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510(k) Data Aggregation
(148 days)
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(267 days)
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(178 days)
The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it's not intended to support or sustain life.
The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce oxygen. The device can separate nitrogen by absorbing through the molecular sieve when the room air enters the device and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 5L/min. The nasal cannula is not sold with the device, users need to purchase accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4.
The maximum altitude the subject device can operate without degradation of concentration is 2000m.
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(290 days)
The Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment (not include emergency medical services environment). The oxygen concentrator for adult use, providing pulsed oxygen flow.
Portable Oxygen Concentrator, model: JAY-1000P is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The JAY-1000P is small, portable and may be used in home, institutional, or travel environment.
The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.
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(177 days)
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.
| Feature | Acceptance Criteria (Subject Device Specification) | Reported Device Performance (from "Specifications" and "Performance" sections) |
|---|---|---|
| Oxygen Concentration | 90% - 3% /+ 5.5% at all settings | 90% - 3% /+ 5.5% at all settings |
| Inspiratory Trigger Sensitivity | <0.12 cmH2O | <0.12 cmH2O |
| Maximum Outlet Pressure | < 28.9 PSI (199 kPa) | < 28.9 PSI (199 kPa) |
| Nominal Sound Level (at setting 2) | Comparable to predicate (39 dBA typical) and within safe limits for patient use. (Subject device: 42.3 dBA) | 42.3 dBA (at setting 2) |
| Maximum Sound Pressure Level (at max flow setting S) | Comparable to predicate (54 dBA) and within safe limits for patient use. (Subject device: 50.5 dBA) | 50.5 dBA (at maximum flow setting S) |
| Battery Duration | Sufficient for portable use (Predicate: unspecified, but implies multiple hours) | 1.5-4.5 hrs |
| Operating Temperature | -5°C to 40°C (23°F to 104°F) | 23 to 104℉ (-5 to 40℃) |
| Operating Humidity | 5% to 90%, non-condensing | 5% to 90%, non-condensing |
| Operating Altitude | 0 to 5000 meters (0 to 16,400 ft) | 0 to 16,400 ft (0 to 5000 meters) |
| Measurement Uncertainties | Pulse volumes: ± 15% of rated volumePressure: ± 0.03 psig (General) / ± 0.05 cm H2O (Inspiratory Trigger Sensitivity)Oxygen concentration: ± 3% (not accounting for temperature, barometric pressure, and time from measurement device calibration) | Stated as listed. |
| Compliance with Standards | Adherence to relevant IEC and ISO standards (e.g., IEC 60601-1, ISO 80601-2-69, ISO 18562 series, IEC 62133-2) | Demonstrated through non-clinical testing. |
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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(132 days)
The Jumao JM-P50A Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients (ages 22 and older) requiring respiratory therapy on a prescriptive basis. It may be used in the home or in professional healthcare facility.
Portable Oxygen Concentrator, model: JM-P50A is a portable oxygen generator that is intended to release oxygen for respiratory therapy by physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula (supplied separately) to channel oxygen from the concentrator to the patient. The JM-P50A is small, portable and may be used in the home or in a professional healthcare facility.
Portable Oxygen Concentrator, model: JM-P50A, uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an air tank. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function.
Portable Oxygen Concentrator, model: JM-P50A, can be used in the home or in a professional healthcare facility. Power options include 100 – 240 V (50- 60Hz) AC power supply, rechargeable battery packs.
Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Portable Oxygen Concentrator, model: JM-P50A, senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient.
The portable oxygen concentrator consists of main unit, battery, power adapter and carry case. The main gas pathway of oxygen concentrator is composed of particle filter, particle filters, air compressor, molecular sieve beds, manifold valve, sensors, air tank.
This is a 510(k) clearance letter for a Portable Oxygen Concentrator (JM-P50A). The document primarily focuses on demonstrating substantial equivalence to a predicate device (Inogen Rove 6 Portable Oxygen Concentrator) through bench testing and compliance with recognized consensus standards. It explicitly states that "There was no clinical testing performed."
Therefore, the provided document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or human-in-the-loop assessment. The information you're asking for, particularly points 1-7 from your prompt, typically applies to studies proving clinical effectiveness or diagnostic accuracy of AI/software as a medical device (SaMD), which is not the case here.
However, I can extract information related to the device's technical specifications and how its performance was evaluated against standards, which serve as a form of acceptance criteria for this type of device.
