Search Results

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 (

Ask a specific question about this device

The Infrared Thermometer is intermittent measurement of ear and forehead temperature at home or hospital. It can be used for anybody, such as infants, children and adults.

Infrared thermometer, model:HW-1

This FDA 510(k) clearance letter for the Dongguan SIMZO Electronic Technology Co. Ltd. Infrared Thermometer, Model: HW-1, does not contain the detailed information required to fill out the acceptance criteria and study information as requested.

The document indicates that the device is an Infrared Thermometer for intermittent measurement of ear and forehead temperature at home or in a hospital for all ages. It mentions the regulation number (21 CFR 880.2910) and regulation name (Clinical Electronic Thermometer), and its regulatory class (Class II).

However, the letter does not provide details such as:

• A table of specific acceptance criteria (e.g., accuracy ranges, precision) or reported device performance against these criteria.
• Sample size used for a test set, its provenance, or retrospective/prospective nature.
• The number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
• Whether standalone performance was evaluated.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• The sample size for the training set or how its ground truth was established.

This document is a formal communication of FDA's substantial equivalence determination, not a summary of the underlying verification and validation studies. Such detailed study information would typically be found in the 510(k) submission itself, which is generally proprietary until redacted and released, or in a separate marketing or technical document from the manufacturer.

Ask a specific question about this device

The Non-contact Forehead Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

The Non-contact Forehead Thermometers are hand-held, battery powered devices designed to measure human body temperature. The subject devices are Infrared thermometers that convert a user's forehead temperature using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when placed in the distance from subject's forehead up to 5-8cm(HW-2,HW-2S,HW-3,HW-302 and HW-303) or 1-2cm(HW-4 and HW-4S).

The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection with the distance from forehead up to 5~8cm(HW-2,HW-2S,HW-3,HW-302 and HW-303) or 1-2cm(HW-4 and HW-4S) and compensation of the temperature reading.

Here's an analysis of the acceptance criteria and study details for the Non-contact Forehead Thermometer, Model: HW-2/HW-2S/HW-3/HW-4/HW-4S/HW-302/HW-303, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The primary standard referenced for performance is ASTM E1965-98. The key performance metric is accuracy.

Note: The subject device's reported accuracy range (35.5°C~42.9°C) is broader than the predicate's 36-39°C range for the higher accuracy specification, which still meets the overall requirements of ASTME1965-98.

Study Details

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

   • Test Set Size: 96 subjects.
   • Age Groups: Divided into three groups:
     • Infant (newborn to 1 year): 32 patients
     • Children (greater than 1 to 5 years old): 32 patients
     • Adult (greater than 5 years old): 32 patients
   • Temperature Distribution: 30% of the subjects in each group had a temperature equaling or exceeding 38.0°C.
   • Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. However, "clinical tests were conducted" implies a prospective study.

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

   • This information is not provided in the summary. The summary only mentions "Clinical data" and that "Clinical tests were conducted." It does not specify how the ground truth (e.g., core body temperature for comparison) was established or who assessed it.

3. Adjudication Method for the Test Set:

   • This information is not provided in the summary.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This device is a medical thermometer, and the standard evaluation involves comparing its readings against a reference thermometer or standard, not assessing human reader improvement with AI assistance.

5. Standalone Performance Study:

   • Yes, a standalone performance study was conducted. The "Clinical data" section describes the evaluation of the device "complied with the requirement of ASTM E1965-98 (2016)." This refers to the accuracy performance of the device itself.
   • Additionally, the "Non-Clinical Data" section lists a "Performance test in home healthcare environment" and "Laboratory accuracy test" as part of the ASTM E1965-98 testing, indicating comprehensive standalone performance evaluation.

6. Type of Ground Truth Used:

   • The primary ground truth for clinical thermometers is typically a reference body temperature measurement obtained through a highly accurate and validated method (e.g., rectal temperature for infants, oral or tympanic for adults, or even invasive core temperature in some research settings) against which the device's forehead temperature readings are compared. The summary does not explicitly state the method used for the reference temperature, but ASTM E1965-98 specifies requirements for this.

7. Sample Size for the Training Set:

   • This device is an infrared thermometer, not an AI/machine learning algorithm that requires a separate "training set." Therefore, this question is not applicable in the context of this device.

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

   • As stated above, this device does not use a training set in the typical AI/ML sense. This question is not applicable.

Ask a specific question about this device