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The 840 Ventilator with Respiratory Mechanics Option is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients with an Ideal Body Weight (IBW) as low as 0.5 kg (with NeoMode option) to adult, and for use in a wide variety of clinical conditions.

The 840 Ventilator with Respiratory Mechanics Options is intended for a wide range of patients ranging from neonate to adult (Vr 5-2500 mL with NeoMode) or from infant to adult (VJ-25-2500 mL).

The 840 Ventilator with Respiratory Mechanics is intended for use in hospital and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.

The Respiratory Mechanics Option enables the 840 Ventilator System to implement three new respiratory maneuvers, and permits the device to calculate and display ten additional measurements for use in the assessment of mechanical pulmonary functions of the patient's airways. The Respiratory Mechanics feature is implemented on the 840 Ventilator through additional functionality in software and by use of the existing User Interface panel. No hardware or firmware changes or additions were required. The 840 Ventilator is a dual-microprocessor controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult (with NeoMode Option) or infant to adult (without NeoMode Option) patients who require either invasive ventilation or non-invasive ventilation (via face mask).

This 510(k) summary (K063650) describes the 840 Ventilator System with Respiratory Mechanics, but it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or clinical performance data.

The document primarily focuses on:

• Device Description: What the device is and what new features the "Respiratory Mechanics Option" adds (three new maneuvers, ten additional measurements).
• Intended Use: The patient population, use environment, and purpose of the device.
• Determination of Substantial Equivalence: It asserts that the device is substantially equivalent to predicate devices based on intended use, materials, design, and technical characteristics, and that it "does not introduce new questions regarding safety or effectiveness."
• Regulatory Compliance: It mentions that software design and development followed FDA guidance (May 29, 1998) and internal company requirements.

Therefore, I cannot provide the requested information from the provided text. The document states that "information provided in this Special 510(k) submission provides comparative, predicate device information and describes development procedures that support the determination of substantial equivalence and assertion that the modified device is safe and effective for its intended use." However, these supporting details, including any performance studies or acceptance criteria, are not included in this summary.

In summary, none of the requested points (1-9) can be answered from the provided text.

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The Puritan Bennett 840 ventilator with Proportional Assist Ventilation® Plus (PAV+) software option is intended for use in spontaneously breathing adult patients whose ventilator ideal body weight (IBW) is at least 25.0 kg. Patients must be intubated with either endotracheal or tracheostomy tubes of internal diameter of 6.0 mm to 10.0 mm. Patients must have satisfactory neural-ventilatory coupling, and stable, sustainable inspiratory drive.

PAV+ is intended for use in hospitals and hospital-type facilities.

Proportional Assist Ventilation Plus is a software option for the Puritan Bennett 840 Ventilator that includes a spontaneous breath type called, Proportional Assist. PAV+ is designed to assist the spontaneous breathing patient with an active neural drive. Proportional Assist amplifies the patient's inspiratory effort. A control function allows the clinician to specify an amplification setting.

The provided text describes a 510(k) submission for the Puritan Bennett 840 Ventilator with Proportional Assist Ventilation® Plus (PAV+) software option, which is a continuous ventilator.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria or specific performance metrics that were established as targets for the PAV+ software. However, it indicates a qualitative acceptance criterion: "substantial equivalence" to legally marketed predicate devices.

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

The document mentions "Clinical simulation testing" and "Evaluations... conducted in a hospital setting" but does not provide specific sample sizes for these test sets. The provenance of the data (country of origin, retrospective or prospective) is also not specified.

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

The document states that "Clinical simulation testing was conducted to evaluate the PAV+ software in the hands of respiratory therapists." This implies that respiratory therapists were the users and evaluators, acting as a form of "expert" group. However, the exact number of these respiratory therapists and their specific qualifications (e.g., years of experience) are not provided. It's also unclear if they established a formal "ground truth" or simply provided feedback and assessments of the software's performance.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. It broadly refers to "evaluations."

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 MRMC comparative effectiveness study is mentioned. The device is a ventilator software option, not an imaging analysis tool that typically involves "readers" in the context of MRMC studies. The focus is on the software's performance and its interaction with a human operator (respiratory therapist) rather than improving human "reading" performance. Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable in this context.

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

The document states, "Performance data includes results from testing at the system level and conducting testing on controls." This suggests some level of standalone testing of the algorithm's components or the overall system without direct human interaction at all times. However, the exact nature and extent of this standalone testing are not detailed. The "clinical simulation testing" and "evaluations... in a hospital setting" clearly involved human-in-the-loop performance.

