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The Airdog X8 Air Purifier is a mobile air cleaner intended to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog X8 has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L5 speed.

The Airdog X8 Air Purifier (X8) is a mobile air cleaner. The air from the room enters the X8 and passes a pre-filter, ionization frame, ionization field, collecting plates and carbon filter that captures particular matter and biological agents from the air. The X8 contains multiple PCB modules, device status indicators, power switch and a display panel, it allows user to select between different operation parameters, including auto-mode, sleep mode and wind speed. The Ionization wireframe and the collecting plate can be cleaned routinely and are reusable. X8 is powered from an AC wall outlet. It is intended to be used indoors only. The device is not intended to be connected to other instruments or medical devices.

The provided text is a 510(k) Summary for the Airdog X8 Air Purifier. It lacks the details typically found in a study proving a device meets specific acceptance criteria, especially for an AI/ML-driven device with complex performance metrics like those involving human readers or expert consensus. This document pertains to an air purifier, and its "performance data" is focused on physical and biological filtration capabilities, not on an AI's diagnostic or assistive accuracy.

Therefore, I cannot extract information related to:

• Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective)
• Number of experts used to establish ground truth and their qualifications
• Adjudication method for the test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size
• Standalone (algorithm only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data)
• Sample size for the training set
• How ground truth for the training set was established

However, based on the provided text, I can infer the "acceptance criteria" and "reported device performance" related to the air purifier's function.

Here's a breakdown of what can be extracted:

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

While not explicitly called "acceptance criteria" with pass/fail thresholds in the typical AI/ML sense, the document lists specifications and test results that serve as performance benchmarks.

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TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):

• To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
• To stimulate healthy muscles in order to improve and facilitate muscle performance .
• To temporarily increase local blood circulation in healthy muscles.

TENS & EMS Device is a pain management device with a combination of TENS and EMS therapy technology.
It can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
TENS & EMS Device (Model: LY-ET-01, LY-ET-04) has 3 modes (Model LY-ET-02 has 5 modes) and one channel, which provide electrical pulse stimulation through the electrode pads to the treatment area. The TENS & EMS Device has the operating elements of ON/OFF knob, Mode Selection button, Intensity adjustment Dial (or Intensity Increase button and Intensity decrease button) and Time Selection button which is user-friendly and easy to control.
The device is equipped with electrode pads and electrode wire is used to connect the pads to the main unit. All the accessories can only be purchased by a local distributor.

This document describes the premarket notification (510(k)) for the TENS & EMS Device (Models LY-ET-01, LY-ET-02, LY-ET-04). This filing primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and comparison, rather than clinical efficacy studies. Therefore, many of the requested elements for acceptance criteria and study proving device meets criteria (especially those related to AI/MRMC studies, human reader improvement, and extensive clinical ground truth establishment) are not applicable in this context.

However, based on the provided text, I can extract information related to the acceptance criteria and the non-clinical studies conducted to demonstrate the device's safety and performance in the context of electrical safety and general device functionality, as required for a TENS/EMS device.

Here's a breakdown of the available information:

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

The document provides a table summarizing non-clinical performance testing. The "Acceptance criteria" column states the general requirements for the tests, and the "Test results" column indicates "Pass" for all listed tests. There are no specific quantitative performance metrics provided as acceptance criteria for the TENS/EMS functionality itself (e.g., specific pain reduction percentages), as this is a non-clinical submission relying on equivalence to a predicate device.

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

• Sample Size for Non-Clinical Testing: "The test sample is the final, finished product." For each listed test (General requirements, Electromagnetic disturbances, Home Healthcare environment, Nerve and muscle stimulators), the sample size is specified as "Model: LY-ET-01, LY-ET-02, LY-ET-04." This implies a representative sample of each device model was used for testing, but specific numerical quantities (e.g., N=3 of each model) are not given.
• Data Provenance: The tests are laboratory "bench testing" conducted by the manufacturer, Jiangxi Royall Smart Technology Co., Ltd. (China). The document does not specify if these were retrospective or prospective tests, but they are typically prospective tests performed to verify compliance with standards for the specific device being submitted. All cited standards (IEC, ISO) are international.

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

This information is not applicable. The device is a TENS & EMS stimulator, and the testing documented is non-clinical (electrical safety, EMC, biocompatibility, usability, software V&V). There is no "ground truth" in the clinical sense (e.g., for disease diagnosis or treatment efficacy) established by experts for these types of tests. Compliance is against published international standards.

