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The eRapid NCP Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

Both the eRapid NCP and the predicate eRapid device are identical in purpose, function, core technology and method of operation. They are single-patient use, reusable electronic nebulizers, using micro-perforated vibrating membrane technology to aerosolize liquid medications. They are for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution, or hospital environment. The devices are hand-held and portable, consisting of a controller and a nebulizer handset, connected with a connection cord. Power input for both devices is provided by either AA batteries, or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country.

The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the eRapid NCP Nebulizer System. It outlines the device's technical specifications, intended use, and comparison to a predicate device. However, it does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML powered medical device.

The document primarily focuses on demonstrating substantial equivalence to a previously cleared nebulizer, relying on the fact that the core aerosol generation technology (the handset) remains identical, and the changes are limited to the controller, connection cord, and power supply. The performance data provided are related to:

• Biocompatibility and Airpath Testing: Ensures materials are safe.
• Electromagnetic Compatibility (EMC) and Electrical Safety: Confirms the device meets relevant safety standards.
• Software Verification and Validation Testing: Addresses the moderate level of concern for the software, confirming it meets IEC 62304 standards.
• Aerosol Performance: Demonstrates that the new controller does not negatively impact the aerosol generation, which is solely determined by the unchanged nebulizer handset.
• Simulated Use Testing: Shows the device performs within specifications throughout its useful life.
• Validation of Cleaning and Disinfection Methods: Confirms the effectiveness of cleaning procedures.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and study details because the provided document does not describe an AI/ML powered medical device or studies related to its performance in classification/prediction tasks.

The document states: "There is no other mechanism in place that changes the aerosol particle size, whether through software and/or user interface. This micro-perforated membrane vibrates at a high frequency against a body of fluid. The vibration source is the piezoelectric actuator that is activated by an electronic drive circuit of the Controller. The actuator and the perforated membrane are the main components of the aerosol head that is in contact with the liquid medication to be aerosolized. Liquid jets are created as an inertial response to the vibration of the membrane. Surface tension and hydrodynamic effects then cause these jets to disperse to produce a stream of precisely controlled droplets." This description clearly indicates a mechanical process for aerosol generation, not one driven or significantly influenced by AI/ML.

To answer your request, I would need a document detailing the validation of an AI/ML powered medical device.

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The eRapid™ Nebulizer System is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

The eRapid Nebulizer System is a modified version of the predicate FDA-cleared eFlow (now Trio ) Electronic Nebulizer, cleared in 510k Nos. K033833 and Special 510K No. K072670, and the Altera® Nebulizer System, cleared in 510(k) No. K100380. Its performance characteristics, however, are comparable to the predicates LC Star, cleared in 510(k) No. K963924, and Micro Mist Nebulizer, cleared in 510(k) No. K930525.

Similarities are that both the eRapid and the predicate Trio and Altera devices are identical in purpose, function, core technology and method of operation. They are singlepatient use, reusable electronic nebulizers, using micro-perforated vibrating membrane technology to aerosolize liquid medications. They are for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution, or hospital environment. The devices are hand-held and portable, consisting of a controller and a nebulizer handset, connected with a connection cord. Power input for both devices is provided by either four AA batteries, or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country.

The eRapid incorporates three design modifications in comparison with the predicate eFlow Technology devices: (1) a larger capacity reservoir, and a smaller volume aerosol chamber; (2) for patient convenience, an accessory that aids in the cleaning of the aerosol head, and; (3) also for patient convenience, added software user-interface functions that allow the device to pause in its operation, as well as to operate the cleaning aid.

Also. while the eRapid and the predicates Trio. LC Star and Micro Mist are for use with those medications prescribed by doctors for nebulization (i.e. general purpose) the Altera has a drug-specific application.

The provided text describes a 510(k) summary for the eRapid Nebulizer System, focusing on its substantial equivalence to predicate devices rather than a standalone study with acceptance criteria for device performance as typically understood for AI/ML devices. Therefore, much of the requested information (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone algorithm performance) is not applicable or cannot be extracted from this document, as it pertains to a different type of medical device submission (nebulizer hardware, not an AI/ML diagnostic or therapeutic system).

However, I can extract information related to the device's technical specifications and how its performance was compared to predicate devices, which can be framed as fulfilling "acceptance criteria" for substantial equivalence.

Here's a breakdown of the information that can be extracted and how it relates to your request:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicate devices in terms of purpose, function, core technology, method of operation, and performance characteristics. The document doesn't list explicit quantitative acceptance criteria as would be typical for an AI/ML performance study (e.g., "sensitivity must be > 90%"). Instead, it compares specific performance metrics to those of predicate devices.

Non-Applicable or Unobtainable Information (for this document type)

The following points are typically relevant for AI/ML performance studies but are not provided or relevant in this 510(k) summary for a physical nebulizer device:

2. Sample size used for the test set and the data provenance: Not applicable. Performance refers to engineering tests (e.g., aerosol characterization, biocompatibility, durability) not analysis of patient data by an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a nebulizer involves physical measurements and engineering standards, not expert medical interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For engineering tests, ground truth is based on standardized measurement techniques (e.g., cascade impaction for aerosol characterization, specified microbial cultures for cleaning efficacy).
8. The sample size for the training set: Not applicable. This isn't an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established: Not applicable.

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