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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 (<4.7um): NBM-1 Adult: 1,132-5,610; NEB001 Adult: 1,208-5,477 NBM-1 Pediatric: 974-4,679; NEB001 Pediatric: 958-4,488 * Ultra-fine Particle Dose (<1.0um): NBM-1 Adult: 258-1,222; NEB001 Adult: 243-1,091 NBM-1 Pediatric: 81-384; NEB001 Pediatric: 98-353 (Similar, Remark 3: "all parameters similar, no statistically measurable differences")
  Dimensions: 50mm(L)×74mm(W)×111mm(H)	60mm×55mm×130mm (Similar, Remark 6)
  Weight: Approx. 106g	Approx. 110g (Similar, Remark 6)
  Differences & Justifications
  Power supply: ZN-103450 Lithium battery: 3.7Vd.c. AC Adapter	DC3.0V, 2×AA batteries (Difference, Remark 4: Lower risk, passed IEC 60601-1)
  Operation environment: 5°C to 40°C, 15% to 90% RH	10 -40°C, 10%-95%RH (Similar, Remark 5: Compliance with IEC60601-1-11)
  Storage environment: -25°C to 70°C, ≤90% RH	-20°C to 70°C, 10%-95% RH (Similar, Remark 5: Compliance with IEC60601-1-11)

Key takeaways relevant to your request, but not available in the provided text:

1. AI/ML Device: This is not an AI/ML device. It's a standard ultrasonic nebulizer.
2. Sample Size for Test Set and Data Provenance (for AI/ML): Not applicable. The "test set" here refers to physical performance measurements of the nebulizer, not a data set for an algorithm. The data provenance would be laboratory testing results.
3. Number of experts and qualifications (for AI/ML ground truth): Not applicable, as there's no diagnostic AI algorithm for which ground truth would be established by experts.
4. Adjudication Method (for AI/ML ground truth): Not applicable.
5. MRMC Comparative Effectiveness Study: Not applicable. This type of study is for evaluating how AI assists human readers in a diagnostic task, which isn't the function of a nebulizer.
6. Standalone Performance (i.e. algorithm only): Not applicable. The device's performance is its ability to nebulize medication, not to diagnose.
7. Type of Ground Truth Used (for AI/ML): Not applicable. The "ground truth" for this device is the objective measurement of its physical and aerosol performance against established standards.
8. Sample Size for Training Set (for AI/ML): Not applicable. There is no AI model requiring a training set.
9. How Ground Truth for Training Set was Established (for AI/ML): Not applicable.

In summary, the provided document is a 510(k) clearance for a physical medical device (a nebulizer) based on substantial equivalence, not an AI/ML diagnostic device. Therefore, the specific criteria and study details requested for an AI/ML device are not present in this text.

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