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The Compressor Nebulizer system is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The nebulizer is driven by the integral air compressor.

The system is designed for use with pediatric (ages 2 years and above) and adult patients in the home, hospital, and sub-acute settings.

The compressor Nebulizer is mainly composed of the compressor and nebulizer kit(Optional). The compressor is mainly composed of shell, compressed motor, pump, fuse wire, air filter, power cord and plug (NB-1100,NB-1101,NB-1102,NB-1103 applicable), PCB (only model NB-1102,NB-1103applicable). The device is equipped with a nebulizer kit including Nebulizer Cup, Air Tube, Mouthpiece(Optional), Adult Mask(Optional), Child Mask(Optional) to easily delivery the medical aerosol. The Nebulizer kit is available in three models/configurations as below.

• NK-101: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask, Mouthpiece;
• NK-301: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask;
• NK-501: Nebulizer Cup, Air Tube, Mouthpiece
  This device operates on the Venturi principle. According to the principle of Venturi, the compressed air of the motor is used to form a high-speed air flow through the small pipe mouth. The negative pressure generated drives the liquid or other fluid to spray together on the barrier, and under the high-speed impact makes the droplets turn into mist particles to spray from the outlet trachea.

The provided FDA 510(k) clearance letter and summary for JOYTECH Healthcare Co., Ltd.'s Compressor Nebulizer (K243468) primarily details the substantial equivalence of the new device to a predicate device, focusing on non-clinical performance testing, specifically particle size characterization.

It's important to note that this document does not describe a study involving human subjects or artificial intelligence (AI). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications for a nebulizer, evaluated through laboratory testing against a predicate device and relevant standards. Therefore, many of the requested points related to AI/MRMC studies, expert ground truth, adjudication methods, and training sets for algorithms are not applicable to this specific device clearance.

Below is an interpretation of the provided information within the framework of your request, focusing on the relevant parts and explicitly stating where information is not available or not applicable.

Acceptance Criteria and Device Performance for JOYTECH Compressor Nebulizer (K243468)

The acceptance criteria for this device are established by demonstrating substantial equivalence to a legally marketed predicate device (Omron Compressor Nebulizer Systems NE-C801, K110860) and by meeting relevant performance standards, particularly regarding aerosol particle characterization. The 'study' proving this is primarily the "Particle Size characterization testing" detailed in the submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by performing "comparative particle test comparison" against the predicate device. The goal is to show that the proposed device performs similarly or equivalently to the predicate across key aerosolization parameters. The performance data provided is the direct result of this testing.

Table: Comparative Particle Test Comparison (Summary of Select Parameters)

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The HeroTracker Sense Device (HTS) is an add-on device which is attached by patients on a metered-dose inhaler (MDI).

HTS is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, inhaler shake, inhaler orientation, inhalation coordination, and inspiratory strength and duration for prescribed inhaler usage.

HTS may be used in the following applications: in clinical practice or clinical trials, where specialists, general practitioners, nurses and educators need to know if a patient has used their prescribed medication or assess inhaler technique.

HTS is designed to work only with the MDI and medication indicated on the HTS label.

HTS is not intended to indicate the remaining quantity of medication in an inhaler and does not include a dose counting function.

HTS is not intended to provide spirometry measurements.

HTS is intended to be used by Metered Dose Inhaler (MDI) users aged 12 years and over.

The HeroTracker Sense (HTS) is a nebulizer accessory. It is an add-on device which is attached by patients on a metered dose inhaler (MDI) and is used to record and analyze data related to medication actuation and technique of use for prescribed inhaler usage. Data is transferred to a mobile application with appropriate settings and is displayed to end users.

The provided FDA 510(k) Clearance Letter for HeroTracker Sense (HTS) does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data.

Here's a breakdown of what can be gleaned from the document and what information is missing:

Missing Information: The document explicitly states "No clinical data was necessary to determine the substantial equivalence of this device." This means there was likely no "performance study" in the traditional sense, with a clinical test set, ground truth experts, adjudication, or MRMC studies. The acceptance criteria for performance would have been established and demonstrated through non-clinical testing.

Therefore, many of the sections you requested (e.g., sample size for test set, number of experts, adjudication, MRMC, specific effect sizes, ground truth type for test set the training set) cannot be answered from the provided text.