Here's an interpretation based on the provided document, addressing what can be extracted and noting what cannot be:
Acceptance Criteria and Device Performance for Portable Oxygen Concentrator (JM-P50A)
Based on the provided 510(k) clearance letter, the acceptance criteria and the "study" (bench testing and standards compliance) focus on demonstrating substantial equivalence to a predicate device and adherence to recognized performance and safety standards. There was no clinical testing performed for this device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the performance specifications of the predicate device and the requirements of various international standards. The "reported device performance" refers to the JM-P50A's demonstrated capability to meet these criteria through bench testing.
| Acceptance Criterion (Based on Predicate Device & Standards) | Reported JM-P50A Device Performance | Discussion of Meeting Criteria |
|---|---|---|
| Oxygen Delivery Mode: Pulse Dose | Pulse Dose | Meets criterion |
| Flow Control Settings: 1,2,3,4,5,6 (Pulse Dose) | Pulse dose setting 1,2,3,4,5,6 | Meets criterion |
| Output Flow (Total volume Per minute, ml/min) per ISO 80601-2-67 +/- 15%: | ||
| - Setting 1: 210 ml/min | 210 ml/min | Meets criterion (within limits) |
| - Setting 2: 420 ml/min | 420 ml/min | Meets criterion (within limits) |
| - Setting 3: 630 ml/min | 630 ml/min | Meets criterion (within limits) |
| - Setting 4: 840 ml/min (Table typo: listed as 84) | 840 ml/min | Meets criterion (within limits) |
| - Setting 5: 1050 ml/min | 1050 ml/min | Meets criterion (within limits) |
| - Setting 6: 1260 ml/min | 1260 ml/min | Meets criterion (within limits) |
| Oxygen Purity: 90% - 3%/+6% at all settings | 90% - 3%/+6% at all settings | Meets criterion |
| Maximum Outlet Pressure: <199 kPa | <199 kPa | Meets criterion |
| Inspiratory Trigger Sensitivity: < 0.12 cm H2O | < 0.12 cm H2O | Meets criterion |
| Warm-up Time: 2 minutes | 2 minutes | Meets criterion |
| Acoustic Noise (Setting 2): 39 dBA (Predicate) | 43 dBA typical at setting 2 | Meets criterion (similar, accepted difference) |
| Acoustic Noise (Maximum system sound pressure): 54 dBA (Predicate) | 61 dBA (JM-P50A) | Meets criterion (similar, accepted difference) |
| Acoustic Noise (Maximum system sound power): 62 dBA (Predicate) | 66 dBA (JM-P50A) | Meets criterion (similar, accepted difference) |
| Safety Standard Compliance: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-1-6, IEC 62133-2, IEC 62366-1 | Compliant with latest versions of these standards | Meets criterion |
| Performance Standard Compliance: ISO 80601-2-69, ISO 80601-2-67 | Compliant with these standards | Meets criterion |
| Biocompatibility: ISO 18562-1, ISO 18562-2, ISO 18562-3, ISO 10993-17 | Compliant with these standards | Meets criterion |
| Software Verification: IEC 62304 and FDA Guidance | Software V&V performed | Meets criterion |
| Operating Environment (Temp): 41 to 104°F (5 to 40°C) | 41 to 104°F (5 to 40°C) | Meets criterion |
| Operating Environment (Humidity): 15% to 90%, non-condensing | 15% to 90%, non-condensing | Meets criterion |
| Operating Environment (Altitude): 0 to 10,000 ft (0-3048m) | 70kPa to 106 kPa (0-10,000 ft) | Meets criterion |
| Shipping & Storage Temp: Within -25 to 70°C (-13 to 158°F) (Predicate range) | -20°C to 60°C (-4°F to 140°F) | Meets criterion (within accepted range) |
| Shipping & Storage Humidity: Up to 90% non-condensing (Predicate) | 10% to 90% non-condensing | Meets criterion (similar, accepted difference) |
| Battery Re-charge Time (Device off): up to 3 hours (Predicate standard battery) | Not more than 3 hours when device is off | Meets criterion |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify a "sample size" in terms of patient data or a test set as would be used in an AI/clinical study. The evaluation was based on bench testing of the device prototype/production unit(s) against engineering specifications and international standards.
