Search Results

When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

The CapSure® PS System consists of a selection of non-sterile, single use titanium alloy rod, screw, and cross connector components that are assembled to create a rigid spinal construct. The components of the CapSure® PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

This 510(k) premarket notification for the CapSure® PS System is for minor modifications to existing screws and relies on substantial equivalence to predicate devices. It does not contain an independent study with acceptance criteria and a device performance table in the typical sense of a new medical device study.

Therefore, many of the requested sections (2-9 relating to sample sizes, expert involvement, ground truth, and comparative effectiveness) are not applicable or cannot be extracted directly from this document.

However, I can describe what was used to demonstrate "performance" in this particular submission:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In this 510(k), the "acceptance criteria" isn't a specific numerical threshold for a clinical outcome or a diagnostic accuracy metric. Instead, it's the demonstration that the modified device performs equivalently to the already cleared predicate devices. The "reported device performance" is that the chosen analysis method (FEA) confirmed this equivalence.

2. Sample size used for the test set and the data provenance:

• Not Applicable. This submission did not involve a test set of patient data. The performance evaluation was based on Finite Element Analysis (FEA) of the device modifications.

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

• Not Applicable. No ground truth was established by experts for a test set in this submission. The evaluation was an engineering analysis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No test set requiring expert adjudication was used.

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. An MRMC study was not done. This submission is for a pedicle screw system, which is a physical implant, not an AI-assisted diagnostic or interpretative device.

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

• Not Applicable. This is not an algorithm or AI device. The "performance" assessment was an engineering simulation (Finite Element Analysis).

7. The type of ground truth used:

• Not Applicable. No "ground truth" in the clinical or diagnostic sense was established. The performance was assessed through engineering analysis (Finite Element Analysis) demonstrating equivalence to already cleared predicate devices.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. No training set was used.

Ask a specific question about this device