Inference from Document's Purpose: The 510(k) process for this device relies heavily on demonstrating that the HeroTracker Sense (HTS) functions similarly to its predicate device (Hailie® Sensor NF0110) and that any differences do not raise new questions of safety or effectiveness. The performance validation would have been against defined specifications for each function, likely derived from the predicate device's capabilities and internal design requirements.

Acceptance Criteria and Device Performance (Based on available non-clinical data)

Since clinical data was not required, the "acceptance criteria" for the device would be met by passing the non-clinical performance and safety tests. The "reported device performance" is essentially that it "passed" these tests and met its internal specifications.

Table of Acceptance Criteria and Reported Device Performance (Inferred from Non-Clinical Testing):

Study Details (Based on available information and limitations)

Given the explicit statement that "No clinical data was necessary to determine the substantial equivalence of this device," the following sections reflect this limitation. The "study" refers to the non-clinical verification and validation activities.

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

   • (Provided above, based on non-clinical testing outcomes).

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of a clinical test set. For non-clinical performance testing (e.g., electrical safety, software validation, sensor accuracy), the sample sizes would refer to the number of devices or test iterations used. This specific detail is not provided in the document.
   • Data Provenance: Not applicable in the sense of patient data. The tests were performed in a lab or testing facility environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No clinical ground truth experts were used as no clinical data was required. Ground truth for non-clinical performance (e.g., whether a sensor accurately detects an actuation) would be established by validated test methods and reference standards, not human expert consensus.

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

   • Not applicable. There was no human expert adjudication as no clinical test set with subjective interpretations was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. The document explicitly states "No clinical data was necessary." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

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

   • Yes, implicitly. The "Performance Testing" section confirms that the device was "verified to meet specifications" and its "correct functionality and compatibility" was verified. This implies standalone performance testing of the device's ability to record and analyze data from the MDI. The "algorithm" itself (which processes sensor data to identify events like actuation, shake, etc.) would have been validated against controlled physical actions.

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

   • Instrumental/Physical Ground Truth: For the non-clinical performance tests, the "ground truth" would be established by controlled physical inputs and reference measurements. For example:
     • For "actuation," the ground truth would be a definitively measured actuation event.
     • For "inhaler shake," the ground truth would be a quantitatively measured shaking motion.
     • For software functionality, the ground truth would be predefined correct outputs for given inputs.

8. The sample size for the training set:

   • Not applicable / Not specified. This device is an electronic data capture accessory. While it uses sensors and potentially algorithms to interpret movements, the document doesn't indicate that it employs machine learning or AI that would require a "training set" in the typical sense (e.g., for image classification or complex pattern recognition). Its function seems to be based on pre-defined thresholds and sensor data processing rather than adaptive learning from a large training dataset. If any "calibration" or initial parameter setting was done, the size of that dataset is not provided.

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

   • Not applicable. As no training set is indicated.

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The AdheResp Smart Breath-actuated Mesh Nebulizer is a system to aerosolize liquid medications for inhalation for patients ranging from pediatrics equal to or greater than 5 years old to adults who can coordinate breathing.

The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities.

The AdheResp Smart Breath-actuated Mesh Nebulizer consists of a main unit, medication reservoir, mouthpiece, key tag and charging cable, or power adapter. The medication reservoir could be further separated into a medication container and an aerosol chamber.

Principle of Operation: There are two key features in the AdheResp Smart Breath-actuated Mesh Nebulizer, which are vibrating mesh nebulization and breath-actuation functions. The AdheResp Smart Breath-actuated Mesh Nebulizer is an active mesh nebulizer. Active mesh nebulizers operate by electrically activating a piezoelectric (PZT) ceramic element that rapidly contracts and expands when applied a voltage to it. The vibrations of the PZT are transmitted to the mesh membrane, which is in contact with the liquid medication loaded in the medication container. This vibration pushes the liquid or suspension through the fine conical holes of the mesh, forming aerosol droplets for the user to inhale.

This document is a 510(k) clearance letter for the AdheResp Smart Breath-actuated Mesh Nebulizer. It outlines the device's characteristics and its equivalence to predicate devices, particularly focusing on performance data related to aerosol delivery.

