(59 days)
The Draeger Infinity PICCO Pod is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the Infinity PICCO Pod measures systolic, 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 monitor to which, the PICCO Pod is connected, presents the derived parameters indexed to body surface area.
The Infinity PICCO Pod is an optional accessory to Draeger Medical Systems' Infinity patient monitoring series (Delta, Delta XL, and Kappa) that provides for determination and monitoring of cardiopulmonary and circulatory variables. The Infinity PICCO Pod acquires cardiac output thermal and invasive blood pressure data from Pulsion Medical transducers and sends this data to the Draeger patient monitors. The Draeger patient monitors contain Pulsion algorithms which are run on this data to calculate a number of cardiopulmonary and circulatory variables.
The provided document is a 510(k) Summary of Safety and Effectiveness for the Dräger Infinity PiCCO Pod. This document primarily focuses on establishing substantial equivalence to a predicate device through non-clinical bench testing and simulator-based testing. It does not contain information about a clinical study involving human subjects, nor does it provide a table of acceptance criteria and reported device performance.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be gathered and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided: The document does not specify quantitative acceptance criteria or reported device performance in the manner requested (e.g., sensitivity, specificity, accuracy). Its focus is on establishing equivalence through bench and simulator testing, not on quantifiable clinical performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot be provided: The document mentions "Extensive bench testing" and "Extensive simulator based testing." It does not specify sample sizes for these tests, nor does it refer to data provenance (country, retrospective/prospective) as these were non-clinical 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):
- Cannot be provided: This information is relevant for studies involving human interpretation or clinical ground truth establishment, which is not described in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided: This is not applicable to the non-clinical testing described.
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:
- Cannot be provided: The device is a diagnostic computer that processes physiological signals; it is not an AI-assisted diagnostic imaging tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially applicable, but details are missing: The device itself is an algorithm-only component (within the larger monitoring system) that calculates variables. The document states "Extensive bench testing has been performed to insure that the software as implemented in the Infinity PICCO Pod is equivalent to that of the Pulsion PiCCO Plus." and "Extensive simulator based testing has been performed to insure that the Infinity PICCO Pod as a complete device is equivalent to that of the Pulsion PiCCO Plus as a complete device." This implies standalone testing of the algorithm's performance against the predicate, but specific performance metrics are not given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied ground truth for non-clinical testing: For bench and simulator testing, the "ground truth" would likely be the known, controlled inputs provided by the test equipment/simulators, and the expected outputs as predicted by the predicate device's established performance or theoretical models. The document doesn't specify the exact nature of this "ground truth" beyond stating the tests were to ensure equivalence.
8. The sample size for the training set:
- Not applicable/Cannot be provided: The document does not describe the development of a novel algorithm from a training set. The device uses "the same algorithms as its predicate, the Pulsion PiCCO Plus." It's essentially implementing existing, validated algorithms in a new hardware configuration.
9. How the ground truth for the training set was established:
- Not applicable/Cannot be provided: As above, this document does not describe the training of a new algorithm.
Summary of what the document states regarding "the study":
The study described in this 510(k) summary is a set of non-clinical tests conducted to demonstrate the substantial equivalence of the Infinity PiCCO Pod to its legally marketed predicate, the Pulsion PiCCO Plus System (K060898).
The tests performed include:
- Extensive bench testing: "to insure that the hardware of the Infinity PICCO Pod is equivalent to the hardware of the Pulsion PiCCO Plus."
- Extensive bench testing: "to insure that the software as implemented in the Infinity PICCO Pod is equivalent to that of the Pulsion PiCCO Plus."
- Extensive simulator based testing: "to insure that the Infinity PICCO Pod as a complete device is equivalent to that of the Pulsion PiCCO Plus as a complete device."
The "acceptance criteria" for these tests are implicitly that the Infinity PiCCO Pod's hardware, software, and complete device performance should be equivalent to that of the Pulsion PiCCO Plus. The document's conclusion states, "The Infinity PICCO Pod is as safe and effective as its predicate, the Pulsion PiCCO Plus..." indicating that these equivalence criteria were met. No specific quantitative performance metrics or study results are detailed in this summary.
§ 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).