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The Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients requiring respiratory therapy on a prescriptive basis. It may be used at home, in institution, vehicle, train, airplane, boats and other transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

Users should follow their doctor's advice on setting the oxygen flow rate and should not adjust the flow rate without consulting a healthcare professional.

Note: Patients should regularly consult with their physician to evaluate the need for adjustments in their oxygen therapy settings.

The Portable Oxygen Concentrator is a Class II, low-risk medical device designed to provide a high-concentration oxygen supply (87%-95.5%) to adult patients requiring supplemental oxygen therapy as prescribed by a healthcare professional. It is intended for use at home, in institution, vehicle, train, airplane, boats and other transport modalities and complies with FAA regulations for in-flight use. The device is not intended for life-support or life-sustaining purposes.

The Portable Oxygen Concentrator utilizes Pressure Swing Adsorption (PSA) technology, which extracts oxygen from ambient air by selectively adsorbing nitrogen through molecular sieve beds. Oxygen is delivered through a pulse dose mechanism, synchronizing oxygen release with the patient's inhalation cycle to optimize efficiency and minimize waste.

The series consists of four models, each offering different pulse dose settings:

• W-R1 (MAX): 1, 2, 3, 4, 5, 6, S
• W-R1: 1, 2, 3, 4, 5, 6
• W-R2: 1, 2, 3, 4, 5
• W-R2 (Lite): 1, 2, 3, 4

The device operates in pulse flow mode and supports multiple power sources, including 100–240V AC (50–60Hz) and a rechargeable lithium-ion battery (14.4V / 6500mAh). While the hardware supports 13.0–16.8V DC input, DC operation is not currently supported, as no DC accessories are provided or authorized. A single battery charge provides up to 4.5 hours of continuous use, ensuring flexibility across various environments.

Designed for portability and efficiency, the W-R Series features a lightweight build (1.8 kg), low noise operation, and an intuitive LCD display. Its ergonomic and user-friendly design has been internationally recognized with six global design awards, including iF, Red Dot, and IDEA, for its usability, portability, and patient-centered innovation.

The device is suitable for operation within a temperature range of -5°C to 40°C (23°F to 104°F), humidity levels of 5% to 90% (non-condensing), and atmospheric pressure from 54kPa to 106kPa. It can function at altitudes up to 5,000 meters (16,400 feet).

The Portable Oxygen Concentrator consists of a casing, compressor, molecular sieve system, solenoid valve, battery, cooling fan, control board, and display screen.

Note: The device does not include a nasal cannula; patients should purchase one separately. The oxygen outlet follows international standards, and recommended cannula specifications can be found in Section 2.12: Cannula Use of the user manual.

The provided FDA 510(k) clearance letter is for a Portable Oxygen Concentrator. This device is not an AI/ML-enabled device. The information requested in the prompt (acceptance criteria, study details, sample size, ground truth, expert adjudication, MRMC studies, etc.) is typically associated with the rigorous evaluation of AI/ML software as a medical device (SaMD) or AI-enabled medical devices, especially those using diagnostic imaging.

Medical devices like portable oxygen concentrators are evaluated primarily on their physical performance characteristics, safety standards, and conformity to established regulations for mechanical and electrical safety. The clearance letter outlines the non-clinical tests performed (safety and performance testing, biocompatibility testing, electrical safety and EMC testing, battery safety testing, and software verification/validation), but these are not the types of studies that involve expert readers, ground truth consensus, or MRMC comparative effectiveness specific to AI diagnostics.

Therefore, I cannot extract the requested information (acceptance criteria in the context of an AI study, sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML) directly from this document, as it pertains to a different type of medical device evaluation.