Here’s the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided text is a 510(k) summary and clearance letter. It summarizes findings and states that acceptance criteria were met, but it does not provide the detailed study protocols, raw data, or the explicit acceptance criteria values themselves in a direct, quantifiable manner for all aspects. Instead, it presents comparative performance data and lists categories of testing. Therefore, some information will be inferred from the context or noted as 'not explicitly stated' if the document does not provide it.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for each parameter in a "limit" vs. "result" format. Instead, it presents comparative performance data against a predicate device and states that the subject device "met its acceptance criteria" and that its performance is "similar." For the purpose of this table, I will present the reported performance of the Subject Device and mention the comparison to the Predicate. The implicit acceptance criterion for the comparative performance data is that the subject device's performance is demonstrably non-inferior or similar to the predicate.

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

• Sample Size for Test Set:
  • For the comparative performance testing (Breath Actuated Particle Characterization): "Testing was performed with 3 samples of each device in triplicate with the 3 drugs." This implies $3 \text{ devices} \times 3 \text{ replicates} = 9$ runs per drug per flow rate for both the subject and predicate devices.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is non-clinical bench testing ("Bench testing," "Non-Clinical Testing Summary"), meaning it's a controlled lab environment, not patient data. It is a prospective study in the sense that the tests were conducted specifically for this submission.

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

• Number of Experts: Not applicable. This device is a nebulizer, and the tests described are bench tests (e.g., particle size, dosage, flow rates). These are physical measurements, not interpretations of medical images or patient conditions that would require expert human readers to establish ground truth.
• Qualifications of Experts: N/A, as noted above.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a study involving human interpretation of data, where adjudication of disagreements would be necessary. The performance data is derived from direct and repeatable physical measurements.

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

• MRMC Study: No. An MRMC study is typically performed for AI/CADe (Computer-Assisted Detection/Diagnosis) devices that assist human readers in interpreting medical images. This device is a nebulizer, a drug delivery system, and its performance is evaluated through bench testing.

• Effect Size of Human Readers' Improvement: Not applicable, as no MRMC study was performed.

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

• Standalone Performance: Yes, in essence. The "AdheResp Smart Breath-actuated Mesh Nebulizer" itself has an algorithm for "Breath Actuation" that "Measures breath and averages the cycle, then delivers aerosol during the designated period." The "Breathe Actuated Particle Characterization Performance Comparison" is a standalone evaluation of the device's physical output based on this internal algorithm responding to simulated breathing patterns (15 LPM and 30 LPM). There is no "human-in-the-loop" for the output of the device itself.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance is established by standardized laboratory measurements using traceable equipment and protocols (e.g., measuring particle size, drug quantity, flow rates) under controlled conditions. This is considered an objective physical truth, not a subjective interpretation. The comparison is made against a legally marketed predicate device's performance.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical medical device (nebulizer) with an embedded algorithm, not a machine learning/AI model that requires a "training set" of data in the typical sense for image recognition or diagnostic purposes. The device's "algorithm" is for controlling the nebulization based on breath patterns, which would be developed through engineering and control system design, not data-driven machine learning.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" in the context of a machine learning model. The "ground truth" for the device's operational parameters (like breath-actuation logic or aerosol delivery range) would be based on established engineering principles, physiological understanding of human breathing, and clinical requirements for drug delivery, validated through rigorous bench testing and potentially human factors testing, though the latter is not detailed in this summary.

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AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.

AllNEB is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home.

This document is a 510(k) clearance letter for a medical device called "AllNEB Breath Actuated Nebulizer." It demonstrates the device's substantial equivalence to a legally marketed predicate device, the AeroEclipse II Breath Actuated Nebulizer (K053605).

The core of the acceptance criteria and proof revolves around comparative performance testing, showing that the AllNEB device performs similarly to the predicate device across various aerosolization metrics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly derived from the performance of the predicate device. The goal is to demonstrate "substantial equivalence," meaning the new device performs similarly to the predicate. The performance of the predicate device, AeroEclipse II Breath Actuated Nebulizer (K053605), serves as the "acceptance criteria," and the "Reported Device Performance" is that of the AllNEB device.

The tables provided in the 510(k) summary (pages 7-16) present a direct comparison of various aerosolization parameters for both the AllNEB (Subject Device) and the AeroEclipse II (Predicate Device) under different conditions (Breath Actuated Mode, Constant-Output Mode, Adult settings, Pediatric settings, and Simulated Breathing).

