Search Results

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.

Ask a specific question about this device

The Portapres Ambulatory Continuous Non-Invasive Blood Pressure Monitor is intended to provide the user with continuous, noninvasive blood pressure and pulse rate monitoring. The Portapres enables 24-hour continuous ambulatory measurements.

The PC-based BeatScope software used with the data from the device provides Modelflow-based computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the pressure waveform, including, cardiac output and total peripheral resistance.

Portapres is a portable, battery-powered device to record continuous non-invasive arterial blood pressure. Portapres is intended for 24-hour continuous recordings in ambulatory subjects. The device includes a Neoprene belt to be worn around the waist, with compartments for the Main Unit with electronics and memory card, a Pump Unit with an air pump, and a NiCd or Li battery pack. Connected to the waist belt Main Unit and Pump Unit is a Wrist Unit, used to interface with the signals from the electronics and air supply in the waist belt to the finger cuffs. The Wrist Unit then connects to a finger cuff, which consists of an inflatable air bladder and an infrared photoplethysmograph. The plethysmograph measures the finger arterial volume which varies with the patient's blood pressure. The Wrist Unit controls the pressure in the cuff bladder so as to keep the arterial volume constant at a level (the setpoint) determined during startup. The Wrist Unit contains a pressure transducer that measures the cuff pressure as an indirect measure of the patient's blood pressure. Also connected to the Wrist Unit is a hydrostatic height correction unit that compensates for the hydrostatic component of the blood pressure in the finger when this is not at heart level. This allows the patient free hand movement in ambulatory applications.

Pressure and volume signals from the finger cuffs are routed from the Wrist Unit to the Main Unit microprocessor for pump control and data acquisition purposes. The microprocessor has an internal flash memory card for storage of blood pressure wave form data.

The Main Unit is equipped with an RS232 serial interface to transfer the data stored in the flash memory card via a Control Unit to a PC and to allow remote control of the Portapres.

Here's a breakdown of the acceptance criteria and study information for the FMS Portapres Ambulatory Noninvasive Blood Pressure Monitor, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for blood pressure accuracy (e.g., standard deviation, mean difference) as might be found in a more detailed validation report or a standard like ANSI/AAMI SP10.

However, the document states that the Portapres is "substantially equivalent in design (methodology) and indications for use" to predicate devices. This implies that its performance is expected to be comparable to these legally marketed devices, which would have themselves met relevant performance standards for blood pressure accuracy.

The 510(k) summary does not include a table of reported device performance metrics such as mean difference and standard deviation against a reference standard. Therefore, I cannot populate a table with specific numerical performance data directly from this document.

Missing Information: Specific numerical acceptance criteria for blood pressure measurement accuracy (e.g., AAMI/ANSI SP10 standards) and the Portapres's direct performance against those criteria are not provided in this summary. The summary focuses on substantial equivalence to predicate devices, assuming those devices met the necessary performance standards.

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

The 510(k) summary does not provide details about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective) that directly demonstrates the device's accuracy against a gold standard.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. It states: "Portapres and Finapres are substantially equivalent in design, methodology, software, manufacture, materials, intended use and principle of operation." This implies that prior testing and validation of the predicate devices (Ohmeda 2300 Finapres, Ohmeda 2350 Finapres, Task Force Monitor 3040, RODA Monitoring System) are being leveraged.

Missing Information: Direct test set sample size, country of origin, or retrospective/prospective nature of data for the Portapres itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no direct test set demonstrating the device's accuracy is described, there is no information provided regarding experts used to establish ground truth. For blood pressure monitors, ground truth is typically established by trained medical professionals using a reference standard (e.g., auscultatory method with a mercury sphygmomanometer) during a clinical validation study.

Missing Information: Number and qualifications of experts are not mentioned as no direct study for the Portapres's accuracy is detailed.

4. Adjudication Method for the Test Set

As no specific test set or study validating the Portapres's accuracy is described, no adjudication method is mentioned.

Missing Information: Adjudication method is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. Blood pressure monitors are primarily direct measurement devices, and their validation focuses on agreement with reference standards, not on improvement in human reader performance.

Missing Information: No MRMC study was conducted or reported.

6. Standalone Performance Study

The 510(k) summary does not explicitly describe a standalone performance study (i.e., algorithm only without human-in-the-loop performance) for the Portapres.

The claim of substantial equivalence implies that the device's performance, by virtue of its "design, methodology, software," is comparable to its predicates, which would have undergone their own standalone validation. The Portapres itself is a device that generates data (blood pressure waveform and derived parameters), and its standalone performance would be its accuracy in doing so compared to a reference standard. The summary does not provide direct evidence of this for the Portapres specifically.

Missing Information: A specific standalone performance study report for the Portapres is not detailed in this summary.

7. Type of Ground Truth Used

Given that no direct study for the Portapres's accuracy is detailed, the specific type of ground truth used to validate the Portapres cannot be explicitly stated from this document.

However, for non-invasive blood pressure monitors, the gold standard (ground truth) for validation typically involves:

• Auscultatory method: Manual blood pressure measurement performed by trained observers using a stethoscope and sphygmomanometer, often with double or triple auscultation and averaging.
• Intra-arterial catheterization: Invasive measurement, used less commonly for routine non-invasive device validation but considered highly accurate.

The summary's reliance on substantial equivalence suggests that the predicate devices were validated against such ground truths.

Missing Information: The specific type of ground truth used for the Portapres's validation is not detailed.

8. Sample Size for the Training Set

The 510(k) summary does not provide information about a training set or its sample size. The device described, the Portapres, is a measurement device that employs algorithms for continuous blood pressure estimation and hemodynamic parameter calculation (like Modelflow for cardiac output). While such algorithms might be "trained" or developed using data, this summary does not provide details of that process or associated sample sizes.

Missing Information: Training set sample size is not provided.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, information on how its ground truth was established is not provided. The algorithms (e.g., Modelflow) would have been developed and validated using physiological data over many years, but these details are not part of this 510(k) submission for the device itself.

Missing Information: Ground truth establishment for a training set is not provided.

Summary of Limitations of the Provided Document:

This 510(k) summary primarily focuses on establishing "substantial equivalence" to existing predicate devices. It does not contain a detailed report of a new clinical validation study for the Portapres itself, which would typically include explicit acceptance criteria, sample sizes, methodology for ground truth establishment, and reported performance metrics. The FDA's acceptance in this case is based on the argument that the new device's design, methodology, and intended use are similar enough to previously cleared devices that it can be presumed to be safe and effective without requiring a full, new, independent clinical validation study report within the summary document.

Ask a specific question about this device