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The Halo® system is an airtight and leak proof closed system drug (CSTD) that 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. The Halo® system also prevents microbial ingress for up to 7 days.

The Halo® is a Closed System Transfer Device (CSTD) for the safe handling of hazardous drugs, especially for the compounding and administering of hazardous drugs according to the National Institute for Occupational Safety and Health (NIOSH) definition of an airtight and leak proof closed system transfer device. It is a sterile singleuse device. There are five components of the Halo® system, Closed Vial Adaptor (CVA), Closed Syringe Adaptor (CSA), Closed Bag Adaptor (CBA), Closed Line Adaptor (CLA), and Closed Vial Converter (CVC). These components integrate with industry standard luer-lock syringes, IV bags, infusion sets, and other patient connections to form a complete closed system. This system 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. In addition, the components are designed to prevent microbial ingress into the system, including maintaining sterility of drugs in the vial for up to 7 davs. The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.

The system uses industry compatible luer locks, bag spikes and spike ports, dual lumen spikes, single lumen needles, and dry to dry compression fit seals when connecting Halo® components together. A single lumen needle perforates the dry-to-dry compression fit seals for the transfer of drugs between Halo® components. Upon separation the needle is retracted and the seal membrane prevents transfer of environmental contaminants into the system and/or escape of drug or vapor.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document details performance testing for various aspects of the Halo® system. The acceptance criteria are generally qualitative ("No Leaks," "Pass") or by reference to established standards.

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

The document does not explicitly state the specific sample sizes (number of devices or tests performed) for each individual test conducted on the Halo® system. It implies that these tests were conducted as part of the regulatory submission (K180574 and referencing K150486).

• Sample Size: Not explicitly stated for each test.
• Data Provenance: The studies were conducted by J & J Solutions, Inc. d/b/a Corvida Medical and their testing partners for regulatory submission to the FDA. This is considered prospective data for the purpose of demonstrating substantial equivalence. The document doesn't specify the country of origin of the labs, but given the FDA submission, it's typically within the US or by labs adhering to US regulatory standards.

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

This section is not applicable to this type of device and study. The Halo® system is a medical device (Closed System Transfer Device) for safe handling of hazardous drugs. Its performance is evaluated through laboratory-based, objective performance testing against established engineering, biological, and chemical standards (e.g., ISO, ASTM, USP). There is no "ground truth" to be established by human experts in the context of diagnostic interpretation, as this is not a diagnostic device.

4. Adjudication Method for the Test Set

This section is not applicable for the same reason as point 3. Adjudication methods are typically used in studies where human interpreters (e.g., radiologists, pathologists) determine a "ground truth" or make diagnoses, and discrepancies need to be resolved. The performance of the Halo® device is measured by quantitative and qualitative outcomes against predefined technical and safety specifications.

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

This section is not applicable. The Halo® system is a physical medical device, not an AI or diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is irrelevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. As stated above, this is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the Halo® device's performance is established through:

• Engineering and Physical Test Standards: Compliance with ISO (e.g., ISO 594, ISO 8536), ASTM (e.g., F2096, F1886, F88), and USP (e.g., USP 788) standards. These standards define the expected physical and chemical properties and performance limits.
• Biological Test Standards: Compliance with ISO 10993 series for biocompatibility and ISO 11135, ISO 11737-1, AAMI/ANSI ST72 for sterility.
• Direct Measurement of Device Functionality: Observing and quantifying performance metrics like "no leaks" in fluorescein or alcohol vapor tests, "pass" for force measurements, and direct measurement of microbial ingress protection (e.g., 7 days protection after 14 penetrations).

8. The Sample Size for the Training Set

This section is not applicable. The Halo® system is a mechanical and biological device that is validated through physical and chemical testing, not through machine learning or AI. Therefore, there is no "training set" in the context of data-driven model development.

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

This section is not applicable for the same reason as point 8.

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