Key Performance Metrics (Acceptance Criteria are inferred to be "similar to predicate"):

• MMAD (Mass Median Aerodynamic Diameter): A measure of the central tendency of the particle size distribution.
• GSD (Geometric Standard Deviation): A measure of the spread or variability of the particle size distribution.
• Total Dose Delivered: The total amount of medication delivered by the nebulizer.
• Total Respirable Dose (0.5-5 µm): The amount of medication delivered as particles within the respirable range (able to reach the lower respiratory tract).
• Coarse Particle Dose (>4.7 µm): The amount of medication delivered as larger particles.
• Fine Particle Dose (4.7 um) | 350 | 218 | Similar |
  | **Fine Particle Dose (

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Model number 1024 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024 is intended for use only when connected to a 22 mm fitting.

Model number 1024A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024A is intended for use only when connected to a 22 mm fitting.

Model number 1025 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025 is intended for use only when connected to a 22 mm fitting.

Model number 1025A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025A is intended for use only when connected to a 22 mm fitting.

Model number 1543 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543 is intended for use only when connected to a 15 mm fitting.

Model number 1543A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543A is intended for use only when connected to a 15 mm fitting.

Model numbers 1024, 1025, 1543, 1024A, 1025A and 1543A are breathing circuit connectors that function as general purpose actuators for dispensing prescribed aerosolized medication from a pressurized metered dose inhaler (hereafter referred to as "pMDI") canister into a breathing circuit.

The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device called the MiniSpacer Dual Spray MDI Adapter. This document is a regulatory submission for a device, which typically describes an engineering verification and validation study rather than a clinical study for AI software.

Therefore, the requested information regarding acceptance criteria and performance against those criteria, especially details such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, and training set information (which are all highly relevant to AI/ML device evaluations), is not present in this document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and general performance, rather than AI-specific metrics.

However, I can extract the following relevant information based on the request, reinterpreting some categories in the context of a non-AI medical device submission:

Acceptance Criteria and Device Performance

• Product: MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
• Study Type: This document describes a premarket notification (510(k)) to establish substantial equivalence to predicate devices, not a clinical trial or AI performance study. The "study" here refers to the engineering verification and biocompatibility assessment for the physical device.

Additional Requested Information (as applicable to this document):

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not specified in the document. The testing described appears to be bench testing for material and functional equivalence.
   • Data Provenance: Not explicitly stated, but the toxicological assessment and comparisons against predicate devices would be based on internal testing and regulatory standards. It's a regulatory submission, not a clinical trial, so "country of origin" of data or "retrospective/prospective" does not apply in the typical sense for patient data.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Not applicable in the context of this device. Ground truth is established through engineering specifications, material standards, and regulatory requirements (e.g., biocompatibility testing interpreted by toxicologists) rather than expert consensus on medical images or patient outcomes.

3. Adjudication method for the test set:

   • Not applicable. This is not a study requiring adjudication of expert interpretations. Compliance is determined by engineering testing and regulatory assessment.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

   • No, an MRMC study was not done. This device is a physical medical component (an actuator for MDI medication), not an AI diagnostic or treatment planning system that would involve human readers interpreting data.

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

   • Not applicable. This device does not involve an algorithm or AI component.

6. The type of ground truth used:

   • For material and functional performance, the "ground truth" is defined by established engineering specifications, performance standards, mechanical testing results, and toxicological assessment standards. For regulatory approval, the ultimate "ground truth" is established by demonstrating substantial equivalence to legally marketed predicate devices through comparative analysis and testing.

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI/ML algorithm.

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The Aerogen® Solo Nebulizer System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physicianprescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment.

Aerogen® Solo Nebulizer is for single-patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.

The Aerogen® USB Controller System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physicianprescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment.

Aerogen® Solo Nebulizer is for single patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.

The Aerogen® Solo Nebulizer System consists of the Aerogen® Solo Nebulizer, which has the proposed modification outlined in these 510(k) applications, and the Aerogen® Pro-X Controller (K133360 for both components and system) or the Aerogen Solo Nebulizer can also be used alternatively with the reference device - Aerogen® USB Controller (K143719).

The Aerogen® Solo Nebulizer is intended to aerosolize physician-prescribed medications for inhalation which are approved for use with a general-purpose nebulizer. It is intended for use on and off mechanical ventilation or other positive pressure breathing assistance and is intended for both intermittent and continuous nebulization.

The Aerogen® Solo Nebulizer is designed to operate in-line with standard ventilator circuits and mechanical ventilators. It operates without changing patient ventilator parameters and can be refilled without interrupting ventilation.

