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The device is intended to monitor, analyze, document, and report hemodynamic data acquired during a cardiac catherization procedure.
The system contains an acquisition subsystem and an analysis subsystem.
The system acquires non-invasive and invasive data parameters. The data is received, displayed, stored, and analyzed in the Q-Cath.
The device is to be used on adult and pediatric patients while undergoing a cardiac catherization procedure.
Patient demographics, registration, patient assessment, procedure log notes, collected physiological and other Q-Cath data can be exported to an information management system.
A Q-Cath remote workstation may be used to access patient files off-line or for the entering of additional patient information or editing of existing patient files. Additionally, the workstation may be used as a means of recording non-invasive vital signs data through the use of qualified third party peripheral monitoring devices.
Multiple Q-Cath systems and workstations may be used and connected to a local area network.
The Q-Cath system is not intended to be the sole means for monitoring a patient's status.

The Q-Cath system is a monitoring and analysis system that is used by Physicians, nurses, technicians and administrators associated with the cardiac catherization (cath) lab. The Q-Cath is a Microsoft Windows® based system with 32-bit architecture. The system contains an acquisition subsystem and an analysis subsystem. The O-Cath organizes patient signals (invasive & non-invasive), and non-physiological signals from external devices. The Signal Conditioning System (SCS) acquisition subsystem contains connectors for the 12 lead surface ECG, four pressure inputs, three HIS inputs, two DC inputs, two types of synchronization waveform outputs and ECG simulator outputs. The optional Vital Statistical System (VSS) acquisition system contains module connections for the non-invasive blood pressure, the SPO2 and two auxiliary modules. The analysis system generates data based upon pressure site locations, ECG data and the entry of information such as cardiac output, oximetry results, and the patient physiological condition. The system stores Full Disclosure data of all waveform data to the O-Cath local computer or can be stored off-line to a file server.

The provided document, a 510(k) summary for the Quinton Q-Cath System, does not contain information regarding acceptance criteria, a specific study proving device performance against such criteria, or details typically found in performance evaluation sections for AI/ML-driven devices.

The document describes a medical device for monitoring and analyzing hemodynamic data during cardiac catheterization procedures. Its purpose is to demonstrate substantial equivalence to a predicate device (Quinton Q-Cath, K862740), focusing on technological comparison, intended use, and safety/effectiveness aspects. The improvements mentioned are primarily related to system architecture (Windows-based, co-resident image analysis, integration of external data) and workflow efficiency, rather than a new analytical algorithm requiring rigorous performance metric evaluation against defined acceptance criteria.

Therefore, I cannot provide the requested information from the provided text. The document does not include details on:

1. Acceptance criteria table and reported device performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision for an analytical task) or acceptance thresholds are mentioned.
2. Sample size for the test set and data provenance: No test set is described.
3. Number of experts and qualifications for ground truth: No ground truth establishment is described as there's no analytical model being evaluated.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on demonstrating that the Q-Cath System is "substantially equivalent in safety and effectiveness" to its predicate device through a comparison of technological characteristics, intended use, and compliance with general safety standards (like IEC 60601-1 and electromagnetic compatibility). It states, "Both devices perform equivalently," and "Generated data is identical," implying that the core functionality related to data generation and initial analysis remains the same as the predicate device, with enhancements primarily in user experience, data integration, and system architecture.

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