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The ultrasonic mesh nebulizer model NM211A is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital & sub-acute care setting.

The ultrasonic mesh nebulizer model NM211A is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient.

The provided text is a 510(k) summary for a medical device (Ultrasonic Mesh Nebulizer Model NM211A), which primarily focuses on regulatory clearance based on substantial equivalence to a predicate device. It states the indications for use but does not contain information about specific acceptance criteria or a study proving the device meets those criteria, especially in the context of AI/ML performance.

Therefore, I cannot provide the requested information from the given document. The document describes a traditional device clearance, not one for an AI/ML-driven medical product that would typically involve acceptance criteria related to algorithm performance, training/test sets, ground truth establishment, or clinical effectiveness studies as described in your prompt.

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The ultrasonic mesh nebulizer model NE105 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital &sub-acute care setting.

The Ultrasonic Mebulizer NE105 is similar to the predicate device, the FDA-cleared Model NE-U22 Micro Air Vibrating Mesh Nebulizer, cleared under 510(k) K062263. Similarities are that both, the NE105 and the predicate NE-U22, are identical in purpose, function, core technology and method of operation. They are single-patient use, reusable electronic nebulizers, using micro-perforated vibrating mesh technology to aerosolize liquid medications. They have the same 'Indication for Use' stating that they are for inhalation therapy by adults and pediatric patients in a home, hospital & sub-acute care setting. Both devices are hand-held and portable. Power input for both devices is provided by either AA batteries or an AC/DC adapter. The model NE105 incorporates several design differences in comparison with the predicate NE-U22, mainly body shape, dimension/weight, a larger capacity reservoir, power source and software controlled electronics.

The provided 510(k) summary for the Ultrasonic Mesh Nebulizer NE105 focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in a typical clinical trial format.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a nebulizer, the "acceptance criteria" are primarily based on demonstrating performance similar to the predicate device and compliance with relevant safety and performance standards. There isn't a direct table of clinical performance metrics like sensitivity/specificity. Instead, the performance is assessed through non-clinical tests.

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

• Sample Size for Test Set: The document does not specify a "sample size" in the context of human subjects or clinical data, as it explicitly states, "The NE105 did not conduct, nor rely upon, clinical tests to determine substantial equivalence." The testing described is primarily laboratory-based and engineering/design validation. For simulated lifetime testing, "an in-house 1000-cycle life test was performed," which could be considered a sample size for that specific test.
• Data Provenance: Not applicable as clinical data was not used for this submission. The tests were performed by various "testing laboratories" and "Piper Medical Lab," implying engineering/testing facilities. The submitter is from China.

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

Not applicable. This submission relies on objective engineering and laboratory test results against established standards and comparison to a predicate device, not subjective expert assessment of clinical data to establish a "ground truth."

4. Adjudication Method for the Test Set

Not applicable. There's no clinical test set requiring adjudication in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device for drug delivery (nebulizer), not an AI-powered diagnostic or interpretive device. Therefore, no MRMC or AI-assisted studies were performed or are relevant.

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

Not applicable. This device does not involve an algorithm for interpretation or diagnosis; it is a physical device for drug delivery.

7. The Type of Ground Truth Used

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

• Compliance with recognized standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-1.
• Benchmarking against a predicate device: Specifically for aerosol characterization (particle size distribution and total medication dose delivered).
• Design validation tests: Ensuring the device meets its own specified design requirements (e.g., software functionality, cleaning effectiveness, simulated lifetime).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable, as no training set was used.

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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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The infrared lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Gaunying Infrared Lamp (Model#: FIR 51, SN-51) is a non-invasive, portable infrared lamp designed to deliver light energy in the infrared spectrum to the target tissue. The light energy is emitted by a built-in Halogen lamp. rated 110-130 Vac. which is enclosed by plastic enclosure, except front panel which is a ceramic / glass plating. Power on/off switch and time setting button is provided in front panel, with which, operator can turn on or off the device and set the treatment time. The treatment time is control by software and shown on the LCD display. The device is connected to mains via a non-detachable power supply with attachment plug. It also includes fuse current, thermal protector and cooling fan as safety component.