To directly answer your request based on the provided document, which is for a Portable Oxygen Concentrator (not an AI/ML diagnostic device):

The FDA 510(k) Clearance Letter for the Portable Oxygen Concentrator focuses on demonstrating substantial equivalence to a predicate device through:

• Same Intended Use: Providing supplemental oxygen to adult patients on a prescriptive basis for respiratory therapy.
• Similar Technological Characteristics: Utilizing breath detection, molecular sieve/pressure swing adsorption, and a pulse dose mechanism.
• Performance Data: Presenting specifications like oxygen concentration, pulse volumes, sound levels, and mechanical/electrical safety.
• Compliance with Recognized Standards: Adhering to various international IEC and ISO standards for medical electrical equipment, biocompatibility, and oxygen concentrators.

The "acceptance criteria" for a device of this type are generally meeting the performance specifications and safety standards outlined in the non-clinical testing section, and demonstrating that any differences from the predicate device do not raise new questions of safety or effectiveness.

Here's a breakdown of the closest equivalents to your requested categories, given the nature of the device and the document:

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

For a portable oxygen concentrator, acceptance criteria are generally related to its physical and performance specifications like oxygen purity, flow rates, noise levels, and battery life, rather than diagnostic accuracy metrics.

Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is primarily through the Non-Clinical Testing Summary described in Section VIII of the 510(k) Summary.

• Safety and Performance Testing: This involved evaluations against ISO 80601-2-69:2020 and ISO 80601-2-67:2020 (standards for oxygen concentrators and oxygen-conserving equipment), and internal bench testing.
• Biocompatibility Testing: Conducted per ISO 18562 series.
• Electrical Safety and EMC Testing: Evaluated per IEC 60601 series standards.
• Battery Safety Testing: Conducted per IEC 62133-2.
• Software Verification and Validation: Conducted per FDA guidance.

These tests collectively demonstrate that the device performs according to its specifications and is safe for its intended use, proving that it meets its "acceptance criteria" for a physical medical device.

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 in the context of an AI/ML test set. For a portable oxygen concentrator, testing involves physical devices. The non-clinical tests would have been performed on a representative sample of manufactured devices (e.g., a certain number of units for durability, environmental, and performance tests). The document does not specify the exact number of physical units tested, as this is standard engineering validation rather than a clinical study with patient data.
• Data Provenance: Not applicable in the context of AI/ML data. This device is tested through engineering bench testing, not clinical data sets. The manufacturer is Nanjing Yinuoji Medical Technology Co., Ltd. in China, so device testing would likely be performed there or at accredited labs globally. The data is prospective in the sense that physical devices were manufactured and then tested, but not in the "retrospective/prospective data collection" sense typically associated with AI/ML studies where patient data is gathered.

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" in the context of AI/ML is about establishing a definitive diagnosis or label for medical images or patient data. For a portable oxygen concentrator, "ground truth" is established by direct physical measurement (e.g., using calibrated sensors to measure oxygen concentration, flow rates, sound levels) and adherence to engineering and safety standards by qualified engineers and technicians. No clinical "experts" in the sense of radiologists or pathologists establishing ground truth for diagnostic accuracy are involved.

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

• Not applicable. This is a concept for reconciling disagreements among human readers or labelers in AI/ML dataset creation. Device performance testing relies on objective measurements against established engineering specifications and international standards, not subjective adjudication.

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. MRMC studies are specifically designed to assess the impact of AI algorithms on human diagnostic performance (e.g., how AI assistance affects radiologists' accuracy). This device does not have an AI component that assists human readers in diagnosis.

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

• While the device has software, "standalone performance" in the AI/ML context refers to the algorithmic performance in diagnostic tasks without human input. Here, the "standalone performance" is the device's ability to mechanically and electronically produce and deliver oxygen according to its specifications, which was tested via Internal Bench Testing and compliance with ISO standards.

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

• As explained in #3, "ground truth" for this device comes from objective physical measurements against predefined engineering specifications and international medical device performance and safety standards. For example, oxygen concentration is measured by an oxygen analyzer, flow rates by flow meters, sound by calibrated sound level meters, etc.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data. Its functionality is based on established mechatronic and chemical-physical principles (Pressure Swing Adsorption).

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

• Not applicable, as there is no "training set" for this type of device.

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