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The TECHNOFLEX DMRX Empty solution container is 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. After use the bag is discarded.

The subject device DMRX Empty Solution Container are IV bags for hospital use which consist of two tubes necessary for the filling of the bag itself and the administration of the solution to the patient. a) fill port to fill the container/injection port for additions of other medications and; b) a spike port to connect an intravascular administration set to the bag to dispense medication. One port is an injection port, which will be used for filling the bag with the solution. The filling will be made with a needle, using aseptic technics by a laboratory personnel or pharmacist. The elastomeric plug is auto sealable and does not require a cap after filling. The administration will be performed by nurses or personnel appropriately trained. They will connect an administration set to the second port which is a twist-off port (spike port). The device is an empty flexible container (bag) made of PP (Polypropylene), SEBS (Styrene Butadiene Copolymer), Thermoplastic Elastomer, PC (Polycarbonate), and Polyisoprene with silicone. One port is an injection port. The empty bag is filled by connecting a needle into the injection port. Using aseptic technics by a trained laboratory personnel or pharmacist, the filling is done by the tube with the injection port connector. After filling, the bag remains closed due to the self-sealing plug which secures 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 second port (spike port). When the bag is already filled, other medications can be added using the injection port. The device will be available in four containment volumes (100mL, 250mL, 500mL, and 1000mL). Bags are double packed and proposed sterilized with e beam radiation.

The FDA 510(k) clearance letter K250459 describes a new device, the DMRX Empty Solution Container, which is an I.V. container for administering intravenous solutions. This clearance document focuses on establishing substantial equivalence to a predicate device, the Gilero, LLC SmartSite Bag (K201936), rather than providing a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, or ground truth details common in clinical or AI algorithm studies.

Based on the provided text, the acceptance criteria are implicitly met through a series of non-clinical tests demonstrating safety and performance comparable to the predicate device. The information is primarily focused on mechanical, material, and sterility aspects, not on AI algorithm performance or human reader studies.

Here's an attempt to structure the information as requested, though it's important to note the document is a regulatory clearance and not a research paper on device performance against specific, quantitatively defined acceptance metrics as might be found for a novel diagnostic device or AI tool.

Acceptance Criteria and Study Details for DMRX Empty Solution Container (K250459)

The device, the DMRX Empty Solution Container, is an I.V. container. Its acceptance criteria are centered on demonstrating safety, effectiveness, and substantial equivalence to a legally marketed predicate device (Gilero, LLC SmartSite Bag, K201936). The study performed is a non-clinical evaluation, primarily consisting of laboratory testing against recognized standards and comparative analysis of materials and design.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance statistics. Instead, the acceptance is based on demonstrating compliance with relevant ISO and USP standards and showing that differences from the predicate do not raise new questions of safety or effectiveness. The "reported device performance" in this context refers to the successful completion and compliance with these tests.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test performed (e.g., how many bags were tested for leakage or particulate matter). The testing is typically performed on a statistically representative number of units according to the respective standards.
• Data Provenance: The data is generated from laboratory testing of the subject device (DMRX Empty Solution Container) in accordance with recognized international and national standards (ISO, USP, ANSI/AAMI, EN). The country of origin for the testing facilities is not explicitly stated, but the manufacturer is Technoflex SAS, located in Bidart, France. The studies are prospective in the sense that they are conducted specifically to validate the device for regulatory submission.

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

This question is not applicable in the context of this device and submission. The ground truth for these non-clinical tests is based on objective measurements against established technical standards (e.g., ISO for biocompatibility, USP for particulates). There is no "ground truth" derived from human expert consensus or clinical judgment for these types of physical and chemical performance tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective and based on direct measurement or observation against predetermined pass/fail criteria defined by the standards. There is no human adjudication process involved as there would be in, for example, a clinical trial or a diagnostic imaging study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a non-clinical submission for an I.V. container, not an AI-assisted diagnostic or therapeutic device that would involve human readers or comparative effectiveness studies of human performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Not applicable. The DMRX Empty Solution Container is a physical medical device (an I.V. bag), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests performed is defined by:

• Objective measurement against established international and national standards: e.g., the limits for particulates specified by USP , the biological response criteria in ISO 10993, or the sterility assurance level (SAL 10⁻⁶) in ISO 11137. These are scientifically and statistically validated criteria, not expert consensus or pathology in a clinical sense.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. As above, this is a physical device, not an AI algorithm.

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