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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 Ultrasonic Nebulizer is intended to transform liquid medications into aerosol form for patient inhalation. The device can be used by adult or pediatric patients for respiratory treatment in the home, hospital or healthcare environment.

The Ultrasonic Nebulizer is a small, compact, and battery powered potable nebulizer which transforms liquid medicines into aerosol form and delivers directly to patient for inhalation. It makes patient's respiratory treatment easier and more convenient.

Here's an analysis of the K-jump® Ultrasonic Nebulizer based on the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of "acceptance criteria" for performance that would typically be found in a detailed validation study. Instead, the document focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and compliance with general safety and performance standards.

However, we can infer some performance characteristics and compliance requirements:

Important Note: The document emphasizes "similar performance" and "compliance with equivalent safety standards" rather than showing specific quantitative performance targets met by the K-jump device and then presenting raw data to prove those targets were met. This is typical for a 510(k) submission where substantial equivalence to a legally marketed predicate device is being demonstrated.

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

The provided document does not specify a sample size for a "test set" in the context of clinical or performance data for this device. The submission relies on demonstrating compliance with recognized standards and similarity in technological characteristics to a predicate device.

• Sample size for test set: Not specified/applicable in this document's context.
• Data Provenance: The document does not describe patient or clinical data that would have a provenance (e.g., country of origin, retrospective/prospective). The data presented for the K-jump device are engineering specifications and compliance declarations.

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

Not applicable. The document does not describe a study involving expert-established ground truth for a test set. This type of submission focuses on engineering specifications and regulatory compliance, not typically on diagnostic accuracy or interpretation by human experts.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication in this document.

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 device is an ultrasonic nebulizer, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is outside the scope of this submission.

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

Not applicable. This device is a medical apparatus, not an algorithm, so "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" concept (e.g., pathology, outcomes data) is not relevant for this type of device submission, which focuses on device functionality, safety, and equivalence to a predicate. The "truth" here is established through engineering testing and compliance with recognized standards.

8. The Sample Size for the Training Set

Not applicable. The K-jump Ultrasonic Nebulizer is a physical medical device, not an AI or machine learning algorithm. Therefore, 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 this device.

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The ultrasonic mesh nebulizer model NE403 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult patients at home, hospital & sub-acute care settings.

Nebulizer NE403 is a mesh screen ultrasonic nebulizer which was used ultrasonic Vibrating Mesh Technology ( VMT). The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies. As with other mesh screen ultrasonic nebulizers, the mesh is caused to vibrate by fluidic contact with a ultrasonic piezoelectric member that is energized by application of a high frequency alternating voltage. The VMT nebulizer is portable and quiet. This nebulizer is powered by four AA alkaline batteries or a cable connecting to an AC adapter. Nebulizer NE403 consists of several function units: liquid medication containment, liquid nebulization and ejection, nebulized medicine (brume) channel (breathing parts), power supply, operating and display unit. liquid medication is poured into medicinde container, transformed into something like brume, which is inhaled by patient via breathing parts, thus, the intended use of device is achieved.

The provided text describes a 510(k) submission for a medical device, the Nebulizer NE403. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria in the format you requested.

Therefore, many of the requested details about acceptance criteria derived from clinical performance studies, such as effect size of AI assistance or ground truth establishment for a training set, are not applicable to this document. The submission explicitly states that no clinical tests were conducted for substantial equivalence.

However, I can extract information related to non-clinical testing and the comparison to the predicate device.

Here's a breakdown of the available information based on your request:

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

Since no clinical acceptance criteria are provided, and the submission focuses on non-clinical testing and substantial equivalence, the "acceptance criteria" can be inferred as meeting the requirements of the listed voluntary design standards and demonstrating comparable performance to the predicate device in specific non-clinical tests.

