Search Results

The Aria sequential circulator is a programmable sequential, pneumatic compression device intended for use by medical professionals and patients at home, for the treatment of the following conditions:

• Chronic edema
• Lymphedema
• Venous insufficiency
• Wound healing

The Aria system consists of two main components: A flow generator and a garment. The garment is to be wrapped around the limb, providing a comfortable fit. The garment has seven (7) chambers that are filled with air by the flow generator to provide compression on the extremity. The Aria system uses a compressand-release massage action, similar to the predicate, in order to stimulate lymphatic vessels in the treated area and encourage fluid clearance.

The Aria system retains similar hardware and performance features of the predicate device. Key features include flow generator, valves, A/C plug pack, lower limb garment, tubing, no-LCD User Interface and ON/OFF button. The Aria System contains a microprocessor-controlled flow generator/blower system that generates pressure from 0-45 mmHG to provide for effective treatment of the conditions described in the IFU.

The Aria flow generator has no control settings and delivers one pre-programmed therapy mode.

This document describes the Inova Labs Aria System, a programmable sequential, pneumatic compression device. It is intended for the treatment of chronic edema, lymphedema, venous insufficiency, and wound healing. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which the device performance is reported with specific numerical targets. Instead, it describes "bench testing" which included performance comparisons to a predicate device. The results of this testing are stated to "demonstrate that the Aria system raises no new safety or effectiveness concerns and is substantially equivalent to the predicate device."

Here's a summary of the characteristics compared with the predicate device (Entre Model PD08-U, K143185):

The "bench testing" areas mentioned for the Aria System were:

• Pressure stability
• Sleeve burst test
• Sleeve leakage test
• Sleeve integrity test
• Pressure accuracy test
• Chamber filling cycle time testing
• Total therapy time

The report generally states that the Aria system "met the Aria System Specification when compared to the predicate device" for these tests, implying that the performance was either equivalent or acceptable relative to the predicate. Specific numerical values for acceptance criteria or detailed results are not provided in this summary.

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

The document primarily discusses non-clinical bench testing. There is no "test set" in the context of patient data described for evaluating device performance. The testing involved physical device units. The provenance of the device units used for bench testing (e.g., country of manufacture) is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as there was no clinical test set requiring expert ground truth establishment. The evaluation was based on bench testing against engineering specifications and comparison to a predicate device.

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

This question is not applicable as there was no clinical test set requiring 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

This question is not applicable. The Aria System is a pneumatic compression device, not an AI-assisted diagnostic or interpretative device that would involve human "readers." No MRMC study was performed.

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

This question is not applicable. The Aria System itself is a standalone medical device (hardware) that delivers therapy; it's not an algorithm whose performance needs to be assessed independently. While it contains a microprocessor and potentially firmware/software for control, the evaluation focuses on the overall device's physical and functional performance through bench testing.

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

For the non-clinical testing, the "ground truth" or reference for evaluating performance was based on engineering specifications for the Aria System and the performance characteristics of the legally marketed predicate device (Entre Model PD08-U, K143185). For example, pressure accuracy would be compared to a calibrated standard.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a "training set" of data for learning.

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

This question is not applicable as there was no training set.

Ask a specific question about this device

Actives DUO2 Oxygen Concentrator System is used on a prescriptive basis by adult patients who are diagnosed as requiring supplemental oxygen. The oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home or institutional/hospital setting.

The Activox DUO2 Oxygen Concentrator is designed to be primarily a stationary device for home/institutional use. The LifeChoice Activox POC is a portable device that provides additional functionality of the Activox DUO2Oxygen Concentrator System. The Activox DUO2 Oxygen Concentrator base unit must be connected to the LifeChoice Activox POC a minimum of once every 45 days in order for the base unit to function as intent of this feature is to ensure the user at least periodically charges the battery powered LifeChoice Activox POC. While the Activox DUO2 is connected, it will charge the internal battery for the LifeChoice Activox POC. The Activox DUO2 can also charge the external battery (sold separately) for the LifeChoice Activox POC after the internal battery is charged.

