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The Flowpresso Device combines heat and compression therapy. Flowpresso is intended to treat postsurgical medical and/or surgical conditions for which localized thermal therapy are indicated.

Flowpresso is intended to be used by, or on the order of, licensed health care professionals based in rehabilitation facilities, outpatient clinics and athletic training settings.

The Flowpresso Compression Device is an AC powered, software-controlled multimodality device, designed to be used in a clinical setting, and under the direction, prescription, or supervision of a licensed healthcare professional.

Flowpresso is a non-invasive physical suit that delivers compression, and heat therapy. The suit has air pressure and heat cables that are connected to a computerized power unit that controls ranges and duration of treatment.

The Flowpresso consists of various inflatable wraps that cover the back/hip and extremities of a fully clothed patient with Velcro fasteners. These multi patient use garments are designed to accommodate different anatomical shapes and sizes of patients that can be cleaned and disinfected in between uses to be reused for different patients. The suit has 22 individual internal chambers that inflate sequentially before its predecessor completely deflates, to provide a progressive pressure without any flow back.

Flowpresso is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust the monitor treatment times, temperature, and compression settings. Flowpresso has two separate modes: sports or relaxation, with different cycles to deliver a specific and individual experience that is supervised by a health care provider. The therapy lasts forty (40) minutes where the health provider will be available to make any adjustments throughout the duration of therapy.

The session begins with air pressure to give the patient a comfortable increased pressure, followed by heat. The health care provider is responsible for adjusting settings of pressure/heat to ensure the patient is comfortable for the entirety of the forty (40) minute session.

The provided document describes the Medella Health Limited FLOWpresso device and its 510(k) summary, comparing it to a predicate device, the Therm-X (K193550). The document focuses on demonstrating substantial equivalence rather than presenting an independent clinical study to establish performance against acceptance criteria in the typical sense of a diagnostic or treatment efficacy study.

Here's an analysis of the acceptance criteria and study information provided, extracting what's available and noting what's not, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, or treatment success rates) and then report the device's performance against those criteria in a clinical setting. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technical and safety testing.

The "acceptance criteria" can be inferred from the various tests performed to ensure the device is safe and performs according to its specifications and regulatory standards. The "reported device performance" are the qualitative findings of passing these tests.

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

This information is not provided in the document. The testing described appears to be bench testing and materials testing, not a clinical trial involving a "test set" of patient data.

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

This information is not applicable and not provided. Since the document describes technical and safety testing rather than a clinical study evaluating diagnostic accuracy or treatment outcome against a "ground truth" established by experts, this detail is absent.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1 consensus) are used in studies where human expert review or consensus is needed to establish ground truth for clinical cases, which is not the type of study described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable and not provided. MRMC studies are typically for evaluating AI in diagnostic imaging or other areas where human readers interpret cases, and the document describes a physical therapy device. The FLOWpresso device does not appear to involve AI/human reader interaction in its described function.

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

This information is not applicable and not provided. The FLOWpresso is a physical hardware device with software controls, not a standalone algorithm. While software validation was performed, it's for controlling the device, not for independent diagnostic or predictive tasks.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the safety and performance tests described, the "ground truth" consists of established engineering standards, material specifications, and regulatory requirements. For example:

• Electrical safety: Adherence to ANSI/AAMI ES60601-1, IEC 60601-1.
• Biocompatibility: Adherence to ISO 10993-5, ISO 10993-10.
• Flammability: Adherence to 16 CFR 1610.
• Software performance: Conformance to established performance requirements and specifications.
• Bench testing: Conformance to predetermined specifications (e.g., pressure accuracy, seam strength).

There is no mention of clinical ground truth (e.g., pathology, outcomes data, or expert consensus on clinical cases) in this 510(k) summary, as it's not a clinical efficacy study.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical therapy device; there is no mention of an algorithm that would require a "training set" of data in the context of machine learning or AI.

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

This information is not applicable and not provided for the same reasons as in point 8.

Summary of the Study Presented:

The document describes bench testing, material testing, and software validation to demonstrate the safety and technical performance of the FLOWpresso device and its substantial equivalence to a predicate device (Therm-X). The "study" is a collection of engineering and materials tests conducted against recognized industry standards and internal specifications. It is a design verification and validation effort rather than a clinical effectiveness study. The purpose is to show that the device meets safety and performance requirements for a Class II medical device, enabling its market clearance based on substantial equivalence. It does not contain information about clinical outcomes, patient data, or AI performance metrics.

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