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The Nuvo Nano Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments.

The Nuvo Nano Portable Oxygen Concentrator (Nano POC) begins its operation with air being pulled into the external air intake filter. This filtered air enters the compressor via a suction resonator and fine filter. Pressurized air then exits the compressor. Next, an electronic valve system directs the air into one of two tubes that contain molecular sieve (sieve beds). The molecular sieve adsorbs (physically attracts) the nitrogen from the air as it is pushed through the sieve beds, this process is called pressure swing adsorption (PSA). As one tube is generating the product gas, the other is being purged of the adsorbed nitrogen. After passing through the oxygen storage tank, the rate of product gas being delivered to the patient is set by a restricting orifice and pulse dose valve based upon detection of a breath. It then passes through a fine particle filter and thru a sensor that detects the oxygen concentration of the product gas before it exits the device through a fire-resistant outlet. Once the product gas leaves the device, it travels to the patient via oxygen tubing and a cannula inserted in the nose. The Nano POC offers the user multiple options to power the device; a detachable lithium ion battery, replaceable by the patient, and an external AC/DC power supply. The device will charge the lithium ion battery when the battery and power supply are both attached. The device operates from 100V to 240V and at 50/60Hz. The device is approximately 8.3″ wide by 3.5″ deep by 6.5″ high (21.6cm x 8.9cm x 16.5cm). The device weighs about 4.7 pounds (2.1 kg) including the battery. The device provides an intermittent supply of oxygen enriched gas at a concentration between 87% and 96% to patients requiring longterm oxygen therapy without the higher cost of bottled oxygen. The device produces a product pressure of less than 170 kPa (25 psig) and flow is set by a controller that delivers pulsed flow rates nominally equivalent to continuous flow rates of 1 to 5 LPM. The device provides pulsed dose delivery of oxygen to the user through a selection of 5 settings; setting 1 delivering the least and setting 5 delivering the greatest amount of oxygen enriched product gas. Oxygen pulse volume per minute is controlled electronically by monitoring the user's breath rate and therefore adjusting bolus volume to deliver the same amount of oxygen per minute to the user. The device does not contain, nor does it produce, any latex, phthalates, harmful chemicals, animal tissue, blood components, or radioactive materials that the user or patient could physically contact. The user has short term surface contact with the device (PC + ABS cabinet and PET HMI overlay), but the nasal cannula has contact with the face for the duration of the treatment. The product gas also has prolonged contact with the respiratory airways. The device is not invasive nor implanted. The device is not life supporting, life sustaining, sterile, or radioactive. The device does not incorporate a medical substance, animal tissue or blood component. The device is reusable and should be used as often as prescribed, for the duration prescribed. Smoking cigarettes while undergoing treatment, especially during treatment, is a contraindication to the intended purpose of the device. Nidek Medical Products, Inc. warns against the use of oil or grease, using the device around an open flame, and using the device without a prescription from a doctor.

The provided text describes the acceptance criteria and the studies performed for the Nidek Medical Products, Inc. Nuvo Nano Portable Oxygen Concentrator (POC).

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench tests and adherence to international standards. It does not refer to 'test sets' in the context of clinical trials with patient data, but rather as test protocols for engineering and safety verification.

• The tests are described as Bench Tests and Biocompatibility Tests.
• Sample size: Not applicable in the context of clinical data for AI, as this is a hardware device. The "sample size" here would refer to the number of devices tested, which is not explicitly stated but implied to be sufficient for compliance with the listed standards.
• Data provenance: Not applicable in the context of clinical data for AI. The data provenance is from the specific testing performed by the manufacturer or contracted labs to demonstrate compliance with the listed ISO and IEC standards. The country of origin of the data is not specified but would be where the manufacturer Nidek Medical Products, Inc. (Birmingham, Alabama, USA) or its testing facilities are located. These tests are prospective, meaning they are performed specifically for the regulatory submission to demonstrate the device's characteristics.

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)

This information is not applicable as the submission is for a portable oxygen concentrator, not an AI/ML-based diagnostic or imaging device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device is based on objective measurements and compliance with engineering and safety standards.

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

This information is not applicable as it pertains to clinical data interpretation, typically in AI/ML studies, not hardware device performance testing against engineering standards.

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 information is not applicable as this is a hardware medical device (portable oxygen concentrator), not an AI-assisted diagnostic tool. No MRMC study was performed or needed.

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

This information is not applicable as this is a hardware medical device, not an algorithm.

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

The "ground truth" for the Nuvo Nano POC is established by:

• Objective Measurements: Directly measuring physical device parameters such as oxygen concentration, flow rates, trigger sensitivity, sound level, battery performance, dimensions, and weight through standardized testing procedures.
• Compliance with International Standards: Demonstrating adherence to relevant IEC and ISO standards for safety, performance, electromagnetic compatibility, usability, and biocompatibility. These standards define the "ground truth" for acceptable device characteristics.
• Biocompatibility Testing: Evaluating materials in the gas pathway against ISO 10993 standards to ensure they are non-toxic and safe for contact with patients.

8. The sample size for the training set

This information is not applicable as this is a hardware medical device and does not involve AI model training with a "training set."

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

This information is not applicable as this is a hardware medical device and does not involve AI model training.

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