This submission is for a modification of the attachment process of the Aperture Plate (AP) to the Oscillator washer, both are components of the core for the Aerogen® Solo Nebulizer. The current method of attachment of the Aperture Plate to the Oscillator washer is by means of Brazing, a metal fusion process, where a copper/gold filler washer is melted in the brazing process to form the bond. The piezo is then attached using a heat cured epoxy adhesive.

The provided documentation is a 510(k) premarket notification for a medical device, specifically the Aerogen® Solo Nebulizer System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against a set of predefined acceptance criteria for a novel device. As such, the document does not contain information on rigorous acceptance criteria and the detailed study design typically seen for a new device's proven performance.

However, it does present "Comparative Particle Characterization Performance" data (Table 2) which can be interpreted as the performance data for the modified device in comparison to its predicate. The "Acceptance Criteria" in this context would be the demonstration that the modified device performs similarly to the predicate device, thereby maintaining substantial equivalence.

Here's an attempt to extract the requested information based on the provided document, interpreting "acceptance criteria" as "similarity to predicate device performance" for the purpose of 510(k) clearance:

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

Since this is a 510(k) showing substantial equivalence, the "acceptance criteria" for the modified device are implicitly that its performance parameters should be within a similar range or deemed not clinically significant compared to the predicate device. The document explicitly states "Similar Cascade Impactor performance and NGI performance" in the comparison column, implying this is the "acceptance" based on the presented data.

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Sodium Chloride Inhalation Solution, USP 3% and 7%
The Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated.

Sodium Chloride Inhalation Solution, USP 0.9%
The intended use of this sterile device is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy and for tracheal irrigation or lavage.

The proposed device is a sterile, preservative-free Sodium Chloride Inhalation Solution, USP, provided in concentrations of 0.9%, 3% and 7% with a nominal fill volume of 3 mL & 5 mL (0.9%), 4 mL (3%) and 4 mL (7%) and supplied in single-use low density polyethylene (LDPE) vials.

The provided FDA 510(k) summary (K232523) describes a Sodium Chloride Inhalation Solution. This is a medical device (a drug-device combination product, specifically an accessory to a nebulizer) and not an AI/ML-powered medical device.

Therefore, the requested information regarding acceptance criteria, study design for AI model performance (including sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, design verification testing, biocompatibility, and meeting USP (United States Pharmacopeia) standards for pharmaceutical solutions and manufacturing. The "Performance Data" section describes validation of the physical and chemical properties of the solution and its container, not the performance of an algorithm or AI model.

However, to answer your request based on the provided document, I will extract the relevant information regarding the device's performance acceptance criteria and study proving it meets those criteria, as described for this specific non-AI medical device.

Acceptance Criteria and Study for Sodium Chloride Inhalation Solution (K232523)

This device is not an AI/ML device, and therefore the traditional metrics and study designs associated with AI performance are not relevant. Instead, the "acceptance criteria" here refer to the product specifications and quality control parameters for a pharmaceutical solution and its container, and the "study" refers to the testing performed to demonstrate compliance with these specifications and established standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "All results met the predetermined acceptance criteria." Specific numerical criteria and their exact corresponding reported values are not fully detailed in this summary document, as is typical for 510(k) summaries which provide a high-level overview. However, the types of criteria and the confirmation of meeting them are listed.

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

• Sample Size: The document does not specify exact numerical sample sizes for each test (e.g., "n=X vials tested for fill weight"). It generally states that "Design verification testing was conducted..." and "The Sodium Chloride Inhalation Solution... are manufactured and tested in an identical manner to the Predicate Device." This implies that standard pharmaceutical quality control and validation sample sizes were used, which are typically defined by internal QMS procedures, relevant ISO standards, and USP monographs.
• Data Provenance: The testing was conducted by the manufacturer, Mankind Pharma Limited, based in New Delhi, India, or its affiliates/contract laboratories. The data provenance is effectively the internal testing records of the manufacturer. This is retrospective in the sense that the testing has already been completed and compiled for the submission.

