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The Marpac Messenger™ attaches to standard 15mm tracheostomy tubes and assists tracheostomy patients with speech by managing airflow.

The Marpac Messenger™ consists of a plastic outer body with an inner flexible diaphragm made of medical grade silicone. The Marpac Messenger™ attaches to the hub of a standard 15mm tracheostomy tube. The one-way valve design of the Marpac Messenger™ allows airflow into the valve when the tracheostomy patient inhales and maintains a closed position during expiration thereby directing airflow up through the larynx, mouth, and nose enabling speech.

The provided text describes a 510(k) submission for the Marpac Messenger™ speaking valve. This is not a study of an AI/ML powered device, but rather a submission for a mechanical medical device, demonstrating substantial equivalence to a predicate device. Therefore, many of the requested criteria regarding AI/ML studies are not applicable.

Here's an attempt to answer the relevant questions based on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission for a mechanical device, the "acceptance criteria" are not framed in terms of AI performance metrics (like sensitivity, specificity, AUC). Instead, the acceptance criterion is demonstrating that the device is substantially equivalent to a predicate device, specifically regarding its operating principle and performance. The primary performance metric mentioned is 'inhalation flow resistance'.

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

The text refers to "Non-clinical test data" for "Inhalation Flow Resistance Chart." It does not specify a sample size for this testing, nor does it provide details on the data provenance (country of origin, retrospective/prospective). This would typically be found in the "Attachment B (Inhalation Flow Resistance Chart)" which is referenced but not included.

3. 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. This is a mechanical device, and "ground truth" as it relates to expert consensus for diagnostic or prognostic AI models is not relevant here. Performance is measured against physical properties (flow resistance).

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

Not applicable. Adjudication methods are typically for expert interpretation in clinical studies, not for non-clinical engineering tests of a mechanical device.

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 is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

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

The "ground truth" in this context would be the measured physical properties (e.g., flow resistance) of both the Marpac Messenger™ and the predicate device, likely obtained through direct testing in a controlled environment.

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device that requires a training set.

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

Not applicable. This is not an AI/ML powered device that requires a training set and associated ground truth.

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