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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 PARI Proneb Max is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers with patients for whom doctors have prescribed medication. It is intended for adult and pediatric patients 2 years and older, and may be used in hospital-type facilities, nursing homes, sub-acute institutions and home environments.

The Proneb Max is a tabletop air compressor for use with jet nebulizers, which aerosolize liquid medications for inhalation by patients with respiratory diseases and conditions. The Proneb Max is to be used with adult and pediatric patients ages 2 years and older, and is intended for sale by prescription only. It may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments. It is provided non-sterile.

The Proneb Max compressor creates an airflow that travels to the nebulizer through tubing. The nebulizer is attached to the compressor for its operation. The Proneb Max compressor is constructed of (1) Teflon; (2) ABS; (3) PBT GF30 and, has the following principal internal subcomponents: (1) cylinder/valve system; (2) piston rod/piston sealing: (3) a patient interface (on/off switch): (4) motor 120V/60Hz: (5) power cord/wire harness; and (6) hoses. Energy source for the device is provided by connection to a 120V/60 Hz mains power source.

The provided text describes the Proneb Max nebulizer compressor and its substantial equivalence to predicate devices, primarily the PARI Vios and the reference device Proneb Ultra. However, it does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human reader performance study.

The acceptance criteria and reported performance in this document relate to the engineering and performance characteristics of a medical device (a nebulizer compressor), not the performance of an AI system or human readers. Therefore, I cannot construct a table based on AI/human reader performance, nor can I answer questions about sample sizes, expert ground truth, adjudication methods, or MRMC studies in the context of AI.

The document discusses nonclinical performance testing for the Proneb Max, including:

• Gas Path Testing: Evaluated for harmful gases (Ozone, CO, CO2, VOCs) and particulates (PM 2.5).
  • Acceptance Criteria: Met all applicable standards.
  • Reported Performance: "All air quality tests concluded that the subject device meets applicable standards."
• Electrical Safety and Electromagnetic Compatibility (EMC): Tested to IEC 60601-1, -2, -6, -11, and IEC 62366.
  • Acceptance Criteria: Met applicable requirements of the listed standards.
  • Reported Performance: "Testing establishes that, with respect to electrical safety, the Proneb Max meets the applicable requirements..."
• Aerosol Characterization: Compared MMAD, GSD, FPF, and FPD with the reference device Proneb Ultra using PARI jet nebulizer cups.
  • Acceptance Criteria: Statistically equivalent to the reference Proneb Ultra.
  • Reported Performance:
    • MMAD: Statistically equivalent to reference Proneb Ultra.
    • GSD: Statistically equivalent to reference Proneb Ultra.
    • FPF: Statistically equivalent to reference Proneb Ultra.
    • FPD: Statistically equivalent to reference Proneb Ultra.
  • Numerical Data Provided (Table 1):

    Metric	Proneb Max / LC Plus (Atrovent)	Proneb Max / LC Plus (Sultanol)	Proneb Max / LC Plus (Pulmicort)	Proneb Ultra / LC Plus (Atrovent)	Proneb Ultra / LC Plus (Sultanol)	Proneb Ultra / LC Plus (Pulmicort)
    Mean values MMAD (µm)	4.1	4.0	6.1	4.1	3.8	6.0
    GSD (µm)	2.2	2.2	1.8	2.2	2.2	1.8
    Fine Particle Fraction (%)	58	59	35	58	61	36
    Fine Particle Dose (µg)	121	712	122	125	710	127

• Simulated Use Test: Assessed if the device remained within specification over its stated useful life.
  • Acceptance Criteria: Remained within the specifications stated in the IFU.
  • Reported Performance: "The testing concluded that the device remained within the specifications stated in the IFU."
• Mechanical Testing (Packaging Drop Test, Environmental Conditions Test): Evaluated packaging integrity and optimal operating conditions.
  • Acceptance Criteria: Packaging satisfactory for transport/storage/sales; relevant environmental conditions established.
  • Reported Performance: "The testing concluded that the packaging is satisfactory for the envisioned uses."; "The testing established these environmental conditions."

In summary, the provided document details the regulatory clearance of a nebulizer compressor based on its physical and performance characteristics, demonstrating substantial equivalence to existing devices through non-clinical testing. It does not describe an AI-driven system or a study involving human readers.

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

The Velox Nebulizer System is a portable, reusable, single-patient use, handheld electronic nebulizer that uses a piezo-driven, micro-perforated vibrating membrane technology to aerosolize liquid medications for the treatment or prophylaxis of respiratory diseases. It is to be used with adult and pediatric patients for whom doctors have prescribed medication, i.e. it is for prescription use only. It may be used in hospital-type facilities, nursing homes, sub-acute institutions and home environments. It is provided non-sterile. The device consists of two major components: the nebulizer and a Controller. The nebulizer contains a medication cap, medication reservoir, aerosol head, aerosol chamber, and mouthpiece. The Controller contains a circuit board, USB connector, patient interface (on/off switch), and AA battery housing. The controller's functions are to conduct power pre-processing, supervise aerosol generation through incorporated software, and generate optical and acoustical feedback to the user. The device is powered by connection to a mains power source via an AC Power Supply or disposable/rechargeable AA batteries. Associated accessories include a cleaning aid and an AC Power Supply.

