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The Smith & Nephew CDS System is intended to dispense and monitor the pressure of fluids during spinal procedures such as discography.

The Smith & Nephew CDS System consists of a control unit with a fluid delivery module with user interface, a remote control and a sterile, single-use fluid delivery syringe, tube set and remote sleeve.

The provided text is a 510(k) summary for the Smith & Nephew CDS System. This document focuses on demonstrating substantial equivalence to an existing predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the information requested in the prompt, such as acceptance criteria, detailed study results, sample sizes for test and training sets, expert qualifications, and ground truth establishment, is not available within the provided text.

Here's why and what can be inferred:

• Acceptance Criteria and Reported Device Performance: This information is typically found in dedicated verification and validation reports or clinical study summaries. The 510(k) summary states that "The proposed CDS System remote control underwent firmware and hardware modifications to improve its performance and reliability," and that "The changes made to the proposed CDS System represent improvements that will improve its performance over the predicate CDS System (K051136)." However, specific quantifiable performance metrics and acceptance thresholds are not provided.
• Sample Sizes and Data Provenance: The document makes no mention of a test set, training set, or any clinical data collection. It discusses modifications to an existing device.
• Experts, Adjudication, Ground Truth: These concepts are relevant to studies where human interpretation or a gold standard is used to validate a device's performance, especially for diagnostic or analytical devices. This document is for a fluid dispensing/monitoring system, and such detailed validation is not presented here.
• MRMC Comparative Effectiveness Study: There is no indication of an MRMC study. The comparison is primarily against a predicate device based on technological characteristics and intended use.
• Standalone Performance: The document does not describe a standalone performance study in the context of diagnostic accuracy (e.g., sensitivity, specificity). The "performance" mentioned refers to the functional improvements of the system's components (firmware, hardware).
• Type of Ground Truth: Not applicable, as detailed performance data based on a defined ground truth is not provided.
• Training Set Sample Size and Ground Truth for Training: Not applicable, as no training set for an AI/algorithm-based device is mentioned.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a modified medical device to a predicate device, rather than a detailed report of a study proving the device meets specific acceptance criteria with performance metrics, sample sizes, and ground truth information.

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