(28 days)
Indicated for use in adults only. The PhysioFlow Enduro PF07 noninvasively measures cardiac output and other related cardiac parameters. These parameters include: CI (Cardiac Index), CO (Cardiac Output), CTI (Contractility Index), dZ / dt max (Maximum value dZ / dt), EDV (End Diastolic Volume), EF (Ejection Fraction), HR (Heart Rate), LCWI (Left Cardiac Work Index), PEP (Pre-Ejection Period), SV (Stroke Volume), SVR (Systemic Vascular Resistance), SVRI (Systemic Vascular Resistance Index), TFI (Thoracic Fluid Index), VET (Ventricular Ejection Time), and ZO (Base Impedance). The Enduro System Model PF-07 is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
The PhysioFlow Enduro Model PF07 is a noninvasive, hemodynamic monitor that utilizes thoracic electrical bioimpedance technology to measure cardiac output and related cardiac parameters. It consists of a small, portable, lightweight (less than 250 gm with batteries) electronic unit that attaches to the patient via a six lead, patient cable using commercially available silver/silver chloride skin electrodes. The electronic unit incorporates recorder capabilities, enabling it to capture and store up to 24 hours of monitor data for later transmission to a host computer running the PhysioFlow PF107 software. Communication options include Bluetooth wireless and USB wired technology. The PhysioFlow PF107 software performs multiple tasks including signal processing and analysis, measured parameter computation, user interface display and control, measurement process control, event marker management, and output display/report generation. Available accessories include the patient cable, a Bluetooth antenna. USB cable, and electronic unit carrying case.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes a "Special 510(k)" submission for the PhysioFlow Enduro Model PF07, which is a modification of a previously cleared device, the PhysioFlow System Model PF05. Special 510(k)s typically rely on demonstrating that modifications to an existing device do not raise new questions of safety or effectiveness and that the modified device performs as intended and is substantially equivalent to the predicate.
In this case, the acceptance criteria for the new device (PhysioFlow Enduro Model PF07) are directly tied to its performance relative to the predicate device (PhysioFlow System Model PF05).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Performance Equivalence to Predicate | Difference between subject and predicate devices across measured parameters | Less than 4% difference |
| Clinical Variability | Acceptable clinical variability for these parameters | 5% |
Summary of Performance: The device's performance, showing a difference of less than 4% compared to the predicate, meets the acceptance criteria as this difference is below the acceptable clinical variability of 5%.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document states "Design verification tests were performed on representative samples" and "Product validation tests were performed in a simulated use setting." However, no specific numerical sample size (e.g., number of patients/subjects or test cases) for the test set is provided.
- Data Provenance: Not explicitly stated. The tests were performed as part of product development and validation, but the country of origin or whether it was retrospective or prospective data is not mentioned. Given it's a simulated use setting test for validation, it likely refers to testing under controlled conditions rather than a clinical trial with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set:
- No information provided regarding an adjudication method. The testing described focuses on comparing the subject device's output to the predicate device's output, essentially using the predicate device's performance as the reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The study described is a device-to-device comparison for technical performance, not a human reader performance study. Therefore, there's no information on the effect size of how much human readers improve with AI vs. without AI assistance. The device is a direct measurement tool, not an AI-assisted diagnostic aid for interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, a standalone performance assessment was effectively done. The "Design verification tests" and "Product validation tests performed in a simulated use setting" compared the device's output (algorithm + hardware) to the predicate device's output. The performance report of "less than 4% difference" refers to the device's standalone measurements.
7. The Type of Ground Truth Used:
- The "ground truth" for the performance study was the performance of the predicate device (PhysioFlow System Model PF05). The study established "a difference between the subject and predicate devices of less than 4% across the measured parameters." This implies the predicate device's established measurements served as the reference for evaluating the new device.
8. The Sample Size for the Training Set:
- Not applicable/Not mentioned. This device is a physiological monitor based on bioimpedance technology, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its underlying principles are established physiological measurements. The document describes traditional "design verification tests" and "product validation tests," not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not mentioned. As explained above, there is no "training set" for this type of device in the context of the provided document. The device's functionality relies on established physics and physiology, not data-driven machine learning.
§ 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.