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C300 Series Air Nebulizer Compressor is intended to provide a source of compressed air to a pneumatic nebulizer for the generation of aerosolized medications for inhalation by a patient, based on a physicians' prescription.
C300 Series Air Nebulizer Compressor is an AC powered air compressor that provides a source of compressed air for home health care use. The compressor should be used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a patient.

The C300 Series Air Nebulizer Compressor is AC line powered (120V) device. Only the compressor unit is supplied by the sponsor. Other accessories which are directly contacted the patients are not included in this application. These accessories include Air Tubing, Nebulizer, Adaptor, Flexi Tubing, and Mouthpiece. Suggest selecting those accessories which have already obtained 510(K) clearance and are available on the market.
The compressor is driven with a motor inside, and is AC line powered (120V) with an on/off switch. Inside of the compressor also have an inlet filter and a filter cover. Outside is a plastic body (including a top cover, a left cover, and a right cover).

This 510(k) summary is for the C300 Series Air Nebulizer Compressor. It does not contain the detailed performance study information typically found for devices involving AI or image analysis. Instead, it demonstrates substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with applicable voluntary standards.

Here's the information based on the provided text, with an explanation of why certain criteria are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document describes a nebulizer compressor, not a device that processes data or images needing a test set for performance evaluation. The "test set" here refers to the device itself being tested for compliance.

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

• Not Applicable. This device is a mechanical compressor. Ground truth, in the context of medical image analysis or diagnostics, does not apply here. Compliance is established through engineering and safety testing against recognized standards.

4. Adjudication method for the test set

• Not Applicable. See explanation above.

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-assisted device, nor does it involve human interpretation of medical images.

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

• Not Applicable. This is a hardware device (an air compressor), not an algorithm.

7. The type of ground truth used

• Engineering and Safety Standards: The "ground truth" for this device's acceptance is its compliance with established electrical safety, electromagnetic compatibility (EMC), and environmental performance standards (IEC 60601-1, IEC 60601-1-2, EPA standards for VOC and PM 2.5). The performance is assessed against these quantifiable metrics and the performance of predicate devices.

8. The sample size for the training set

• Not Applicable. This device uses traditional engineering and manufacturing processes, not machine learning or AI that would involve a "training set."

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

• Not Applicable. See explanation above.

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Infrared Ear Thermometer (IRT-21 and IRT-22), designed with infrared technology, is used to measure body temperature from ear canal. Press the ON/OFF button to turn on the power, insert the probe into the ear canal then press the SCAN button to measure the temperature, when you hear a beep sound, the measurement is complete. Infrared Ear Thermometer (IRT-21 and IRT-22) is intended for household and hospital use on people of all ages.

Infrared Ear Thermometer (IRT-21 and IRT-22) is used to measure body temperature from ear canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces. Probe cover is used for measuring to ensure accurate temperature measurement. For hygienic purpose, it is advised to discard the probe cover after each use. Press the ON/OFF button to turn on the power, the symbol 1888 appears immediately. Insert the probe into the ear canal then press the SCAN button to measure the temperature, when you hear a beep sound, the measurement is complete. The temperature is graduated on 0.1 Tor 0.1 ℃, reading a range of 89.6°F -- 109.2°F (32°C -- 42.9°C ). The ambient temperature environment is intended for used is 50°F -- 104°F (10°C-40°C).

The provided text describes a 510(k) submission for an Infrared Ear Thermometer (IRT-21 and IRT-22). Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 100 patients were enrolled for the clinical trial.
• Data Provenance: Not explicitly stated, but based on the overall submission from "Choice Smart Health Care Company Limited" in Hong Kong, and the study being a "clinical trial" it is likely prospective, though the exact country of origin for the patient data is not specified.

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

• The document does not mention the use of experts to establish a "ground truth" in the traditional sense of medical image or diagnostic interpretation. Instead, the ground truth was established by a "reference thermometer" for comparative purposes in the clinical study. The number or qualifications of individuals using the reference thermometer are not provided.

4. Adjudication Method for the Test Set

• No adjudication method (e.g., 2+1, 3+1) is mentioned. The clinical study involved comparing the infrared thermometer to a reference thermometer, implying a direct comparison rather than an adjudication process by multiple expert reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC comparative effectiveness study was done. This device is an infrared ear thermometer, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable.

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

• Yes, the device performance, particularly the accuracy, electrical safety, and biocompatibility, was evaluated in a standalone manner against established standards (ASTM, IEC, ISO). The clinical study also assesses the device's performance directly against a reference thermometer, which is a standalone evaluation of the device itself.

7. The Type of Ground Truth Used

• Clinical Study: The ground truth for the clinical study was established using a reference thermometer. The study involved a "comparison study" and "clinical repeatability testing" against this reference.
• Non-Clinical Tests: For accuracy testing, a controlled environment likely provided standardized temperature points (35°C/95°F, 37°C/98.6°F, 41°C/105.8°F) as a form of ground truth for calibration and verification.

8. The Sample Size for the Training Set

• This device is a hardware device (infrared ear thermometer) and does not inherently have a "training set" in the context of machine learning or AI models. The concept of a training set is not applicable here. The manufacturing and calibration processes would involve internal quality control and testing, but these are distinct from a "training set" for an algorithm.

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

• As stated above, the concept of a "training set" does not apply to this device.

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It is an electronic thermometer used for clinical temperature measurement. It is intended for use at home and hospital environment for both children and adult.

The Rapid Digital Thermometer is an electronic thermometer by using a thermistor as the temperature sensor. The thermometer uses a 1.5V button battery for operation.

The provided text describes the 510(k) summary for the Rapid Digital Thermometer, Model RDT-18-XY. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific performance metric against acceptance criteria in the way a clinical trial for an AI diagnostic device would.

Therefore, many of the requested categories for AI device studies (e.g., sample size for test set/training set, number of experts, adjudication methods, MRMC studies, standalone performance with AI assistance, type of ground truth) are not applicable to this submission as it's for a simple electronic thermometer.

However, I can extract the acceptance criteria and performance information that is relevant.

Acceptance Criteria and Device Performance

Study Information (Relevant to this device type)

1. Sample size used for the test set and the data provenance: Not explicitly stated as a clinical study with a specific test set. Performance testing was conducted according to ASTM E1112 standards, which typically involve a specified number of measurements or devices for testing, but the exact sample size for these non-clinical tests is not detailed in the provided summary. The data provenance would be from internal lab testing based on the standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a digital thermometer, "ground truth" would be established by reference temperature standards and measurement protocols, not expert consensus.
3. Adjudication method for the test set: Not applicable. Performance testing for a thermometer involves direct measurement against known standards.
4. 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 diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a standalone electronic device, not an AI algorithm. Its performance is inherent to its design and calibration.
6. The type of ground truth used: For accuracy and other performance metrics, the ground truth would be established by reference temperature standards and calibrated measurement equipment as per ASTM E1112.
7. The sample size for the training set: Not applicable. This device does not use machine learning or require a training set.
8. How the ground truth for the training set was established: Not applicable.

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