- Data Provenance: The data provenance for performance testing originates from bench testing conducted by the manufacturer and/or accredited testing laboratories to demonstrate compliance with standards. The country of origin of the device manufacturer is China (Jiangsu Jumao X-Care Medical Equipment Co., Ltd.). The data is prospective in the sense that it's generated from testing the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was not a study involving human interpretation or clinical data where expert ground truth would be established. The "ground truth" here is the established scientific and engineering principles underpinning device performance, as codified in international standards and the performance of the predicate device.
4. Adjudication method for the test set
Not applicable. No human adjudication was involved as this was not a clinical or AI performance study requiring human interpretation consensus.
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 device is a medical hardware device (portable oxygen concentrator), not an AI/software-driven diagnostic tool that assists human readers. The document explicitly states: "There was no clinical testing performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device in the context of diagnostic performance. The device has "embedded software" that controls its functional cycle, and this software was verified and validated against IEC 62304 and FDA guidance, but this is distinct from an AI generating diagnostic outputs.
7. The type of ground truth used
The "ground truth" in this context is established by:
- International Consensus Standards: e.g., ISO 80601-2-67, ISO 80601-2-69, ANSI AAMI ES60601-1, IEC series, ISO 18562 series. These standards define accepted performance limits and test methodologies for portable oxygen concentrators.
- Predicate Device Specifications: The performance characteristics of the legally marketed predicate device (Inogen Rove 6 Portable Oxygen Concentrator) serve as a benchmark for demonstrating substantial equivalence.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI that requires a "training set" of data in the typical sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for AI/ML in this context.
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(128 days)
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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(267 days)
The Portable Oxygen Concentrator, model: Spirit-3, is intended to provide supplemental oxygen in a home, institutional, or travel environment. And the device is used with adult only, not used with pediatrics, infant, or neonate patients, etc.
Portable Oxygen Concentrator, model: Spirit-3, is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to deliver oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. Portable Oxygen Concentrator, model: Spirit-3, is capable of continuous use in a home, institutional, or travel environment. Power options include 100 – 240 V (50/ 60Hz) AC power supply, DC power supply and rechargeable lithium-ion battery. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories.
The FDA 510(k) clearance letter and supporting documentation for the Portable Oxygen Concentrator (Spirit-3) do not describe a study involving an AI/ML component or human readers. Therefore, there is no information available regarding acceptance criteria related to AI/ML performance, sample sizes for test or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
The provided document focuses on demonstrating the substantial equivalence of the Spirit-3 Portable Oxygen Concentrator to predicate devices through technical specifications, non-clinical performance testing (bench testing), and compliance with various international standards. The "performance" being discussed in the document refers to the physical and functional performance of the oxygen concentrator itself (e.g., oxygen concentration, flow control, electrical safety, biocompatibility), not the performance of an AI/ML algorithm in an image or data interpretation task.
Therefore, many of the requested categories are "Not Applicable" (N/A) in the context of this specific regulatory submission.
However, I can extract the acceptance criteria and reported device performance for the Spirit-3 Portable Oxygen Concentrator based on the non-clinical tests described.
