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This device is intended for the delivery of high flow respiratory gases (within the limits of its stated technical specifications) to patients in a hospital by appropriately qualified healthcare professionals.

This product is not intended to be used on patients with bypassed upper airways.

This product is not intended to be life-sustaining or life-supporting.

This product is not intended for apneic ventilation.

The F&P Optiflow Air/Oxygen Flow Source is a respiratory high flow therapy device designed to generate a flow of air and/or oxygen. The device allows selectable flow rates up to 70L/min with selectable oxygen concentrations ranging from 21% to 100%.

The subject device is a multi-patient use prescription only device, provided in a non-sterile state. It operates at flow ranges between 0 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.

The provided FDA 510(k) clearance letter and summary for the "F&P Optiflow Air/Oxygen Flow Source" is for a hardware device, a breathing gas mixer, not a software or AI-driven diagnostic device. Therefore, the majority of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI/software performance is not applicable based on the provided document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and compliance with general medical device standards. There is no information regarding AI-specific performance metrics, clinical studies involving human readers, or detailed ground truth establishment for diagnostic capabilities.

Below is a table summarizing the general performance data found, where applicable, according to the structure requested, along with an explanation for the absence of AI-specific information.

Acceptance Criteria and Device Performance for F&P Optiflow Air/Oxygen Flow Source

This device is a hardware breathing gas mixer, not an AI or software-driven diagnostic tool. As such, the typical acceptance criteria and study designs associated with AI performance (e.g., sensitivity, specificity, human reader improvement, adjudication, ground truth for AI training/testing) are not present in this 510(k) summary. The "performance data" section primarily refers to compliance with safety, electrical, and performance standards for medical electrical equipment and gas mixers.

1. Table of Acceptance Criteria and Reported Device Performance:

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The Midas Flowmeter is intended for use as a continuous flow conscious sedation system to deliver a mixture of nitrous oxide and oxygen gases to a patient. When used with the electronic automatic vacuum switch (eAVS), the Midas Flowmeter is used to control the scavenging of waste analgesic gas.

The Midas Flowmeter is used within a healthcare environment during a nitrous oxide (N20)/oxygen (O2) conscious sedation system. The device is a digitally controlled, software driven, continuous flow device that precisely meters nitrous oxide and oxygen medical gases and delivers gas mixtures to a conscious, spontaneously breathing patient. The Midas Flowmeter uses electronic mechanisms to control the flowrate and mixture percentage of gases delivered to a patient. The optional eAVS is an accessory to the Midas Flowmeter. It is used within the nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The eAVS connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The eAVS is specifically designed to work with the Midas Flowmeter and all functionality control of the eAVS has been integrated into the user interface of the Midas Flowmeter.

The provided document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices. It primarily discusses comparisons of technical characteristics and compliance with recognized standards.

Crucially, this document does NOT contain explicit acceptance criteria tables or a detailed study report that proves the device meets specific performance metrics in a clinical or simulated environment with ground truth from experts, as would be expected for an AI/ML powered device.

The document states:

• "The characteristics of the Midas Flowmeter and optional eAVS do not require clinical investigation due to safety and efficacy being supported by non-clinical testing performed."
• "The verification and validation testing of the Midas Flowmeter and optional eAVS was found to be acceptable and supports the claims of substantial equivalence."

This indicates that the device's performance was evaluated through bench testing and compliance with recognized consensus standards, rather than a clinical study involving human readers or expert-established ground truth for a test set.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or the type of ground truth used, because such a study (as described in the prompt) was not performed or detailed in this 510(k) submission.

The document focuses on:

• Comparison of Technical Characteristics: Showing the Midas Flowmeter and eAVS are similar in function, intended use, and technology to predicate devices (FlowStar Touch Digital Mixer Flowmeter and Nitronox Scavenger Plus).
• Compliance with Standards: Listing various IEC, ISO, AAMI, and ASTM standards that the device was tested against to demonstrate safety and performance (e.g., IEC 60601-1 for basic safety, ISO 11195 for gas mixers).
• Non-clinical Performance Data (Bench Testing): A bulleted list of "performance bench testing" categories like "Gas Flow Rate Adjustment," "Touchscreen Display," "Accuracies and Faults," and "Life Testing." However, it does not provide the specific acceptance criteria for these tests nor the detailed results in a quantitative manner as requested. It simply states that "The results of the testing demonstrated that the Midas Flowmeter and optional eAVS met all of the acceptance criteria for functional, operational, and performance characteristics..."

