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The PureFill Oxygen Compressor is indicated to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting or life sustaining.

Environment of use: - Sub-acute care facilities and home settings

The PureFill Oxygen Compressor is designed to accept low pressure (14-30 PSIG) oxygen from existing oxygen concentrators and pressurize the oxygen to 2,000 PSIG to fill patient's portable oxygen cylinders.

This document describes the PureFill Oxygen Compressor, a device designed to pressurize low-pressure oxygen from concentrators to fill portable oxygen cylinders. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to previously cleared predicate devices.

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

Since this is a 510(k) submission for a physical medical device (an oxygen compressor), the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices across various aspects, including indications for use, technology, environment of use, patient population, and performance specifications. There are no explicit "acceptance criteria" in terms of clinical accuracy metrics like sensitivity or specificity as would be found for an AI/ML device. Instead, the performance is compared to the predicate devices.

Here's a table summarizing the comparison of the PureFill Oxygen Compressor to its predicate devices, which serves as the "reported device performance" against the implicitly accepted standards of the predicate devices:

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

This document details a 510(k) submission for a physical medical device (an oxygen compressor), not a software or AI/ML device. Therefore, the concept of a "test set" with "data provenance" as applied to clinical data (e.g., patient images, electronic health records) is not applicable here.

The "testing" mentioned is primarily non-clinical bench testing to confirm the device meets engineering and safety standards, and performance specifications comparable to predicates. The document does not specify sample sizes in terms of, for example, number of patients or clinical cases.

The non-clinical tests performed included:

• Materials testing (VOC, PM25, Ozone, CO, CO2)
• Performance Bench Testing (ES60601-1, IEC 60601-1-2, IEC 61000-6-3, EN55011 CISPR 22, Altitude, Fill rate, Oxygen Pressure Surge Testing, Material Selection and Cleaning of Components, Autogenous Ignition Temperature Test, Acoustic Noise, Audible Acoustic Energy).

These tests are typically conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility, rather than derived from real-world patient data in a specific country. They are prospective tests conducted on prototypes or production units of the device.

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. As explained above, this is a physical device with non-clinical testing. "Ground truth" in the context of expert medical opinion for diagnostic accuracy is not relevant here. The "truth" for this device's performance is objective measurements from engineering tests (e.g., pressure output, filling time, oxygen concentration verified by laboratory equipment).

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

Not applicable. There is no clinical test set requiring expert adjudication for this type of device. Performance is determined by objective measurements against engineering specifications and comparison to predicate device specifications.

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 specific to evaluating the impact of diagnostic aids (often AI) on human reader performance in interpreting medical images or other diagnostic data. This device is an oxygen compressor, not a diagnostic aid.

6. 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 or AI.

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

The "ground truth" for this device's performance is established through:

• Engineering Specifications: The device is tested against its own design specifications for parameters like pressure output, fill rates, power consumption, and alarm thresholds.
• International Standards: Compliance with recognized electrical safety, electromagnetic compatibility, and medical device standards (e.g., ES60601-1, IEC 60601-1-2) serves as a "ground truth" for safe operation.
• Predicate Device Performance: The functional and performance characteristics of the legally marketed predicate devices serve as an established benchmark for "acceptable" performance in the market.

8. The sample size for the training set

Not applicable. This is a physical device; there is no "training set" like there would be for an AI/ML algorithm. The device design and manufacturing processes are developed based on engineering principles and regulatory requirements.

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

Not applicable, as there is no training set for this physical device.

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The Chad Therapeutics Evolution Model OM-900M is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 6 liters per minute, in their home and for ambulatory use.