7. The Type of Ground Truth Used

The document doesn't explicitly define a "ground truth" in the sense of a gold standard (like pathology or outcome data) for the PAV+ software's performance. Instead, the "ground truth" appears to be implicitly established by:

• Comparison to predicate devices: The functionality and performance of the PAV+ software were assessed against the known characteristics and performance of the Puritan Bennett 840 Ventilator with Volume Ventilation Plus and the Dräger EvitaXL with SmartCare/PS.
• Clinical judgment/experience of respiratory therapists during simulation and hospital evaluations.
• Measured characteristics of the patient (pulmonary compliance and total pulmonary resistance) as inputs for the PAV+'s proportional pressure augmentation, implying that the algorithm's calculations and subsequent actions were verifiable.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This submission is for a medical device software, and while software development typically involves training and testing, the regulatory filing focuses on the final performance demonstration. The term "training set" is usually associated with machine learning models, and while PAV+ involves complex algorithms, it's not explicitly framed as an AI/ML product requiring a distinct "training set" description in this 2006 K05.

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

As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is also not provided.

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The Puritan Bennett DataFlow™ Data Management Software is intended to augment the Puritan Bennett PB-700 Renaissance® II Spirometer System and the Nellcor Puritan Bennett NPB-500 Simplicity™ Spirometer System's data management capability.

Puritan Bennett DataFlow™ Data Management Software is a software program used in conjunction with the Puritan Bennett PB-700 Renaissance® II Spirometer System and the Nellcor Puritan Bennett NPB-500 Simplicity™ Spirometer System to transfer patient test data from the spirometer to an IBM compatible Personal Computer. Once transferred, the DataFlow software allows the operator to perform any or all of the following: edit or add patient demographic information, archive the test, search for and retrieve archived test(s), print test reports, compare archived tests, and export test data for use by other application software.

The Puritan Bennett DataFlow™ Data Management Software is a data management program for spirometers. The provided text outlines its intended use and summarizes how the manufacturer demonstrated substantial equivalence to a predicate device. However, it does not contain detailed information regarding specific acceptance criteria or a comprehensive study report with quantitative performance metrics.

Based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on verifying that the software performs as intended according to its specifications and that its technological characteristics are the same as the predicate device. It does not provide a table of specific acceptance criteria (e.g., "data transfer accuracy > 99%") or quantitative performance metrics for the device itself.

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

The document mentions "The performance of the DataFlow software program was comprehensively tested," but it does not specify a sample size for any test set or provide details about data provenance (e.g., country of origin, retrospective/prospective). This likely indicates that the testing was function-based verification and validation rather than a clinical study with patient data.

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

The document describes software verification and validation, not a study involving human experts to establish ground truth for a test set. Therefore, this information is not applicable and not provided.

4. Adjudication Method:

Given that the testing described is software verification and validation, an adjudication method in the context of expert review for a test set is not applicable and not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study is relevant for diagnostic devices that involve human interpretation. This device is data management software. Therefore, an MRMC comparative effectiveness study is not applicable and not mentioned.

6. Standalone Performance:

The software is described as a "PC-based standalone software program." The testing mentioned ("The performance of the DataFlow software program was comprehensively tested") refers to its standalone functional performance in conjunction with the spirometers. However, it's not a "standalone" in the sense of an AI algorithm performing a diagnostic task without human input; it's a data management tool. The document does not provide quantitative standalone performance metrics for specific tasks (e.g., "data transfer success rate").

7. Type of Ground Truth Used:

The ground truth for this type of software (data management) would be its adherence to its own specifications and correct execution of its defined functions. It would not typically involve pathology, outcomes data, or expert consensus in the way a diagnostic AI algorithm would. The document implies that the ground truth was the functional specifications and the correct operation of the software.

8. Sample Size for the Training Set:

This software is not an AI/ML algorithm that requires a training set in the conventional sense. It's a data management program. Therefore, information about a "training set" sample size is not applicable and not provided.

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

As there is no training set for this type of software, this information is not applicable and not provided.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through functional verification and validation, confirming that the data management software performs as intended according to its specifications and is technologically similar to a predicate device. It does not contain the detailed quantitative performance metrics or study designs typically associated with clinical studies for diagnostic devices or AI algorithms.

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The PB700 Renaissance II Spirometry System is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician's offices, laboratories, and occupational health testing environments.

The PB700 Spirometry System consists of the Renaissance II Spirometer, the PB710 Base Station, AC Adapter, the disposable FSII Flow Sensor, a syringe adapter (for calibration), and nose clips. Optional accessories include calibration syringe, printer and serial communications cables, and a compatible printer. The Renaissance II Spirometry System is designed for use in the diagnosis, assessment, and monitoring of certain lung diseases.

The provided document is a 510(k) summary for the PB700 Renaissance II Spirometry System. It primarily focuses on demonstrating substantial equivalence to a predicate device (PB100 Renaissance Spirometry System) rather than detailing specific acceptance criteria and a comprehensive study report with the requested metrics.