Here's the information derived from the provided text, adapted to the requested format where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature / Test | Acceptance Criteria (from Standards/Predicate Device Comparison) | Reported Device Performance (Spirit-3) |
|---|---|---|
| Oxygen Concentration | 90%-3%/+6% at all settings (Same as predicate) | 90%-3%/+6% at all settings |
| Startup time | 2 minutes (Same as predicate) | 2 minutes |
| Acoustic Noise | Similar to 55.3 dBA at 0.84 LPM (predicate) | 55 dBA at 0.75 LPM (Similar) |
| Electrical Safety | Compliance with IEC 60601-1 | Complied with ANSI AAMI ES60601-1, IEC 60601-1-11, IEC 60601-1-8, ISO 80601-2-69, ISO 80601-2-67, IEC TS 60601-4-2:2024, CISPR 25: 2021 |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Complied with IEC 60601-1-2 |
| Biocompatibility - Cytotoxicity | Compliance with ISO 10993-5:2009 | Tested and complied (explicitly stated in "Discussion of difference" for patient contact materials) |
| Biocompatibility - Sensitization | Compliance with ISO 10993-10:2021 | Tested and complied (explicitly stated in "Discussion of difference" for patient contact materials) |
| Biocompatibility - Irritation | Compliance with ISO 10993-23:2021 | Tested and complied (explicitly stated in "Discussion of difference" for patient contact materials) |
| Biocompatibility - Particulate Matter (Breathing Gas Pathway) | Compliance with ISO 18562-2:2017 | Tested and complied |
| Biocompatibility - Volatile Organic Compounds (Breathing Gas Pathway) | Compliance with ISO 18562-3:2017 | Tested and complied |
| Software Verification & Validation | Performs as intended according to FDA Guidance | Performed and demonstrated as intended |
| Battery Safety | Compliance with IEC 62133-2 | Tested and verified via IEC 62133-2 |
| Operating Condition (Temperature) | Within acceptable range (Predicate: 5 to 40˚C) | 10˚C to 35˚C (Narrower, but compliant with ISO 80601-2-69) |
| Operating Condition (Humidity) | Within acceptable range (Predicate: 10% to 90%) | 15% to 75%, noncondensing (Narrower, but compliant with ISO 80601-2-69) |
| Operating Condition (Altitude) | Within acceptable range (Predicate: 0 to 3048 meters) | 0 to 3000 meters (Narrower, but compliant with ISO 80601-2-69) |
| Pulse mode bolus size | Similar to 42 mL per breath at setting 4 with 20 BPM (predicate) | 37.5mL per breath at setting 4 with 20BPM (Smaller, but covered by subject device and does not raise new questions of safety and effectiveness) |
| Rated breath rate | Similar to 10 - 40 Breath per minute (predicate) | 15 - 40 Breath per minute (Narrower, but meets ISO 80601-2-67:2020 requirement for disclosure and covered by predicate range) |
| Maximum oxygen discharge pressure | Close to 151.68kPa (22psi) (reference device) | 150kPa (21.8psi) (Higher than predicate, close to reference device, no new questions of safety/effectiveness) |
Study Proving Device Meets Acceptance Criteria
The study conducted to prove the Spirit-3 Portable Oxygen Concentrator meets its acceptance criteria was a series of non-clinical bench tests and evaluations demonstrating compliance with recognized consensus standards and comparison to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of an AI/ML algorithm being evaluated. For the performance testing of the physical device, it implicitly refers to the specific unit(s) of the Spirit-3 device undergoing testing. The document does not specify the number of devices tested but implies standard product testing.
- Data Provenance: The tests were conducted internally or by accredited labs as part of the manufacturing and submission process for Jiangsu Yuyue Medical Equipment & Supply Co., LTD. (China). This is prospective testing of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical oxygen concentrator, not an AI/ML diagnostic or interpretative device that requires expert ground truth for output validation.
4. Adjudication method for the test set:
- Not Applicable. As no expert interpretation was required. Device performance was objectively measured against predefined standard requirements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is relevant for AI/ML systems that assist human readers in tasks like image interpretation. The Spirit-3 is a portable oxygen concentrator and does not involve human reading or AI assistance in that capacity.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device does not involve a standalone algorithm for diagnostic or interpretative purposes. "Standalone" performance in this context refers to the device's inherent mechanical, electrical, and oxygen delivery performance.
7. The type of ground truth used:
- The "ground truth" for the performance of the portable oxygen concentrator is defined by the international consensus standards mentioned (e.g., ISO 80601-2-69, ISO 80601-2-67, IEC 60601-1, ISO 10993 series) and the specifications of the predicate devices. These standards provide benchmarks and methodologies for evaluating physical and electrical safety, essential performance, and biocompatibility.
8. The sample size for the training set:
- Not Applicable. This device does not use an AI/ML training set.
9. How the ground truth for the training set was established:
- Not Applicable. No AI/ML training set was employed for this device.
