(209 days)
The QFlow™ 500 is intended for extravascular monitoring of microcirculation blood flow in buried tissues. Example of this application included (but are not limited to) 1) the monitoring of buried muscle or esophagus following free muscle transfer or esophageal reconstruction, 2) monitoring soft tissue microcirculation following reconstructive surgery, such as oral and facial reconstruction, 3) monitoring cerebral blood flow during and following neurosurgery for head trauma.
The QFlow™ 500 has application where real-time determination of any tissue perfusion is desired, whether it is for measurement or monitoring utilization. The system may be used in the Intensive Care Unit, Operating Room, Radiology Suite or in a standard patient care room. However, the system is not designed for use during patient transport.
The QFlow™ 500 consists of a thermal diffusion probe and a monitor.
The QFlow™ 500 Perfusion System Probe thermally interacts with tissue. It contains two thermistors embedded at the distal tip of the probe. It is available in a range of lengths from 60 cm to 120 cm and less than 1 mm in diameter. The probe contains an EEPROM for the storage of probespecific calibration data, data on the cumulative time the probe has been in use, and a verification key to insure the origin of the probe. The probe connector physically connects the probe to the umbilical cord which connects to the monitor.
The QFlow™ 500 Monitor controls the thermistors in the Probe.
Perfusion data are displayed on the monitor. The current perfusion value, temperature and thermal conductivity are be displayed in numeric form. The data are also displayed in the form of a graph as a function of time.
The monitor is capable of storing data for up to 10 days. All of this stored data may be reviewed by the user at any time during this period. Printing of data is also an option from the monitor. There is also the capability of uploading data from the monitor to an external computer for further analysis.
The provided text describes a 510(k) summary for the Hemedex, Inc. QFlow$^{\text{TM}}$ 500 Perfusion Monitoring System. It outlines the device, its intended use, comparison to predicate devices, and the performance testing performed to demonstrate substantial equivalence.
However, the document focuses on compliance with electrical safety, thermal safety, electromagnetic compatibility, electromagnetic emissions, and probe integrity standards. It does not present acceptance criteria or reported device performance in terms of microcirculation blood flow measurement accuracy or clinical efficacy. The "Performance Testing" section lists various standards the device was tested for compliance with, but it does not detail the specific performance metrics or acceptance thresholds related to its core function of monitoring microcirculation blood flow.
Therefore, many of the requested items cannot be extracted from the provided text.
Here is an attempt to address the request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria and reported device performance are related to compliance with general safety and electrical standards, not the direct performance of blood flow monitoring.
| Acceptance Criterion (Type) | Reported Device Performance (Reference) |
|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (1988) 2nd Edition, + A1: 1991 + A2: 1995. UL2601, UL standard for Safety, Medical Electrical Equipment, Part 1: General Requirements for Safety, First Edition. |
| Thermal Safety | Compliance with IEC 60601-1 (1988) 2nd Edition, + A1: 1991 + A2: 1995. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC60601-1-2: 1993. |
| Electromagnetic Emissions | Compliance with EN 55011. |
| Probe Integrity | Compliance with ISO 10555 Sterile, single-use intravascular catheters Part 1: General Requirements. |
| Biocompatibility | Compliance with ISO 10993: 1997 Part 1: Guidance on selection of tests. |
Regarding the study that proves the device meets the acceptance criteria, the document states:
"Bench testing, animal studies and biocompatibility testing was performed on the QFlow 500."
"The QFlow™ 500 is tested for compliance with the following standards for electrical safety, thermal safety, electromagnetic compatibility, electromaqnetic emissions and probe integrity."
This indicates that these tests were conducted, and the device was found to comply with the listed standards. No further details about the specific studies, their methodology, or results are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the text. The document mentions "bench testing," "animal studies," and "biocompatibility testing" but does not detail the sample sizes, study design (retrospective/prospective), or data provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the text. The testing mentioned (compliance with standards) does not typically involve expert review for ground truth in the same way clinical diagnostic studies do.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the text. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments, which are not detailed here.
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
An MRMC comparative effectiveness study is not mentioned in the text. The device is a monitoring system, not an AI-assisted diagnostic tool that requires human reader improvement evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The QFlow™ 500 is a monitoring system that directly measures and displays perfusion data. Its "standalone" performance would refer to its accuracy and reliability in measuring the intended physiological parameter. While "bench testing" and "animal studies" were performed, the text does not explicitly describe a standalone performance study with specific metrics for blood flow measurement accuracy (e.g., compared to a gold standard measurement technique). It only states compliance with safety and integrity standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the compliance tests mentioned (electrical safety, thermal safety, etc.), the "ground truth" would be the specifications and requirements defined by the international and national standards themselves. For the stated purpose of "extravascular monitoring of microcirculation blood flow," the document does not specify the ground truth used to validate the device's accuracy in measuring blood flow.
8. The sample size for the training set
This information is not applicable/not provided. The QFlow™ 500 is a physical measurement device based on thermal diffusion principles, not a machine learning model that requires a "training set" in the context of AI.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the reasons stated in point 8.
§ 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).