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

• Sample Size for Test Set: Not applicable in the context of a clinical test set. Non-clinical tests were performed on the device itself and its components. The document doesn't specify the "sample size" of devices or components tested for each non-clinical criterion.
• Data Provenance: The non-clinical testing was conducted by the manufacturer, Foshan Gaunying Electronics Co.,Ltd., or outsourced as part of their design validation. The context is a regulatory submission for a device manufactured in China. This is retrospective data from internal testing and compliance work.

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

• Not Applicable. No clinical test set requiring expert-established ground truth was part of this 510(k) submission. Non-clinical tests are validated against engineering specifications, standards, and comparison to a predicate device.

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

• Not Applicable. There was no clinical test set or subjective assessment requiring an adjudication method.

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 device is a nebulizer, a physical medical device for drug delivery, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For Non-Clinical Tests: The "ground truth" for the non-clinical tests was based on engineering specifications, recognized international and national standards (IEC 60601-1, IEC 60601-1-2, EN 13544-1), and the performance characteristics of the legally marketed predicate device (Omron Micro Air Vibrating Mesh Nebulizer, K062263). For biocompatibility, it was adherence to ISO 10993 standards.

8. The sample size for the training set:

• Not Applicable. There was no "training set" in the context of machine learning or an AI algorithm.

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

• Not Applicable. As above, no training set was involved.

Summary from the document:

The Nebulizer NE403 demonstrates substantial equivalence through non-clinical testing by:

• Meeting design requirements and conforming to voluntary design standards.
• Showing comparable aerosol performance, dose variability, and particle size variability to the predicate device (Omron Micro Air Vibrating Mesh Nebulizer, K062263).
• Demonstrating biocompatibility according to ISO standards for patient-contacting parts.
• Having the same intended use and fundamental technological characteristics as the predicate device.

The study presented here is a 510(k) premarket notification which relies on demonstrating substantial equivalence to a predicate device, not on extensive clinical trials with detailed acceptance criteria for diagnostic performance as would be seen with AI or imaging devices.

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K-jump Health Co., Ltd. Ultrasonic Nebulizer System includes a DC powered ceramic resonator and a fan that provides a source of mist for home health care use. The device is used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

The KN-9210 uses the ultrasound vibration technique in which a piezeoelectric ceramic installed as a generator of ultrasound wave when powered key pressed and system been powered on. The medicine solution on the semi-oval cup can be converted to mist through the water medium which propagated the ultrasound from resonator on the device. Then, a mini fan on the device drives the mist or aerosol through the air flow chamber and mouth piece installed on the top cover to the patient. The patient can use this aerosol for his/her respiratory therapy with two-safety valve installed on the mouthpiece which is standed on the top of drug ampoule.

The device consists of a piezeoelectric ceramic, a fan, a plastic body (including a top cover, a main body, a rear cover, an inlet filter, a filter cover, a nebulization chamber and an air-flow chamber), a medicine cup, a printed circuit board with electronic components, a DC socket, an AC adapter power source (or a rechargeable battery assembly as an optional power source), and a key for ON/OFF operation.

The provided submission is for an Ultrasonic Nebulizer System (Model KN-9210), which is a medical device and not an AI/ML software device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets them, especially those related to AI/ML performance, is not directly applicable in the typical sense for this document.

However, based on the provided text, I can extract and infer information relevant to the device's performance characteristics and the non-clinical tests conducted to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the available information, adapted to the requested structure where possible, but noting the absence of AI-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a nebulizer, the acceptance criteria relate to its physical performance in delivering medication. The "reported device performance" are the results of the performance testing conducted.

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

• Sample Size for performance tests: Not explicitly stated. The document mentions tests were conducted on "three medicines" (Atrovent, Bricanyl, Pulmicort), implying at least three distinct test cases for the nebulization performance metrics. For biocompatibility and other engineering tests, typical sample sizes are generally smaller and defined by applicable standards.
• Data Provenance: Not explicitly stated, but the testing would have been conducted by or for K-jump Health Co., Ltd., likely in Taiwan (country of origin of the company). The studies are non-clinical, bench-top performance tests, making them prospective in the sense that they were specifically designed and executed to evaluate the device.