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(171 days)
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"):
| Acceptance Criteria Category | Specific Acceptance Standard/Criterion (Implied or Explicit) | Reported Device Performance / Compliance |
|---|---|---|
| Safety & Electrical | ANSI AAMI ES 60601-1 (General Safety) | Complies with AAMI ANSI ES60601-1 |
| IEC 60601-1-11 (Home Healthcare) | Complies with IEC 60601-1-11 | |
| Electromagnetic Comp. | IEC 60601-1-2 (EMC) | Complies with IEC 60601-1-2 |
| Performance (Oxygen Conc.) | ISO 80601-2-69 (Oxygen Concentrator Equ.) | Complies with ISO 80601-2-69 |
| ISO 80601-2-67 (Oxygen-conserving Equ.) | Complies with ISO 80601-2-67 | |
| Software | IEC 62304 (Software Verification) | Complies; Software V&V performed per FDA Guidance |
| Usability | IEC 60601-1-6 (Usability) | Complies with IEC 60601-1-6 |
| Alarms | IEC 60601-1-8 (Alarm Systems) | Complies with IEC 60601-1-8 |
| Biocompatibility | ISO 18562-1, -2, -3 (Breathing Gas Pathways) | Complies with ISO 18562-1, -2, -3 |
| ISO 10993-1, -5, -10, -23 (Biological Evaluation - Patient Contact) | Complies with ISO 10993-1, -5, -10, -23 | |
| Battery Safety | IEC 62133-2 (Lithium Batteries) | Complies with IEC 62133-2 |
| Oxygen Concentration | 90%-3%/+6% at all settings (P2-TOC) | "90%-3%/+6% at all settings" (vs. Predicates 90% +/- 3%) - Risk mitigated by ISO 80601-2-67: 2020 testing. |
| Acoustic Noise | ≤ 60dB (A) (Gear 10 of pulse mode/ Gear 5 of continuous mode) | "litter bigger than predicate device Model 1000" but "standard requirements have been met" (ISO 80601-2-69, IEC 60601-1) |
| Physical Dimensions/Weight | (Not a specific standard, but compared to predicates) | Different from predicates but risks mitigated by ISO 80601-2-69, EC60601-1, ISO 80601-2-67 testing. |
| Flow Rates | (Not a specific standard, but compared to predicates) | Continuous: 1.0-3.0 LPM (Same as predicates). Pulse: 5-200 ml Pulse Volumes (differs from predicates, max flow rate is smaller) - risks mitigated by various ISO/IEC testing. |
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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(281 days)
Intended to produce oxygen for emergency use at 6 LPM flow rate for at least 15 minutes (90 liters) for individuals 17 years and older requiring emergency or supplemental oxygen.
The Rugged Oxygen Generator (ROG) is intended for environment such as emergency use, home use, and commercial use and is OTC. The ROG is designed to provide supplemental oxygen and is a single use product. The ROG is a chemical oxygen generator that produces a minimum of 90 liters of oxygen at ≥96% purity for minimum of 15 minutes with an average flow rate of 6 liters per minute or greater. There is a need for oxygen in a variety of applications/locations where compressed oxygen cylinders are not suitable.
Principle of Operation: The subject device is initiated though a friction interaction between an integrated phosphorous match and the candle block. To initiate, open the lid and turn the dial clockwise 2-3 times. The turning of the dial will rotate the match and screw the match down into the candle block. This will start the chemical reaction, which will produce oxygen. Once oxygen is flowing, close the lid and place the face mask onto patient.
Here's a summary of the acceptance criteria and study information for the Rugged Oxygen Generator (ROG) based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| % Oxygen | 96% (Predicate: 99%. Note: USP defines medical oxygen purity as > 93%) |
| Flow rate minimum | 6 LPM |
| Duration | At least 15 minutes |
| Initiation of oxygen flow | 5 seconds |
| Housing temperature | <45°C Maximum |
| Temperature of gas at outlet | <40°C Maximum |
| Storage temperatures | 0° to + 40°C / 32° to +104°F |
Study Information
The provided document describes non-clinical bench testing to demonstrate that the subject device met its acceptance criteria. This is not a study on diagnostic accuracy or comparative human-AI performance.
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Sample size used for the test set and the data provenance: Not explicitly stated as this is non-clinical bench testing of a physical device. The testing was conducted by the sponsor, Molecular Products Ltd. (UK).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance features like oxygen purity, flow rate, and temperature is established through direct measurement and adherence to specifications.
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Adjudication method for the test set: Not applicable for non-clinical bench testing. Performance metrics are measured directly.
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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 device is an oxygen generator, not an AI-powered diagnostic tool.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm. Bench testing evaluates the device's inherent performance.
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The type of ground truth used: Direct physical measurements and adherence to engineering and performance specifications (e.g., flow rate, purity, temperature limits). Biocompatibility testing was also performed, where the ground truth is established by relevant ISO standards (ISO 18562-2 and ISO 18562-3) and their pass/fail criteria.
-
The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
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How the ground truth for the training set was established: Not applicable.
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