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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 eQuinox Oxygen System is intended for the administration of supplemental oxygen. The eQuinox Oxygen System is prescription legend required.

The eQuinox Oxygen System is an oxygen concentrator that provides continuous flow or in pulse mode, an oxygen bolus. The eQuinox Oxygen System is based on pressure swing adsorption (PSA) principles. The eQuinox Oxygen System operates from AC power, or rechargeable batteries. This device delivers supplemental oxygen for patients through the molecular sieve beds and is designed to conserve the use of oxygen while operating in pulse flow mode. During pulse flow mode, oxygen is delivered to the patient through a pulse flow valve when the start of inhalation is detected. The eQuinox Oxygen System consists of pneumatic and electrical components, AC power supply, DC cable and lithium ion batteries. The system has inlet filtration, air compressor, and Synthetic Zeolite molecular sieve beds with a rotary valves, outlet filtration, electronic flow control and audible / visual alarms.

This document is a 510(k) summary for the eQuinox Oxygen System, which is an oxygen concentrator. The device is being submitted for substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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The CAIRE Companion 5, Oxygen Concentrator, is Intended for the administration of supplemental oxygen up to 5 liters/minute. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Not Found

I am sorry, but based on the provided document, there is no information available regarding an acceptance criteria table, device performance report, or any study involving AI or human readers.

The document is a letter from the FDA regarding the 510(k) premarket notification for the "CAIRE Companion 5 Oxygen Concentrator." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. The "Indications for Use Form" specifies that the device provides supplemental oxygen up to 5 liters/minute and is not intended for life support or patient monitoring.

The document discusses regulatory compliance and the device's intended use, but it does not contain any data or discussion about:

• Acceptance criteria for device performance.
• Reported device performance metrics (e.g., accuracy, sensitivity, specificity).
• Any studies involving test sets, training sets, ground truth establishment, or expert reviews.
• AI algorithm performance, human-in-the-loop studies, or standalone algorithm performance.
• Sample sizes or data provenance for any studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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The Caire Spirit 300 will provide a source of supplemental oxygen for ambulatory healthcare patients by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device (digital oxygen conserving device-DOCD). The Spirit 300 is neither a life sustaining nor life supporting device.

The spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure relief valves, a manifold, an electronic printed circuit board conserving device (digital) and a protective case. The dewar has a capacity and capability to store 0.3L of liquid oxygen. The economizer regulator either draws gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below the 20 PSI, the economizer regulator will draw liquid oxygen, from the bottom of the dewar, which must then have to pass through a long vaporizing coil. The economizer regulator assures a longer duration time for the unit, because it allows the gas in the dewar headspace to be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold, dependent on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or diverts a 2L PM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent settings for 1, 1.5, 2, 3, 4 and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosage just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.

This document is a 510(k) summary for the Caire Inc. Spirit 300 Portable Liquid Oxygen Unit. It describes the device, its indications for use, and confirms that modifications have not altered the fundamental scientific technology of the predicate device.

Based on the provided text, there is no acceptance criteria or study information that describes device performance in the way requested. This document is a regulatory submission summary for substantial equivalence, not a detailed technical report of performance testing against specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Here's why:

• Type of Document: This is a 510(k) summary, primarily focused on demonstrating "substantial equivalence" to a predicate device for regulatory approval. It asserts that modifications haven't altered fundamental technology, but it doesn't present the detailed test results or the specific acceptance criteria for those tests.
• Focus on Equivalence: The core of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by comparing technical characteristics and demonstrating that any differences don't raise new questions of safety or effectiveness. It's not typically about proving performance against a novel set of clinical acceptance criteria with detailed study results as one might find for a PMA or CE Mark submission.

The document states: "Caire Inc confirms that the modifications described here within have not altered the fundamental scientific technology of the predicate device (Spirit 300) cleared under 510(K) number K013251." This is the primary "proof" offered in this summary, not a new study.

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The Spirit 300 HAS will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing 93% liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. The Spirit 300 HAS is intended to be transfilled only by the In-X Corporation's Home-Away System. The Spirit 300 HAS is neither a life sustaining nor life supporting device.

The Spirit 300 HAS is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure safety relief valves, a manifold, an electronic printed circuit board conserving device and a protective case. The dewar has a capacity and capability to store 0.3 liters of liquid oxygen. The vaporizer coil warms the oxygen gas to a suitable temperature, as it exits the dewar. Dependant on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent setting for 1, 1.5, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosages just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting. The Spirit 300 HAS is filled from a concentrator liquefaction device.

