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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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The Watchhaler is a holding chamber intended to administer aerosolized medication with a Metered Dose Inhaler. For pediatric patients (3 years and older). The environment of use includes home care, nursing homes, sub-acute institutions, and hospitals

The Watchhaler is a spacer primarily used in the pediatric population for the inhalation of approved MDIs for the therapy of the upper and lower respiratory system. The design of the device is held in the shape of a colored toy animal to address its users, the children. The device consists of a balloon which is enclosed by a translucent housing. During inhalation the balloon collapses with the speed of deflation controlled by a mechanical valve. The fixed volume of the balloon and the low inhalation flow provided by the valve help to ensure a constant drug delivery.

This document is a 510(k) Premarket Notification for a medical device (Watchhaler) and does not describe a clinical study or present data demonstrating the device meets acceptance criteria. Instead, it aims to establish substantial equivalence to predicate devices. Therefore, most of the requested information cannot be extracted from this document.

However, based on the provided text, here's what can be gathered regarding acceptance criteria and the comparison to predicate devices, recognizing that this is not a study proving the device meets performance criteria, but rather a submission arguing for substantial equivalence based on attributes:

1. A table of acceptance criteria and the reported device performance

The document doesn't present "acceptance criteria" in the traditional sense of performance metrics with thresholds that were tested against. Instead, it lists attributes of the proposed Watchhaler and implicitly argues that these attributes are substantially equivalent to predicate devices. The "reported device performance" would be the listed attribute itself.

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

This information is not provided. The document does not describe a test set or data generation.

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)

This information is not provided. The document does not discuss ground truth established by experts for a test set.

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

This information is not provided. The document does not describe an adjudication method for a test set.

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

A MRMC comparative effectiveness study was not done. The device is a physical medical device (spacer/holding chamber), not an AI-assisted diagnostic tool.

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

A standalone performance study was not done. The device is a physical medical device, not an algorithm.

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

This is not applicable as there is no mention of a study generating data against a "ground truth" in the device's performance. The basis for approval is substantial equivalence to legally marketed predicate devices, meaning its attributes and intended use are similar enough to devices already deemed safe and effective.

8. The sample size for the training set

This information is not provided. The document does not describe a training set.

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

This information is not provided. The document does not describe how ground truth for a training set was established.

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The AKITA2 APIXNEB 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, sub-acute institution, or hospital environment.
The AKITA2 APIXNEB is intended for patients 3 years and older who can coordinate breathing.

The AKITA? APIXNEB nebulizer and the handset together constitute a single patient, 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 AKITA2 . APIXNEB nebulizer handset.
• . A nebulizer handset based upon the PARI e-Flow™, K033833, which uses piezoelectric vibration of a perforated stainless steel membrane (head) for the aerosol generation.
• . Single patient use, reusable
• Nebulization only during inhalation phase .
• . Smart Card series for defined patient breathing patterns

The provided text describes the AKITA2 APIXNEB nebulizer system and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for a study proving device performance in the context of an AI/ML medical device, nor does it detail a study methodology as requested.

The document is a 510(k) premarket notification for a traditional medical device (a nebulizer), not an AI/ML-driven device. Therefore, many of the requested categories related to AI/ML evaluations (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable or present in this submission.

The document discusses "safety and effectiveness testing" which includes various performance tests (e.g., flow performance, trigger pressure performance, nebulization time performance), but it does not specify acceptance criteria for these tests nor does it provide a report of the device's performance against specific numerical or qualitative targets. Instead, it states that these tests were "done" to demonstrate substantial equivalence and safety/effectiveness.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's an attempt to fill in the table based on the available information, with many fields noted as "Not applicable" or "Not provided."

Acceptance Criteria and Reported Device Performance

Study Details (AI/ML Specific - Not applicable to this device)

1. Sample size used for the test set and the data provenance: Not applicable; this is a traditional medical device, not an AI/ML device. No test set for an algorithm is mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth for an AI/ML model test set is discussed.
3. Adjudication method for the test set: Not applicable; no test set for an AI/ML algorithm is mentioned.
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: Not applicable; this is not an AI-assisted device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable; this is not an AI-driven device.
6. The type of ground truth used: For traditional device performance tests, the "ground truth" would be established by validated measurement techniques and adherence to industry standards, but specific methodologies and validation for each test are not detailed in this summary. It's not clinical ground truth (e.g., pathology, outcomes).
7. The sample size for the training set: Not applicable; this is a traditional medical device, not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable; no training set for an AI/ML model is discussed.

Summary of available information:

The K072019 submission for the AKITA2 APIXNEB nebulizer system focuses on demonstrating substantial equivalence to existing predicate devices (I-neb Insight, ProDose, eFlow™, AutoNeb). The device is a traditional nebulizer, not an AI/ML-driven medical device.

To support substantial equivalence and claims of safety and effectiveness, a series of performance tests were conducted, including:

• Flow performance
• Trigger Pressure performance
• On/Off performance
• Nebulization Time performance
• Time lag performance
• Timing Parameters
• Life Time test
• Cleaning performance
• Smart Card performance
• Inhalation / Exhalation resistance
• VOC and PM25 testing
• Electrical safety, EMC, EMI, Mechanical and environmental testing

The document states that these tests were performed, and the conclusion is that "There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices." This implies that the device performed acceptably in these tests, aligning with the performance of the predicate devices. However, specific acceptance criteria (e.g., numerical ranges, pass/fail thresholds) and the detailed results of these tests are not provided in this non-confidential summary. The study design and results are presented as foundational for the "substantial equivalence" claim rather than a detailed report against specific performance criteria.

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