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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 and screw components that are assembled to create a rigid spinal construct. The rod and screw 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.

The provided text describes a 510(k) summary for the CapSure® PS System, a pedicle screw spinal system. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, rather than a study evaluating the performance of a device against specific acceptance criteria.

The information typically found in a study demonstrating device performance against acceptance criteria (such as detailed performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment) is not present in this type of regulatory submission. The 510(k) pathway focuses on establishing that a new device is as safe and effective as another legally marketed device (the predicate device) through comparison, often including mechanical testing for physical equivalence.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document states:

• Substantial equivalence: The CapSure® PS System is substantially equivalent to the predicate device, CapSure® PS System (K081228), manufactured by Spine Wave, Inc.
• Proof of equivalence: "mechanical testing demonstrated that the CapSure® PS System is equivalent to its predicate device. The minor differences between the CapSure® PS System and the predicate device do not raise any new questions of safety or effectiveness."

This indicates that the "study" demonstrating the device meets approval criteria was primarily a mechanical testing study comparing it to the predicate device. However, no specific quantitative acceptance criteria or detailed performance results from this testing are provided in the summary.

Here's why the requested information is absent and what can be inferred:

1. Table of acceptance criteria and reported device performance: Not provided. The 510(k) summary asserts "equivalence" based on mechanical testing without detailing the specific criteria or results.
2. Sample size used for the test set and data provenance: Not applicable in the context of a 510(k) summary focused on mechanical equivalence. "Test set" here refers to mechanical samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Mechanical testing typically involves engineers and standardized testing protocols, not medical experts establishing ground truth for diagnostic accuracy.
4. Adjudication method for the test set: Not applicable for mechanical testing for 510(k) equivalence.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance with AI and is not relevant for a spinal implant's mechanical equivalence.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This device is a physical implant, not an algorithm.
7. Type of ground truth used: For mechanical testing, the "ground truth" would be established by industry standards (e.g., ASTM standards) and the performance of the predicate device under those standards.
8. Sample size for the training set: Not applicable (no algorithmic training involved).
9. How the ground truth for the training set was established: Not applicable.

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