The Inovo Evolution OM-900M is a microprocessor-controlled device, which is a combination of a oxygen pressure regulator and a oxygen conserver, designed for use with ambulatory oxygen systems. The built in oxygen regulator reduces the oxygen pressure from the oxygen cylinder to ensure proper operation of the oxygen conserving device. The low pressure oxygen enters the conserver portion of the device where the breath detection circuitry and inhalation sensors control the low pressure oxygen to deliver a precise amount of supplemental oxygen at a specific point in the breathing cycle. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute depending on the user setting. The OM-900M is also able to detect motion via a 3 axis accelerometer. If motion is detected the software will automatically increase the oxygen delivery(active mode) to the patient. After motion has ceased, the software will then revert to the original rest setting(rest mode). The motion technology is taken from a previously cleared device Chad Sage Model TD-100 - K033364.

The Inovo Evolution OM-900M is an oxygen conserver. The provided text describes the device, its intended use, and a comparison to predicate devices, focusing on the addition of a motion detection feature.

Here's an analysis to extract the requested information regarding acceptance criteria and the study proving the device meets them:

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

The provided 510(k) summary (K113111) for the Inovo Evolution OM-900M does not explicitly state a table of quantifiable acceptance criteria with corresponding device performance metrics for the overall device or its new motion detection feature. Instead, it relies on demonstrating substantial equivalence to predicate devices through verification and validation activities.

However, based on the text, the implicit acceptance criteria are that the modifications (motion detection software and hardware) do not introduce new safety and effectiveness issues and that the device functions as intended, similar to the predicate devices.

The "reported device performance" is broadly stated as passing all tests outlined in the validation protocols. Specific quantitative performance targets for the motion detection feature itself (e.g., accuracy of motion detection, response time to motion, or how much oxygen delivery increases) are not detailed 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 does not specify a separate "test set" in the context of and AI/algorithm-focused study with a defined sample size of patients or images. The verification and validation activities (PV-192 and PV-193) are described as testing the software and hardware of the device. This implies engineering or laboratory testing rather than a clinical trial with human subjects.

Therefore, information on sample size for a "test set" and data provenance (country of origin, retrospective/prospective) related to AI/algorithm performance is not applicable or provided in this 510(k) summary. These types of details are typically found in clinical study reports, which are not included here.

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 information is not applicable as the document does not describe a study involving expert-established ground truth for a test set (e.g., for image interpretation or disease diagnosis). The verification and validation activities are for the device's functional performance, not for an AI algorithm making diagnostic interpretations.

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

This information is also not applicable as there is no mention of a test set requiring adjudication of findings, which is typical for clinical studies involving multiple reviewers or diagnostic outputs.

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

No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is relevant for AI systems that assist human readers in tasks like medical image interpretation. The Inovo Evolution OM-900M is an oxygen conserver with a motion detection feature, not an AI-powered diagnostic tool in that sense.

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

The device's motion detection feature can be considered a standalone algorithmic component that senses motion and automatically adjusts oxygen delivery without direct human intervention once activated. The "Non Clinical Verification" section describes that the software for the motion detection algorithm underwent full Software Verification and Validation (PV-192), and the hardware was tested via Product Validation (PV-193).

However, the nature of these tests is focused on the correct functioning of the motion detection system (e.g., does it detect motion, does it switch to active mode, does it revert to rest mode correctly) rather than a comparative performance against a "ground truth" of human activity, or direct clinical outcomes. The document does not provide specifics on the metrics used to assess this "standalone" performance beyond stating that it "passed all tests."

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

For the verification and validation of the motion detection feature, the "ground truth" would likely be based on engineering specifications and predefined performance thresholds for the accelerometer and associated software.

• For software verification (PV-192), the ground truth for tests would be the expected software behavior based on the Software Requirements Specification (SP-210) and Software Design Description (SP-209). For example, if a specific motion is simulated, the device should switch to active mode.
• For hardware validation (PV-193), the ground truth would involve confirming that the accelerometer correctly senses motion within specified parameters and that the additional button functions as intended.

It is not based on expert consensus, pathology, or clinical outcomes in the traditional sense of a diagnostic AI system study.