The provided text describes the regulatory clearance of a medical device (Velox Nebulizer System) and does not contain information about an AI/ML powered device. Therefore, it is impossible to extract the requested information regarding acceptance criteria and study details for an AI/ML powered device.

The document is a 510(k) premarket notification for a nebulizer, a physical medical device. The "Software Verification and Validation Testing" section mentions that the software for this device is of a "moderate" level of concern and controls basic functions of the nebulizer (power, aerosol generation, user feedback) but there is no indication that it uses AI or machine learning algorithms for its operation or for diagnostic purposes.

Therefore, I cannot provide the detailed information requested for an AI/ML powered device, such as effect size of human readers improving with AI, standalone performance, or details about ground truth establishment for AI/ML models.

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The PARI O-PEP is intended for use as a Positive Expiratory Pressure Device, and is designed to help patients improve secretion clearance. The PARI O-PEP is intended for adult and pediatric patients ages 5 and older, for use in home, hospital, and sub-acute institutions.

The PARI O-PEP (Oscillating Positive Expiratory Pressure) is a small, single patient use, reusable oscillating PEP therapy device. The PARI O-PEP is a respiratory therapy device designed for temporary application to mobilize secretions or mucous in the lower respiratory tract, strengthen the respiratory tract and alleviate shortness of breath. The patient exhales repeatedly into the device against a movable ball, causing a vibration that is transmitted to the lungs. This causes the deeper respiratory tract to open. By doing this, secretions are mobilized and able to move up the airways. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

Here's a breakdown of the acceptance criteria and study information for the PARI O-PEP device based on the provided text, using the requested format.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against predefined acceptance criteria from a comprehensive clinical trial. Therefore, much of the requested information regarding detailed study design, ground truth establishment, expert adjudication, or MRMC studies for AI devices is not applicable or not present in this type of submission. The performance assessment here is primarily non-clinical and comparative.

Acceptance Criteria and Device Performance (Based on Non-Clinical Comparative Testing)

The "acceptance criteria" for the PARI O-PEP, in the context of this 510(k) submission, are primarily defined by its ability to perform comparably to its predicate device (Flutter D and Flutter) in key functional metrics: oscillatory frequency and expiratory resistance. Biocompatibility and cleaning efficacy are also established.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details (Non-Clinical Comparative Testing)

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated as a number of devices. The testing involved comparing the PARI O-PEP device against the predicate Flutter device across a "range of flow rates between 5 and 30 LPM and angular positions of 0 and 30 degrees." This suggests multiple measurement points for each device.
   • Data Provenance: The data is from non-clinical laboratory testing performed by the manufacturer, PARI Respiratory Equipment, Inc. The country of origin for the data is not specified, but it would be expected to be where PARI conducts its testing, likely the USA given their address. The data is prospective in the sense that the tests were specifically conducted for this 510(k) submission to demonstrate equivalence.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not Applicable. This was a non-clinical, objective performance test comparing physical properties (pressure, frequency) of devices, not a diagnostic device requiring expert interpretation of results. The "ground truth" was the measured performance of the predicate device under controlled conditions.

3. Adjudication Method for the Test Set:

   • Not Applicable. No human adjudication was involved in comparing the physical performance parameters of the devices. The comparison was based on direct measurements.

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:

   • No. This device is a mechanical respiratory therapy device, not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI" are not relevant.

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

   • No. This is a mechanical medical device, not an algorithm or AI system.

6. The Type of Ground Truth Used:

   • For the performance tests (expiratory resistance, oscillating frequency): The "ground truth" was the measured physical performance of the legally marketed predicate device (Flutter/Flutter D) under standardized laboratory conditions. The PARI O-PEP's performance was measured and compared against these established values.
   • For biocompatibility and cleaning efficacy: The "ground truth" was adherence to established regulatory standards (ISO 10993 series and AAMI TIR No. 30).

7. The Sample Size for the Training Set:

   • Not Applicable. This is a non-AI, mechanical device. There is no concept of a "training set." The device itself is manufactured based on engineering design.

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. As there is no training set for a mechanical device, there is no ground truth to establish for it in this context.

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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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The PARI Sinus is a compressor nebulizer system, designed to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the upper airways. The PARI Sinus is intended for adult and pediatric patients consistent with the indications for aerosol medication, in homes, hospitals, and sub-acute institutions.

The PARI Sinus is a single patient use, reusable aerosol therapy device for delivery of prescribed medications to the upper airway. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments. The PARI Sinus utilizes a combination of aerosol flow and vibration to effectively deliver aerosolized medications to the upper airway.