This submission for the Activox DUO2 Oxygen Concentrator System focuses on demonstrating substantial equivalence to predicate devices rather than proving a new or novel performance claim. Therefore, the traditional concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as might be seen for an AI/ML diagnostic device with performance metrics like sensitivity, specificity, or AUC, is not directly applicable here.

Instead, the acceptance criteria are implicitly met by demonstrating that the Activox DUO2 System is "as safe and as effective" as the predicate devices based on design verification tests and a comparison of technological characteristics.

Here’s a breakdown of the information as requested, adapted to the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of submission, "acceptance criteria" are the characteristics of the predicate devices that the new device must match or be equivalent to. The "reported device performance" is how the Activox DUO2 demonstrates this equivalence.

2. Sample Size Used for the Test Set and Data Provenance

This submission does not involve a "test set" in the sense of patient data for evaluating diagnostic performance. Instead, the "testing" refers to design verification tests on the physical device. The sample size for these engineering tests (e.g., number of units tested for vibration, shock, EMC) is not specified in this summary. The data provenance would be internal to Inova Labs, based on their engineering and quality assurance processes, and would be prospective testing of the manufactured devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. "Ground truth" in the context of expert review of patient data is not relevant for this engineering device submission. The "truth" is established by adherence to engineering specifications and international standards.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for this type of technical device testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic aid (often AI-based) on human reader performance, which doesn't apply to an oxygen concentrator.

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

No, "standalone performance" in the context of an algorithm or AI is not applicable here. This device is a mechanical/electronic medical device.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the safety and effectiveness of the Activox DUO2 System is multi-faceted:

• Engineering Specifications: The device's performance characteristics (e.g., oxygen concentration, flow rate, alarm thresholds) are designed to meet predefined internal specifications.
• International Standards: The device's performance and safety are measured against recognized national and international standards for oxygen concentrators (e.g., IEC 60601-1, IEC 60601-1-2, ISO 8359).
• Predicate Device Performance: The "truth" for substantial equivalence is the established performance and safety profile of the legally marketed predicate devices. The Activox DUO2 must perform equivalently or better.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm that learns from data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set.

Ask a specific question about this device

The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.

The LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life supporting. The device provides approximately 90% oxygen to patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 5.0 liters per minute in increments of 1.0 liter per minute. The LifeChoice is a portable device which can be used in a home, institution or travel environment. The device uses molecular sieve pressure swing adsorption technology.

This document, specifically a Special 510(k) Summary for the Inova Labs LifeChoice Oxygen Concentrator (Model OXY1000), describes the device and its indications for use, but does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as one would expect for an AI/ML medical device submission.

The document explicitly states: "The technologies used in the modifications to the LifeChoice Oxygen Concentrator do not create any new questions of safety and effectiveness. Benchtop performance testing and comparison of performance characteristics have demonstrated that the modified LifeChoice is substantially equivalent to the previously marketed version."

This indicates that the submission is based on substantial equivalence to a predicate device (K072688) and relies on benchtop testing for performance, rather than a clinical study with human subjects, ground truth establishment, or specific acceptance criteria for AI/ML performance metrics.

Therefore, many of the requested sections about AI/ML specific evaluation are not applicable based on the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria in the provided document. The basis for acceptance is "substantial equivalence" to a predicate device (K072688).
• Reported Device Performance: The document states the device:
  • Provides approximately 90% oxygen.
  • Delivers oxygen on a demand flow basis at an equivalent rate of 1.0 LPM to 5.0 LPM in increments of 1.0 LPM.

Therefore, a table cannot be constructed as requested for AI/ML performance.

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

• Not applicable. The document refers to "benchtop performance testing" and comparison of characteristics, not a clinical test set with human subjects or data provenance typically associated with AI/ML evaluations.

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. This device is an oxygen concentrator, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth for a test set.

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

• Not applicable. No clinical test set or adjudication method is mentioned.

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 not an AI/ML system and no MRMC study was performed.

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

• Not applicable. This is a hardware medical device, not an algorithm.

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

• Not applicable. The performance is based on the physical output of oxygen and flow rates, verified through engineering/benchtop testing, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it's not an AI/ML system.

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

• Not applicable. No training set is used for this device.

Ask a specific question about this device