In summary, none of the specific elements required to answer your prompt (e.g., table of acceptance criteria with reported performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details) are present in this 510(k) document because the device is a hardware system (a gas mixer) and was cleared based on non-clinical bench testing and adherence to recognized standards, not clinical performance studies with AI/ML components involving human expert review or data-driven ground truth.

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The Maxtec MaxBlend 2+p is intended to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen and pressure being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e., hospital, subacute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life-supporting device or life sustaining device.

The Maxtec MaxBlend 2+p is an oxygen delivery device which incorporates an air/oxygen blender, battery powered oxygen and pressure monitor, and an adjustable flowmeter, all in a single assembly. The integral air/oxygen blender provides precise mixing of medical grade air and oxygen. The flowmeter provides control of the flow rate delivered. The oxygen monitor measures the oxygen concentration from the blender's gas flow, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also allows the user to monitor pressure simultaneously using adjustable high and low alarm limits.

The document describes the Maxtec MaxBlend 2+p, a medical device combining an air/oxygen blender, oxygen monitor, pressure monitor, and flowmeter. The 510(k) submission seeks substantial equivalence to existing predicate devices (Maxtec MaxBlend 2 - K161718 and MaxO2ME+p - K221734), particularly highlighting the addition of a pressure monitoring feature.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for several performance aspects are implicitly derived from the comparative tables (Table 1 and 2) where the subject device's specifications are listed and compared to the predicate devices. The "Reported Device Performance" for the subject device is simply its stated characteristics, which are claimed to meet or be identical to the predicate device specifications, thereby meeting the acceptance criteria based on substantial equivalence.

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Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient

This is a device which can precisely dose a mixture of medical oxygen and medical nitrous oxide, depending on the adjusted mixture, for the sedation of patients in hospitals and at the dentist. The operator, a dentist is able to adjust the total flow and the concentration of nitrous oxide of this flow. Depending on these settings the level of sedation of the patient can be controlled by the operator. The FlowStar ® Analog Mixer device has been created with the following safety features. The total flow emitted can consist of a maximum of 70 % nitrous oxide, the mix up of gas types is prevented by mechanical encodings and the flow of pure nitrous oxide in the absence of a missing oxygen supply is prevented by a fail-safe device.

Two rotary knobs are used to select the desired total flow and N20/O2 gas mixture. The total flow can consist of between 0 (100% O₂) and 70 (30% O₂) percent N₂O. The minimum output of 30 % O2 prevents from a hypoxic mixture for the patient. The FlowStar® Analog Mixer device has an integrated O2 Flush knob which delivers at least over 40 l/min of pure oxygen if the user presses the knob to flush the N20 out of the patient circuit after the treatment or in the situation the patient is over sedated.

The FlowStar Analog Mixer device has an alarm system which generates an alarm in the case of an insufficient O2 supply. The device will shut off the sedation when the O2 supply reaches a critical level.

The FlowStar ® Analog Mixer has an integrated Bag T. The mixed gas to it. The Bag T is a device with one additional input and two outputs. The additional input is a valve which opens when the adjusted total flow is too low for the patient. The gas mixture is then enriched with additional ambient air. The first output of the Bag T is for the connected breathing bag which is filled by the mixing device when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the connected scavenger system and finally to the patient

The provided text is a 510(k) Premarket Notification for a medical device called "FlowStar Analog Mixer Flowmeter." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria for an AI/ML-based algorithm.

Therefore, the requested information regarding acceptance criteria, device performance from a test set, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from this document as it does not describe a clinical performance study of an AI/ML algorithm.