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

• This device is a mechanical/electronic medical device (nebulizer), not an AI/ML diagnostic tool requiring expert interpretation for "ground truth." The performance metrics (e.g., particle size, flow rates) are measured objectively by laboratory instruments and protocols, rather than through expert consensus.
• Hence, this criterion is Not Applicable in the context of this device and submission.

4. Adjudication Method for the Test Set

• Again, this criterion is Not Applicable for a hardware device like a nebulizer. Adjudication methods like 2+1 or 3+1 are used in studies where human readers review and provide consensus on findings (e.g., medical images for AI ground truth).

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

• This is Not Applicable. An MRMC study is relevant for AI/ML diagnostic tools that assist human readers. The K-jump Ultrasonic Nebulizer System is a therapeutic device that delivers medication; it does not involve human readers interpreting a "case" in the diagnostic sense.

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

• This is Not Applicable. This concept applies to AI/ML algorithms, not a physical medical device like a nebulizer.

7. The Type of Ground Truth Used

• For the performance testing, the "ground truth" would be established by objective measurements from calibrated laboratory equipment according to recognized standards (e.g., for particle size distribution, flow rates).
• For biocompatibility, the "ground truth" is determined by standardized laboratory tests for cytotoxicity, irritation, and sensitization, with results compared against pass/fail criteria from relevant international standards (e.g., ISO 10993).
• For EMC, Electrical, Mechanical, and Environmental Testing, the "ground truth" is compliance with relevant national and international safety and performance standards.

8. The Sample Size for the Training Set

• This is Not Applicable. As a physical medical device, there is no "training set" in the AI/ML sense. Design and development would follow engineering principles, not machine learning training.

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

• This is Not Applicable for the same reason as point 8.

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The DDI Ultrasonic Nebulizer System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings.

The DDI Ultrasonic Nebulizer System is a mesh screen ultrasonic nebulizer that operates in an identical fashion as other mesh screen nebulizers. The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies and provide fine particles to the patient's lungs. The DDI Ultrasonic Nebulizer System is powered by a cable connecting to a 115 VAC power source with the AC adapter or two AA alkaline batteries.

Here's an analysis based on the provided text, outlining the acceptance criteria and the study details for the DDI Ultrasonic Nebulizer System:

The provided document (K090307) is a 510(k) summary for a Medical Device. For 510(k) submissions, the primary "study" is often a comparison of technical characteristics and performance to a legally marketed predicate device, rather than a traditional clinical trial with acceptance criteria for new device performance metrics. The goal of a 510(k) is to demonstrate substantial equivalence, not necessarily to prove absolute efficacy or safety with new, independent studies.

Therefore, the "acceptance criteria" for this device are implicitly the performance specifications and safety standards met by its predicate devices, and the "study" is the comparison against those predicates to establish substantial equivalence.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative targets in the document. Instead, the DDI Ultrasonic Nebulizer System is deemed acceptable because its performance parameters are "statistically identical" to the predicate devices. The table below presents the key performance characteristics reported for the new device and its predicates, implying that matching or being substantially similar to these predicate values constitutes acceptance.

Study Details Proving Acceptance

The "study" for this 510(k) submission is primarily a nonclinical comparison of technical characteristics and performance against two legally marketed predicate devices:

1. Omron Micro-Air Vibrating Mesh Nebulizer (K062263)
2. Health & Life Co. Ultrasonic Nebulizer System Model HL 100 (K081738)

The conclusion states that "All of the performance parameters of the devices are statistically identical, and do not raise any new safety or efficacy." This forms the basis of the substantial equivalence determination.

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

   • The document does not describe a clinical "test set" in the traditional sense of patient data. The evaluation appears to be based on bench testing of the device's technical specifications and electrical safety.
   • Data provenance is not explicitly stated as country of origin, but it is implied to be from the manufacturer's internal testing as part of their regulatory submission. The data is retrospective in the sense that it's comparing a new device against established predicate device specifications, and the testing of the new device likely occurred prior to the submission date.

