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The Altera" Nebulizer System is intended specifically for the aerosolization of Cayston" (aztreonam for inhalation solution) using vibrating membrane technology. The device is intended for adult and pediatric patients who have been prescribed Cayston, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

The Altera™ Nebulizer System (hereinafter referred to as "Altera") is a drug specific version of the FDA-cleared eFlow Electronic Nebulizer, originally cleared in 510k No. K033833, and as modified in Special 510K No. K072670.

Both the Altera and the predicate eFlow are identical in purpose, function, core technology, basic design, materials and method of operation. They are single-patient use, reusable electronic nebulizers that employ 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. Both devices are hand-held and portable, consisting of a control, or base unit and a nebulizer handset, connected with a connection cord. Power input for both the Altera and the predicate eFlow 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.

However, unlike the predicate eFlow the Altera is drug-specific, intended for use only with aztreonam for inhalation solution.

The provided text describes the Altera™ Nebulizer System, a medical device, and its testing to demonstrate substantial equivalence to predicate devices, rather than a study proving it meets specific acceptance criteria in the manner of a clinical trial for a new therapeutic or diagnostic device. The device is a nebulizer, and the testing focuses on its physical performance and safety characteristics.

Therefore, many of the requested categories like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable in this context. The "ground truth" here relates to engineering specifications and performance benchmarks compared to predicate devices.

Here's an adaptation of the requested table and information, focusing on the available details from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of patient data or clinical images. The testing described is primarily engineering and performance-based for the device itself.

• Sample Size: Not applicable in the traditional sense of a clinical test set. The "samples" would be units of the nebulizer components (e.g., "Aerosol Heads 25, 30, 35 and 45" for lifetime testing) or laboratory measurements. The exact number of units tested is not provided.
• Data Provenance: The data appears to come from internal testing conducted by PARI Respiratory Equipment, Inc. ("PARI conducted simulated lifetime testing," "PARI performed an aerosol characterization"). The AZLI New Drug Application (NDA) 50-814 and an eFlow Electronic Nebulizer product description provided reference data for the drug-specific testing, implying external or previously established data points for comparison. The country of origin for the testing itself is not explicitly stated, but PARI Respiratory Equipment, Inc. is based in Midlothian, Virginia, suggesting US-based operations. The testing is retrospective in the sense that it relies on established engineering principles and comparisons to existing, cleared devices.

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

Not applicable. "Ground truth" in this context is based on:

• Established engineering specifications (e.g., TOR, MMD, GSD, RF, TM, RM values).
• Microbiological testing standards for cleaning/disinfection efficacy.
• Environmental safety standards for airpath testing (VOCs, particulates, gases).
• International and national electrical and electromagnetic compatibility (EMC) safety standards (e.g., IEC 60601-1-2, UL 1431).
• Performance data of legally marketed predicate devices and drug-specific NDA data.

These "ground truths" are objective measurements against regulatory and technical benchmarks, not subjective expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The testing methods described are objective and quantitative (e.g., cascade impaction, laser light scattering, microbiological efficiency control tests). They do not involve human interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where different human readers interpret medical images or data, and their performance is compared with and without AI assistance. The Altera™ Nebulizer System is a therapeutic device for drug delivery, not a diagnostic imaging or data interpretation system.

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

Yes, in a sense, a "standalone" performance assessment of the device's physical and technical characteristics was done. The evaluations (simulated lifetime, cleaning validation, aerosol characterization, airpath testing, electrical/EMC safety) describe the device's inherent performance according to its design, independent of human interaction beyond basic operation according to IFU. There is no "algorithm" in the AI sense for which to measure standalone performance.

7. The Type of Ground Truth Used

The ground truth used for the Altera™ Nebulizer System is a combination of:

• Engineering Specifications/Industry Standards: For properties like particle size distribution (MMAD, MMD, GSD, RF, TM, RM), device lifetime, and electrical/EMC safety.
• Regulatory Standards: For cleaning/disinfection efficacy (microbiological efficiency).
• Predicate Device Performance Data: Performance benchmarks derived from previously cleared devices (eFlow, LC Star, I-neb AAD System).
• Existing Drug Application Data: Specific aerosol performance characteristics for aztreonam solution were benchmarked against data from AZLI New Drug Application (NDA) 50-814, which served as the "ground truth" for drug delivery efficacy.

8. The Sample Size for the Training Set

Not applicable. The Altera™ Nebulizer System is a mechanical/electronic device, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

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