8. The sample size for the training set

This information is not applicable. The motion detection functionality appears to be based on an algorithm that processes accelerometer data rather than a machine learning model that requires a "training set" of data to learn from. The description suggests a rule-based or threshold-based system rather than a deep learning approach.

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

This information is not applicable as there is no mention of a training set for a machine learning algorithm.

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The Chad Therapeutics Evolution Model OM-900 is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 7 liters per minute, in their home and for ambulatory use

The Inovo Evolution is a microprocessor-controlled device, which is a combination of a oxygen pressure regulator and a oxygen conserver, designed for use with ambulatory oxygen systems. The built in oxygen regulator reduces the oxygen pressure from the oxygen cylinder to ensure proper operation of the oxygen conserving device. The low pressure oxygen enters the conserver portion of the device where the breath detection circuitry and inhalation sensors convert the low pressure oxygen to deliver a precise amount of supplemental oxygen at a specific point in the breathing cycle. It delivers boluses of oxygen that is equivalent to 1 to 7 liters per minute depending on the flow rate setting

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Inovo Evolution OM-900 Series:

Disclaimer: The provided text is a 510(k) summary from 2010. It focuses on demonstrating substantial equivalence to a predicate device, which means it might not contain the detailed, quantitative acceptance criteria and study results typically found in full clinical study reports or newer FDA submissions. Much of the information requested (e.g., sample sizes for training/test sets, expert qualifications, specific metrics for acceptance criteria) is not present in the provided document.

Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Inovo Evolution OM-900 Series is primarily a submission for substantial equivalence. It does not explicitly state quantitative acceptance criteria in a table format with corresponding performance results in the way a performance study might. Instead, it relies on demonstrating that its design, function, and features are comparable to the predicate device (Chad Therapeutic Lotus Models OM-700 & OM-700S) and that testing confirms it performs as intended and meets the same "performance criteria" as the predicate.

The key acceptance criteria, as implied by the document, revolve around:

• Same Intended Use: The device must serve the same purpose for the same patient population.
• Basic Modes and Settings: It must offer comparable operational modes and settings.
• Similar Materials: The materials used should be equivalent.
• Equivalent Oxygen Delivery Method: The fundamental way it delivers oxygen should be the same.
• Performance (General): Testing must demonstrate it meets performance criteria and functions as intended, implying that its oxygen delivery characteristics (bolus size, equivalence to L/min, breath detection) are comparable to the predicate.

Since no specific quantitative metrics or a comparative table are provided in the document, I cannot populate a table with "acceptance criteria" vs. "reported performance" with specific numbers. The document states a general conclusion:

"together with the results of testing demonstrates the device to be substantially equivalent to the predicate device in terms of meeting performances criteria and functioning as intended."

This indicates that internal testing was conducted to ensure the device performs similarly to the predicate, particularly regarding breath detection (even though the circuitry is new) and bolus sizes. The bolus sizes are explicitly mentioned as "the same with the exception of one additional setting No. 7."

Detailed Study Information (Based on Available Text)

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

   • Not provided. The document states "results of testing," but does not specify the type of testing (e.g., in vitro, animal, human clinical), sample size, or data provenance. Given the nature of a 510(k) for an oxygen conserver, it's likely initial testing focused on engineering and performance verification in a lab setting, possibly with some human-factors or usability testing, rather than a large clinical trial with patient data.

2. 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/Not provided. This type of information is usually relevant for studies involving image interpretation or diagnostic accuracy where expert consensus is needed to establish ground truth. For an oxygen conserver, ground truth would likely be established through objective measurements of oxygen delivery, breath detection accuracy, and functionality, rather than expert interpretation.

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

   • Not applicable/Not provided. Adjudication methods are typically used in studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved to establish ground truth. This is not the type of study described or implied for this device.