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

   • This is not applicable as there was no "test set" requiring expert ground truth in the context of diagnostic interpretation. Ground truth for device performance parameters (e.g., nebulization rate, particle size) would have been established through standardized engineering and laboratory testing protocols.

3. Adjudication method for the test set:

   • Not applicable, as there was no "test set" requiring human adjudication in the context of interpretation.

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

   • No, a MRMC comparative effectiveness study was not done. This submission is for a medical device (nebulizer) that delivers medication, not a diagnostic imaging or screening tool that would involve human readers interpreting cases.

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

   • This is not applicable, as the device is a physical medical device (nebulizer), not an algorithm or AI system. Its performance is inherent to its design and mechanical/electrical operation.

6. The type of ground truth used:

   • The "ground truth" for the device's performance characteristics (e.g., nebulization rate, particle size, battery life, dimensions) would have been established through laboratory measurements and engineering specifications. For electrical safety, the ground truth is defined by compliance with the referenced international standards (IEC 60601, EN 60601-1, EN 60 601-1-2).

7. The sample size for the training set:

   • Not applicable. This device is not an AI or machine learning system, so there is no concept of a "training set" in this context.

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

   • Not applicable as there is no training set.

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The HL100 Ultrasonic Nebulizer System utillizes the state-of-the-art elecctrospray technology that sprays liquid medication in aerosol form and deliveries it directly to the adult and pediatric patients who suffer from asthma, Chronic Obstructive Pulmonary Disease (COPD) such as emphysema and chronic bronchitis, or other respiratory diseases that are characterized by obstruction to air flow for breathing.

The Health and Life Model HL100 is a mesh screen ultrasonic nebulizer that operates in an identical fashion as other mesh screen ultrasonic nebulizers, including the referenced predicate device. The device creates aerosols of liquid medication of droplets from a mesh (aperture plate) vibrated at ultrasonic frequencies. As with other mesh screen ultrasonic nebulizers, the mesh is caused to vibrate by fluidic contact with a ultrasonic piezoelectric member that is energized by application of a high frequency alternating voltage. The HL100 Ultrasonic Nebulizer System consists primarily of a Main Unit and a Medication Chamber. The Main Unit and the Medication Chamber are single patient re-usable. The Main Unit contains all control circuitry and is powered by a cable connecting to a 115 VAC power source with the AC adapter or two AA alkaline batteries. No medication comes into contact with the Main Unit, only the Medication Chamber. The patient interface consists of a mouthpiece or an optional mask. When the device is turned on, the ultrasonic piezoelectric member vibrates, causing the mesh to vibrate. Liquid medication in the reservoir is caused to be aerosolized by the vibrating mesh into the patient interface where the aerosol particles can be inhaled by the patient.

The provided text describes a 510(k) summary for the Health and Life Model HL100 Ultrasonic Nebulizer System. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is not an AI/ML device.

The document primarily focuses on establishing substantial equivalence to a predicate device (Omron Model NE-U22V MicroAir Nebulizer K062263) through non-clinical tests.

Here's a breakdown of why an AI/ML framework cannot be applied:

• Device Type: The HL100 is a physical medical device (ultrasonic nebulizer) that mechanically aerosolizes medication. It does not use algorithms, AI, or machine learning for any part of its function or diagnosis.
• Study Type: The submission explicitly states: "Nonclinical tests have been performed comparing the HL100 Ultrasonic Nebulizer System to the predicate device and have shown that the performance of the HL100 Ultrasonic Nebulizer System is substantially equivalent to the performance of the predicate device. No clinical tests were conducted." This means no human subject data was collected or analyzed in the manner required for an AI/ML device study.
• Lack of AI/ML Specific Information: The document contains no mention of:
  • Algorithms, models, or software
  • Performance metrics like sensitivity, specificity, AUC, or accuracy typically used for AI/ML.
  • Training data, test sets, ground truth establishment by experts, or adjudication methods.
  • Multi-reader multi-case (MRMC) studies or standalone algorithm performance.

Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device studies because the provided document describes a conventional medical device demonstrated to be substantially equivalent via non-clinical performance comparisons, not an AI/ML product.

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To be used to convert liquid medication into aerosol for inhalation by patients.

Not Found

The provided text describes an FDA 510(k) clearance for the AeroLife Model P2C Ultrasonic Nebulizer. It does not contain information about acceptance criteria for a device's performance, nor does it detail a study proving such criteria are met. The document is a regulatory approval letter, not a scientific study report.

Therefore, I cannot provide the requested information based on the given text.

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The GUAN HONG Model# AC103/DR 103 Ultrasonic Nebulizer is an ultrasonic nebulizer that is intended for use in the treatment of asthma, COPD and other respiratory allments in which an aerosolized medication is required during therapy. The GUAN HONG Model# AC103/DR 103 Ultrasonic Nebulizer is not intended for use with Pentamidine. It is intended for single patient use.

GUAN HONG Ultrasonic Nebulizer (Model MH-AC 103 & MH-DR 103) is designed to spray liquids in aerosol form into gases directly to the patient for use by the adult and pediatric population.

The Ultrasonic Nebulizer units contains a piezoelectric crystal that generate ultrasonic waves which are transmitted through buffer water to medication cap and convert the liquid medication into an aerosol. The Nebulizer medication cap is designed for single-patient use and holds up to 5ml of medication for Model # AC 103 , 8 ml for Model # DR 103.

Inhalation can be made through nose or mouth. Attachments that are used during the nebulization process include MOUTHPIECE, ADULT MASK; PEDIATRIC MASK, NOSE FORK , CONNECTOR, CORRUGATED TUBE.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Guan Hong Model #AC103/DR 103 Ultrasonic Nebulizer:

Based on the provided 510(k) summary, the information regarding specific acceptance criteria and detailed study results is very limited. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical performance study as might be seen for novel or high-risk devices.

Therefore, for many of the requested points, the answer will be "Not found in the provided text."

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not found in the provided text.
• Data Provenance: Not found in the provided text. The device is manufactured in Taiwan, R.O.C., but the location of the comparison study is not specified. It is likely a prospective study, but this is not explicitly stated.

3. 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 found in the provided text. The study mentioned is a "comparison study with a device that uses an auscultatory method" to validate repeatability, implying a technical or clinical measurement of output rather than expert interpretation of images or symptoms which would typically require "ground truth" established by experts.

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

• Not applicable as no expert adjudication for ground truth is mentioned or implied for this type of device and study.

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

• No, an MRMC comparative effectiveness study was not done. This device is an ultrasonic nebulizer, not an AI-powered diagnostic tool. The "comparison study" mentioned is likely focused on the device's physical performance characteristics (e.g., aerosol output, particle size distribution) against a reference or predicate device, not on human reader performance with or without AI.

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

• Yes, a standalone study was done, though not in the AI sense. The term "standalone" here would apply to the device's own performance characteristics (e.g., nebulization rate, particle size) being evaluated. The document states a "comparison study with a device that use auscultatory method was performed to validate the performance of the GUAN HONG Model# MH-AC103 / MH-DR 103 Ultrasonic Nebulizer." This is a standalone evaluation of the device itself.

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

• Not explicitly stated, but inferred to be technical or clinical measurements. For a nebulizer, "ground truth" in a comparison study would likely refer to objective measurements of aerosol output parameters (e.g., Mass Median Aerodynamic Diameter (MMAD), Fine Particle Fraction (FPF), nebulization rate) obtained through standardized characterization methods, and possibly clinical indicators of medication delivery if a clinical study was performed (which is only vaguely alluded to).

8. The sample size for the training set

• Not applicable. This device does not involve AI or machine learning models that require a "training set."

