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The ToxiSeal™ Vial Adaptor mechanically prohibits environments from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.

The ToxiSeal™ Vial Adaptor devices are single-use, sterile, non-pyrogenic CSTD drug vial adaptors that are fitted to the drug vials and are sealed against the closures of the vials. They are used as sterile interfaces between the drug vials and the ProSeal™ Injector or the ProSeal™ Injector Plus (both are syringe adaptors) for the injection of diluents into the drug vials and/or withdrawal of liquids from the vials. Changes proposed in this Special 510(k) Submission are as follow: Removed external balloon and added activated carbon filter.

The provided document is a 510(k) summary for the ToxiSeal™ Vial Adaptor (K241823). It describes the device, its intended use, a comparison to a predicate device, and performance data supporting its substantial equivalence. However, the document does not contain information about an AI/software device or a comparative effectiveness study involving human readers with and without AI assistance.

Therefore, I cannot provide information for points 5, 8, and 9 of your request as they are not present in the document.

Based on the available information regarding the medical device itself (ToxiSeal™ Vial Adaptor), here's the information related to acceptance criteria and the studies conducted:

The ToxiSeal™ Vial Adaptor is a physical medical device, not an AI/software product. Therefore, the "acceptance criteria" and "study that proves the device meets acceptance criteria" are related to its functional performance, biocompatibility, and sterility, rather than AI performance metrics.

Acceptance Criteria and Device Performance (for a physical device)

The document outlines the various tests performed to demonstrate the device's conformance to recognized standards. The "acceptance criteria" are implied by the conformance to these standards and the findings that the device "met the acceptance criteria therein" or "did not raise any new or different questions of safety or effectiveness."

Here's a table summarizing the acceptance criteria (standards/tests) and the reported device performance.

Now addressing the specific points of your request based on the provided document:

1. A table of acceptance criteria and the reported device performance

   • See the table above. Note that for a physical medical device, "acceptance criteria" are typically defined by conformance to established performance standards and successful completion of specified tests.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Sample Sizes: The document does not specify the exact sample sizes used for each performance test (e.g., number of devices tested for leak integrity, biocompatibility, etc.). It mentions that tests were "performed on the Subject devices," "on devices under K241476," or "on device under K222929," implying samples were used from these device types.
   • Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission to the FDA, the data would typically be generated by the manufacturer or contract labs following international and US standards. The studies, being part of device verification and validation prior to market clearance, are generally prospective in nature for the tests conducted on the subject device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • This question is not applicable to this type of medical device submission. Ground truth established by experts (like radiologists for imaging AI) is relevant for diagnostic accuracy studies of software/AI. For a physical device like a vial adaptor, the "ground truth" is based on objective measurements against established engineering and biological standards. There are no human "experts" establishing a diagnostic ground truth here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • This question is not applicable as there is no diagnostic test set or human interpretation being adjudicated. The tests are quantitative and involve laboratory measurements.

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 document describes a physical medical device, not an AI software. No MRMC study was conducted or is relevant for this device.

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

   • Not applicable. This is not an algorithm/AI device. The device's performance is standalone in the sense that its mechanical and biological properties are tested independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • The "ground truth" for this medical device is the objective measurement of physical properties, chemical properties, and biological safety against predefined engineering, material, and biocompatibility standards. Examples include:
     • Meeting specific leakage rates.
     • Absence of fragmentation.
     • Demonstrating specified penetration force.
     • Absence of microbial ingress.
     • Absence of cytotoxicity, sensitization, systemic toxicity, pyrogenicity, and meeting particulate matter limits.
     • Maintaining sterility over shelf-life.
   • It's based on quantitative laboratory testing results compared to acceptance criteria defined by recognized standards (ISO, ASTM, USP, NIOSH).

8. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device; there is no "training set."

9. How the ground truth for the training set was established

   • Not applicable. As there is no training set for an AI model, this question does not apply.

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The ToxiSeal™ Vial Adaptor with External Flip Balloon mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.

The ToxiSeal™ Vial Adaptor with External Flip Balloon devices are single-use, sterile, nonpyrogenic CSTD drug vial adaptors that are fitted to the drug vials and are sealed against the closures of the vials. They are used as sterile interfaces between the drug vials and the ProSeal™ Injector or the ProSeal™ Injector Plus (both are syringe adaptors) for the injection of diluents into the drug vials and/or withdrawal of liquids from the vials. In addition, the ToxiSeal™ Vial Adaptor with External Flip Balloon devices equalize the pressure difference which occurs when fluid or air is added to or removed from the drug vial. This neutral pressure is maintained utilizing an external balloon/ expansion chamber.

This is a 510(k) summary for a medical device called "ToxiSeal™ Vial Adaptor with External Flip Balloon". This submission seeks to demonstrate that the new device, which has some material and design changes compared to a previously cleared predicate device, is substantially equivalent and does not require a new premarket approval application.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a comparative format for each specific criterion. Instead, it lists the standards and types of tests performed, implying that the device met the requirements of these standards. The "Reported Device Performance" in this context refers to the affirmation that testing was conducted and demonstrated conformance with the cited standards and previously cleared devices' performance.

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

• Sample Sizes: The document does not explicitly state the specific number of units or samples used for each individual test. It mentions that testing was performed "on the Subject device" or "on test samples in their finished form aged to the intention i the Subject device validation lots."
• Data Provenance: The document does not specify the country of origin of the data. The studies are described as "bench performance verifications and validations" and refer to past clearances (K222929, K240433, K192075) for much of the leveraged data, implying these were laboratory-based tests. The submission originates from Singapore.

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

This information is not applicable to this type of device submission. The device is a physical medical device (vial adaptor), not an AI/ML-based diagnostic or prognostic tool that would require expert-established ground truth for a test set. The validation relies on technical performance standards and biocompatibility.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable. This is not an AI/ML-based diagnostic device where reader studies would be relevant.

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

This information is not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by conformance to recognized industry standards (ISO, ASTM, USP, ANSI/AAMI) for mechanical, chemical, biological, and sterility properties. For example:

• Mechanical Integrity: Conformance to ISO 22413, ISO 8536-4.
• Biocompatibility: Conformance to ISO 10993 series.
• Sterility: Conformance to ISO 11135.
• Particulate Matter: Conformance to USP .
• Shelf-life: Conformance to ASTM 1980-16.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI/ML system that utilizes a training set.

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

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

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