(301 days)
The AESCULON®, AESCULON® CHF Clinic™, AESCULON® Hypertension Clinic™ and AESCULON® Pacemaker Clinic™ are intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
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The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria. However, it does provide some information about the device and its claimed performance compared to a predicate device.
Here's an attempt to answer the questions based on the limited information provided, mostly inferring from the comparison to the predicate device:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state quantitative acceptance criteria or a formal performance report with specific metrics. Instead, it focuses on the theoretical differences in how the AESCULON® and its predicate device (BIOZ.COM®) interpret the impedance measurements. The "performance" here is implied by its claim of "substantial equivalence" and its different theoretical interpretation.
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Ability to measure base impedance ($Z_0$) | Measures $Z_0$ |
| Ability to measure maximum rate of change of impedance $\left(\frac{dZ(t)}{dt}\right)_{MIN}$ | Measures $\left(\frac{dZ(t)}{dt}\right)_{MIN}$, but interprets it as being related to peak aortic blood acceleration, deriving an index of contractility (ICON™). |
| Ability to measure left-ventricular flow time (FT) | Measures $FT$ |
| Substantial equivalence to predicate device's function as a hemodynamic monitor, cardiac output monitor, cardiovascular monitor | Deemed substantially equivalent to predicate device (BIOZ.COM®), despite differences in theoretical interpretation. |
2. Sample size used for the test set and the data provenance
This information is not provided in the document. There is no mention of a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. There is no mention of experts or ground truth establishment for a test set.
4. Adjudication method for the test set
This information is not provided in the document. The document does not describe any test set or adjudication process.
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
This type of study is not applicable to this device. The AESCULON® is a hemodynamic monitoring device, not an AI-assisted diagnostic tool that would involve human readers interpreting images.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a standalone hemodynamic monitor. Its performance is based on its algorithms for interpreting bioelectrical impedance. There isn't a "human-in-the-loop" aspect described that would necessitate a standalone vs. assisted comparison in the typical sense of AI-driven diagnostic tools. The document describes the core algorithms and their theoretical interpretation of measurements.
7. The type of ground truth used
The document does not explicitly state the type of ground truth used for any validation study. Given the nature of a hemodynamic monitor, potential ground truths could involve:
- Invasive direct measurements of cardiac output (e.g., Swan-Ganz catheterization)
- Direct observation of physiological parameters
- Comparison to well-established, validated hemodynamic monitoring methods.
However, none of this is detailed in the provided text. The document primarily focuses on the theoretical interpretation of measurements and comparison to a predicate device.
8. The sample size for the training set
This information is not provided in the document. The document describes the algorithms and their theoretical basis, but not how they were developed or trained on specific datasets.
9. How the ground truth for the training set was established
This information is not provided in the document. As there is no mention of a training set, there is also no information on how its ground truth might have been established.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.