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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

Important Note: The document states, "There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices." This is the primary "acceptance criterion" in a 510(k) pathway, implying that the device performs equivalently to the listed predicate devices in the noted categories. Specific quantitative thresholds for these categories are not provided.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified. Standard performance testing for medical devices is typically conducted in a laboratory setting, but the geographical origin or whether it's retrospective/prospective is not mentioned.

3. Number of Experts Used and Qualifications

• Number of Experts: Not applicable. This type of performance testing for a nebulizer typically involves technical measurements and comparisons, not expert clinical evaluation of images or data in the way, for example, a diagnostic AI device would.
• Qualifications: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests described (e.g., cascade impactor, electrical safety) involve objective measurements against standards or predicate devices, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images), often with and without AI assistance, to assess diagnostic performance. The AKITA JET is a drug delivery device (nebulizer system), not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Yes, in a sense. The described performance tests (e.g., particle characterization, delivery, electrical safety) are conducted on the device itself without human-in-the-loop clinical interpretation. The "algorithm" in this context refers to the device's operational programming (e.g., for breathing patterns, controlled inhalation flow), and its performance would be assessed as part of the overall device functionality. However, it's not a "standalone algorithm" performance in the way a diagnostic AI would be evaluated.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the performance tests would be established by:
  • Objective Measurements: Against established physical and engineering standards (e.g., for particle size distribution, electrical safety, VOC emissions).
  • Predicate Device Performance: The measured performance parameters of the AKITA JET were compared directly to those of the predicate devices (PARI LC Sprint, AKITA 2 APIXNEB, Vortran AutoNeb) to establish substantial equivalence.

8. Sample Size for the Training Set

• Sample Size: Not specified. Nebulizers are hardware devices with embedded software; they don't typically undergo machine learning "training" in the same way an AI diagnostic algorithm would. The development process involves engineering, design, and internal testing, which could be considered an iterative development ("training") process, but a specific "training set sample size" as relevant to AI/ML is not applicable or provided here.

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

• Ground Truth Establishment: Not applicable as defined for AI/ML models. The functionality and performance of the nebulizer system were established through engineering design principles, manufacturing specifications, and testing against those specifications and relevant regulatory standards.

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