(202 days)
ReDS is intended for use by qualified health care practitioners and by patients, under the direction of a physician, in hospitals, hospital-type facilities and home environment, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
ReDS is indicated for patients:
- With fluid management problems
- Taking diuretic medication
- Living with Heart Failure
- Recovering from Coronary Artery Disease related event .
The ReDS Wearable System ("ReDS") is a non-invasive thoracic base wave impedance monitor that provides measurement of patient lung fluid content. ReDS™ technology measures wave impedance of biological tissues. Low power electromagnetic (EM) signals are emitted into the body, and intercepted by sensors on the body. The wave impedance is a function of the distributed tissue conductivity and capacitance properties, and is representative of tissue fluid content.
The system consists of a Wearable Vest connected to a bedside console, as well as a cloud application. The Wearable Vest encases two sensors and an attachment mechanism. The Bedside Console is an enclosure housing the electronic modules, an embedded computer and a touch-screen display. The device software provides the management of the device as well as analysis of the measured signals, graphic display of readings, reporting, and communications functionality to enable remote patient monitoring.
The provided text describes the ReDS™ Wearable System, an impedance plethysmograph, and its regulatory filing (K150095). However, it does not contain a table of acceptance criteria nor the specific quantitative results of a study proving the device meets those criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various testing, and general statements about passing results. It mentions "All performance testing passed according to defined acceptance criteria, demonstrating that the device performs as expected," but does not detail what those criteria or results were for key performance metrics related to measuring lung fluid content.
Therefore, many of the requested sections cannot be filled with specific information from the provided text.
Here is a summary of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not provided in the document. The document states "All performance testing passed according to defined acceptance criteria," but does not list those criteria or specific performance metrics (e.g., accuracy, precision) for the ReDS™ Wearable System in quantifiable terms. It only broadly states that the device was evaluated for its accuracy in quantifying lung fluid content.
2. Sample Size for Test Set and Data Provenance:
- Test Set Sample Size: "Clinical studies were conducted to provide preliminary clinical performance data... in patients presenting various fluid content levels." The exact number of patients in the clinical studies is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the clinical data. It generally refers to it as "clinical studies." It does not specify if the studies were retrospective or prospective, though the description "preliminary clinical performance data" suggests prospective data collection in a study setting.
3. Number of Experts and Qualifications for Ground Truth:
- Not specified. The document does not describe how ground truth was established for the clinical studies, nor if experts were used for this purpose.
4. Adjudication Method:
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not performed/reported. This study focuses on a standalone device or comparison against predicate devices, not a human-AI assisted workflow.
6. Standalone (Algorithm Only) Performance:
- Yes, implicitly. The entire submission describes the ReDS™ Wearable System as a standalone device ("non-invasive thoracic base wave impedance monitor that provides measurement of patient lung fluid content") and its performance in various tests (bench, animal, clinical studies) is in a standalone context. The document states, "The performance of ReDS in the clinical setting was consistent with the findings of the nonclinical studies."
7. Type of Ground Truth Used:
- Not explicitly stated for the clinical studies involving human subjects. The animal study (porcine model) aimed to "demonstrate the ReDS accuracy in quantifying lung fluid content," implying some form of direct measurement or gold standard for lung fluid in animals. For human clinical studies, "quantification of pulmonary fluid level" is mentioned, suggesting comparison against an established method, but that method is not detailed (e.g., could be another imaging modality, invasive measurements, or clinical assessment, none of which are specified).
8. Sample Size for Training Set:
- Not specified. The document discusses "clinical studies" for performance data, but does not differentiate or specify a separate "training set" for model development.
9. How Ground Truth for Training Set was Established:
- Not specified, as no training set details are provided.
§ 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.