(62 days)
The Windsurfer is a system for acquiring, digitizing, storing, displaying and reviewing hemodynamic data (vital signs). The Windsurfer is intended for use in hospital cardiac catheterization laboratories.
Windsurfer is a standard hemodynamic monitoring system for monitoring vital signs before, during and after catheterization procedures. Windsurfer is intended to acquire, display, store, analyze and process vital signs and log all cath lab activity. There are tools for entering measurements, calculations and procedure notes. Windsurfer also acquires patient information from other hospital information systems and makes hemodynamic information available to them. Windsurfer is connected to a patient in the cath lab via: - ECG leads . - Invasive Blood Pressure transducers . - . SpO2 finger clip - NIBP cuff . Windsurfer uses an intuitive interface that clearly displays patient data, procedure data, waveforms and numeric values. The performing physician views the monitor in the cath lab and conveys instructions and procedure notes to the certified technician, who operates the application using a touch screen, keyboard and mouse, for maximum convenience.
Here's an analysis of the provided text regarding the Windsurfer device, focusing on the acceptance criteria and study information.
It is important to note that the provided text is a Summary of Safety and Effectiveness for a 510(k) submission. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device and typically does not contain detailed information about performance studies, acceptance criteria, sample sizes for training/test sets, ground truth establishment, or multi-reader studies. These details are usually found in the full 510(k) submission, particularly in sections related to performance testing.
Based on the provided text, many of your requested items cannot be fully answered.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state any quantitative acceptance criteria or detailed performance metrics from a specific study for the Windsurfer device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (VERICIS Physiolog, K013032). The "performance" mentioned is implicitly that it performs as intended as a hemodynamic monitoring system.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "Windsurfer is a standard hemodynamic monitoring system for monitoring vital signs before, during and after catheterization procedures." |
| Not specified in document | "Windsurfer is intended to acquire, display, store, analyze and process vital signs and log all cath lab activity." |
| Not specified in document | "There are tools for entering measurements, calculations and procedure notes." |
| Not specified in document | "Windsurfer also acquires patient information from other hospital information systems and makes hemodynamic information available to them." |
2. Sample size used for the test set and the data provenance
The document does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance study. The 510(k) summary relies on comparison to a predicate device rather than presenting results from a de novo clinical trial with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not describe any process for establishing ground truth using experts, as it does not report on a specific performance study that required such an evaluation.
4. Adjudication method for the test set
The document does not describe any adjudication method as it does not report on a specific performance study where expert consensus or adjudication would be required.
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
The document does not mention any MRMC comparative effectiveness study and does not refer to AI assistance. The Windsurfer is described as a "standard hemodynamic monitoring system," not an AI-powered diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not mention any standalone algorithm performance testing. The device is described as a monitoring system operated by a certified technician with a physician viewing the monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify any type of ground truth, as it does not present data from a performance study that would require such a determination.
8. The sample size for the training set
The document does not mention a training set sample size. This device, as described, is a data acquisition and display system, not a machine learning or AI algorithm that typically requires a training set.
9. How the ground truth for the training set was established
The document does not mention a training set or how ground truth for it would be established, as it's not a machine learning device.
In summary: The provided 510(k) Notification for Windsurfer is a high-level summary that establishes substantial equivalence to a predicate device. It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically found in full regulatory submissions for devices requiring extensive clinical performance testing. This type of device (a hemodynamic monitoring system) typically demonstrates performance through verification and validation activities (e.g., electrical safety, EMC, software validation) and comparison to the predicate, rather than large-scale clinical trials with extensive ground truth establishment by experts.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).