Search Results

The SafPace™ System is a two part system consisting of a Monitoring/Wedge Pressure Catheter and a Temporary Transluminal V- Pacing Wire. The catheter is designed for accurate measurement of cardiac output, direct measurement of pulmonary artery blood temperature, pressure monitoring, and infusing solutions. The SafPace™ catheter may also be used for temporary ventricular pacing. The V-Pacing Wire is used for temporary ventricular pacing only when used with the SafPace™ catheter. The wire may also be used for intraventricular ECG monitoring.

The SafPace™ System is a two part system consisting of a Monitoring/Wedge Pressure Catheter and a Temporary Transluminal V- Pacing Wire. The catheter is designed for accurate measurement of cardiac output, direct measurement of pulmonary artery blood temperature, pressure monitoring, and infusing solutions. The SafPace™ catheter may also be used for temporary ventricular pacing. The V-Pacing Wire is used for temporary ventricular pacing only when used with the SafPace™ catheter. The wire may also be used for intraventricular ECG monitoring.

The provided document is a 510(k) summary for the SafPace™ System, a medical device for temporary cardiac pacing and monitoring. This type of submission focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed clinical study data with acceptance criteria for a novel AI/software component. Therefore, much of the requested information about AI model performance, multi-reader studies, and detailed ground truth establishment is not applicable or available in this document.

However, I can extract the information that is present and describe why other requested details are absent.

Acceptance Criteria and Device Performance

The document describes the device's acceptable performance in terms of safety and effectiveness through comparisons to predicate devices and adherence to manufacturing quality control. There are no explicit, quantifiable acceptance criteria or reported device performance metrics in the format requested for a specific AI model's output (e.g., sensitivity, specificity, AUC).

Instead, the "acceptance criteria" are implied by the following statements:

• Substantial Equivalence: The device must be "substantially equivalent" in materials, form, and intended use to predicate devices, implying it meets similar safety and effectiveness profiles. This is the primary "acceptance criterion" for a 510(k) submission.
• Material Suitability: Materials used "have an established history of medical use and that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product."
• Manufacturing Quality Control: "All finished products are tested and must meet all required release specifications before distribution." This includes "physical testing, visual examination (in process and to: finished product)."
• Conformance to Design Specifications: "Physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications."

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Missing Information & Why

The following requested information is not present in the provided 510(k) summary because this document describes a traditional medical device (catheter and pacing wire), not an AI/ML-driven software product. Therefore, the concepts of "test sets," "training sets," "ground truth," "expert readers," and "AI models" are not applicable to this submission.

1. Sample size used for the test set and the data provenance: Not applicable. No test set for an AI model.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for an AI model.
3. Adjudication method for the test set: Not applicable.
4. 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. There is no AI component involved.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable. No training set for an AI model.
8. How the ground truth for the training set was established: Not applicable.

This 510(k) submission focuses on demonstrating the physical, functional, and material equivalence of the SafPace™ System to previously cleared devices for cardiac monitoring and provisional pacing. It relies on established engineering principles, material science, and manufacturing quality controls rather than data-driven performance metrics for an AI algorithm.

Ask a specific question about this device