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SaphenaMEDICAL Anti-Embolism Stockings are intended to:

• Help to prevent the pooling of blood in the legs by applying controlled pressure to the legs.
• Help to prevent Deep Vein Thrombosis (DVT) and, edema and leg discomfort in . individuals subjected to immobility.

SaphenaMEDICAL Anti-Embolism Stockings are ready-to-wear for post-operative/ surgical, reclining or bed-confined patients, to help prevent pooling of blood and fluid in the extremities by applying controlled graduated pressure. The fabric used is comprised of nylon and lycra which is used in the predicate devices.
The SaphenaMEDICAL Anti-Embolism Stockings provide controlled, uniform graduated conpression, as is provided in all of these substantially equivalent products, starting with more compression circumferentially at the ankle at approximately 18 mmHg (based on average ankle size) then gradually decreases up to the proximal end. (14mmHg at the mid-calf and 8mmHg at the upper thigh)
Compression for the SaphenaMEDICAL Anti-Embolism Stockings, as well as all the predicate devices, is provided by lycra that acts circumferentially on the extremity. The gradient compression present in these products helps reduce capillary leakage and improve capillary and lymphatic drainage and/or absorption. Consequently, they can be used to manage the same indications, i.e. edema and lymphedema.
The Anti-Embolism Stockings are not made with natural rubber latex.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the SaphenaMEDICAL® Anti-Embolism Stocking as substantially equivalent to existing predicate devices. Since this is a substantial equivalence submission, the acceptance criteria are implicitly aligned with the performance characteristics of the predicate devices. The reported device performance is presented as being equivalent to these predicates.

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

The document states, "Performance Data: The Anti-Embolism products being submitted are substantially equivalent to the predicate product in material content, function and indication bench testing demonstrated that the safety and effectiveness of the SaphenaMEDICAL Anti-Embolism Stockings is equivalent to the predicate devices."

This indicates that the evaluation of the SaphenaMEDICAL® Anti-Embolism Stocking was primarily based on bench testing and comparison to predicate devices, not a clinical study involving human subjects or a test set of data in the way one might evaluate an AI algorithm. Therefore, there is no explicit sample size mentioned for a "test set" in the context of patient data.

The "data provenance" is derived from the established performance and characteristics of the predicate devices, which are already legally marketed.

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

Given that this is a 510(k) submission for substantial equivalence based on bench testing and comparison to predicate devices, there is no mention of experts establishing a ground truth for a test set in the context of clinical data or image interpretation. The "ground truth" here is the established performance and safety of the predicate devices, as recognized by regulatory bodies.

4. Adjudication Method for the Test Set:

Not applicable, as there was no clinical test set requiring adjudication in the way an AI algorithm's performance might be evaluated. The evaluation focused on bench testing and comparison to predicate specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs without AI assistance:

Not applicable. This submission is for a physical medical device (anti-embolism stockings), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

Not applicable. The device is not an algorithm, so standalone performance is not relevant in this context.

7. The Type of Ground Truth Used:

The ground truth used for this submission is implicitly the established performance and safety profiles of the legally marketed predicate devices. The SaphenaMEDICAL® Anti-Embolism Stocking demonstrates substantial equivalence through its material content, function, indications for use, and bench testing results aligning with these predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of medical device.

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