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The Empty EVA Bag is an empty container used for administration of solutions to the patients using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

The product is an empty flexible container (bag) in plastic material, that is to be filled before use, intended for the administration of intravenous infusion solutions), and provided sterile. It is provided in two different configurations, with three tubes or one tube:

• bag with 3 tubes: The empty bag is filled by connecting it to containers (generally glass bottles) filled with the solutions to be administered. The filling is done through the tube with the big bore connector where the non- re-opening clamp is located; this tube is closed with a screwed cap (air-tight closure). After filling, the bag is clamped by means of the non-re-opening clamp and closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the access port (spike port). When the bag is filled, other drugs can be added using the second access port (injection port). The device is available in multiple containment volumes ranging from 250mL to 5000mL.
• bag with 1 tube: the bag is provided with one tube used both for the filling of the bag and the administration of the solution to the patient. The tube is closed with a screwed male Luer cap (air-tight closure). The filling is done by connecting the female Luer connector of the tube to the containers filled with the solutions to be administered. After filling, the bag is clamped by means of a pinch clamp and closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration line via the same female Luer connector. It is available in multiple containment volumes of 50mL, 100mL, and 250mL.

The provided text is a 510(k) summary for the Haemotronic S.p.a. Empty EVA Bag. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, many of the requested elements for an acceptance criteria study report are not explicitly available in the provided document.

However, I can extract the information related to the non-clinical tests performed to support the substantial equivalence claim, which serves a similar purpose in demonstrating device safety and performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria with corresponding performance results in a table format. Instead, it lists standards the device meets or tests that were performed to confirm performance. The general acceptance criterion for all these tests is that the device meets the requirements of the specified standards, implying successful completion without adverse findings.

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

The document does not specify the sample sizes used for any of the non-clinical tests. The data provenance is associated with laboratory testing to "demonstrate substantial equivalence," implying a prospective nature (testing performed specifically for this submission). The country of origin of the data is not specified, but the company is based in Italy.

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

This is not applicable as the study is a non-clinical, laboratory-based testing of a medical device, not an AI or diagnostic study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

This is not applicable for non-clinical, laboratory-based testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the performance of diagnostic devices or AI algorithms where human interpretation is a factor.

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

No, this is a purely physical medical device (an empty bag), not an algorithm or software-based device.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by the standards and specifications outlined in documents like ISO 10993, ISO 15747, ISO 80369-7, and USP monographs. Compliance with these established scientific and regulatory benchmarks forms the basis of the "truth" for device performance.

8. The Sample Size for the Training Set:

This is not applicable. There is no training set as the device is not an AI/ML algorithm.

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

This is not applicable. There is no training set.

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The Empty EVA Bag is an empty container used for administration of TPN (Total Parenteral Nutrition) solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

The device is an empty flexible container (bag) in EVA material (Ethylene-vinyl acetate), that is to be filled up before use and intended for the administration of intravenous infusion solutions (TPN-Total Parenteral Nutrition). The bag is provided with three tubes necessary for the filling of the bag itself and the administration of the solution to the patient. The empty bag is filled by connecting it to containers (generally glass bottles) containing one or more solutions. The filling is done by the tube with the big bore connector where the non-re-opening clamp is located. After filling, the bag is clamped by means of non-re-opening clamp ad closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the access port (spike port). When the bag is already filled, other medications can be added using the second access port (injection port). The device will be available in multiple containment volumes ranging from 250mL to 5000mL.

This document describes the premarket notification (510(k)) for the "Empty EVA Bag" device. It is not an AI/ML medical device submission, so the questions regarding AI/ML-specific study design (training/test sets, expert adjudication, MRMC studies) are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device ("Empty EVA Solution Container, Acta Medical, K121161") through non-clinical testing of the physical properties and biocompatibility of the device.

Here's an attempt to answer the questions based on the provided text, noting where AI/ML specific criteria do not apply:

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

The document does not provide explicit numerical acceptance criteria values for each performance test. Instead, it states that "All the necessary safety and performance tests in support of substantial equivalence to the predicate device were conducted" and implies that the device met the requirements of the listed standards and internal specifications. The "Conclusion" for each "Feature" in the "TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE" table effectively serves as the "reported device performance" in relation to the predicate.

2. Sample sizes used for the test set and the data provenance

The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of bags tested for volume capacity, tensile strength, etc.). It only indicates that "Nonclinical tests were conducted."

Data provenance: The testing was conducted to support an FDA 510(k) submission, suggesting it was performed by the manufacturer (Haemotronic S.p.a. in Italy) or a qualified testing lab. The data would be prospective, as it was generated specifically for this submission to demonstrate device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of medical device submission. Ground truth in this context refers to meeting engineering and biocompatibility standards, not clinical diagnostic accuracy assessed by experts.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication process for this type of non-clinical, physical, and biocompatibility testing. The "ground truth" is determined by established engineering and biological standards.

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 is not an AI/ML driven diagnostic device, and no human reader studies were conducted or required.

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

Not applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used

The "ground truth" for this device's performance is based on:

• Compliance with recognized international standards (e.g., ISO 10993 series for biocompatibility, ISO 15747 for plastic containers, ISO 11137 for sterilization, ISO 11607 for packaging).
• Compliance with internal specifications for various physical properties (Bag Volume Capacity, Resistance to hot printing removal, Hangar Tensile Force, Hydraulic seal and mechanical resistance of the non-re-opening clamp).
• Pharmacopeial standards (USP<788> for Particulate Matter).

Essentially, the device meeting the specified quantitative and qualitative criteria defined by these standards and internal specifications constitutes the "ground truth" for its safety and performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no training set for an algorithm. Device manufacturing processes would involve quality control and validation using samples, but not like an AI training set.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The Empty EVA Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

The Empty EVA Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

The empty bags are filled by connecting them to containers - generally glass bottles closed by a pierceable membrane - containing one or more solutions through standard spikes and tubing. After filling, the transfer set is removed and the bags are clamped by means of inviolable clamps to secure the contents prior to their administration. To make the fluid outflow from the bag towards the patient, the container can be then attached to an intravascular administration set via the spike port and twist - off connector.

When the bag is already filled, other medications can be added using the injection port. The bags range in volume capacity from 150 ml to 5000 ml.

The device is sold sterile and cannot be re-used or re-sterilized; it is discarded after use. The Empty EVA Bag is intended for use by qualified staff.

The provided text describes the 510(k) premarket notification for the "Empty EVA Bag" (K181393) and its substantial equivalence to a predicate device. However, this document does not contain information about the acceptance criteria and study design for performance comparison that would be typically associated with AI/ML-driven medical devices.

Instead, this document focuses on demonstrating substantial equivalence of a physical medical device (an empty IV bag) through:

• Comparison of technological characteristics with a predicate device.
• Non-clinical bench testing to demonstrate compliance with standards and safety/performance aspects of the device itself (e.g., biocompatibility, sterilization validation, physical performance tests).

Therefore, I cannot provide the requested information about acceptance criteria for AI/ML performance, sample sizes for test sets (as there isn't an AI test set described), expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The "studies" mentioned in this document are non-clinical bench tests for the physical properties and safety of the IV bag, not observational or interventional studies on human subjects with an AI component.

Key takeaway: The provided text is for a sterile IV container, not an AI/ML device. Thus, the specific metrics and study designs requested for AI/ML are not applicable here.

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