The document discusses:

• Device Description: A breathing gas mixer for administering Nitrous Oxide and Oxygen.
• Indications for Use: Administering an adjustable mixture of Nitrous Oxide and Oxygen to a conscious, spontaneously breathing patient.
• Safety Features: O2 fail-safe system, alarm for insufficient O2 supply, O2 flush knob, mechanical encodings to prevent gas mix-up.
• Non-Clinical Testing: Compliance with standards like ISO 18562 (biocompatibility), ISO 14971 (risk management), ISO 15223-1 (labeling symbols), CGA V-5 (connectors), ISO 11195 (gas mixers), and IEC 62366-1 (usability testing). This mainly involves bench testing to ensure the physical and functional aspects of the device meet safety and performance standards.
• Clinical Testing: The document explicitly states, "Clinical testing was not required to establish substantial equivalence."

In summary, this document is a regulatory submission for a physical medical device (a gas mixer), not a clinical performance study for an AI/ML algorithm. As such, the specific metrics and study design elements requested in your prompt (e.g., acceptance criteria for an AI model's accuracy, expert reads, ground truth for data sets) are not relevant to this type of device and its regulatory clearance process as described here.

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Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient.

The device will be available in two models: (Details below) FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 50 %, and FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 70 %.

50% and 70% represent the maximum nitrous oxide concentration. The FlowStar Touch O2- N₂O Mixer for Analgesia is a device which can precisely dose a mixture of medical oxygen and medical nitrous oxide, depending on the adjusted mixture, for the sedation of patients in hospitals and at the dentist. The operator, a doctor or a dentist is able to adjust the total flow and the concentration of nitrous oxide of this flow. Depending on these settings the level of sedation of the patient can be controlled by the operator. The Baldus® Touch O2- N2O Mixer for Analgesia device has been created with the following safety features. The total flow emitted can consist of a maximum of 70 % nitrous oxide, the mix up of gas types is prevented by mechanical encodings and the flow of pure nitrous oxide in the absence of a missing oxygen supply is prevented by a fail-safe device. An integrated Touch pad is used to select the desired N₂O /O2 gas mixture. The total flow can consist of between 0 (100% O2) and 70 (30% O2) percent N₂O. The minimum output of 30 % O2 prevents from a hypoxic mixture for the patient. The FlowStar TouchO2- N2O Mixer for Analgesia device has an integrated O2 Flush function which delivers at least 30 l/min of pure oxygen to flush the N20 out of the patient circuit after the treatment. The FlowStar TouchO2- N₂O Mixer for Analgesia device has an alarm system which generates an alarm in the case of an insufficient O2 supply. The device will shut off the sedation when the O2 supply reaches a critical level. The gas mixture output of the FlowStar TouchO2- N2O Mixer for Analgesia device is connected to the Bag T. The Bag T is a device with two inputs and two outputs. One input is the gas mixture from the mixing device. The other input is a valve which opens when the adjusted total flow is too low for the patient. The gas mixture is then enriched with additional ambient air. The first output of the Bag T is for the connected breathing bag which is filled when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the scavenger system and finally to the patient. The main accessories for the proposed device are a Breathing Bag and a Double Mask Scavenger System.

The device includes a microprocessor-controlled valve system that precisely meters Oxygen and Nitrous Oxide gases for analgesic purposes. The inputs of the touchpad influence the gas flow inside of the device. The firmware is considered to be of a moderate level of concern.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the FlowStar Touch Digital Mixer Flowmeter:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabulated format with specific numerical targets. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Accutron Digital Ultra K052335) through comparisons of characteristics and compliance with recognized standards. The "performance" is implicitly demonstrated by meeting the standards and showing similar or improved characteristics compared to the predicate.

Below is a table summarizing the characteristics where performance could be inferred or compared:

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The air-oxygen mixer Quality Mix is used to administer a continuous, precise mix of medical air and medical oxygen through its outlet ports - to infants, children and adults. The exact fractional inspiratory oxygen concentration (FiO2) corresponds to the selected FiO2 setting on the control knob (dial).

It is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician in professional healthcare settings.

This product is not intended for use as a life supporting device.

