(109 days)
The Medi-Stim VeriQC System is intended for use as an intraoperative system utilizing ultrasonography to visualize blood flow and to guide surgeons to successfully plan and accomplish surgical interventions. The clinical indications for the device are:
- Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular- and transplantation-surgery.
- Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures.
- Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures.
- Provides guidance to prepare surgical plans at the initiation of surgery and to support the successful accomplishment of surgery including detection and location of vessels during surgical procedures.
- Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.
The VeriQC system incorporates several ultrasound modalities that can be used during a variety of surgical interventions. The system utilizes the well established technology of transit-time flow measurements to accurately measure blood flow in veins and arteries intraoperatively. In addition, the system provides ultrasound echocardiography for intraoperative imaging of the cardiovascular circulatory system. The system supports both B-Mode (2D) grayscale imaging, color Doppler (CFM) and pulsed wave Doppler (PW-Doppler). The system also has the ability to connect other external physiological signals such as blood pressure, ECG and other auxiliary signals provided by other monitoring systems.
The VeriQC transducer selection includes both transit-time probes for blood flow measurements on various vessel sizes and types as well as an intraoperative imaging probe.
This 510(k) summary for the MediStim VeriQC System primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technology, and safety testing rather than a clinical performance study with specific acceptance criteria.
Therefore, many of the requested sections regarding clinical study design for performance acceptance criteria cannot be extracted directly from this document.
Here's an attempt to answer based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative clinical acceptance criteria or a direct clinical performance study against such criteria. The "Summary of Testing" states: "Testing included EMC, Safety testing and Acoustic Safety Measurements. The MediStim VeriQC has also been verified and validated according to functional and software requirements." This refers to engineering and regulatory compliance, not clinical performance metrics like sensitivity, specificity, or accuracy compared to a ground truth in a patient population.
Therefore, a table cannot be populated as requested. The submission focuses on substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
No clinical test set is described or referenced in this document for the purpose of evaluating clinical performance against specific acceptance criteria. The submission relies on the established safety and effectiveness of its predicate devices and its own technical validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. No clinical test set with ground truth established by experts is described for performance evaluation.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement
No MRMC comparative effectiveness study is mentioned or implied in this 510(k) summary. The submission focuses on the device's technical capabilities and its equivalence to other devices, not on improving human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device (MediStim VeriQC System) is an intraoperative ultrasound and flow measurement system. Its primary function involves direct measurements and imaging, often in real-time by a surgeon or clinician. It is not an AI algorithm that would typically undergo standalone performance testing as understood in the context of diagnostic AI. The "algorithm" here refers to the underlying system's measurement and imaging processes, which are verified through functional and software requirements.
7. The Type of Ground Truth Used
For the functional and software verification/validation mentioned, the ground truth would typically be established by:
- Engineering specifications and standards: For EMC, safety, and acoustic safety.
- Reference measurements/phantoms: For validation of flow measurements and imaging capabilities against known physical properties.
- Comparison to predicate device performance (implicitly): The claim of substantial equivalence relies on the predicate devices having established safety and effectiveness, meaning their performance served as an implicit "ground truth" for what is acceptable in the market.
No explicit clinical ground truth (e.g., pathology, clinical outcomes, expert consensus on patient data) is described as being used for performance testing in this summary.
8. The Sample Size for the Training Set
Not applicable. This document does not describe the development or training of an AI algorithm in the contemporary sense. The system's "training" would be through its engineering design, calibration, and software development processes to meet its stated functionalities.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no mention of a training set for an AI model, the method for establishing ground truth for such a set is not relevant here.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).