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

This is not applicable. For this type of device (a sterile saline solution), "ground truth" is established by laboratory analytical methods that measure chemical composition, sterility, pH, etc., against predefined specifications (e.g., USP monographs). Human experts are involved in reviewing and validating the test methods and results, but not in establishing a "ground truth" through consensus reading of images or clinical assessments comparable to an AI/ML study.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication is relevant for subjective assessments (e.g., agreement between multiple readers on image findings). For objective chemical/physical tests, the results are quantitative and either meet or do not meet the specification; there is no "adjudication" in the sense of resolving inter-rater disagreement.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human performance in diagnostic tasks. This device is a solution used with a nebulizer, not a diagnostic AI tool.

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

This is not applicable. There is no algorithm or AI component in this device. The "performance" refers to the intrinsic properties of the sodium chloride solution and its sterile container.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Compendial Standards: Primarily the United States Pharmacopeia (USP) monographs for Sodium Chloride Inhalation Solution and general chapters for various tests (e.g., USP for Sterility, USP for Bacterial Endotoxins, USP for Identification, USP for Minimum Fill, USP for Osmolality, USP for Particulate Matter, USP for Foreign Matter, USP for pH, USP for Uniformity of Dosage Unit, USP for Container Closure Integrity).
• Internal Specifications: Derived from the device design and quality system, often based on these compendial standards and engineering requirements for the vial and its functionality.
• International Standards: e.g., ISO 10993 series for biocompatibility.

8. The Sample Size for the Training Set

This is not applicable. There is no AI model to train for this device. The "training" in manufacturing refers to process validation and optimization, not data feeding for a machine learning algorithm.

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

This is not applicable, as there is no AI training set.

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The AddiPak® Unit Dose Vial may be used in conjunction with a non-ventilator nebulizer for lavage therapy, or for tracheal irrigation.

These products are single-use, disposable, and intended for inhalation only.

AddiPak® unit dose solutions are pre-filled vials of bland liquids for inhalation therapy.

Contents of these products may be sterile water or a 0.45% sodium chloride solution (half-normal saline). Vials are factory-sealed, made of translucent, color-coded polyethylene, and are available in two sizes (3mL and 5mL). These products are single-use, and intended for inhalation only. Color-coded vials identify contents as sterile water (blue) and half-normal 0.45% saline (green).

The pre-filled vials have a perforated, break-away twist cap for dispensing solution. When twisted by the user, cap breaks away and open a small hole for solution to pass through. Vials are designed with inverted graduations to allow the clinician to read volume while dispensing solution. Addipak unit dose vials conforms to the specifications of United States Pharmacopeia – National Formulary, Sterile Water for Inhalation and Sterile Sodium Chloride for Inhalation monograph.

This document pertains to the clearance of a medical device (Hudson RCI® AddiPak® Unit Dose Vial) and does not describe artificial intelligence (AI) or machine learning (ML) device performance. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Acceptance Criteria and Device Performance

The acceptance criteria for the Hudson RCI® AddiPak® Unit Dose Vial are based on demonstrating substantial equivalence to a predicate device (Hudson RCI® AddiPak® Unit Dose Vials K142153) and satisfying various non-clinical testing requirements. The reported device performance is presented through a comparison of the proposed device's characteristics against the predicate and reference devices, along with summaries of non-clinical testing.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Not Applicable for this Device Type)

The provided document describes the FDA clearance for a physical medical device (unit dose vials containing saline or sterile water) and its equivalence to a predicate device. It does not involve any artificial intelligence (AI) or machine learning (ML) components. Therefore, the following information fields, which are specific to AI/ML device studies, are not applicable to this submission:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, no ML test set.
2. 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): Not applicable, no ground truth for ML.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no ML test set.
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, no AI component.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, no ground truth for ML.
7. The sample size for the training set: Not applicable, no ML training set.
8. How the ground truth for the training set was established: Not applicable, no ML training set.

In summary, the FDA clearance for the Hudson RCI® AddiPak® Unit Dose Vial was based on demonstrating substantial equivalence through non-clinical testing of material properties, performance, and comparison to existing predicate and reference devices, not on AI/ML performance studies.

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The portable (Ultrasonic) nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/ institutional settings, home, schools, and long-term care facilities. It is not intended for use with Pentamidine.

The Portable (Ultrasonic) nebulizer NBM-1 is small, handheld, internally powered general purpose nebulizer which utilizes ultrasound vibrating mesh technology to generate aerosol. The Portable (Ultrasonic) nebulizer provides a vapor mist of medicine that has much smaller particles and can travel much deeper into the patient's lungs, resulting in much faster relief. The ultrasonic nebulizer is made up of main unit, medicine cup, adult mask, kid mask and mouth piece. The shell of nebulizer, battery cover and spray nozzle are made of ABS, the button decoration ring is silica gel, the medicine cup and button are made by PC, the mask is made of PVC, the mouth piece is made of PP and the nebulizer piece is stainless steel.

