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The FreeStyle Comfort Oxygen Concentrator can deliver concentrated oxygen with either a fixed-minute pulse delivery or can be set to operate using autoSAT pulse delivery. The FreeStyle Comfort is used on a prescriptive basis by patients requiring supplemental oxygen to increase blood oxygen saturation. FreeStyle Comfort may be used in the home, institution, and transport modes.

The FreeStyle® Comfort® is a reusable, lightweight portable oxygen concentrator weighing 5 lbs. (2.3 kg) with the lithium-ion single battery pack, and 6 lbs. (2.7 kg) with the optional lithium-ion double battery pack. The FreeStyle Comfort's light weight and portability allow the user to receive supplemental oxygen while traveling, shopping or while at home. The FreeStyle® Comfort® complies with FAA guidelines for use onboard commercial aircraft.

The FreeStyle® Comfort® oxygen concentrator has 5 flow settings delivering up to 1050 mL of concentrated oxygen per minute. The subject device has two delivery options, autoSAT® Pulse or Fixed Minute Pulse, providing 90% (+5.5% / -3%) of concentrated oxygen. Like the predicate device, the FreeStyle® Comfort® releases a pulse of oxygen (bolus) at the beginning of inhalation by using oxygen conserving technologies. The oxygen conserving technology detects inhalation and quickly delivers a pulse of oxygen to the user. This method of oxygen delivery increases device portability, ambulation, and battery life for extended use away from the home, as compared with continuous O2 flow oxygen concentrators.

The outer enclosure of the FreeStyle® Comfort® is made of UL/CSA-approved PC/ABS plastic. The innerworkings include two alloy cylinders, each filled with molecular sieve (referred to as sieve beds), an internal piston air compressor, valves, tubing assembly, electrical wiring harness, filters, and control board.

FreeStyle® Comfort® does not require sterilization and is not a single use device.

Operating Principles
The control board uses software to operate the unit. The device operating principle is a process known as Pressure Swing Adsorption, or PSA. Air is drawn into the device through the air intakes to the air compressor. Pressurized air flows from the air compressor to each of the (molecular) sieve beds in cycles. As one sieve bed is filled with pressurized air, the oxygen passes through the sieve bed. As the oxygen travels through the sieve bed, the nitrogen molecules collect on the molecular sieve. At the end of the cycle, the nitrogen is purged using enriched oxygen, then the process begins again with the alternate sieve bed (one sieve bed depressurizes while the other sieve bed is pressurized). This process continuously repeats from one sieve bed to the other, producing highly concentrated oxygen. Concentrated oxygen flows from the sieve beds to the product tank, then through sensors that measures both oxygen concentration and flow, then delivered to the patient.

AutoSAT Feature
Traditional pulse dosing supplies the same amount of oxygen delivered to the patient per minute regardless of the number of breaths taken. If the patient inhales more often, such as during physical activity like walking, the amount of oxygen delivered decreases per breath to maintain the same volume of oxygen per minute. The autoSAT (automatic titration to patient's respiratory rate) function delivers a consistent pulse dose (bolus) volume of oxygen (up to 40 breaths per minute). As breath rate increases during physical activity, the amount of oxygen delivered will stay the same per breath, which increases the volume of oxygen delivered per minute.

The autoSAT function is a default setting in the FreeStyle Comfort. The user can change the setting to traditional dosing by using the membrane touchpad to switch off the autoSAT function. During normal operation, if after more than 15 seconds the device does not detect breath inhalation, the device will automatically begin dosing @ 20 breaths per minute until breath inhalation is detected. Upon detection, the device will resume normal operation in autoSAT mode.

Inhalation Sensitivity
The FreeStyle® Comfort® offers an inhalation sensitivity mode. The user can adjust the sensitivity settings values from 1-5, where 1 is the least sensitive, 5 is the most sensitive. The sensitivity function has a default setting of >-0.1 cm H2O and a maximum adjustable range of -0.3 to -0.40 cm H2O, negative pressure (inhalation) to trigger the flow (bolus) of O2 to the user. In cases where shallow breathing cannot be detected at the device (default) sensitivity setting, the user can adjust the setting with the membrane keypad to increase inhalation sensitivity to trigger oxygen delivery at the desired flow setting.