4. 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

   • No. An MRMC comparative effectiveness study is not mentioned and is not relevant for an oxygen conserver device, which is a therapeutic device, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable/Not provided in this context. While the device is microprocessor-controlled and has "breath detection circuitry," it's a medical device delivering oxygen, not an AI algorithm generating a diagnosis or prediction without human interaction. Performance testing would have evaluated the device's standalone operation and its ability to deliver oxygen accurately based on detected breaths. However, the term "standalone" in the context of AI performance metrics (algorithm only) is not relevant here.

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

   • Objective Measurements/Engineering Specifications. For an oxygen conserver, ground truth would be established through objective measurements based on engineering specifications and physiological principles. This would include accurately measuring:
     • Oxygen flow rates and bolus sizes
     • Accuracy of breath detection
     • Battery life
     • Pressure regulation
     • Safety parameters (e.g., leaks, pressure limits)
   • The document implies that these measurements were compared against the predicate device's known performance characteristics and relevant standards.

7. The sample size for the training set

   • Not applicable/Not provided. This device is hardware-based with microprocessor control, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves design, engineering, and iterative testing/refinement of the hardware and embedded software.

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

   • Not applicable/Not provided. As above, the concept of a "training set" and its "ground truth" is not directly applicable to this type of device development process. Ground truth for the underlying principles (e.g., desired oxygen bolus sizes, breath detection sensitivity) would be established by medical standards, physiological requirements, and the performance characteristics of the predicate device.

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The Inovo AccuPulse Single Lumen Pneumatic Conserving Regulator is used to deliver a prescribed flow of medical-grade oxygen to the patient while conserving gas from a high-pressure oxygen cylinder, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.

The Inovo, Inc. AccuPulse Conserving Regulator is a high pressure oxygen regulator and conserving device that is combined into a single compact unit. It is designed to extend the use time of oxygen cylinders. The AccuPulse senses the start of inhalation and immediately releases a short "pulse" of oxygen to the patient. Since all of the "pulse" of oxygen finds it way deep into the lungs, less oxygen is required to accomplish the same effect as traditional continuous-flow oxygen requlators.

The AccuPulse Conserving Regulator contains an integral regulator with a CGA 870 style yoke. The regulator portion reduced the pressure to about 22PSIG. The AccuPulse then delivers oxygen to the patient by sensing the beginning of inhalation using a diaphragm, which opens a sliding valve for a specific period of time controlled by pneumatic timing. The unit is designed to deliver 12 cc/lpm of oxygen to the patient at flows from 1 LPM to 6 LPM.

The AccuPulse also has a continuous mode that delivers selectable continuous flow in the event of device failure.

Patient inspiration is detected by a pressure-sensitive diaphragm set by the manufacturer in the range of 0.10 to 0.35 cm H2O. The device is capable of delivering a bolus of oxygen at the beginning of the patient's inhalation at breathing rates up to 40 breaths per minute (BPM). Patients with more rapid breathing rates than 40 BPM will cause the device to "skip" breaths.

This 510(k) summary describes a medical device, the Inovo, Inc. AccuPulse Conserving Regulator, which is an oxygen conserving device. The information provided is for regulatory clearance and does not detail a study in the context of typical clinical trials with specific acceptance criteria outcomes. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

Here's an analysis of the provided text in relation to your questions:

Device Acceptance Criteria and Performance (as determined by non-clinical testing for substantial equivalence)

The document does not explicitly state "acceptance criteria" in the format of specific quantitative thresholds that need to be met for clinical effectiveness. Instead, the "acceptance" is based on demonstrating that the device performs similarly to predicate devices and does not raise new questions of safety or effectiveness. The performance testing conducted is described as "Non-Clinical Test Performed for Determination of Substantial Equivalence."

The "reported device performance" is summarized by stating that "non-clinical testing supplied demonstrates that there are no differences in their performance characteristics."

Study Details Based on the Provided Text:

This submission is for a 510(k) premarket notification, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical (human) studies to establish new safety or effectiveness claims with specific acceptance criteria and ground truth.

1. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. This was a non-clinical performance testing (bench testing), not a clinical trial with a "test set" of patient data. The tests were performed on the device itself.
• Data Provenance: Not applicable, as there is no patient data or clinical data described. The tests were performed in a lab setting by the manufacturer.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There was no "ground truth" derived from expert consensus for a test set of patient data. The performance tests are objective measurements of the device's physical and functional characteristics.

3. Adjudication method for the test set:

• Not applicable. No clinical test set or adjudication process for clinical outcomes is described.

4. 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 pneumatic oxygen conserving regulator, not an AI-powered diagnostic or imaging device that would involve human readers or AI assistance in interpretation.

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

• Not applicable. This is not an algorithm or AI device. The device operates independently once set by a healthcare provider for a patient's prescribed flow. The "standalone" performance was demonstrated through the non-clinical bench tests.

6. The type of ground truth used:

• For the non-clinical performance and safety tests, the "ground truth" implicitly refers to engineering specifications, recognized industry standards (e.g., ASTM G175), and the performance characteristics of predicate devices. The device's performance was measured against these objective criteria rather than against expert consensus or pathology in a clinical setting.

7. The sample size for the training set:

• Not applicable. This device is a mechanical/pneumatic device. There is no "training set" in the context of machine learning or AI.

8. How the ground truth for the training set was established:

• Not applicable. See point 7.

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The Inovo Independence Conserving Regulator is used to deliver a prescribed flow of medical-grade oxygen to the patient while conserving gas from a high-pressure oxygen cylinder, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.

The Inovo, Inc. Independence Conserving Regulator is a high pressure oxygen regulator and conserving device that is combined into a single compact unit. It is designed to extend the use time of oxygen cylinders. The Independence senses the start of inhalation and immediately releases a short "pulse" of oxygen to the patient. Since all of the "pulse" of oxygen finds it way deep into the lungs, less oxygen is required to accomplish the same effect as traditional continuous-flow oxygen regulators. The Independence Conserving Regulator contains an integral regulator with a CGA 870 style yoke. The regulator portion reduced the pressure to about 22PSIG. The Independence then delivers oxygen to the patient by sensing the beginning of inhalation using a pressure switch, which opens a solenoid valve for a specific period of time controlled by a microprocessor. The unit is designed to deliver 16 cc/lpm of oxygen to the patient at flows from 1 LPM to 6 LPM. The unit is powered by a single "AA" battery. The Independence also has a continuous flow back-up mode that delivers selectable continuous flow in the event of battery or device failure. The device has a two-color LED to indicate battery status. By depressing a "Battery test" switch, the device will show a Green light to indicate the battery is good. When the battery is below 0.9 vDC, the LED will be Red, indicating the battery must be changed. Under any circumstance, the "Continuous" mode can supply oxygen therapy in the event of battery failure. Patient inspiration is detected by a pressure switch set by the manufacturer in the range of 0.10 to 0.35 cm H2O. The device is capable of delivering a in the fango on at the beginning of the patient's inhalation at breathing rates up to 40 breaths per minute (BPM). Patients with more rapid breathing rates than 40 BPM will cause the device to "skip" breaths.

I am sorry, but the provided text does not contain detailed acceptance criteria and a study that proves the device meets those criteria in the format requested.

The document is a 510(k) summary for the Inovo, Inc. Independence Conserving Regulator, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study against specific acceptance criteria.

Here's what the document does provide in relation to your request:

