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The IPC-Boot is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both. The IPC-Boot is intended to assist patients, suffering from lymphatic or venous disorders, by treating many conditions including: Prevention of deep vein thrombosis (DVT), Enhancement of blood circulation, Reduction of post-operative pain and swelling, Reduction of wound-healing time, Stasis dermatitis, Treatment and assist healing of cutaneous ulceration, Venous stasis ulcers, Leg ulcers, Chronic venous insufficiencies, Reduction of edema, Prevent pooling of fluids in limbs, Lymphedema

IPC-Boot is actually a very similar version of C-Boot's legally marketed device, cleared under 510(k) number K041659. Similarly to the legally marketed device, it is made of the same materials and has the same design, technology and performances. The only modification that was made to the predicate device is the addition of external electric pump that can activate the device electrically when the patient is immobile. This modification provides a solution for such patients. The patient may choose whether the device will be used mechanically (self powered), by walking (as the original device) or electrically as the modified new device: IPC-Boot, when patient is immobile. The IPC-Boot is a wearable pneumatic compression technology embodied in a therapeutic boot that has the potential to increase treatment efficacy and improve the quality of life for peripheral vascular and lymph disorders patients. The IPC-Boot contains boot legging with inflatable sleeves from the patient's foot up to the knee. The IPC-Boot uses an external electric pump. The pump is generated the air to inflate the sleeves through the control system for producing intermittent compression to the lower limb. C-Boot's solution integrates the technological advantages of dynamic compression pumps that enable preset sequential pressure control which is identical to the pressure level of the preamended device (predicate). This enables the patient to individualize treatment regimes, with the mobility benefit of static compression stockings that activate the calf muscle pump and strengthened the body's natural tendency to enhance lymphatic and venous return, The modified device covers both self-powered and electrical compression devices and creates one integrated device.

This 510(k) summary describes a device, the IPC-Boot, which is an electrical lymph and venous-insufficiency system. The submission focuses on demonstrating substantial equivalence to a predicate device (C-Boot, K041659) by highlighting that the new device is a very similar version with the primary modification being the addition of an external electric pump for electrical activation when the patient is immobile. The submission asserts that this modification does not affect the device's intended use or alter its fundamental scientific technology.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., pressure output ranges, cycle times, safety thresholds) for the IPC-Boot, nor does it present detailed study results against such criteria.

Instead, the submission states:

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

The provided text does not include any information regarding the sample size used for the test set, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective nature). The tests mentioned are "non-clinical" and seem to be engineering verification and validation rather than clinical studies with human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Given that the document refers to "non-clinical tests" and "legally marketed device specification," it is highly unlikely that "experts" (like radiologists) were used to establish ground truth in the way medical imaging or diagnostic devices would require. The tests appear to be related to engineering specifications and performance, which would likely be assessed by engineers or technicians. No specific information on experts or their qualifications is provided.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant to clinical studies involving human interpretation or assessment, especially in cases of disagreement among experts. Since the tests described are non-clinical and focus on device specifications, an adjudication method in this sense is not applicable and not mentioned in the document.

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

No MRMC comparative effectiveness study was done or mentioned. The submission is focused on demonstrating substantial equivalence through non-clinical testing of the modified device against the predicate's specifications, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The IPC-Boot is a physical medical device (pneumatic compression boot), not an algorithm or an AI-driven system. Therefore, the concept of a "standalone" algorithmic performance study does not apply to this device. The evaluation would be on the device's mechanical and electrical performance as a standalone unit.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be the legally marketed device's (predicate device's) specifications and performance characteristics. The modified device was evaluated against these established benchmarks. The text indicates: "The modified device was tested with accordance to C-Boot's legally marketed device specification and all acceptance criteria were met." This implies that the 'ground truth' was a set of engineering and performance standards derived from the predicate device.

8. Sample Size for the Training Set

Since the IPC-Boot is a physical medical device and not an AI/machine learning system, a "training set" in the context of algorithm development is not applicable and not mentioned. The device itself is manufactured, not "trained."

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

As there is no training set for this type of device, the method of establishing its ground truth is not applicable. The reference points for performance were the predicate device's specifications.

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