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The Vial Adapter 15mm is indicated for the transfer and mixing of drugs contained in vials

The vial adapter is a one piece molded polycarbonate device that is used to aide in the reconstitution and transfer of drugs contained in vials. The sterile device pierces the elastomeric septum of a drug vial with its integrated spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the "legs" of the vial adapter. The opposing side of the vial adapter contains a Luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the drug vial. After drug removal, the syringe is removed and the vial adapter is properly discarded with the drug vial.

The proposed device, Vial Adapter 15mm, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy.

The proposed device, Vial Adapter 15mm is a 15mm version of the currently available 13mm Vial Adapter or 20mm Vial Adapter. The device consists of a piercing spike and integrated Vial Adapter (15mm) for access to the drug/solution vial.

The device does not contain any medicinal substances, and can be used with standard drug vials. It is intended for use in healthcare facilities or in home environment by a care-giver to aid and support prescribed treatment and therapy.

The device does not contain any medicinal substances, and can be used with standard drug vials.

The provided document focuses on the 510(k) summary for the Medimop Vial Adapter 15mm, asserting its substantial equivalence to a predicate device. While it lists various performance tests, it does not provide a detailed study or specific acceptance criteria with reported device performance values in a format requested.

The document mentions that "All testing met the required acceptance criteria," but it does not elaborate on what those criteria were or the actual quantitative results achieved for each test.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for any of the performance tests. It mentions "Representative samples from every lot of product are tested for bacterial endotoxin," but no numerical sample size is given for this or any other test.

The data provenance is internal testing performed by Medimop Medical Project Ltd., as indicated by "Tested to internal performance standards." No country of origin for the data (other than the company's location in Israel) or whether it was retrospective or prospective is stated.

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

Not applicable to this type of device and testing. The "ground truth" for a medical device like a vial adapter is typically based on established engineering and materials science standards, not expert consensus in a diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. The testing described is objective performance testing against engineering standards.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging or AI-driven decision support systems where human reader performance is a key metric. The Vial Adapter is a mechanical device.

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

Not applicable. This device does not involve algorithms or AI. The performance tests are standalone in the sense that they evaluate the device's physical properties and functionality.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests relies on:

• Established engineering standards: e.g., "Tested per ISO 11607-1" for packaging, "ISO 11137-1, ISO 11137-2 and AAMI TIR 33" for sterilization, and "ISO 10993-1" series for biocompatibility.
• Internal performance standards: for tests like Total Penetration Force, Detachment Force, etc. These internal standards are derived from engineering requirements and risk assessments.
• Pharmacopoeial standards: e.g., USP for pyrogenicity.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.

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

Not applicable, as there is no training set.

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The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV bag and an external IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.

The proposed device, Vial2Bag Direct Connect, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy.

The proposed device. Vial2Bag Direct Connect is available with 13mm Vial Adapter or 20mm Vial Adapter. The device consists of the Vial2Bag piercing spike and cover, the twist-off connector and an integrated Vial Adapter (13mm or 20mm) for access to the drug/solution vial.

Up to 3 Vial2Bag Direct Connect can be consecutively connected by inserting the spike of one device into the twist off connector of the previous device.

The device does not contain any medicinal substances, and can be used with standard drug vials.

This is a 510(k) premarket notification for a medical device (Vial2Bag™ Direct Connect), not an AI/ML device. Therefore, the requested information regarding AI/ML device acceptance criteria and study details is not applicable to this document. The document describes modifications to an existing device and the performance testing conducted to ensure substantial equivalence to a predicate device.

However, I can extract information related to the device's performance testing and general characteristics from the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted, but it does not explicitly define specific numerical acceptance criteria for each test. Instead, it states for all tests: "All testing met the required acceptance criteria." This implies that internal, pre-defined acceptance criteria were used and successfully achieved.

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

The document does not specify the exact sample sizes used for each performance test. It only states that "The modifications to the proposed device were evaluated within the Medimop design control system." The data provenance is internal to Medimop Medical Project Ltd., based in Israel. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission to evaluate the modified device.

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

This information is not applicable. The device is a physical medical device, not an AI/ML product that requires expert-established ground truth for performance evaluation in the context of image interpretation or diagnosis. The "ground truth" for the performance tests would be defined by engineering specifications and relevant regulatory standards.

4. Adjudication Method for the Test Set:

Not applicable for a physical device's performance testing. The tests are typically objective measurements against predefined criteria.

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

Not applicable. This is a physical device, not an AI/ML diagnostic tool.

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

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

7. Type of Ground Truth Used:

For the performance tests, the "ground truth" is a combination of:

• Internal performance standards: Defined by the manufacturer (Medimop) for functionality, penetration force, detachment forces, torque, ductility, and air leakage.
• International Standards: e.g., ISO 11607-1 for packaging, ISO 11135-1:2007 for sterilization, ISO 10993-7:2008 for ETO and ECH residuals, ISO 10993-1 and G95-1 for biocompatibility assessment, and specific ISO 10993 sub-standards, ASTM F756, and USP 151 for various biocompatibility tests.
• Regulatory requirements: e.g., acceptable Endotoxin levels.

8. Sample Size for the Training Set:

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

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

Not applicable.

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