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

Not applicable, as this is related to clinical ground truth establishment or reader studies, which were not 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

Not applicable. This is not an AI-powered diagnostic or therapeutic device. The submission is for a TENS & EMS device, demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing.

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

Not applicable. This is not an algorithm-only device. It's a physical medical device.

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

For the non-clinical tests, the "ground truth" is compliance with the requirements and limits defined in the referenced international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-10, IEC 60601-1-11, IEC 62366-1, ISO 10993 series).

8. The sample size for the training set

Not applicable. This type of device does not involve a "training set" in the context of machine learning or AI.

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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DT100 Digital thermometer is intended for the measurement of human body temperature by doctor or consumers in the hospital or home. It can be used for axillary, oral and rectal measurement. The product is reusable and provided non-sterile. The device is for people of all ages.

DT100 digital thermometer is a fast, highly accurate, and easy to use clinical instrument for measuring patient temperatures by oral, axillary or rectal means. The digital thermometer is a hand-held, reusable, multi-user, battery operated device. It has one model DT100.

The provided text is an FDA 510(k) summary for a digital thermometer (DT100). It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results for novel AI-powered diagnostic devices. Therefore, a direct answer to the request regarding AI acceptance criteria, specific test set details, expert ground truth, MRMC studies, or standalone algorithm performance, as typically seen in AI/ML device submissions, cannot be fully provided from this document.

However, I can extract the relevant information from the document that pertains to the device's performance and the non-clinical testing performed to demonstrate its safety and effectiveness.

Here's a breakdown of the information that can and cannot be extracted:

Information that can be extracted related to acceptance criteria and performance:

• Acceptance Criteria (Accuracy) and Reported Device Performance: This is explicitly stated in the substantial equivalence table.
• Non-Clinical Performance Data: The document lists the standards the device was tested against (Biocompatibility, Electrical Safety/EMC, Performance Testing, Software V&V). While it doesn't give specific results for each test (e.g., exact current leakage values), it states the device was evaluated according to these standards, implying it met their requirements.
• Ground Truth Type for Non-Clinical Testing: For performance, it relies on established standards (e.g., ASTM E1112 for accuracy).

Information that cannot be extracted (as it's beyond the scope of this 510(k) for a conventional thermometer):

• Sample sizes for a test set (as no clinical test set in the AI/ML sense was used for performance evaluation).
• Data provenance (not applicable for a simple thermometer's non-clinical testing).
• Number of experts, qualifications, or adjudication methods (not applicable as no expert-review based ground truth was established for "cases").
• MRMC comparative effectiveness study (not applicable).
• Standalone algorithm performance (not applicable, as it's a hardware device, not an algorithm).
• Sample size for training set (not applicable, as it's not an AI/ML device).
• How ground truth for training set was established (not applicable).

Based on the provided document for the DT100 Digital Thermometer:

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

Notes on Acceptance Criteria and Performance:
The document states that the DT100 Digital Thermometer's accuracy is the same as the predicate device (Fudakang Digital thermometer; Model: BTA41-CN). The non-clinical testing performed (against standards like ASTM E1112) would have implicitly confirmed that the device met this accuracy requirement.

2. Sample sized 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 applicable. For this type of conventional electronic thermometer, performance is demonstrated through non-clinical laboratory testing against recognized standards (e.g., ASTM E1112), not a "test set" in the context of an AI/ML algorithm requiring patient data.
• Data Provenance: Not applicable. The testing is laboratory-based and performed to international and national standards.

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 applicable. Ground truth for a digital thermometer's accuracy is established by highly accurate reference temperature measurements in a controlled laboratory environment, not by expert consensus on clinical cases.

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

• Not applicable. See point 3.

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 standalone digital thermometer, not an AI-assisted diagnostic tool.

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

• Yes, in a sense. The device's performance (accuracy, electrical safety, biocompatibility, etc.) was evaluated as a standalone product through non-clinical laboratory testing according to relevant standards. The "algorithm" here essentially refers to the device's internal temperature measurement and display mechanism, which operates without human intervention beyond taking the measurement.

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

• For performance (accuracy): The ground truth is established by highly precise and calibrated reference thermometers and temperature baths/devices, as per the requirements of standards like ASTM E1112. This is an objective, physical measurement standard rather than a subjective human interpretation.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. See point 8.

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