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

• Not applicable. This device does not involve AI or machine learning models that require a "training set" or ground truth for such a set.

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The NebSonic N550 Nebulizer delivers nebulized medication for patients on mechanical ventilation or for patient use independent of a ventilator. The NebSonic is indicated for adult, pediatric, and neonatal patients.

The NebSonic N550 Nebulizer is an ultrasonic nebulizer designed to deliver nebulized medication to patients being mechanically ventilated without affecting ventilator performance or patient data. It is powered by external AC (100-240 volts), allowing its use with patients on mechanical ventilation or for patient use independent of a ventilator. The NebSonic N550 Nebulizer contains piezoelectric crystal that generates ultrasonic vibrations that travel through distilled water in a vial to liquid medication in a medication cup. The vibrations convert the medication into an aerosol mist. The nebulized medication is carried to the patient by the gas traveling through the ventilator breathing circuit.

The provided text describes a 510(k) submission for the Newport NebSonic N550 Ultrasonic Nebulizer, a traditional 510(k) submission (K041082). The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's efficacy through a clinical study with acceptance criteria in the typical sense.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define specific "acceptance criteria" in terms of clinical or performance benchmarks (e.g., a specific percentage improvement in a clinical outcome, or a defined accuracy threshold for a diagnostic device). Instead, it states that:

"Testing was conducted to characterize particle size and drug mass generated by the NebSonic N550 Nebulizer in comparison to a predicate device. The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use."

This implies that the "acceptance criteria" were met if the device's particle size and drug mass characteristics were comparable or within an acceptable range relative to the predicate device. However, the specific numerical criteria for "comparable" are not provided.

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

The document mentions "thoroughly evaluated at the unit and system level" and "comprehensive testing," but it does not specify the sample size for any test set. The data provenance is also not explicitly stated as retrospective or prospective, or country of origin. Given the nature of a medical device submission for a nebulizer, it's highly likely that this testing involved in vitro laboratory experiments on a sample of manufactured devices, rather than human subjects or a clinical study.

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

This information is not applicable and not provided in the document. The "ground truth" for a nebulizer's performance typically comes from direct measurements using specialized equipment (e.g., laser diffraction for particle size, gravimetric analysis for drug mass), not expert consensus in the way a diagnostic imaging study would require.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication is relevant for subjective assessments, typically in clinical trials or diagnostic studies. For objective performance metrics like particle size and drug mass, direct measurement is performed.

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

This information is not applicable. The NebSonic N550 is an ultrasonic nebulizer, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant to this device.

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

This information is not applicable. The device is an ultrasonic nebulizer, a physical medical device for drug delivery, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance (particle size and drug mass) would have been established through direct experimental measurements in a laboratory setting, using standardized methodologies for nebulizer characterization. This is an objective measurement, not based on expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic device.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical product directly performing its function, not a machine learning model that requires a training set.

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

This information is not applicable. As it's not an AI/ML device, there is no training set or ground truth for such a set.

Summary of the Study:

The study described for the NebSonic N550 Nebulizer was a device performance characterization study primarily focused on demonstrating substantial equivalence to existing predicate devices. It involved:

• In vitro testing of the nebulizer's performance.
• Measured parameters: particle size and drug mass generation.
• Comparison to predicate devices (Siemens Servo Ultra Nebulizer, Models 145 and 345; Puritan-Bennett EasyNeb Nebulizer).
• Compliance with various industry recognized standards (IEC 60601-1-2:1993, CSA 22.2 No 601-1-M90, UL 2601-1, EN 55011:1998 &A1:1999) for electrical safety and electromagnetic compatibility.

The 510(k) clearance (K041082) indicates that the FDA found this testing and comparison sufficient to determine that the NebSonic N550 Nebulizer is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use. The documentation provided focuses on the regulatory submission process for a traditional medical device, not a diagnostic or AI-powered system, which would necessitate different evaluation methodologies.

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