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The EQUASHIELD™ System reconstitution and transfer system is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs for intravenous infusion or injection.

The EQUASHIELD™ System has an additional Protective Plug accessory which functions as a feature that mechanically prohibits the entrance of any objects into the EQUASHIELD™ System by physically blocking and protecting the system's connector ports.

The EQUASHIELD™ System Protective Plug is used as a "cork" for blocking EQUASHIELD™ connector openings, thus providing the system with further protection, mainly during the transportation and conveying of the EQUASHIELD™ System together with other accompanied items (used routinely by the hospital), where EQUASHIELD™ components might be squeezed in a transportation container together with other items which could accidently cause damage due to penetration of such items into the EQUASHIELD™ System's connector ports. The Protective Plug is inserted into the EQUASHIELD™ connector ports' openings and mechanically prohibits entrance of any accompanied items.

The provided text describes the EQUASHIELD™ System Protective Plug and its clearance process, but it does not contain the detailed information typically found in a study proving device performance against acceptance criteria. Instead, it is a 510(k) Summary.

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

Acceptance Criteria and Reported Device Performance

The document states that "All functional tests results, post mimicking the actual conditions, met the specification predetermined acceptance criteria". However, the specific quantitative or qualitative acceptance criteria themselves are not explicitly listed in the provided text. Similarly, the detailed "reported device performance" against these criteria is only summarized as having "met the specification predetermined acceptance criteria."

Table of Acceptance Criteria and Reported Device Performance:

Missing Information from the Provided Text:

Below is a list of the specific points from your request that are not present in the provided 510(k) summary:

1. Specific Acceptance Criteria: The document only states that tests "met the specification predetermined acceptance criteria" but does not detail what these criteria were (e.g., what constitutes an acceptable visual inspection, specific force requirements for detachment, flow rates, etc.).
2. Sample size used for the test set: The document mentions "a conveyance simulation was performed by exposing the new device to the actual use conditions," but does not specify the number of devices or components tested.
3. Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The applicant is from Israel, but the location of testing is not explicitly stated.
4. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of study involved non-clinical performance data (physical tests), not expert review of medical images or data.
5. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
6. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is for AI/human reader performance.
7. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.
8. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is the performance of the device against engineering specifications and functional requirements in a simulated environment, rather than a clinical ground truth like pathology.
9. The sample size for the training set: Not applicable. This is a physical device, not an AI algorithm.
10. How the ground truth for the training set was established: Not applicable.

Summary of Study Information (Based on Available Text):

• Study Type: Non-clinical performance testing, specifically a "conveyance simulation."
• Purpose: To verify that the EQUASHIELD™ Protective Plug performs as intended and does not compromise the safe use of the entire EQUASHIELD™ system, and to demonstrate substantial equivalence to predicate devices.
• Tests Conducted: Visual tests, detachment tests, and fluid flow through the entire system.
• Conditions: The device was exposed to "actual use conditions" mimicking conveyance.
• Outcome: All functional tests met predetermined acceptance criteria. The tests demonstrated that the system components functioned appropriately after Protective Plug assembly and detachment, and that the plug prevented penetration into the system's ports during conveying.
• Predicate Devices: The original EQUASHIELD™ System (K083152) and the EQUASHIELD™ Luer Lock Connector Pair (K091389). The new device was considered substantially equivalent to these devices.

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The EQUASHIELD™ Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.

EQUASHIELD™ is a closed system for drug transfer and reconstitution. The EQUASHIELD™ system consists of an adaptor to the medication vial (Vial Adaptor), a proprietary piston syringe (Syringe Unit), an adaptor for connection to the infusion bag for injection (Spike Adaptor 1), an adaptor for connection to the infusion bag for withdrawal (Spike Adaptor W) and an adaptor to the Luer Lock (Luer Lock Adaptor). The EQUASHIELD™ system is a closed system - it prohibits the escape of hazardous drugs and vapors to the surrounding environment, by air-tight enclosing of air and all contaminants within the system.

The provided text includes a 510(k) summary for the EQUASHIELD™ System, a closed drug transfer system. However, it does not contain detailed information regarding specific acceptance criteria, a comprehensive study design with reported performance metrics, sample sizes for test or training sets, ground truth establishment methods, or expert qualifications as requested.

The document only states that:

• "A series of bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance."
• "A simulated clinical test was performed in order to evaluate the Plastmed EQUASHIELD™ System and to ensure it performs its intended use as a closed drug transfer system. The simulated test has demonstrated that the EQUASHIELD™ system performs its intended use."
• "Both bench tests and simulated clinical test have shown that the device performs its intended use."

Without further details, it is impossible to populate the requested table and information points accurately.

Here's a breakdown of what cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: No specific quantitative or qualitative acceptance criteria are listed, nor are any performance metrics and their results reported. The document only offers general statements of "satisfactory performance" and "performs its intended use."

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The testing involves bench and simulated clinical tests, but it's unclear if "experts" were involved in establishing ground truth (e.g., for contamination assessment).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.

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 closed drug transfer system, not an AI-assisted diagnostic or imaging device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Again, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For bench and simulated clinical tests, ground truth would typically refer to established standards or verifiable measurements of containment or drug transfer accuracy.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document only offers a high-level overview of performance validation, stating that tests were performed and results were satisfactory. It lacks the granular detail required to complete the requested information.

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