Warning: By using flows above 70 LPM, the risk of high flow such as ar trapping, barotrauma, and gastric insufflation (leading to possible aspiration) can occur.

The air-oxygen blender Quality Mix is a compact air/oxygen mixing device, which provides a precise mixing of medical grade air and oxygen gases. The blender is a pneumatic powered device with flowmeters which can be connected to outlet ports to regulate the gas flow.

The Quality Mix series medical air / oxygen blender includes following models: Quality Mix High Flow; Quality Mix High Flow XL and Quality Mix Low Flow; Quality Mix Low Flow XL.

The Quality Mix series air / oxygen blender is designed, tested and manufactured in accordance with the standard ISO 11195:2018 Gas mixers for medical use - Stand - alone qas mixers.

The Acceptance Criteria and the study proving the device meets them are detailed below, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The device is the Quality Mix Blender, Oxymixer. The acceptance criteria are largely derived from compliance with the ISO 11195:2018 standard for gas mixers for medical use and are demonstrated through performance specified in comparison to the predicate device (Precision Blender K053232).

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

The provided text describes non-clinical performance and safety testing. There is no mention of a "test set" in the context of patient data or clinical samples for the device itself. The testing was performed on the device units in a laboratory setting. No specific sample size (i.e., number of devices tested) is explicitly stated for each test, but it is implied that testing was conducted on representative units of the Quality Mix Blender series. The provenance of this data is from the manufacturer's internal testing as well as cooperation with an authorized, certified competence center for medical oxygen blenders for usability testing (likely in Germany, as the manufacturer is based in Germany). This is a retrospective analysis of device performance against established standards.

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

This information is not applicable as the study described is non-clinical performance testing of a medical device against engineering standards, not a diagnostic or AI-assisted clinical study requiring expert ground truth in the traditional sense. The "ground truth" for these tests are the objective measurements and specifications outlined in the referenced international standards (e.g., ISO 11195:2018, IEC 62366-1, ISO 14971).

4. Adjudication Method for the Test Set

Not applicable. This was non-clinical device performance and safety testing against established engineering and performance standards, not a clinical study involving human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This submission is for a breathing gas mixer, which is a hardware device (Quality Mix Blender), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. As stated above, this is a hardware device, not an algorithm or AI-powered system.

7. The Type of Ground Truth Used

The ground truth used for these evaluations is based on International Standards and established engineering specifications. These include:

• ISO 11195:2018 (Gas mixers for medical use - Stand-alone gas mixers)
• ISO 14971:2007 (Medical devices - Application of risk management to medical devices)
• IEC 62366-1:2015 (Medical devices - Application of usability engineering to medical devices)
• EN 1789:2007+A2:2014 (Medical vehicles and their equipment - Road ambulances)
• EN 60068-2-6:2008 (Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal))
• EN 60068-2-27:2009 (Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock)
• EN 60068-2-64:2008 (Environmental testing – Part 2-64: Tests – Test Fh: Vibration, broadband random and guidance)
• DIN EN ISO 15002:2020-05 (Flow-metering devices for connection to terminal units of medical gas pipeline systems)
• ISO 15001:2010 (Anesthetic and respiratory equipment - Compatibility with oxygen)
• ISO 18562-1, -2, -3 (Biocompatibility evaluation of breathing gas pathways in healthcare applications)

These standards define the performance metrics, test methods, and acceptable ranges for the device's functionality, safety, and compatibility.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a hardware medical device, not a machine learning or AI algorithm.

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

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

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The Nitronox Plus is intended to provide a mixture of N20/02, on demand, to a conscious, spontaneously breathing patient. The Nitronox Plus is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates.

The Nitronox Plus is a portable "on demand" analgesia system used to deliver a mixture of nitrous oxide and oxygen gases to a conscious, spontaneously breathing patient. The device is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates. It is only for use in a healthcare setting by healthcare professionals. The Nitronox Plus is available in three models which differ only in adjustability and maximum ratio of nitrous oxide that can be delivered. The Nitronox Plus features a 0-70% N2O adjustable model, 0-50% N2O adjustable model, and 50% N2O/50% O2 fixed model.

