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The Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

The Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used with a specific drug nor is it distributed with such drugs.

The nebulizer has a trigger that allows the patient or clinician to activate the nebulizer which then generates respiratory size aerosolized liquids into gasses that are delivered directly to the patient This trigger function conserves medication and reduced environmental for breathing. contamination by medication. This nebulizer is also available with an attachable BFE/VFE filter that connects to the exhalation port of the nebulizer.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that performance testing was conducted.

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

Not applicable. This device is a nebulizer and its performance is measured against physical parameters (respirable mass, treatment times) rather than expert interpretation of medical images or data.

4. Adjudication Method for the Test Set:

Not applicable.

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

No MRMC study was conducted. The performance testing compared the Atlantean Trigger Nebulizer directly to a predicate device (Hudson RCI Micro Mist) based on physical performance metrics.

6. Standalone Performance Study:

Yes, a standalone performance study was conducted. The Atlantean Trigger Nebulizer's performance in terms of respirable mass and treatment times at 5LPM was directly compared to the predicate device.

7. Type of Ground Truth Used:

The ground truth was established through direct measurement of physical performance characteristics of the devices, specifically respirable mass and treatment times at a given flow rate. This is essentially objective, measurable data rather than a subjective interpretation like expert consensus or pathology.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware product, not an AI/ML algorithm that requires a training set.

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

Not applicable.

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The SB100II Fingertip Pulse Oximeter is a non-invasive device intended for the spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The SB100II is not intended for continuous monitoring.

The SB10011 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a translucent part of the body, in this case the finger. This SB1001 contains the electronics to interface to the integral sensor. This sensor consists of a light emitting diode and a photoelectric cell placed on either side of the finger. Red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood. The SB10011 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult and pediatric patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the SB100Il display digital values for both the SpO2 and Pulse. Pulse amplitude is displayed graphically by means of a vertical bar, which elevates in synch with the pulse cycle. The SB1001 is powered by two "AAA" batteries. The wavelength of red LED is 660nm and Infrared LED is 905/880nm with maximum optical output power of 4mW. The device incorporates a battery state indicator and provides a visual indication of low battery.

Here's a breakdown of the acceptance criteria and the study information for the SB100II Finger Pulse Oximeter, based on the provided documents:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Discussion of Performance vs. Criteria:

• SpO2 Accuracy: The SB100II reports an accuracy of +/-3% in the 70-99% range. The document states this is "Similar, actual Arms 2.5 Meets FDA guidance for non-motion ≤ 3.0 % Meets ISO 9919 for non-motion

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