The provided 510(k) summary describes a therapeutic heating device (Infrared Lamp) and its equivalency to existing predicate devices. The "acceptance criteria" in this context are not explicitly defined as specific numerical targets for performance metrics (like sensitivity/specificity for a diagnostic device). Instead, the acceptance criteria are implicitly that the device's performance, particularly its heating capability, is similar to or better than a legally marketed predicate device and that it meets relevant safety standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995)
• IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests; Edition 2.1)
• UL 60601-1, first edition, 2003, deviations to IEC 60601-1. |
  | The difference in intended use (prescription vs. OTC) for the FIR 51, SN-51 model (K110721 vs K102149) does not raise new questions of safety and effectiveness. | The labeling of the subject device (K110721) is "readable and understandable for over-the-counter use." The difference does not raise new questions of safety and effectiveness, leading to a substantial equivalence determination. |
  | The differences in technological characteristics (e.g., wavelength) between the FIR 51, SN-51 and the TDP CQ-27 Heat Lamp do not raise new questions of safety and effectiveness. | The subject device uses 600 nm - 2000 nm infrared (Near-infrared and Short-wavelength infrared), while the predicate uses 2 to 25 microns (Long-wavelength infrared and Far infrared). The submission claims that "The different wavelength will not affect the effectiveness of device." It also argues the subject device might have "less" burn risk due to visible heating. A comparison test showed both devices achieve the therapeutic temperature range of 41-45°C. Risk management report shows all risks are under control. |
  | The device maintains safety when used by layperson users (for OTC use). | "As identical predicates of these devices have been in safe and effective applications by layperson users. Over-The-Counter variance is requested." (Refers to the prior model K102149.) The new device passes safety testing and the risk management report indicates controlled risks. |

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

• Test Set (Performance Testing): The description refers to "a person" for the performance testing of the subject device. This implies a very limited sample size, possibly n=1, or at most a very small convenience sample. It does not specify a statistically significant sample size.
• Data Provenance: The testing was conducted by the manufacturer, Foshan Gaunying Electronics Co., Ltd., in China. It appears to be prospective testing specifically for this submission, not retrospective data.

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

• This device is a therapeutic heating device, not a diagnostic device that requires expert consensus for "ground truth" on medical findings. The "ground truth" for its performance is objective physical measurement (temperature increase).
• No experts are mentioned as establishing ground truth in the traditional sense for diagnostic accuracy.

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

• Not applicable. The performance testing involved direct temperature measurement using an electronic thermometer, not subjective interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a therapeutic physical device, not an AI-assisted diagnostic tool involving human "readers."

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

• Not applicable. This is a therapeutic physical device, not an algorithm. Its performance is inherent to its physical operation.

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

• The "ground truth" for the device's performance is objective physical measurement:
  • Skin temperature increase measured by an electronic thermometer.
  • Compliance with international electrical safety and EMC standards.
  • Comparison of heating efficacy against a legally marketed predicate device.

8. The sample size for the training set

• Not applicable. As a physical therapeutic device, there is no "training set" in the context of machine learning or AI models. The device's design and manufacturing are based on engineering principles and standards, not data training.

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

• Not applicable, as there is no training set for this type of device.

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The Gaunying Infrared Lamp ( Model #: IL50) is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; the temporary increase in local blood circulation.

Gaunying Infrared Lamp (Model#: IL50) has a high-quality glass ceramic plate (ceramic infrared). Glass ceramic plates are also used on hobs and when used in conjunction with illuminants guarantee intensive and safe infrared radiation.

Here's an analysis of the Gaunying Infrared Lamp (Model IL50) based on the provided 510(k) summary, aiming to answer your specific questions.

Important Note: This device is a basic therapeutic heating lamp. The acceptance criteria and testing described are for physical performance and safety, not for diagnostic accuracy or complex AI performance metrics like those seen in medical imaging.

1. Table of Acceptance Criteria and Reported Device Performance

• Sensor (skin) temperature never exceeded 45°C. |
  | | Temperature Homogeneity/Consistency (implied by predicate comparison) | Device "tracks temperature readings" of the predicate device, indicating comparable heat output. |
  | Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, UL 60601-1 standards. | Device is "manufactured to comply" with these standards. (No specific test results detailed, but compliance is stated). |
  | Usability | Operating Instructions (OI) are clear and allow safe and effective operation by lay people. | Initial study showed questions, but revised OI led to no difficulties for a new study group. Concluded OI clear and effective. |
  | Equivalence to Predicate | Similar intended use and comparable performance (specifically heat output characteristics). | Same intended use. Wavelength difference considered not to affect effectiveness. Bench test showed temperature readings tracked predicate device. Concluded "as safe and effective as the predicate device" and "substantially equivalent." |

