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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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