(15 days)
The Schwarzer cardis heart catheter measuring systems with hemodynamical evaluation software are indicated for the registration, display, real-time recording, printout and storage of biophysiological data. Hemodynamic signals as intracardiac pressure and ECG signals are recorded and displayed and a number of hemodynamic calculations are performed based on the measured values of the input signals.
The Schwarzer cardis systems are intended for use in catheterization labs.
The Schwarzer cardis systems are indicated for use with patients of all ages under direct supervision of a physician or other trained health care professionals.
The Schwarzer cardis heart catheter measuring systems with hemodynamical evaluation software are indicated for the registration, display, real-time recording, printout and storage of biophysiological data. Hemodynamic signals as intracardiac pressure and ECG signals are recorded and displayed and a number of hemodynamic calculations are performed based on the measured values of the input signals.
This document is a 510(k) summary for the Schwarzer cardis heart catheter measuring system. It does not contain a detailed study and acceptance criteria proving the device's performance. Instead, it states that the device is substantially equivalent to a predicate device (CATHCOR Desktop 510(k) Number K0021137) based on identical or comparable physical characteristics, design, safety, efficacy, and intended use.
Therefore, many of the requested details about acceptance criteria, study specifics, and ground truth establishment are not present in this document.
Here's a breakdown of the information that can be extracted and a clear indication of what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided as specific numerical criteria. The acceptance is based on substantial equivalence to a predicate device. | Not provided as specific numerical performance metrics. The device is stated to be "equivalent to the predicate device" and that "Physical characteristics including design, safety and efficacy characteristics and intended use of the cardis systems and the predicate device are either identical or comparable." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. This document is a 510(k) summary, which often summarizes findings rather than detailing the full study methodology. It claims substantial equivalence rather than presenting an independent performance study with a test set.
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)
- Not provided. As there's no independent performance study detailed with a test set requiring ground truth, this information is not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. Not applicable due to the absence of a detailed performance study with a test set.
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
- No. This document does not mention an MRMC comparative effectiveness study. The device is a "programmable diagnostic computer" for physiological data acquisition and hemodynamic calculations, not an AI-assisted diagnostic tool in the sense of image interpretation where MRMC studies are common.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly stated as a standalone study in this summary. The document focuses on the system's (hardware and software) equivalence to a predicate device for its defined functions (registration, display, recording, printout, storage, and calculation of biophysiological data). The "stand-alone" performance is implicitly covered by the claim of equivalence to the predicate device for these functionalities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided. Ground truth methodology for performance evaluation is not detailed as the submission relies on substantial equivalence.
8. The sample size for the training set
- Not provided. As the device is for collecting and calculating biophysiological data based on measured values, rather than an AI/machine learning model whose performance depends on a training set, this information is not relevant or provided.
9. How the ground truth for the training set was established
- Not provided. Not applicable for the reasons mentioned in point 8.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).