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Closed System drug Transfer Device (CSTD) for safe preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress.

The Equashield system consists of a piston syringe (Syringe Unit), an adaptor to the medication vial (Vial Adaptor), an adaptor for the infusion bag for injection (Spike Adaptor 1), an adaptor for the infusion bag for withdrawal (Spike Adaptor W), an adaptor for female luer lock ports (Luer Lock Adaptor), nursing pair connectors for male and female luer lock ports (Female LL Connector and Male LL Connector), and a protective plug (Protective Plug). The Equashield closed system consists of 8 components that are dedicated to each other to create a system. The components are not intended to be used individually. Vial Adaptor is 48 x 31mm, 23mm at distal end. Plug is 51 x 17mm large. Female luer lock is 50 x 23 mm with a 5.2mm ID. Male luer lock is 42 x 21mm with a 15mm depth. Spike Adaptor is 75 x 42 mm and the height is 22mm.

The provided text is a 510(k) Summary for a medical device (Equashield Closed System Drug Transfer Device), which focuses on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and detailed study results. Therefore, much of the requested information cannot be extracted from this document.

Here's what can be inferred or explicitly stated based on the provided text, and where information is missing:

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a numerical or categorical format with corresponding "reported device performance." Instead, it relies on demonstrating adherence to established consensus standards and substantial equivalence to predicate devices. The core performance claims are related to preventing microbial ingress and minimizing exposure to hazardous drugs.

Missing Information (Not available in the provided text):

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document mentions "performance data" in the context of substantial equivalence but does not provide details on specific studies, sample sizes, or data provenance.
2. 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 for this type of device and submission. There isn't "ground truth" established by experts in the sense of image interpretation or diagnosis. The "ground truth" here would be objective physical and chemical tests verifying the device's functionality.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as there's no human adjudication of results in the traditional sense for this device. Performance is measured through empirical tests.
4. 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 a physical medical device, not an AI-powered diagnostic tool engaging human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" would be established through objective laboratory testing against specified standards (e.g., measuring microbial ingress, assessing leak-proof connections, verifying pressure equalization, physical integrity tests for sharps protection). The document refers to adherence to ISO standards (e.g., ISO 22413:2010 for transfer sets, ISO 10993 for biocompatibility).
7. The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model.
8. How the ground truth for the training set was established: Not applicable. This is a physical medical device.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document states that the Equashield System Generation 2, its accessories, and components follow FDA recognized consensus standards. This implies that studies (tests) were conducted to demonstrate compliance with these standards. The specific standards listed are:

• ISO 594-1:1998, ISO 594-2:1998 (Luer fittings)
• ISO 7886-1:1993 (Sterile hypodermic syringes)
• ISO 8536-4:2010 (Infusion equipment, gravity feed)
• ISO 10993-1:2009, ISO 10993-4:2002, ISO 10993-5:2009 (Biological evaluation)
• ISO 14971:2007 (Risk management)
• ISO 22413:2010 (Transfer sets for pharmaceutical preparations)
• ISO 23908:2011 (Sharps injury protection)

The document explains that "Equivalence was determined using a side by side tabular comparison between the predicate and proposed devices which included: Features, Intended Use, Labeling, Materials, Specifications, Performance Data, and Technological Aspects." This comparison, along with adherence to recognized standards, forms the basis of their claim for substantial equivalence and, by extension, meeting the necessary performance expectations for safety and effectiveness. However, detailed results of these performance studies or comparisons are not provided in this summary.

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