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Air compression Leg Massager is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health, it can simulate kneading and stroking of tissues by using an inflatable garment.

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The provided text is a 510(k) clearance letter from the FDA for an "Air compression Leg Massager." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Sample size for a test set.
• Data provenance for a test set.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is solely an FDA clearance letter based on substantial equivalence, not a detailed report of a performance study. K240373 refers to a Class II device (Powered Inflatable Tube Massager) which typically undergoes a different type of review process than novel AI/ML-driven diagnostic devices that would require such extensive performance data.

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The Infrared Thermometer (Model: Y2001, Y20002) is intended for the intermittent measurement and monitoring of human body temperature from forehead. The device is indicated for use for people of two months and above at homecare and in hospital.

Infrared thermometer (Model: Y20001 , Y20002) are a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead when measure from 1-3cm of the subject's forehead with no contact. The temperature will displayed on the screen, and the reference body site is axilla. Infrared thermometer (Model: Y20001, Y20002) use a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the thermometer for ambient temperature readings. The device consists of measuring sensor, PCB, buttons, a LCD and an enclosure.

The difference between two models are size, weight and button settings. Y20001 has four buttons(Test button, °C/°F button, "B/S"button, "M" key) and Y20002 has two buttons(Function button, Measurement button). The functions of the two models are same. Infrared thermometer (Model: Y20001,Y20002) have the following features:

1. The device is intended to be reusable for home use and clinical use.
2. Switching of temperature unit between °C and °F.
3. The latest 32 sets of memory for measuring human body and object; the user can view or delete the previous measurement results.
4. Buzzer on or off to set the prompt tone on or off.
5. Prompt tone function.
6. Low battery indication, and auto power-off

Here's a breakdown of the acceptance criteria and study details for the Infrared Thermometer (Models: Y20001, Y20002), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria for this medical device revolve around its accuracy in measuring body temperature. These are primarily derived from recognized international and national standards.

Note on Accuracy: While the table states "± 0.3°C / 0.5°F", the comparison table (Note 4) mentions the subject device's accuracy being wider than the predicate within the range of 36.0°C - 39.0°C. However, the overall claim is that it still meets the performance standards based on the test reports. This implies that the ±0.3°C/0.5°F stated is the overarching acceptable tolerance.

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

• Sample Size: Each clinical study evaluated 150 subjects.
• Data Provenance: Not explicitly stated regarding the country of origin of the data. The studies were designed to evaluate subjects across specific age groups and a portion of fever patients, suggesting it was a prospective study conducted for regulatory submission.

The subjects were divided into three age groups with 50 subjects in each group:
* Infants: two months to one year
* Children: greater than one to five years
* Adults: greater than five years old

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the clinical accuracy test. However, for clinical thermometers, the "ground truth" (reference temperature) is typically obtained using a highly accurate, calibrated reference thermometer according to the specified standard (ISO 80601-2-56). The measurement itself, and hence the ground truth, relies on the precision of the reference device and adherence to standardized measurement protocols, rather than expert interpretation of an image or similar data.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. For a clinical thermometer's accuracy assessment, adjudication methods like 2+1 or 3+1 are typically used for subjective evaluations (e.g., image interpretation). Here, the comparison is quantitative: the device's reading versus a reference standard's reading.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging where human readers interpret results, and the AI's impact on their performance is being evaluated. For a thermometer, the performance is measured purely on its accuracy against a known standard.

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

Yes, the primary clinical accuracy testing described is a standalone performance test of the device. The "clinical accuracy testing" evaluates the device's ability to measure human body temperature accurately as per ISO 80601-2-56 requirements, without human intervention affecting the measurement result itself. It compares the thermometer's reading directly to a reference method, acting as an algorithm-only performance assessment in the context of a medical device that outputs a direct measurement.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy test was established by comparing the infrared thermometer's readings to reference temperature measurements obtained according to the requirements of ISO 80601-2-56:2017. This typically involves a highly accurate, calibrated reference thermometer measuring core body temperature from a different site or a more invasive method, or using a specified (e.g., oral or rectal) reference thermometer, against which the non-contact device is compared. This is a type of objective measurement standard ground truth.

8. The Sample Size for the Training Set

The document does not provide any information about a training set. This device is a measurement tool, not an AI/ML algorithm that requires a separate training data set for model development. The performance is based on the physical design, sensors, and firmware logic, which are validated through bench and clinical testing.

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

Not applicable, as no training set is mentioned or implied for this type of device. The device's operational parameters and calibration would be established through engineering design and bench testing, not through supervised learning with a specific "training set" in the AI/ML sense.

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