The provided text is a 510(k) summary for the Spirit 300 HAS Portable Liquid Oxygen Unit. It describes the device and its intended use, but it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance criteria and validation study results in detail. While device performance in terms of flow settings is mentioned in the device description, specific acceptance criteria for these performances and the studies validating them are not provided in this summary.

Therefore, I cannot fulfill the request for information on acceptance criteria and the study that proves the device meets them based on the provided text.

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The CAIRE Spirit 300 will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. The Spirit 300 is neither a life sustaining nor life supporting device.

The Spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuuminsulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure safety relief valves, a manifold, an electronic printed circuit board conserving device and a protective case. The dewar has a capacity and capability to store 0.3 liters of liquid oxygen. The vaporizer coil warms the oxygen gas to a suitable temperature, as it exits the dewar. The economizer regulator riams the ony gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below 20 PSI, the economizer regulator will draw liquid oxygen from the bottom of the dewar, which must then have to pass through a long vaporizing coil. The economizer regulator assures a longer duration time for the unit, because it allows the gas in the dewar head regulator be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold. Dependant on the flow selection setting, the manifold either delivers the gas to the the manifolial Deportually diverts a 2 LPM continuos flow directly to the oxygen outlet. The continuos flow setting is labeled CF on the flow selector. The conserving device has equivalent settings for 1, 1.5, 2, 3, 4 and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosages just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.

This document describes a 510(k) premarket notification for the CAIRE Spirit 300, a portable liquid oxygen unit. However, the provided text does not contain acceptance criteria or a study that proves the device meets specific performance metrics in the way you've outlined.

The document primarily focuses on establishing substantial equivalence to predicate devices (CAIRE Stroller, Puritan Bennett HELiOS, DeVilbiss LP05PP) based on technological characteristics and non-clinical testing. It states that the Spirit 300 "oxygenates similarly" to the predicate devices.

Therefore, I cannot provide the requested information in the format because the data is not present in the provided text.

Here's why and what information is available:

• Acceptance Criteria and Reported Device Performance: This information is typically found in performance testing reports, which are not included here. The document only generically states "non-clinical testing clearly shows that the Spirit 300 oxygenates similarly" to predicate devices. It notes slight differences, such as the Spirit 300 being "more sensitive" and oxygenating "a little better at the higher flow settings" than the DeVilbiss product.
• Sample Size (test set) and Data Provenance: Not specified. "Non-clinical testing" is mentioned, but no details on the number or type of tests, or the origin of any data, are provided.
• Number of Experts and Qualifications: Not specified. This typically relates to ground truth establishment for diagnostic or interpretive devices, which the Spirit 300 is not.
• Adjudication Method: Not applicable or specified.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for diagnostic devices where human readers interpret results, often with AI assistance. The Spirit 300 is an oxygen delivery device.
• Standalone (algorithm only) performance: Not applicable. This device is not an algorithm, but a physical medical device.
• Type of ground truth used: Not applicable in the context of diagnostic performance. For a device like this, performance would be measured against engineering specifications (e.g., oxygen flow rate, concentration, duration).
• Sample size for the training set: Not applicable. This device does not use a training set in the context of AI/ML.
• How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance/equivalence:

• Description of the Device: The Spirit 300 is a small, lightweight liquid oxygen portable unit with a vacuum-insulated cryogenic dewar, vaporizer coil, economizer regulator, pressure safety relief valves, manifold, electronic printed circuit board conserving device, and protective case. It has a 0.3-liter liquid oxygen capacity.
• Intended Use: Provides supplemental oxygen for ambulatory home healthcare patients by vaporizing medical grade liquid oxygen and dispensing it via an integral electronic conserving device. It is not a life-sustaining or life-supporting device.
• Technological Characteristics vs. Predicate Devices:
  • CAIRE Stroller: Spirit 300 has an integral electronic conserving device (delivers doses with patient inhalation) vs. Stroller's continuous flow. Spirit 300 is smaller/lighter. Dewar design, plumbing, fill connectors, relief valves, and vent valves are similar. Non-clinical testing showed similar oxygenation.
  • Puritan-Bennett HELiOS: Spirit 300 has an integral electronic conserving device vs. HELiOS's pneumatic conserving device. Otherwise, similar. Non-clinical testing showed similar (or significantly better) oxygenation.
  • DeVilbiss #LP05PP: Similar technical operation of conserving devices. Spirit 300 is 0.34L capacity vs. DeVilbiss 0.49L. Non-clinical testing showed similar oxygenation, with Spirit 300 being more sensitive and oxygenating "a little better at the higher flow settings."

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