The provided FDA 510(k) summary for the "Portable (Ultrasonic) Nebulizer" (K230379) does not describe a study involving an AI/Machine Learning diagnostic device or human-in-the-loop performance. Instead, it describes a Class II medical device which is a nebulizer, and its substantial equivalence determination to a predicate device.

Therefore, the request for acceptance criteria and studies proving an AI device meets acceptance criteria (including details like expert ground truth, MRMC studies, standalone performance, training/test set sample sizes, etc.) cannot be fulfilled from the provided document. The document focuses on the physical and electrical safety, performance, and biocompatibility of a medical device, not on the performance metrics of an AI algorithm.

Here's a breakdown of what the document does provide, and why it doesn't fit the requested AI/ML framework:

• Device: Portable (Ultrasonic) Nebulizer (NBM-1) and its predicate device (Intelligent Mesh Nebulizer K171549). These are physical devices that aerosolize liquid medications.

• Acceptance Criteria/Performance (as reported for a physical device): The document reports various physical and performance characteristics, comparing them to the predicate device and relevant standards. This is done to demonstrate "substantial equivalence."

  Acceptance Criteria (from predicate/standards)	Reported Device Performance (NBM-1)
  General
  Product Code: CAF	CAF (SE)
  Regulation #: 21CFR868.5630	21CFR868.5630 (SE)
  Intended Use	Similar (Pediatric 5+ years, adult patients in hospital/institutional settings, home, schools, long-term care facilities; not for Pentamidine) (SE, Remark 1)
  Principle of operation: Vibrating mesh	Vibrating mesh (SE)
  Aerosolization: Continuous during inhalation/exhalation	Continuous during inhalation and exhalation (SE)
  Compressed gas source: None needed	None needed (SE)
  Duration of Use: Single patient, multi-use	Single patient, multi-use (SE)
  Waterproof: IP22	IP22 (SE)
  Protection against electric shock: Type BF applied part	Type BF applied part (SE)
  Type of protection against electric shock: Internally power equipment	Internally power equipment (SE)
  Model of operation: Continuous operation	Continuous operation (SE)
  Power off: ON / OFF Button	On/Off button (SE)
  Patient Connector: Mouthpiece/masks	Mouthpiece or masks (SE)
  Biocompatibility: Compliance with ISO 10993	All patient contacting materials compliant with ISO 10993 (various parts, e.g., -3, -5, -6, -10, -11, -17, -18) and ISO 18562 (various parts, e.g., -1, -2, -3). Concluded biocompatible. (SE)
  Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-1-11	Compliance with AAMI/ANSI ES60601-1:2005/(R)2012, C1:2009/(R)2012 and A IEC 60601-1-11:2015. (SE)
  EMC: Compliance with IEC 60601-1-2	Compliance with IEC 60601-1-2:2014. (SE)
  Software: Compliance with FDA Guidance & IEC 62304	Software verification and validation conducted per FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 1, 2005" and IEC 62304:2015. (SE)
  Clinical Performance
  Ultrasonic Oscillation Frequency: Approx. 110KHz	110 KHz ± 10KHz (SE)
  Nebulization rate: ≥ 0.2 ml/min	>0.2mL/min. (SE)
  Medicine Capacity: 8ml max, 0.5ml min	6 ml (Similar, Remark 2: "within the predicate device"; tested for safety & performance)
  Aerosol Performance (Particle Size MMAD, GSD, Doses)	Subject (NBM-1) vs. Predicate (NEB001) for Various Drugs (Albuterol Sulfate, Ipratropium Bromide, Cromolyn Sodium) - Adult & Pediatric:

