnostic or treatment outcome.

4. Adjudication method for the test set

• This information is not provided.

5. 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

• No MRMC comparative effectiveness study was done. This device is a surgical instrument, not an imaging AI or diagnostic tool where such a study would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a surgical instrument system, not an algorithm.

7. The type of ground truth used

• For the non-clinical cadaveric testing, the "ground truth" would likely be the ability of the instruments to perform the intended surgical actions (e.g., removal of bony and soft tissue to decompress neural elements) without breakage or functional failure, as observed by the operating surgeon(s) during the simulation. This is performance validation, not clinical ground truth.

8. The sample size for the training set

• Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable.

In summary, the provided submission focuses on demonstrating substantial equivalence to legally marketed predicate devices for a surgical instrument system, rather than proving clinical effectiveness or diagnostic performance through specific acceptance criteria and clinical trials.

Ask a specific question about this device