(255 days)
The Transonic COstatus system is indicated for use in patients 1 month or older with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
The proposed device is a variation of the COstatus system (K080116) which can measure the same parameters in patients 2 years and above. The COstatus system uses a peristaltic pump to circulate a small volumes blood passed the sensors rather than using a hemodialysis circuit. The system can thereby be used on any patient with arterial and venous access lines. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.
This document is a 510(k) summary for the Transonic COstatus System for Infants. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. It states that the device is safe and effective based on safety testing, and animal and clinical validation studies. However, this document does not contain explicit acceptance criteria tables or detailed results of specific studies with performance metrics, sample sizes, ground truth establishment, or multi-reader multi-case study information.
The document discusses the following:
1. Table of acceptance criteria and reported device performance:
The document states that "Prior to shipment, the finished products are tested and must meet all required release specifications before distribution." and that "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures that ensure the products performance parameters conform to the product design specifications." However, it does not provide any specific acceptance criteria (e.g., accuracy thresholds, precision limits) or quantitative performance results (e.g., mean absolute error, correlation coefficients) for cardiac output measurement.
2. Sample sized used for the test set and the data provenance:
The document mentions "animal and clinical validation studies were also performed to establish equivalence of cardiac output measured by COstatus with those made by standard clinical methods such as thermodilution, etc." However, it does not specify the sample size (number of animals or patients) or the data provenance (e.g., country of origin, retrospective/prospective nature) for these studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document refers to "standard clinical methods such as thermodilution" for comparison. This implies that the ground truth would be established by these methods. However, it does not mention any "experts" in the context of establishing ground truth for the test set, nor does it specify the number or qualifications of any such experts.
4. Adjudication method:
Given that expert consensus is not explicitly mentioned for ground truth, no adjudication method is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
The COstatus system measures physiological parameters and is not an imaging device typically evaluated with MRMC studies comparing human reader performance. Therefore, no MRMC comparative effectiveness study is mentioned or implied.
6. Standalone performance:
The COstatus system is designed to directly measure physiological parameters. Its performance, as implied by "animal and clinical validation studies," would be its standalone performance against a ground truth method. The document states that "equivalence of cardiac output measured by COstatus with those made by standard clinical methods such as thermodilution" was established. This implicitly refers to standalone performance, but no quantitative results are provided.
7. Type of ground truth used:
The ground truth used was "standard clinical methods such as thermodilution."
8. Sample size for the training set:
The document makes no mention of a training set. The COstatus system is a device based on "indicator dilution techniques," which usually implies a direct measurement principle rather than a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
As no training set is mentioned, this information is not applicable or provided.
In summary, this 510(k) document provides high-level information about the safety and effectiveness of the Transonic COstatus System for Infants, but lacks the specific detailed study results and acceptance criteria typically found in more comprehensive device performance reports. The focus is on demonstrating substantial equivalence to predicate devices and adherence to safety standards.
§ 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).