Power Options
FreeStyle Comfort is powered with either a single or double lithium-Ion battery pack or with an external AC/DC power source (A/C wall outlet or DC vehicle). FreeStyle® Comfort® includes a built-in battery charger that will automatically recharge the battery pack when the unit is plugged into an external power source, except during use on a commercial aircraft. When an AC/DC power source is not readily available for battery recharge, the battery pack can easily be removed for quick replacement by pressing the battery release button and sliding the battery pack out from the device.

Device battery is capable of up to 8 hours of operation using the 8-cell battery, and 16 hours with the 16-cell battery, depending on the selected flow setting and user's breathing rate. The battery charge status is displayed on the keypad LCD during normal operation.

User Interface
The touch membrane keypad display allows the user to operate the device. The user can select the desired pulse dose volume and view the operating status. Once the user completes the selection process, the display screen will enter "standby" mode and then dims after 20 seconds. Pressing any button on the keypad will wake the display screen from standby mode. Oxygen delivery from the device to the user is channelled via a nasal cannula/tubing assembly, manufacturer Salter Labs (SunMed, LLC.), P/N 1600 (K911740). The end user is required to follow the cannula manufacturer's instructions for length of use, maintenance, and replacement requirements.

Keypad/Alarms
Operating information, battery, and operating status is displayed on the keypad LCD window. The subject device comes equipped with both visual and audible alarms.

The FreeStyle Comfort features the following visual and audio safety alarms:

• Low oxygen concentration
• System malfunction due to high temperature, high system pressure or compressor fault
• System malfunction due to low temperature, low pressure or fan failure
• Flow Rate failure due to obstruction of gas pathway (cannula blockage)
• Low battery (activates at 20% battery power and intensifies alarm at 5% battery power)
• Auto-dosing until warm up is complete and breath detection is activated
• After 15 seconds of no breath detected the unit shifts from autoSAT to auto-dose.

Wireless Connectivity
The FreeStyle Oxygen Concentrator utilizes Bluetooth technology that pairs the portable oxygen concentrator to a mobile device or tablet using the myCAIRE App.

The myCAIRE™ app connects patients with home care providers (DME), allowing DMEs to view usage hours and flow settings of a connected CAIRE oxygen concentrator. The system uses wireless technology (BLE) to transmit information from the concentrator to a smart device, which then sends it to the home care provider. Home care providers can assist patients by addressing device notifications and supplying recommendations for troubleshooting remotely.

myCAIRE™ shares data from CAIRE oxygen concentrators without altering settings, performance, or therapy. It is not intended for monitoring, diagnosis, or treatment. The connection only sends data to the app in raw format, decodable solely by Caire, with no Protected Health Information or Personally Identifiable Information transmitted.

Associated Accessories
The device comes equipped with a rechargeable 8-cell lithium-Ion battery pack, A/C power supply/cord, DC power supply. Optional equipment consists of a 16-cell lithium-Ion battery pack for extended use and the desktop battery charger.

The following components are included with this FreeStyle® Comfort® 510(k) submission:

• 8-cell Battery Pack, lithium-Ion
• A/C power supply/power cord and plug
• Carrying case/shoulder strap
• DC Power Supply
• User manual
• 16-cell Battery Pack, lithium-Ion
• Carry All Accessory Bag (stores the device and accessories)
• Desktop Battery Charger
• Backpack
• Spare Replacement Filters

The provided FDA 510(k) clearance letter and summary for the FreeStyle Comfort Oxygen Concentrator do not contain information about studies involving acceptance criteria related to a device's performance with human readers or AI assistance.

This document focuses on establishing substantial equivalence for a medical device (an oxygen concentrator) based on its technological characteristics, intended use, and adherence to performance standards, rather than evaluating an AI algorithm's diagnostic performance in a clinical setting. Therefore, the requested information categories are not applicable to the provided text.

