Search Results

The Whisper Pump System™ is a suction device intended for aspiration of secretions and body fluids from wounds and is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. Whisper Pump System™ is appropriate for use on the following wounds:

• Pressure ulcers
• Diabetic/neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Post-operative and dehisced surgical wounds
• Explored fistulas
• Skin flaps and grafts

The Whisper Pump System™ is a device to remove bodily fluids for wound drainage and can be used by patients over an extended period of time as recommended by a physician. The device has a rechargeable battery and therefore is portable. A microprocessor controlled electronic battery charging unit in the suction device guarantees the safe charging of the battery, and overcharging of the battery. The Whisper Pump System™ itself is not a sterile device but can use disposable (sterile) items from other manufacturers but these items are not a part of the Whisper Pump System™, (e.g. various hose sets, containers, trocars and catheters) which have been designed for the wound drainage. The purpose of this traditional 510(k) was to modify the outer case dimensions, carrying handle ergonomics, canister bracket, and internal component reconfiguration.

This document is a 510(k) premarket notification for a medical device called the Whisper Pump System™. It is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically involve traditional clinical studies with patient data and ground truth for AI algorithms, as it is for a physical device (a powered suction pump) and not an AI/ML software as a medical device (SaMD).

Therefore, many of the requested categories for AI/ML performance studies are not applicable or cannot be extracted from this document, as the "device" in question is hardware.

Here's an analysis based on the provided text, focusing on the engineering and safety performance rather than AI/ML diagnostic performance:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is primarily assessed against established medical device safety and electromagnetic compatibility standards, and functionality relating to its purpose as a suction pump.

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

This is not applicable in the context of an AI/ML algorithm. The "testing" referred to in the document is for the physical device's engineering and safety characteristics against standards. No patient data or clinical images are involved in this type of submission for this device.

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

This is not applicable. Ground truth, in the context of AI studies, refers to expert interpretations or pathological diagnoses on patient data. This document describes testing of a physical pump device against engineering standards.

4. Adjudication Method for the Test Set

This is not applicable. No expert adjudication for clinical data is mentioned as this is not an AI/ML device.

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

No such study was conducted or is relevant for this type of device. The Whisper Pump System™ is a stand-alone physical suction pump, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This is not applicable. The device is a physical pump, not an algorithm. Its "standalone performance" refers to its ability to meet the specified engineering and safety standards.

7. The Type of Ground Truth Used

This is not applicable in the context of AI/ML. The "ground truth" for this device's performance relies on objective measurements and tests against established engineering and safety standards, and functional specifications defined by the manufacturer. For example, pressure measurements to verify suction, electrical tests for EMC, and thermal tests for overheating.

8. The Sample Size for the Training Set

This is not applicable. There is no AI/ML algorithm involved, therefore no training set.

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

This is not applicable. There is no AI/ML algorithm involved, therefore no training set or ground truth establishment for it.

Summary for this specific device (Whisper Pump System™):

The Whisper Pump System™ is a physical medical device (a powered suction pump). The "performance" and "acceptance criteria" discussed in this 510(k) document relate to its engineering specifications, safety, electromagnetic compatibility, and manufacturing quality, primarily demonstrating substantial equivalence to a predicate device. The information requested regarding AI/ML algorithm performance (test sets, training sets, ground truth, expert adjudication, MRMC studies) is not relevant to this type of device submission. The study proving the device meets acceptance criteria involved engineering and safety testing against recognized international and national standards (e.g., IEC 60601 series, ISO 10993) and internal software/product validation tests.

Ask a specific question about this device