Search Results

The HydroBoot device is indicated to provide compressive therapy on the lower legs and feet to help manage chronic swelling and ulceration due to venous insufficiency and lymphedema.

The HydroBoot device is intended to provide compressive therapy on the lower legs and feet to help manage chronic swelling and ulceration due to venous insufficiency and lymphedema. The HydroBoot achieves its pressure against the foot and leg from the hydrostatic pressure of water that fills the walls of the boot. The pressure depends only on the depth of the water, so a pressure gradient from the foot to the knee is obtained.

The provided document describes the 510(k) summary for the HydroBoot device (K022233). It is important to note that this document is a summary for regulatory clearance and does not typically contain the detailed raw data, exhaustive study protocols, or statistical analyses that would be found in a full clinical or engineering study report.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the HydroBoot does not present specific quantitative acceptance criteria or a direct performance table in the way a clinical trial detailed report might. Instead, the "acceptance criteria" are implied by the process of demonstrating "substantial equivalence" to predicate devices. The primary performance characteristic discussed is the ability to produce therapeutic pressure levels.

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

• Sample Size: The document states that "Testing using pressure sensors was carried out on volunteers." However, it does not specify the number of volunteers used in this testing.
• Data Provenance: The document does not explicitly state the country of origin. Given that Incappe, Inc. is located in Vicksburg, MS, and the submission is to the FDA, it is highly probable the testing was conducted in the United States. The study was prospective in nature, as it involved actively "carrying out" testing with pressure sensors on volunteers.

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

This information is not provided in the 510(k) summary. The testing appears to be focused on physical pressure measurements, and the "ground truth" seems to be derived from scientific measurements of hydrostatic pressure and objective sensor readings rather than expert clinical assessment of patient outcomes or conditions. If clinical outcomes were being assessed for "ground truth," experts would be mentioned, but this is not the case here.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The testing described is focused on objective pressure measurements (using pressure sensors) rather than subjective assessments or interpretations that would require an adjudication method.

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

• Was it done? No. This type of study is typically done for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. The HydroBoot is a therapeutic device, and the testing described is focused on objective physical parameters (pressure), not human interpretation of diagnostic data.
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

• Was it done? Yes, in a way. The "testing using pressure sensors" on volunteers, described under "F. TESTING", represents a standalone performance assessment of the device's ability to produce pressure. The device's performance in generating pressure was measured directly on volunteers. This is an assessment of the device's intrinsic mechanical/hydraulic function.

7. Type of Ground Truth Used

• The ground truth used was based on objective physical measurements and scientific principles. Specifically:
  • Predicted values from the height of the water column: This relies on established principles of hydrostatics.
  • Pressure sensor measurements: These provide objective quantitative data on the actual pressure exerted by the device.
  • The comparison was to "demonstrate equivalence... in producing a therapeutic level of pressure," implying that "therapeutic level of pressure" is a known and accepted standard for these types of devices, possibly derived from clinical literature or predicate device performance.

8. Sample Size for the Training Set

The document does not specify a training set sample size. The HydroBoot is a mechanical/hydraulic device, not an AI/machine learning algorithm, so the concept of a "training set" in the context of machine learning is not directly applicable. The "testing" referred to is performance validation, not algorithm training.

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

Not applicable, as there is no mention or implication of an AI/machine learning algorithm requiring a "training set" as understood in that context. The device's mechanism is based on hydrostatic pressure, a well-understood physical principle.

Ask a specific question about this device