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The Finometer is intended to be used when there is a need for a noninvasive hemodynamic monitor. The Finometer provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow as well as in various hemodynamic parameters derived from these pressure and flow signals. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers.

The noninvasively blood pressure waveform is measured by using the Finapres method of Peñáz/Wesseling. Hemodynamic parameters include cardiac output and total peripheral resistance based on the Modelflow method of Wesseling.

The Finometer is intended to be installed and operated by a qualified physician or operator. Pressure measurements are validated for subjects above 18 years of age. The only mode of measuring blood pressure accurately is when the device is used with the return-to-flow method of calibration, if the pressure data are to comply with the recommendations of the AAMI SP10 standard.

Modelflow built-in calibration is useful from 18 years on. Cardiac output measured with this device under the Modelflow model requires a calibration with thermal dilution.

The physiological parameters provided by the device have clinical significance only if determined by a physician and should not be used as the sole means for a patient's diagnosis.

The data provided by the device can be further processed by the included PC-based BeatScope software.

The Finometer Noninvasive Hemodynamic Monitor is a stationary device to record continuous noninvasive arterial blood pressure as well as additional hemodynamic parameters.

The Finometer is a stationary device. It consists of the Main Control Unit with electronics and a solidstate disk for storage. The Main Control Unit also contains the two pressurized air circuits, including air pumps, for the measurements using the Finapres methodology and for the RTF calibration methodology. A Frontend Unit is used to provide an interface for the electronic signals from the Main Control Unit electronics and air supply to the forger cuffs, an arm cuff, and an analog input/output unit. The Frontend Unit connects the Main Control Unit to the forger cuff, which in turn consists of an inflatable air bladder and an infrared photoplethysmograph

The Main Control Unit microprocessor has an internal solid-state disk storing up to 24 hours of continuous blood pressure and derived hemodynamic data. The Main Control Unit is equipped with an RS232 serial interface to transfer the data stored in the Finometer disk to a PC and to allow remote control of the Finometer.

The analog input/output unit provides four analog signal outputs for connection to other data acquisition systems, and provides three analog signal inputs for sampling and storing of external signals simultaneously with the Finometer data. An external (intra-arterial) blood pressure signal can be used to replace the finger blood pressure. The Finometer then will use the external pressure signal to derive all parameters.

BeatScope PC-software is also delivered with the Finometer to enable downloading, viewing, and further handling of Finometer data. BeatScope provides the capability of on-line monitoring, storage, and limited control of a Finometer measurement on a remote PC.

The provided text is a 510(k) summary for the FMS Finometer Noninvasive Hemodynamic Monitor. It focuses on establishing substantial equivalence to predicate devices and describes the device's intended use and technological characteristics.

Crucially, the document does NOT contain a study proving the device meets specific acceptance criteria. It states, "No new technology, materials, or change in efficacy have been introduced by FMS in the manufacture of the FMS Finometer Noninvasive Hemodynamic Monitor." This implies reliance on the predicate devices' established performance rather than a new effectiveness study for this specific 510(k) submission.

Therefore, I cannot fulfill most of your request for information related to an acceptance criteria study. However, I can extract what is mentioned about performance and relevant details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions compliance with the AAMI SP10 standard for blood pressure data when using the return-to-flow calibration method. It also states that pressure measurements are "validated for subjects above 18 years of age." However, specific numerical acceptance criteria (e.g., mean difference, standard deviation) from a performance study are not provided.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. The 510(k) does not describe a new performance study with a test set. It relies on the substantial equivalence to predicate devices (Ohmeda 2300 Finapres, Ohmeda 2350 Finapres, Task Force Monitor 3040), whose original studies would have established their performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. No new performance study described in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No new performance study described in this 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. This device is a noninvasive hemodynamic monitor, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device calculates hemodynamic parameters independently without human intervention during the measurement process, but the interpretation and clinical significance are the physician's responsibility. It's an algorithm-only measurement device, but no standalone performance study specific to this 510(k) is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the predicate devices, continuous blood pressure (and derived values) would likely have been validated against invasive arterial lines (for blood pressure) and potentially thermal dilution or other established methods for cardiac output. However, this 510(k) does not detail how the ground truth was established for the predicate devices or for any new validation of the Finometer. It only states that "Cardiac output measured with this device under the Modelflow model requires a calibration with thermal dilution."

8. The sample size for the training set:

Not applicable. The document does not describe a new training set or a machine learning model specific to this 510(k) for which a training set would be required. The device utilizes "Finapres methodology" and "Modelflow method," which are established physiological models, not machine learning algorithms in the modern sense.

9. How the ground truth for the training set was established:

Not applicable. No training set is described in this document.

In summary, this 510(k) relies on the substantial equivalence of the Finometer to its predicate devices rather than presenting a new, comprehensive study detailing its performance against specific acceptance criteria. The document states that "No new technology, materials, or change in efficacy have been introduced," suggesting that the performance characteristics of the predicate devices are considered valid for the Finometer.

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