Specifically, the document does not mention:

• A table of acceptance criteria and reported device performance in relation to AI performance or human reader analysis. It provides specifications for the oxygen concentrator itself, such as oxygen concentration, flow settings, and physical dimensions.
• Sample size, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set to establish ground truth for an AI system.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size of human readers with/without AI assistance.
• Standalone (algorithm only) performance.
• Training set sample size or ground truth establishment for a training set. The training set concept is relevant to AI/machine learning models, which are not described in this submission.

The "studies" mentioned in the document are primarily non-clinical engineering and safety tests to ensure the device meets recognized international standards for medical electrical equipment and oxygen concentrators. These include:

• Non-clinical Testing:
  • ISO 80601-2-69 (Particular Requirements for Basic Safety and Essential Performance of Oxygen Concentrator Equipment)
  • ISO 80601-2-67 (Particular Requirements for Basic Safety and Essential Performance of Oxygen-Conserving Equipment)
  • Tests for Pulse, volume; Pulse Time; Trigger Sensitivity; Oxygen Concentration Performance; Oxygen Sensor Accuracy; Visible/Audible Alarms
  • Software verification and validation
  • Electrical Safety / Electro-Magnetic Compatibility (EMC) / RFID
  • Biocompatibility (ISO 18562-2:2017 - Particulate matter, ISO 18562-3:2017 - Volatile organic compounds)
  • Sound testing.

The acceptance criteria for the FreeStyle Comfort Oxygen Concentrator are implicit in its performance specifications (e.g., Oxygen Concentration of 90% +5.5% / -3%) and its successful demonstration of compliance with the listed ISO/IEC standards. The "study" proving it meets these criteria is the suite of non-clinical tests described.

In summary, the provided text describes a medical device (oxygen concentrator) and its regulatory clearance process, which differs significantly from the evaluation pathway for AI-powered diagnostic devices. Therefore, the questions related to AI algorithm performance are not answerable from this document.

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The Portable Oxygen Concentrator P2-TOC is intended to provide supplemental low flow oxygen.

The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.

The Portable Oxygen Concentrator P2-TOC is a device that uses the principle of molecular sieve pressure swing adsorption to increase oxygen concentration by adsorption of nitrogen and other gas components. The device needs to be used with a nasal oxygen cannula, which can provide oxygen supplementation to the user.

The Portable Oxygen Concentrator P2-TOC has two oxygen supply modes, namely continuous oxygen supply mode and pulse oxygen supply mode. Hereinafter referred to as "continuous mode" and "pulse mode" .

In the continuous mode, the Portable Oxygen Concentrator P2-TOC can continuously deliver oxygen at a fixed flow rate. In the pulse mode, the Portable Oxygen Concentrator P2-TOC is able to deliver oxygen only when the user inhales by detecting the human respiratory rate.

The provided text describes a 510(k) premarket notification for a Portable Oxygen Concentrator (P2-TOC). It details the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence. However, the document does not contain information related to an AI/ML-enabled device or a study involving human experts, ground truth establishment, or comparative effectiveness with AI assistance.

Therefore, I cannot fulfill most of the requested points as the provided document is for a physical medical device (portable oxygen concentrator) and not an AI/ML diagnostic or therapeutic device.

The document primarily focuses on:

• Device Description and Indications for Use: What the portable oxygen concentrator does.
• Principle of Operation: How it separates oxygen from air.
• Comparison with Predicate Devices: Demonstrating similarity in function and safety to already-marketed oxygen concentrators.
• Non-Clinical Tests Performed: This section lists various engineering and safety standards (electrical safety, EMC, software verification, biocompatibility) that the device complies with. These are standard tests for medical devices to ensure quality and safety, not AI model performance.
• Absence of Clinical Accuracy Testing: Explicitly states "There was no clinical testing performed." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical means.