The Nitronox Plus is a pneumatic system. Oxygen and nitrous oxide are supplied to the device through flexible hoses. Inlet gas is regulated and equalized through the use of an oxygen piloted dual diaphragm regulator. The inlet pressure of both gases and the mixed gas pressure are displayed on the front panel of the device through the use of pressure gauges. The device is designed to function with a medical breathing circuit and face mask or mouthpiece accessory.

Delivery of mixed gas starts with a patient's demand; upon inhalation through a face mask or mouthpiece, a demand valve opens and supplies mixed gas to the patient through the connected Medical Breathing Circuit. In adjustable models, the healthcare professional is able to set the desired concentration through the use of a control knob on the front panel. Mixed gas is supplied through the breathing circuit until inhalation ceases.

The Nitronox Plus contains several safety features. Pneumatically powered alarms for both gas inlets alert the user when either gas supply begins to deplete. The device will also maintain delivery of the set concentration with depleting oxygen pressure. Once the oxygen pressure drops below a certain threshold, the device will allow ambient air to be delivered through an Emergency Air Intake valve. The device also features a key lock to control the nitrous oxide gas supply, allowing healthcare professionals to prevent unauthorized use of the device.

The provided text describes the safety, operational, and performance requirements for the Nitronox Plus breathing gas mixer, but it does not provide a specific table of acceptance criteria or detailed results of a study proving the device meets those criteria, especially at the level of detail requested for AI/diagnostic studies. Instead, it broadly states that performance testing was conducted and demonstrates the device meets "all design input requirements."

Therefore, many of the requested details cannot be extracted from this document, as it focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed performance study with specific metrics, sample sizes, and ground truth methodologies relevant to AI or diagnostic devices.

However, I can provide what can be inferred from the text based on its content about non-clinical performance testing.

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

The document does not provide a specific table of quantitative acceptance criteria or detailed reported device performance values. It generally states that "performance testing was conducted to verify performance characteristics, safety features, capabilities compared to the predicate device, and biocompatibility." The "reported device performance" is essentially that the device "meets all design input requirements, including functional, operational, and performance requirements."

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

This information is not explicitly provided in the document. The testing described is "non-clinical performance testing," which typically involves bench testing, engineering verification, and validation, rather than clinical studies with human subjects or data sets.

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 and is not provided. The "ground truth" in this context would likely refer to engineering specifications and measurements, not expert consensus on diagnostic images.

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

This information is not applicable and is not provided. Adjudication methods are typically used in clinical trials or studies involving expert review, which is not the type of testing described here.

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 such study was conducted or is mentioned in the document. This is a breathing gas mixer, not an AI or diagnostic imaging device.

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

This is not applicable as the device is a physical breathing gas mixer, not a software algorithm. Its "performance" is inherently standalone in that it functions according to its design specifications.

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

The "ground truth" for this device would be established through engineering specifications, validated test methods, and measurement standards for gas mixtures, pressure regulation, alarm functionality, and other specified device characteristics. The document implies that these standards were used in the "performance testing."

8. The sample size for the training set

This information is not applicable as the device is not an AI model requiring a training set.

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

This information is not applicable as the device is not an AI model.

Summary of available information regarding the acceptance criteria and study:

The document states that "performance testing was conducted to verify performance characteristics, safety features, capabilities compared to the predicate device, and biocompatibility; validate reprocessing activities; and ensure usability of the device to meet patient needs when used as intended."

The study proving the device meets its acceptance criteria is referred to as "non-clinical performance testing."

• Acceptance Criteria (Implied): The device "meets all design input requirements, including functional, operational, and performance requirements." These requirements would likely include specifications for N2O/O2 mixture accuracy, pressure regulation (45-60 psi input, low pressure mixed gas output), alarm activation thresholds (e.g., N2O/O2 input below 35 psi), demand valve responsiveness, and the proper functioning of safety features like the O2 piloted system, DISS fittings, and the Emergency Air Intake Valve.
• Reported Device Performance: "The results of performance testing demonstrate that the Nitronox Plus meets all design input requirements..." and "Performance testing supports the conclusion that the subject device is as safe and effective as the predicate device, and therefore the two devices are substantially equivalent."

