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The Device allows for the connection of a manual resuscitation bag without the disconnection of the ventilator circuit/system or the removal of the ASPR-Care™ CSS dual swivel T-piece connector.

The Argyle ASPR-Care Manual Resuscitation Bag Adapter is an accessory to the Argyle Closed Suction System. The adapter provides the trained clinician with an accessory that facilitates the manual ventilation of the patient, without requiring the opening of the ventilator circuit or removal of the closed suction system from a patient 's artificial airway. The accessory is designed for use strictly with the Argyle ASPR-Care Closed Suction System.

The provided text describes a 510(k) submission for the Argyle® ASPR-Care™ Closed Suction System Accessory Manual Resuscitation Bag Adapter. The focus of the submission is to demonstrate substantial equivalence to a previously cleared device (K955831) and certify its functional performance and biocompatibility.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance

Study Details

It's important to note that the provided 510(k) summary is generally brief and focuses on demonstrating substantial equivalence rather than a detailed clinical trial. Therefore, some of your requested information, particularly regarding detailed human reader studies or large-scale outcome data, is not present in this type of submission.

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

   • Sample Size (Functional Test): Not explicitly stated. The text mentions "various ventilators" were tested, but not the specific number of units or test cycles.
   • Data Provenance: Not specified. It's presumably conducted by the manufacturer (Sherwood Davis and Geck) in the USA, given the submission location, but this is not explicitly stated. The testing appears to be prospective for the functional evaluation of the accessory itself.

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 / Not Provided. This type of information is typically relevant for diagnostic imaging or clinical decision support AI, where expert consensus is needed to define a "ground truth" for disease detection or classification. For this device (a medical accessory adapter), the "ground truth" for functional performance is based on direct observation of alarm activation and system behavior, not expert interpretation of complex data. The evaluation was done by "trained clinicians" but no specific number or qualifications are given beyond "trained."

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

   • None. Adjudication methods are typically used when there's subjective interpretation or disagreement among experts trying to establish a ground truth. For the functional testing described (alarm activation time), the outcomes are objective and directly observed.

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:

   • No. This is not relevant for this medical device accessory. MRMC studies are used for evaluating diagnostic or decision-making AI systems, often in imaging. This device is a mechanical accessory; it does not involve human readers interpreting data or AI assistance.

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

   • Yes (in principle, for the functional test). The "functional test" described (time to alarm) evaluates the device's inherent mechanical and system-level performance. While a "trained clinician" performs the installation, the core measurement (alarm activation) is a standalone function of the device's interaction with the ventilator. However, this is not an "algorithm" in the AI sense.

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

   • Functional Measurement/Observation. For biocompatibility, the ground truth is established by adherence to recognized standards (ISO 10993, ANSI/AAMI 10993) and prior testing of the same materials. For functional performance, the "ground truth" is the objective observation of alarm activation in response to specific actions (insertion without bag, insertion with bag, during the breathing cycle).

7. The sample size for the training set:

   • Not Applicable / Not Provided. This device does not use an "AI algorithm" that requires a training set in the conventional sense (e.g., for machine learning). The functional performance is based on its mechanical design and interaction with existing systems.

8. How the ground truth for the training set was established:

   • Not Applicable / Not Provided. As noted above, there is no "training set" for an AI algorithm for this device.

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