• 1. A table of acceptance criteria and the reported device performance: This is not present in a tabular format detailing specific criteria (e.g., accuracy, reliability) and the numerical performance against them. The document lists "Performance Testing Included" such as Promoted Ignition ASTM G175, Hydrostatic Test, Proof Pressure Test, Conservation Test, Flow Regulation Test, Environmental Testing, and Electromagnetic Compatibility, but it does not specify the acceptance criteria for each or the reported results.
• 2. Sample sized used for the test set and the data provenance: This information is not provided. The document mentions "bench testing contained in our submission and non-clinical testing supplied" but does not detail sample sizes or data provenance.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable and not mentioned, as there was no clinical study.
• 4. Adjudication method for the test set: Not applicable and not mentioned, as there was no clinical study.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, it explicitly states "Discussion of Clinical Test Performed: Not Applicable."
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone medical device, but there isn't a "standalone algorithm performance" in the context of an AI-driven device, as this is a mechanical/electronic oxygen regulator. The performance tests ("bench testing," "non-clinical testing") would represent standalone device performance.
• 7. The type of ground truth used: For the non-clinical tests, the "ground truth" would be established engineering standards and specifications (e.g., ASTM G175 for promoted ignition, industry standards for hydrostatic and proof pressure tests, and internal specifications for conservation and flow regulation).
• 8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The document's primary goal is to establish substantial equivalence to predicate devices through non-clinical performance testing and comparison of technological characteristics, rather than a detailed report of clinical study results against specific, quantified acceptance criteria.

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The Economizer Conserving Requlator is used to deliver a prescribed flow of gas to the patient while conserving gas, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.

The Inovo, Inc., Economizer Conserving Regulator is a high pressure oxygen requlator and conserving device that is combined into a single compact unit. It operates in the same manner as traditional oxygen pressure regulators with the added benefit of having a conserving device included. It is constructed with an aluminum one piece body with all brass in the high pressure zones. The system is designed for an ambulatory patient with a high pressure oxygen cylinder. This unit requires no electrical power source. It operates with an operating pressure of 200 to 3000 psig and a nominal outlet pressure of 22 psi.

The device can function as a standard continuous flow regulator or as a conserving device which will double a patient's ambulatory time over that of a continuous oxygen system.

In conserving mode, the flow of oxygen is controlled by the patients inhalation and exhalation, which triggers a sensing diaphragm within the control module. As a result, the unit starts flowing oxygen when the user begins the inhalation cycle. Conversely, the unit shuts off the flow of oxygen when the user ceases inhalation.

It includes a click style flow control with selectable outlet flow that ranges 1 to 6 LPM by .5 LPM increments. The device can easily be switched between continuous or conserve mode without turning the device off.

The device uses a dual lumen cannula attached to two outlet ports. The first port senses the inhalation of the patient . The second port delivers the oxygen. In the "Conserve" mode, the device should be used only with the Hudson Dual Lumen Cannula (K# 961150) or a cannula with the same pneumatic characteristics.

The provided text describes a 510(k) summary for the Inovo, Inc. Economizer Conserving Regulator. This submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It explicitly states "Clinical Tests Performed: Not Applicable," meaning no human studies were conducted for this submission.

Therefore, an acceptance criteria table and information regarding human study parameters (sample size, experts, adjudication, MRMC studies, standalone performance) cannot be extracted from this document, as such studies were not performed or reported.

However, based on the non-clinical tests performed, we can infer the types of acceptance criteria that would have been used for each test.

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

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. The efficacy and safety were evaluated through non-clinical (bench) testing, not on a human test set.
• Data Provenance: Not applicable for human data. All data is from non-clinical laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No human test set requiring expert ground truth was used.

4. Adjudication method for the test set:

• Not applicable. No human test set requiring adjudication was used.

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 an oxygen conserving regulator, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

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

• The "standalone performance" in this context refers to the device's function as an oxygen conserving regulator. All the performance tests listed (Conservation Test, Flow Regulation Test, Flow Response Test, etc.) represent the device's standalone performance in a simulated or bench environment.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" was established by engineering specifications, industry standards (e.g., ASTM G175), and established criteria for functional performance of oxygen delivery devices. For example, a flow regulation test would be evaluated against calibrated flow meters, and a conservation test against expected oxygen consumption metrics.

8. The sample size for the training set:

• Not applicable. This device is a mechanical/pneumatic device and does not involve machine learning or an algorithm that requires a "training set" in the computational sense.

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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