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The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek S is intended for adult and pediatric patients.

The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

The provided document, K060357, describes a 510(k) submission for the PARI Trek™ S nebulizer compressor. This device is a nebulizer compressor, which is a mechanical device, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as ground truth, expert adjudication, MRMC studies, training set, etc.) are not applicable in this context.

The submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical performance summaries.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of devices tested. It refers generally to "PARI Trek™ S was tested with various nebulizers."
• Data Provenance: The testing appears to have been conducted by the manufacturer, PARI Innovative Manufacturers, Inc., in the context of their 510(k) submission. No information on country of origin of data or whether it was retrospective or prospective is explicitly stated for this non-clinical testing, though it would implicitly be prospective testing for the new device.

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

Not applicable. This device is a mechanical nebulizer compressor, and its performance was evaluated against technical specifications (e.g., airflow, particle size distribution when paired with nebulizers) rather than medical interpretations requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this involves technical performance metrics, not diagnostic interpretations requiring adjudication.

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, and no human reader studies are mentioned or relevant for its substantial equivalence demonstration.

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" for the non-clinical tests would be the established scientific and engineering principles for measuring nebulizer compressor performance (e.g., standards for measuring Total Output Rate, Mass Median Diameter, and particle size distribution). The comparison was made against the performance of legally marketed predicate devices, implying those predicate devices' performance serves as a benchmark for "comparable" criteria.

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device, so there is no training set involved.

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

Not applicable. As this is not an AI/ML powered device, there is no training set or ground truth establishment relevant to AI/ML.

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