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510(k) Data Aggregation
(239 days)
AKITA JET
The AKITA JET is a nebulizer system that will be used with patients for whom doctors have prescribed medication (except pentamidine) for nebulization in the home care, nursing home, subacute institution, or hospital environment.
The AKITA JET nebulizer and the AKITA JET nebulizer handset together constitute a multi-use, electronic nebulizer system designed to aerosolize liquid medications. The system includes and features:
- An electrically powered compressor which provides an air flow to the AKITA JET ● nebulizer handset.
- . A nebulizer handset based upon the PARI LC Sprint, K060399
- Single patient, multi-use in the home setting .
- . Multiple patient, multi-use in the hospital and clinical settings
- .
- . Nebulization only during inhalation phase
- Smart Card series for defined patient breathing patterns .
The provided document is a 510(k) summary for the AKITA JET nebulizer system, demonstrating substantial equivalence to predicate devices. It outlines the device description, indications for use, and a high-level overview of performance tests conducted. However, it does not contain detailed information about specific acceptance criteria or the study data that would allow for a comprehensive answer to your request regarding detailed performance metrics, sample sizes, ground truth establishment, or multi-reader studies.
The document focuses on comparing the AKITA JET to predicate devices across several categories to prove substantial equivalence rather than presenting a de novo performance study against pre-defined acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, based solely on the information given in the provided text.
Here's what can be extracted and what is missing:
Acceptance Criteria and Study Information for AKITA JET Nebulizer System
The provided 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo acceptance criteria with specific quantitative thresholds that are then met by a new study. The performance tests mentioned are generally for comparison with existing similar devices or to ensure basic safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied by comparison to predicates) | Reported Device Performance (Implied from comparison) |
|---|---|
| General Attributes | |
| - Indications for Use (Similar to predicates) | Meets (Substantially equivalent) |
| - Patient Population (Similar to predicates) | Meets (Substantially equivalent) |
| - Environments of Use (Similar to predicates) | Meets (Substantially equivalent) |
| Nebulizer Performance | |
| - Particle Characterization (Compared to PARI LC Sprint K060399) | "performance tests were done" (Implied: comparable) |
| - Delivery during inhalation (Compared to AKITA2 K072019, AutoNeb K935693) | "performance tests were done" (Implied: comparable) |
| - Delivery based on breathing patterns (Compared to AKITA2 K072019) | "performance tests were done" (Implied: comparable) |
| - Algorithm to program breathing patterns (Compared to AKITA2 K072019) | "performance tests were done" (Implied: comparable) |
| - Controlled inhalation flow (Compared to AKITA2 K072019) | "performance tests were done" (Implied: comparable) |
| - Use of programmable Smart Cards (Compared to AKITA2 K072019) | "performance tests were done" (Implied: comparable) |
| Safety and Effectiveness Testing | |
| - Cascade Impactor testing | "Included" (Implied: Met safety/effectiveness benchmarks) |
| - VOC, PM2 |
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