(366 days)
The PULSION PICCO-2 is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVOX™ oximetry module connected to a compatible oximetry probe, the PiCCO-2 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 thermodilution technique. In addition, the PiCCO-2 measures heart rate, systolic, and diastolic and derives mean arterial 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 PiCCO-2 monitor presents the derived parameters indexed to body surface area.
The PULSION PiCCO-2 is a microprocessor-based instrument intended for the determination and monitoring of cardiopulmonary and circulatory variables. When the optional CeVOX™ optical module and probe are connected to the PiCCO-2, the monitor measures oxygen samuation in adults or pediatrics. In addition, the PiCCO-2 measures heart rate, systelic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO-2 presents the derived parameters indexed to body surface area.
The Pulsion PiCCO-2 with Optional CeVOX Accessories is a device intended for measuring and monitoring cardiopulmonary and circulatory variables. The provided text, K091786, describes the device and claims substantial equivalence to predicate devices, but does not include any study data or detailed acceptance criteria for the quantitative performance of the device based on a clinical or non-clinical study involving a specific test set. Instead, it lists specifications for various parameters.
Here’s a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document lists "Accuracy" and "Remark" for each parameter, which can be interpreted as the acceptance criteria and the stated performance. However, it's crucial to note that these are specifications for "actual production output" and not the results of a specific study comparing the device to a ground truth as typically understood in a performance study.
| Label | Unit | Lower limit | Upper limit | Acceptance Criteria (Accuracy*) | Reported Device Performance |
|---|---|---|---|---|---|
| CO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Coefficient of variation ≤ 2% (Valid over full range) |
| GEDV | ml | 40 | 4800 | Coefficient of variation ≤ 3% | Coefficient of variation ≤ 3% (Valid over full range) |
| ITBV | ml | 50 | 6000 | Coefficient of variation ≤ 3% | Coefficient of variation ≤ 3% (Valid over full range) |
| EVLW | ml | 10 | 5000 | Coefficient of variation ≤ 6% | Coefficient of variation ≤ 6% (Valid over full range) |
| PCCO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Coefficient of variation ≤ 2% (Valid over full range) |
| SV | ml | 1 | 250 | Coefficient of variation ≤ 2% | Coefficient of variation ≤ 2% (Valid over full range) |
| SO2 | % | 1 | 99 | ±2% | ±2% (Valid from 40 - 99%) |
| SvO2 | % | 1 | 99 | ±2% | ±2% (Valid from 40 - 99%) |
| ScvO2 | % | 1 | 99 | ±2% | ±2% (Valid from 40 - 99%) |
Note: The "Reported Device Performance" column directly mirrors the "Acceptance Criteria" because the document states these are "Statistical evaluation based on random examination of actual production output," implying these are the designed and expected performance characteristics, rather than empirically derived results from a specific clinical study detailed in this submission.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The provided document does not describe a specific clinical or non-clinical study with a defined test set, sample size, or data provenance for the purpose of demonstrating device performance against specific acceptance criteria. The performance claims are based on "Statistical evaluation based on random examination of actual production output," which is primarily a manufacturing quality control statement rather than a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical study or test set with expert-established ground truth is described in the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical study or test set requiring adjudication is described in the provided document.
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
Not applicable. The PULSION PiCCO-2 is a microprocessor-based instrument for measuring physiological variables, not an AI-assisted diagnostic imaging device that typically involves human readers. No MRMC study is mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions as a standalone monitor, providing measurements of cardiopulmonary and circulatory variables. The "Functional/Safety Testing" section states, "The PULSION PiCCO-2 with optional CeVOX™ accessories has successfully undergone functional testing demonstrating equivalence to the predicate devices. The subject and predicate devices are similar in design, principle of operation, materials of construction, intended use, labeling and manufacturing processes. In vivo non-clinical testing, sterilization validation and biocompatibility testing was conducted. Results of all non-clinical testing met associated acceptance criteria and did not raise new issues of safety and/or effectiveness."
While functional testing and "in vivo non-clinical testing" were conducted, the document does not detail the results against the specific performance metrics listed in the table or explicitly state a "standalone performance study" in a quantifiable manner as understood for diagnostic algorithms. The primary claim is substantial equivalence to predicate devices, supported by functional and safety testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for the "Statistical evaluation based on random examination of actual production output" or for the "in vivo non-clinical testing." For a device measuring physiological parameters, ground truth would typically come from highly accurate reference instruments or established clinical gold standards, but this is not detailed in the submission provided.
8. The sample size for the training set
Not applicable. This device is described as a "microprocessor-based instrument" that measures and monitors physiological variables. It is not an artificial intelligence or machine learning model that typically undergoes "training" on a dataset in the conventional sense. Therefore, no training set sample size is applicable or mentioned.
9. How the ground truth for the training set was established
Not applicable. As noted in point 8, no training set is described for this device.
§ 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).