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

• Functional Performance Test: 2 devices (Gaunying Infrared Lamp Model IL50).
  • Data Provenance: Not explicitly stated, but implies internal bench testing conducted by the manufacturer, likely in China (where the company is based). This is a retrospective evaluation of a manufactured product.
• Usability Test: An initial group of 10 people (5 females, 5 males). A second group of 10 people for re-testing.
  • Data Provenance: Not explicitly stated, but implies internal testing by the manufacturer. This would be a prospective user study.
• Comparison Temperature Test: Not explicitly stated, but assumed to be 1 subject device (IL50) and 1 predicate device (Xinfeng Heating Lamp).
  • Data Provenance: Not explicitly stated, but implies internal bench testing. This is a retrospective evaluation.

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

There are no "experts" in the traditional sense of medical specialists establishing ground truth for this type of device. The ground truth for functional performance (temperature output) is based on instrument measurements (digital temperature sensor) and engineering specifications (e.g., target temperature ranges).

For the Usability Test, the "ground truth" was an observable measure of user comprehension and ability to operate the device based on the Operating Instructions, observed by the study facilitators. No specific "experts" in usability were mentioned, but the observers effectively served this role.

4. Adjudication Method for the Test Set

• Functional Performance Tests: No explicit adjudication method described. The results are quantitative measurements from instruments. The two devices in the initial heat output test tracked "near 100%", implying consistency without needing further adjudication.
• Usability Test: The adjudication was based on direct observation of user interaction and their verbal feedback/questions. The Operating Instructions were revised based on this feedback. The re-test observed a lack of difficulties, effectively adjudicating the revised instructions as clear. There's no "2+1" or similar method, as it's a qualitative observation of user behavior.

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. This device is an infrared lamp for therapeutic heating, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

Yes, in essence. The functional performance and comparison tests were standalone in the sense that they evaluated the device's physical output (heat generation) directly through measurement, without human intervention affecting its output. The "algorithm" here is the device's internal mechanism for generating infrared light and heat. Its performance was measured intrinsically.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Functional Performance:
  • Instrumental Measurements: Digital temperature sensor readings served as the primary ground truth for heat output.
  • Engineering/Physiological Specifications: The desired effective temperature (>40°C) and the safety threshold (

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The Gaunying Infrared Lamp ( Model #: FIR 51, SN-51) are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Gaunying Infrared Lamp (Model#: FIR 51, SN-51) has a high-quality glass ceramic plate (ceramic infrared). Glass ceramic plates are also used on hobs and when used in conjunction with illuminants guarantee intensive and safe infrared radiation.

The Gaunying Infrared Lamp (Model#: FIR 51, SN-51) is intended to emit energy in the infrared spectrum to provide topical heating. The acceptance criteria and the study proving the device meets these criteria are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document describes "a performance testing with the subject device" and "a comparison testing with the subject device and predicate device." However, specific sample sizes (e.g., number of units tested, number of measurement points per unit) are not explicitly stated. Instead, it refers to conducting tests on "the subject device" at various distances.
• Data Provenance: The tests were conducted by the manufacturer, Foshan Gaunying Electronics Co., Ltd., in China. The data appears to be retrospective relative to the 510(k) submission date, as the testing reports are cited within the summary.

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

This section is not applicable as the evaluation primarily involved performance and safety testing against objective physical parameters (temperature measurements, compliance with electrical standards), not diagnostic interpretations requiring expert consensus. The "ground truth" for efficacy was established through demonstrating the ability to raise tissue temperature to a known therapeutic range.

4. Adjudication Method for the Test Set:

This section is not applicable as there was no expert review or adjudication of diagnostic findings. The tests involved direct physical measurements.

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 section is not applicable. The device is an infrared lamp for therapeutic heating, not a diagnostic imaging device involving human readers or AI assistance.

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

This section is not applicable. The device is a physical therapeutic device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used was based on objective physical measurements (temperature readings) and established scientific understanding that a specific temperature range (41-45°C) is effective for the stated therapeutic purposes. Compliance with international electrical safety standards also served as a "ground truth" for safety.

8. The Sample Size for the Training Set:

This section is not applicable. As a physical device, there is no "training set" in the context of machine learning or AI models.

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

This section is not applicable for the same reason as above.

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