  • Particle Size (MMAD):
    NBM-1 Adult: 2.09-2.10; NEB001 Adult: 2.27-2.37
    NBM-1 Pediatric: 3.66-3.64; NEB001 Pediatric: 3.73-3.73
  • Geometric Standard Deviation:
    NBM-1 Adult: 1.94-1.78; NEB001 Adult: 1.80-1.67
    NBM-1 Pediatric: 2.01-1.97; NEB001 Pediatric: 2.10-1.90
  • Total Dose Delivered by device:
    NBM-1 Adult: 1,529-7,236; NEB001 Adult: 1,541-6,983
    NBM-1 Pediatric: 1,593-7,394; NEB001 Pediatric: 1,624-7,279
  • Total Respirable Dose (0.5-5um):
    NBM-1 Adult: 1,048-5,341; NEB001 Adult: 1,133-5,157
    NBM-1 Pediatric: 961-4,581; NEB001 Pediatric: 932-4,369
  • Coarse Particle Dose (>4.7um):
    NBM-1 Adult: 397-1,626; NEB001 Adult: 333-1,507
    NBM-1 Pediatric: 618-2,715; NEB001 Pediatric: 665-2,790
  • **Fine Particle Dose (

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The Hudson RCI® TurboMist™ Nebulizer is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing.Its use is indicated when a licensed healthcare professional prescribes or administers medical aerosol to a patient using a small volume nebulizer.

The patient population includes adult and pediative (greater than 22 lbs or 10 kg) patients that are spontaneously breathing.

The product is a single patient, multi-use, non-sterile, disposable, prescriptive device intended to be used in a hospital or homecare environment.

The Hudson RCI® TurboMist™ Nebulizer System (herein referred to as "TurboMist system" or "subject device") consists of the TurboMist small volume nebulizer and a patient interface, which may include a swivel mouthpiece ors an aerosol mask and elbow adaptor. The aerosol mask is available in adult and pediatric versions. The TurboMist small volume nebulizer is a hand-held, breath-enhanced jet nebulizer designed to aerosolize liquid medications as prescribed by a physician. The nebulizer is powered by an external compressed air or oxygen source, and the aerosol is created by an internal jet located inside the nebulizer jar. The nebulizer is designed to entrain additional room air upon patient inhalation, enhancing aerosol generation and resulting in a faster nebulization rate than traditional jet nebulizers.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the Hudson RCI® TurboMist™ Nebulizer System. It details the device's indications for use, technological characteristics, comparison to predicate devices, and a summary of non-clinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Particle Size Characterization: Not explicitly stated, but testing was performed on "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)" and "the primary predicate with a mouthpiece and aerosol mask." This implies at least one sample of each configuration for each device. The data for the secondary predicate was a "review of published test data in the 510(k) summary table."
• Shelf Life: Not explicitly stated how many samples were aged, but it was "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)."
• Useful Life: Not explicitly stated how many samples were tested, but it was "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)."
• Cleaning & Disinfection: Not explicitly stated how many samples were tested, but it was "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)."
• Biocompatibility: Not explicitly stated, but testing was performed on "the subject device as well as both proposed patient interfaces (mouthpiece and aerosol mask)."
• Gas Pathway: Not explicitly stated how many samples were tested, but it was "the subject device as well as both proposed patient interfaces (mouthpiece and aerosol mask)."

Data Provenance: The studies appear to be prospective testing conducted specifically for this 510(k) submission, with the exception of the secondary predicate's particle size data which was a retrospective review of published data. The document does not specify the country of origin for the data generation, but it is for a US FDA submission by Medline Industries LP (headquartered in Northfield, Illinois, USA), suggesting the testing was performed, overseen, or compiled for a US regulatory context.

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

This document describes non-clinical performance and safety testing of a medical device (nebulizer). It does not involve human subject data or diagnostic performance where "ground truth" would be established by experts or adjudicated. The "ground truth" for these tests is defined by established engineering and scientific standards (e.g., ISO, AAMI, FDA guidance) for physical and chemical properties, functionality, and biological safety. Therefore, this section is not applicable in the context of this 510(k) summary.

4. Adjudication Method for the Test Set:

Not applicable, as this is a non-clinical device performance and safety study, not a diagnostic study requiring expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. This document describes the substantial equivalence of a physical medical device (nebulizer) through non-clinical performance and safety testing, not the comparative diagnostic effectiveness of a reader-dependent system or AI.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

As noted in section 3, the "ground truth" for the non-clinical tests is represented by the established scientific and engineering standards, guidance documents (e.g., FDA guidance, ISO standards, AAMI standards), and the pre-defined product specifications/acceptance criteria that the device must meet to demonstrate safe and effective performance and substantial equivalence to predicate devices. These are objective measures rather than expert consensus on a diagnostic outcome or pathology.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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