This is a substantial equivalence (510(k)) submission, which focuses on demonstrating that a new device is "as safe and effective" as a legally marketed predicate device, rather than providing detailed clinical efficacy trial data, which would be typical for a PMA submission or for AI/diagnostic devices. The "study" here is a set of "non-clinical performance tests" that show the device functions according to its engineering and safety specifications, aligning with the predicate device's performance profile (where applicable, and noting differences and new features).

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The Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen, on demand, to a conscious, spontaneously breathing patient.

Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device intended to administer an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen mixture to provide pain relief, on demand, to a conscious, spontaneously breathing, patient.

The device provides two input connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has a control knob for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be administered by an inspiratory effort by the patient.

A selection knob is used to select desired N20/02 gas mixture. The adjustable range is from 25% O2 (NJO 75%) to 100% O2 (N3O 0%), with the minimum of 25% oxygen output to eliminate the possibility of delivering a hypoxic mixture.

The Oxygen Enrichment Function is designed to provide 30 L/min of 100% oxygen in order to flush any residual gas from the patient circuit following the completion of the patient treatment.

The built-in pneumatically powered alarm system will generate both visual and audible alarms should either nitrous oxide or oxygen input fall below 40 PSI, and the device will be automatically shut off should oxygen input falls below 35 PSI.

The main accessories for the proposed device are a disposable Patient Circuit and a Mouth Piece or a universal Face Mask.

The provided text describes the regulatory clearance of a medical device, the Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System, and its substantial equivalence to a predicate device, the Equinox® Relieve (K113687). However, the document does not contain the typical comprehensive study report details that would allow for a complete answer to all parts of your request. This document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical trial.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format typically seen for algorithm performance (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, it relies on demonstrating equivalence to a predicate device and adherence to relevant standards. The "performance" reported is primarily comparative.

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

The document describes "comparative performance testing" and "bench testing." These are laboratory-based tests comparing the proposed device against the predicate and against standards. It does not involve human subjects or patient data in the sense of a clinical trial. Therefore, specific "sample sizes" of a test set derived from patient data are not applicable here.

• Sample size for test set: Not applicable (bench testing, not patient data).
• Data provenance: Bench testing results, comparing the proposed device to the predicate device and relevant international standards (e.g., ISO 11195, ISO 80601-2-13). The country of origin for the test data is not specified but is presumably where the manufacturing and R&D for O-Two Medical Technologies Inc. takes place (Canada, as per the address). The testing is prospective for the purpose of demonstrating equivalence for the new device.

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

This information is not provided. For bench testing, ground truth is established by objective measurements against known physical and chemical standards and the specifications of the predicate device. Experts in this context would likely be engineers and testers.

4. Adjudication method for the test set

Not applicable. The testing described is objective, physical measurement and comparison, not expert adjudication of a diagnostic outcome.

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 gas mixing and delivery system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.

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

This refers to an algorithm's performance without human intervention. This concept is not applicable to a physical gas mixing and delivery system. Its "performance" is inherent in its mechanical and pneumatic operation.

7. The type of ground truth used

For the aspects involving comparison to the predicate device, the "ground truth" for equivalence was the performance and specifications of the legally marketed predicate device (Equinox® Relieve/K113687). For aspects related to safety and functionality specifications, the ground truth was defined by international standards such as ISO 11195:1995 and ISO 80601-2-13:2011.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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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The MaxBlend 2 and MaxBlend Lite are designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e.. hospital, sub-acute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life supporting device.

The MaxBlend family of blenders, MaxBlend 2 and MaxBlend Lite, are oxygen delivery devices which incorporate an air/oxygen blender, battery powered oxygen monitor, and an adjustable flowmeter, all in a single assembly. The air/oxygen blender provides precise mixing of medical grade air and oxygen. The flowmeter provides control of the flow rate delivered. The oxygen monitor measures the oxygen concentration from the blender's gas flow, displays these measured concentrations, and provides user selectable high and low oxygen alarms.