Here's what I can extract from the provided text regarding acceptance criteria and performance, focusing on what is relevant for a physical medical device:

The "acceptance criteria" for a physical device like a Portable Oxygen Concentrator are typically defined by compliance with recognized consensus standards and performance specifications. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to show compliance with these standards and performance specifications.

1. Table of Acceptance Criteria and Reported Device Performance (Based on "Comparison with predicate device" and "Non-Clinical Tests Performed"):

Regarding the points specific to AI/ML devices, I must state that the document does not provide the requested information for the following reasons:

2. Sample size used for the test set and the data provenance: Not applicable. This document describes testing for a physical device's compliance with engineering standards, not an AI model trained on data. There is no concept of a "test set" from a data perspective. The "testing" refers to bench testing of the physical hardware and embedded software. Data provenance would not be a relevant concept as it pertains to clinical data for AI model training/testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth established by experts is mentioned. The ground truth for device performance is based on physical measurements against established engineering and medical device standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring expert 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. This is a physical oxygen concentrator, not an AI-assisted diagnostic or therapeutic device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to a physical device, not a standalone AI algorithm. While it has embedded software, its "performance" is measured by its physical output (oxygen concentration, flow rate) and adherence to safety standards, not by an algorithm's classification or detection accuracy.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is determined by direct measurement of physical parameters (e.g., oxygen purity, flow volume, noise levels) and compliance with specified engineering and safety standards, as detailed in the "Non-Clinical Tests Performed" section.

8. The sample size for the training set: Not applicable. This is for an AI/ML model, not a physical medical device. The device itself is manufactured; it doesn't "learn" from a training set in the AI sense.

9. How the ground truth for the training set was established: Not applicable. See point 8.

In summary, the provided document is a regulatory submission for a physical Portable Oxygen Concentrator, and therefore, the information requested, which pertains to AI/ML device performance and validation studies, is not present. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this device are based on demonstrating compliance with a comprehensive set of recognized consensus engineering and safety standards through non-clinical bench testing.

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The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications.

The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively.

The VOCSN unified respiratory support system is a mechanical ventilator which combines additional conventional therapies into a single device. Additional therapies include oxygen, cough assist, and suction.

The device description will be broken down by therapy; i.e., ventilation, oxygen concentration and delivery, cough assist, and suction.

The provided text describes a medical device, the VOCSN Unified Respiratory System, and its various components, along with comparisons to predicate devices and adherence to performance standards. However, it does not describe a study involving an AI algorithm's performance or human reader improvements. Therefore, I cannot provide details on sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies, as these elements are not present in the document.

Instead, the document focuses on the VOCSN Unified Respiratory System's regulatory submission (510(k)) to the FDA, demonstrating its substantial equivalence to previously cleared medical devices. This involves non-clinical performance testing against user and product requirements and compliance with international standards.

I will structure the answer based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance (as derived from the text):

The acceptance criteria are generally framed as compliance with specific international and FDA guidance standards, as well as meeting internal User Requirements and Product Requirements Specifications. The "reported device performance" is essentially the statement that the device is compliant with these standards and requirements, and that verification/validation testing was successfully completed. Specific quantitative performance targets are not always explicitly stated in the summary but are implied by compliance with the referenced standards.

Ventilation Component:

Oxygen Concentrator Component:

Cough Assist Component:

Suction Component:

Heated Wire Patient Circuit Accessory:

Bacteria Filter Accessory:

Regarding AI-specific questions:

The provided document describes a physical medical device (VOCSN Unified Respiratory System), not an AI algorithm. Therefore, the following information is not present in the text:

2. Sample size used for the test set and the data provenance: Not applicable as no AI test set is described. The device performance was validated and verified through simulated use conditions and testing against various standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device validation and verification typically involve engineering and clinical experts during the design and testing phases, but not specifically for establishing "ground truth" in the context of an AI model's performance.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is relevant for AI-assisted human reading tasks, which is not the subject of this document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" here is compliance with engineering specifications and regulatory standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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