The PARI Sinus 510(k) submission primarily relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria in the traditional sense of a diagnostic or therapeutic efficacy study. Therefore, the "acceptance criteria" here refer to parity with predicate device performance in key engineering metrics, and the "study" is a series of non-clinical tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The acceptance criteria are implicitly defined as "comparable" to the predicate devices' performance, without specific numerical thresholds being provided in this summary. This is common for 510(k) submissions demonstrating substantial equivalence for devices of this nature.

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

• Sample Size: Not applicable in the context of human subjects or distinct data samples for a clinical test set. The "test set" here refers to the device itself being tested in a lab setting.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory environment, likely by the manufacturer, PARI Respiratory Equipment, Inc. No information on country of origin of data in a human context, or retrospective/prospective status is relevant here.

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

• Not Applicable. This submission solely reports on non-clinical engineering and performance characteristics. There is no human interpretative element or "ground truth" established by experts in the context of clinical outcomes or images.

4. Adjudication Method for the Test Set

• Not Applicable. As there is no human interpretation or subjective assessment involved, an adjudication method for a test set is irrelevant for this submission.

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

• No. A MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not completed/is not required to show substantial equivalence."

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

• Not Applicable. The device is a nebulizer system, not a software algorithm or AI-powered diagnostic tool. The concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: The "ground truth" for the non-clinical tests would have been established by comparing the PARI Sinus's performance against industry standards, internal specifications, and the known performance metrics of the predicate devices. For example, MMAD is measured using established aerosol science methods.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

• Not Applicable. As there is no training set for an algorithm, this question is not relevant.

In summary, the PARI Sinus 510(k) relies on demonstrating engineering comparability through non-clinical testing to legally marketed predicate devices, negating the need for clinical studies with human subjects or AI-specific evaluation metrics.

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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 PARI Vios is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The PARI Vios is intended for adult and pediatric patients for use in hospital, clinic, or home environments.

The PARI Vios nebulizer compressor is a small, lightweight AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The device is non-sterile and prescriptionuse only.

The provided documentation describes the PARI Vios nebulizer compressor, but it does not contain information related to acceptance criteria for an AI/ML powered device or a study involving such a device.

Instead, it's a 510(k) summary for a medical device (a nebulizer compressor) that compares its performance to predicate devices. The "performance" mentioned refers to physical characteristics of the nebulizer compressor itself, not the performance of an algorithm or AI.

Therefore, I cannot provide answers to the requested categories (acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC, standalone, ground truth, training set) as they are relevant to AI/ML device studies, which are not detailed in this submission.

Here's a breakdown of what is provided, as it relates to the general concept of device performance:

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

The document doesn't explicitly state "acceptance criteria" with numerical targets. Instead, it states that the PARI Vios's performance is "comparable to the predicate devices" for the following metrics:

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The PARI PEP S is intended for use as a Positive Expiratory Pressure Device, and is designed to help patients exercise their lungs properly and improve secretion clearance. The PARI PEP S may be used by itself or in conjunction with aerosol drug therapy. The PARI PEP S is intended for adult and pediatric patients, for use in home, hospital, and sub-acute institutions.

The PARI PEP S is a small, single patient use, reusable PEP therapy device for use as a stand alone PEP device or for use with aerosol drug delivery. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

The provided information is for the PARI PEP S Positive Expiratory Pressure Device (K090829). This device is an Incentive Spirometer, which is a mechanical device, not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for training/test sets, ground truth establishment for AI/ML, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or provided in this 510(k) summary.

However, I will extract and present the relevant information that is available regarding its performance and the study details.

Acceptance Criteria and Device Performance:

The 510(k) summary indicates that the PARI PEP S was tested to compare its performance to predicate devices (PARI PEP and TheraPEP). The acceptance criteria are implicitly defined by "comparable to the predicate devices" for the tested parameters.

Study Details:

1. Sample size used for the test set and the data provenance: Not applicable. The testing described is a comparison of functional characteristics (resistance) rather than a clinical trial with patient data. No specific sample size for a "test set" of patient data is mentioned as clinical testing was not performed or required.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical outcomes or interpretations by experts is not relevant for this type of device comparison test.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept applies to clinical image interpretation or diagnostic performance, which is not relevant here.
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 a non-AI mechanical device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a non-AI mechanical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a mechanical device performance comparison. The "ground truth" here would be the measured physical properties of the predicate devices.
7. The sample size for the training set: Not applicable. This is a non-AI mechanical device.
8. How the ground truth for the training set was established: Not applicable. This is a non-AI mechanical device.

Additional Information from the 510(k) Summary:

• Study Type: Non-Clinical Test Summary focused on comparing performance (expiratory and inspiratory resistance) of the PARI PEP S to legally marketed predicate devices (PARI PEP and TheraPEP).
• Clinical Performance Summary: "Clinical testing was not completed/is not required to show substantial equivalence." This statement confirms that clinical studies, which would typically involve patient data and clinical endpoints, were not part of this submission for substantial equivalence.
• Conclusion: "PARI PEP S meets performance requirements and raises no new issues of safety or effectiveness." This indicates that the comparative non-clinical testing was sufficient to demonstrate substantial equivalence to the predicate devices for the given indications for use.

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