The MaxBlend 2 incorporates the air/oxygen blender within its enclosure. The MaxBlend Lite may be provided with or without the blender component pre-assembled, allowing the user to install the oxygen monitor/flowmeter module, the MaxBlend Lite component, on an existing compatible blender. The addition of the MaxBlend Lite module is intended to improve the safety of an existing air/oxygen blender that is in the user's possession. Both devices use the exact same oxygen monitor sensor and electronics, MaxO2ME (K153659). Both devices use the exact same components/assemblies in the flowmeter and sensor bleed manifold which form the gas pathway to the patient. The only substantive difference is the form of the enclosure for the monitor electronics.

This document is a 510(k) Premarket Notification from Maxtec, LLC, regarding their MaxBlend 2 and MaxBlend Lite devices. It aims to demonstrate substantial equivalence to a predicate device, the Bird Sentry Blender (K973646), and references other cleared devices (K153659 – Maxtec MaxO2ME, K883038 - CareFusion / Bird - Blender, K925982 - BioMed Devices - Blender).

Here's an analysis based on your request, highlighting that this document outlines non-clinical testing for a medical device that mixes and monitors breathing gases, not a typically AI-powered diagnostic imaging device. Therefore, many of the requested categories (like MRMC studies, roles of experts for ground truth, sample sizes for training/test sets for AI models, etc.) are not applicable or are addressed differently in the context of hardware device performance testing.

Acceptance Criteria and Device Performance (Non-Clinical/Hardware)

The acceptance criteria are primarily based on meeting the performance specifications of the predicate device and established standards for medical devices of this type. The "reported device performance" is generally stated as "passed" or "meets the acceptance criteria" for various tests.

1. Table of Acceptance Criteria and Reported Device Performance

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The GMX Series Medical Air/Oxygen Blender is designed to dispense a continuous blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients.

The GMX Series Medical Air/Oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of air/oxygen mixtures is required. The GMX Series Medical Air/Oxygen blender includes two models: GMX30U-AIR/O2, GMX120U-AIR/O2. The GMX Series Medical Air/Oxygen blender is designed, tested, and will be manufactured in accordance with the following standard: ISO 11195 Gas mixers for medical use - Stand-alone gas mixers 1995.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document compares the GMX Series Medical Air/Oxygen Blender (the device) to the Precision Blender (the predicate device). The acceptance criteria are implicitly those of the predicate device, demonstrating that the new device meets or is substantially equivalent to these performance metrics.

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

The document describes non-clinical tests based on compliance with voluntary standards (ISO, USP, ASTM, IEC). It does not specify a "test set" in terms of patient data or a specific number of items tested. Instead, it refers to performance testing and final acceptance testing. The data provenance is not explicitly stated as country of origin but implies laboratory testing to meet international and US standards. The study is prospective in the sense that the device was manufactured and then tested against these standards.

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

This information is not applicable. The "ground truth" for this device is based on established engineering and medical device performance standards. It doesn't involve clinical evaluations by medical experts to establish a "ground truth" for diagnostic accuracy, but rather verification that the device physically performs as specified and meets safety requirements.

4. Adjudication Method for the Test Set

This information is not applicable. The compliance is determined by meeting the specified values in the standards, not by an adjudication process as would be used in clinical studies.

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

An MRMC comparative effectiveness study was not done. The device is a medical air/oxygen blender, not an AI-powered diagnostic or assistive tool for human readers.

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

This is a physical medical device (an air/oxygen blender), not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. Its performance is inherent to its mechanical and pneumatic design and is tested directly.

7. The Type of Ground Truth Used

The ground truth used is engineering and performance standards, specifically:

• ISO 11195 Gas mixers for medical use – Stand-alone gas mixers 1995
• USP :2012—Particulate Matter in Injections
• ASTM D 5466-01(2007): Standard Test Method for Determination of Volatile Organic Chemicals in Atmospheres (Canister Sampling Methodology)
• IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
• The performance specifications of the legally marketed predicate device (Precision Blender K053232).

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI algorithm that requires a training set.

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

This information is not applicable, as there is no training set for this type of device.

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