(16 days)
The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.
The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.
The provided text describes the PulsioFlex Monitoring System with PiCCO Module and its intended use, along with a table of performance specifications. However, it does not contain details about a specific study proving the device meets its acceptance criteria, nor does it describe the methodology of such a study.
The table presented is a list of acceptance criteria (or "specifications" as labeled in the document) rather than a direct report of a study's results. The "Accuracy*" column states "Coefficient of variation ≤ 2%" or "+2%", which are the target performance metrics the device is expected to meet, not observed performance from a study. The "Remark" states "Statistical evaluation based on random examination of actual production output," which hints at some form of quality control or validation, but does not provide details of a formal study.
Therefore, many of the requested details cannot be extracted from the provided document.
Here's a summary of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides the acceptance criteria (specifications) for various parameters. It does not provide a separate column for "Reported Device Performance" from a dedicated study. The "Accuracy*" column represents the target criteria.
| Label | Unit | Lower Limit | Upper Limit | Acceptance Criteria (Accuracy) | Remark |
|---|---|---|---|---|---|
| CO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Valid over a full range |
| GEDV | ml | 40 | 4800 | Coefficient of variation ≤ 3% | Valid over a full range |
| EVLW | ml | 10 | 5000 | Coefficient of variation ≤ 6% | Valid over a full range |
| PCCO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Valid over a full range |
| SV | ml | 1 | 250 | Coefficient of variation ≤ 2% | Valid over a full range |
| SO2 | % | 1 | 99 | ±2% | Valid from 40-99% |
| SvO2 | % | 1 | 99 | ±2% | Valid from 40-99% |
| ScvO2 | % | 1 | 99 | ±2% | Valid from 40-99% |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any particular test set. The remark "Statistical evaluation based on random examination of actual production output" does not specify a sample size.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: Not mentioned or applicable. This device is a monitoring system for physiological variables, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device itself is a standalone monitoring system. The document lists its performance specifications, implying standalone performance. However, there is no detailed description of a "standalone study" with specified methodology.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physiological measurements like cardiac output, volumes, and oxygen saturation, ground truth would typically be established by validated reference methods or gold standards (e.g., direct Fick method, thermodilution from pulmonary artery catheter, blood gas analysis). The document does not specify how the accuracy was determined, only the target accuracy.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable in the context of this document. The device descriptions pertain to a physiological monitoring system and not a machine learning model that would require a "training set."
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).