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The Enteral Drainage System is intended to allow the evacuation of excess gas and drainage of gastrointestinal fluids from patients utilizing an enteral device.
The Enteral Medicine Straw is intended for drawing and delivery of medicine to patients through an ENFit syringe.

The Enteral Drainage System and the Enteral Medicine straw are intended to be used during enteral nutrition treatments in combination with enteral feeding tubes, syringes and other compatible enteral medical devices.

The Enteral Drainage System is intended to allow the evacuation of excess gas and drainage of gastrointestinal fluids from patients utilizing an enteral device.
The device consists of:

• a bag in DEHP FREE PVC, equipped with a hydrophobic 3μm filter to allow gas escape;
• two short PVC tubes (5-6 cm) on top and bottom of the bag; the bottom one is equipped with a male enteral connector, and the top one with a female enteral connector that is capped off with an ENFit-compatible cap;
• a clamp to regulate the fluid flow, placed over the bottom tube.

It is available in five sizes, depending on the volume of the bag included in the device:

• MED50LU, Enteral drainage bag 50 ml;
• MED100LU, Enteral drainage bag 100 ml;
• MED250LU, Enteral drainage bag 250 ml;
• MED500LU, Enteral drainage bag 500;
• MED1000LU, Enteral drainage bag 1000 ml.

The device is connected to the nasogastric or naso-jejunal feeding tube between feeding sessions to allow the drainage of stomach or intestinal fluids and gasses in excess. The transparency of the materials allows for constant monitoring and visualization of drained fluids. The bag must be placed at a lower level than the patient's stomach and also acts as a venting device.

The Enteral Medicine straw, coded C005LU, is intended for drawing and delivery of medicine to patients through an ENFit enteral syringe. It consists of a male enteral connector (that allows the connection to a compatible enteral syringe) and a tubing in thermoplastic polyurethane.
Once the fluid is drawn up from the container into the syringe, the cannula must be disconnected, and the syringe can then be connected to another medical device (normally, a feeding tube or a gastrostomy tube) to administer its content to the patient.

All enteral connections of the subject devices are designed to avoid for inadvertent delivery of enteral feedings through the intravenous route. i.e., the devices cannot be connected to devices endowed with a luer connector.

The devices are sterilized with Ethylene Oxide (EtO).

These devices are targeted to neonatal, pediatric and adult patients, with compromised or limited gastric motility; they are for single patient use and can be reused multiple times within a twenty-four-hour period, after which they are to be replaced.

The provided text is a 510(k) clearance letter and an associated 510(k) Summary for the HMC Premedical S.p.a. Enteral Drainage System and Enteral Medicine Straw. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance and biocompatibility testing. It does not include information about human factor studies, clinical trials, or studies involving human readers or expert panels for ground truth determination.

Therefore, many of the requested criteria cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

The document broadly states that the device "met the pre-determined acceptance criteria" for performance tests and "comply with the applicable sections of the standards cited below." However, it does not explicitly list specific numerical acceptance criteria or the exact reported performance values for the tests mentioned (Misconnection testing, leak testing, tensile strength testing, dimensional requirements, integrity of device packaging).

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

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not specified. These are laboratory tests, not clinical data from specific countries.

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 expert-based ground truth was established as these were non-clinical performance and biocompatibility tests, not clinical efficacy studies involving human interpretation.

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

Not applicable. No adjudication method was used as these were non-clinical performance and biocompatibility tests.

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 medical accessory (drainage system, medicine straw), not an AI-powered diagnostic or assistive technology. No MRMC study was mentioned or would be relevant for this type of device.

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

Not applicable. This device is a medical accessory, not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" was defined by the requirements and specifications outlined in the referenced international standards (e.g., ISO 80369-3, ISO 80369-20, ISO 20695, ISO 10993 series, USP , ISO 11607-1, ASTM standards). Successful adherence to these standards constituted the "truth" for device performance and safety in a non-clinical setting.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/ML model.

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