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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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The eFlow® is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.

The PARI eFlow® Electronic Nebulizer is a small, single-patient use, reusable electronic nebulizer for the inhalation treatment of aerosol medications. It is a hand-held device, containing a capped medication cup that can be filled by the user. Power input is provided by either four AA batteries or a DC or AC adapter. Alternate power cords/plugs/adapters allow its use in any country.

Here's a breakdown of the acceptance criteria and study information for the eFlow® Electronic Nebulizer, based on the provided text:

Based on the provided text, the device in question is a modified eFlow® Electronic Nebulizer, specifically the addition of a new control unit with an LCD. The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical trials with specific acceptance criteria in the same way a new drug or high-risk medical device might.

The "acceptance criteria" here are implicitly tied to demonstrating that the modifications do not adversely affect safety or performance and that the modified device remains substantially equivalent to the predicate. The study described focuses on technical verification and validation, not on clinical performance metrics like sensitivity, specificity, or reader agreement.

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1-2
• CAN/CSA C22.2 NO 601.1-M90
• UL 1431 |
  | Stress Testing
  (Compliance with specified standards for intended operational environment) | Testing performed to the applicable requirements of:
• IEC/EN/DIN 60068-2-3
• 60068-2-6
• 60068-2-14
• 60068-2-29
• 60068-2-64
• 60068-2-78 |
  | Overall Impact on Performance, Safety, or Effectiveness
  (No new issues or adverse effects) | "Testing demonstrated that the modifications to the new, optional control unit do not affect the performance of the eFlow Electronic Nebulizer, and raise no new issues of safety or effectiveness."
  "The addition of the modified unit does not affect the intended use, or alter the fundamental scientific technology of the legally-marketed PARI eFlow."
  "Additionally, there is no change to the legally-marketed device's: (1) materials; (2) performance specifications; (3) dimensional specifications: (4) environmental specifications: (5) energy sources; or; (6) packaging." |
  | Substantial Equivalence to Predicate Device
  (Based on 21 CFR 807.87 and New 510(k) Paradigm) | The manufacturer believes the modifications are substantially equivalent to the eFlow® Electronic Nebulizer (K033833), cleared on May 5, 2004.
  (The FDA's letter concurs with this finding of substantial equivalence). |

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

The provided text does not contain information about a "test set" in the context of patient data. The testing described is primarily engineering and software verification/validation on the device itself. Therefore, concepts like country of origin or retrospective/prospective data are not applicable to the reported studies.

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

This information is not applicable to the type of testing described. The studies focus on technical compliance with standards and the functionality of the device's new components, not on medical diagnoses or interpretations by experts for a clinical "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a "test set" requiring adjudication by experts in the context of medical diagnoses.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or at least not described in this document. This submission focuses on the technical aspects of a device modification, not on clinical performance comparisons of human readers with or without AI assistance.

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

This is not applicable. The device is an electronic nebulizer, which is a physical medical device for drug delivery, not an AI algorithm. Its performance is inherent in its electromechanical function and software control, not in an "algorithm only" sense like a diagnostic AI.

7. The Type of Ground Truth Used

The "ground truth" for the reported studies is primarily the technical specifications and requirements defined by the referenced industry standards (e.g., IEC, CAN/CSA, UL, DIN) and the manufacturer's own SOPs. For software, it's the expected functional behavior as defined in specifications. For electrical safety and EMC, it's compliance with the limits and conditions of the standards.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical electronic nebulizer, and the testing described is not related to training an AI algorithm.

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

This information is not applicable for the same reason as above – no AI algorithm training is described.

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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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