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The Lympha Press Plus device is intended for treatment of lymphatic disorders, venous disorders, post- mastectomy lymph-edema and dysfunction of the "Muscle Pump".

The Lympha Press Plus Device is a programmable sequential compression therapy device with compression garments for the treatment of lymphatic and venous disorders. The Lympha Press Plus device consists of a main console and compression garments. The main console contains an air compressor that is regulated by a mechanical air pressure regulator. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments containing up to 12 overlapping pressure cells. The sleeve fits on the affected limb and can be easily adjusted to any limb size within the sleeve tolerance.

Acceptance Criteria and Device Performance Study for the Lympha Press Plus Device

This document describes the acceptance criteria and the study that proves the Lympha Press Plus device meets these criteria, based on the provided FDA 510(k) summary.

Evaluation Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria, statistical analysis, and performance metrics as typically found in a clinical trial report for novel devices. Therefore, the information below is derived from the context of substantial equivalence and assumes that the "acceptance criteria" for a 510(k) submission are met by showing similar technological characteristics and intended use to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not describe a specific clinical test set, corresponding sample size, or data provenance (e.g., country of origin, retrospective/prospective). 510(k) submissions for substantial equivalence often rely on comparative analysis of technical specifications, existing clinical data for predicate devices, and sometimes bench testing, rather than a new clinical trial with a "test set" in the context of AI/diagnostic algorithm validation.

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

As there is no specific test set or clinical study described in detail, there is no information about experts used to establish ground truth. Substantial equivalence for this type of device typically relies on regulatory review of technical specifications and comparison to predicate devices, not expert consensus on a diagnostic outcome.

4. Adjudication Method for the Test Set

Given the lack of a defined test set for a clinical study, no adjudication method is described in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key metric. The Lympha Press Plus is a therapeutic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Lympha Press Plus is a mechanical therapeutic device, not an algorithm or AI system. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" implicitly refers to the established safety and effectiveness of the legally marketed predicate devices (Lympha Press, Jobst Extremity Pump, and Sequential Circulator). The Lympha Press Plus device claims substantial equivalence to these devices, meaning its
"ground truth" for regulatory approval is based on its similarity to products already proven safe and effective through their own regulatory pathways (which could have included clinical trials, post-market surveillance, or pre-amendment status).

8. The Sample Size for the Training Set

The Lympha Press Plus device is a mechanical therapeutic device, not an AI/machine learning model. Therefore, the concept of a "training set" does not apply.

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

As stated above, the concept of a "training set" does not apply to this device.

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The EUREDUC TP03 is intended for :

• Lymphedema of lower extremities; post surgical or congenital ;

• Postmastectomy lymphedema ;

• Dysfunction of the muscle pump ;

• Pre, post phases of surgery.

a pneumatic unit in a plastic casing with :

• a microprocessor controlled pump;
• a control panel
• a range of garments connectable to the unit:
• leg boots;
• arm sleeves;

The provided text is a 510(k) summary for a medical device (EUREDUC TP03), which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission does not typically include detailed studies proving performance against acceptance criteria in the way a clinical trial for a new drug or novel device would. Instead, substantial equivalence is demonstrated by comparing technical characteristics and intended use to a predicate device.

Therefore, many of the requested items (e.g., sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types for training) are not applicable to this type of submission as the focus is on comparative technical characteristics, not clinical performance studies with specific statistical endpoints against acceptance criteria.

Below is an attempt to address the request based only on the provided text, highlighting where information is not available or not relevant for this type of submission.

1. Table of acceptance criteria and the reported device performance

Based on the provided text, there are no explicitly stated "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the EUREDUC TP03. The submission focuses on demonstrating substantial equivalence to a predicate device by comparing technical characteristics. The "performance" reported is in terms of these technical characteristics matching or being similar to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. The provided text does not describe a "test set" in the context of a clinical performance study. The comparison is based on the technical specifications of the device and its predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No test set or ground truth establishment by experts is described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set or adjudication method is described.

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

• Not applicable. This device is a pneumatic drainage system, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• Not applicable. This device is a physical pneumatic pump system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. The concept of "ground truth" as used in performance evaluation for diagnostic or AI devices is not relevant to this submission. Substantial equivalence is based on comparison to an existing device.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is a physical medical device, not a machine learning algorithm requiring training data.

9. How the ground truth for the training set was established

• Not applicable. As above, no training set or ground truth for it is relevant to this device's submission.

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