Here's an analysis based on the provided text, addressing each point to the best of its ability or explaining why the information is not available:

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

   The document explicitly states: "The modified PB700 Renaissance II Spirometry System has been tested and found to meet all design criteria." However, it does not provide a table outlining specific acceptance criteria (e.g., flow measurement accuracy, volume measurement accuracy, specific ranges of operation) nor the quantitative reported performance for these criteria. The submission relies on establishing substantial equivalence to the predicate device, implying that if the device meets its design criteria, and those designs are equivalent to a legally marketed device, then it is acceptable.

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

   This information is not available in the provided text. The document states "The modified PB700 Renaissance II Spirometry System has been tested..." but does not detail the nature of this testing, the sample size of any test sets (patient or otherwise), or the provenance of any data.

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 available in the provided text. As the submission focuses on functional equivalence of a diagnostic spirometer, the concept of "ground truth" derived from expert review (as in image analysis) is not directly applicable in the same way. Performance would typically be assessed against calibrated reference instruments.

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

   This information is not available in the provided text. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of this type of device submission.

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 information is not applicable and not available in the provided text. The PB700 Renaissance II Spirometry System is a diagnostic spirometer measuring physiological parameters (volume and flow); it is not an AI-assisted diagnostic tool that would involve "human readers" interpreting outputs in the sense of image analysis or similar diagnostic aids. Therefore, an MRMC study with AI assistance is not relevant to this device.

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

   The device is a standalone diagnostic tool in the sense that it measures and calculates spirometry parameters. Its performance is inherent in its measurements. The document implies performance was assessed in a "standalone" fashion as it states "has been tested and found to meet all design criteria." However, specific details of how this "standalone" performance was measured (e.g., tests against known flow/volume standards, clinical trials) are not provided. The comparison is primarily against the predicate device's technological characteristics.

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

   For a spirometer, "ground truth" would typically be established using calibrated reference instruments (e.g., highly accurate flow/volume simulators or calibration syringes with known volumes). The document mentions a "syringe adapter (for calibration)" as part of the system, suggesting calibration against known standards. However, the specific type of ground truth used during the validation testing is not detailed.

8. The sample size for the training set

   This information is not applicable and not available in the provided text. Spirometers like the PB700 Renaissance II are typically based on established physical principles (e.g., pressure differential across a pneumotachograph) and calibration, not machine learning algorithms that require "training sets" in the conventional sense. The "calculations to express the volume in clinically relevant terms" refer to standard physiological equations and comparisons to published reference values, not a trained model.

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

   This information is not applicable and not available due to the reasons stated in point 8.

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The 840 Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.

The 840 Ventilator System is a "Continuous Ventilator", a Class II device, per 21 CFR Part 868.5895. This device is designated as Class I, Type B equipment, per IEC 601-1. The 840 Ventilator's gas delivery system consists of two proportional solenoid valves, PSOLs and an active expiratory valve. Previously cleared modes of ventilation include Assist Control, AC, Synchronized Intermittent Mandatory Ventilation, SIMV and Spontaneous, SPONT. The 840 Ventilator System supplies mandatory or spontaneous breaths with a preset level of positive end expiratory pressure, PEEP, trigger sensitivity and oxygen concentration. A mandatory breath can be either pressure or volume controlled, except in the optional BiLevel mode, when it is always pressure-controlled. A spontaneous breath type allows patient inspiratory flows of up to 200 L/min, with or without pressure support. This 840 Ventilator modification comprises the addition of a new ET/Tracheostomy Tube Compensation, "TC", feature. This feature is implemented on the 840 Ventilator through additional functionality in software and by using the existing User Interface panel. "TC" has been added as a Breath Type choice in the Touch Screen SPONT Type menu. The ventilator's pneumatic design and electrical circuitry remain functionally unchanged.

The provided text is a summary of a 510(k) submission for a medical device, the Puritan-Bennett 840 Ventilator System with ET/Tracheostomy Tube Compensation Option. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study in the way one might for a novel diagnostic AI.

The document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the context of a new diagnostic algorithm. Instead, it focuses on demonstrating that the modified ventilator is substantially equivalent to existing predicate devices.

Therefore, many of the requested sections (Table of acceptance criteria, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, sample size for training set, how training ground truth was established) cannot be answered from the provided text. These are typically elements of studies designed to validate the performance of new diagnostic or predictive algorithms, which is not the primary purpose of this 510(k) submission.

The relevant information from the document pertains to the device's intended use and the regulatory pathway.

Here's a breakdown of what can be extracted based on the nature of the submission:

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

This information is not present in the provided document. The document describes the device modification and its intended use, emphasizing its substantial equivalence to predicate devices. It does not lay out specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity for a diagnostic claim) or report detailed numerical performance metrics for the modified feature. The assessment in a 510(k) is about safety and effectiveness in comparison to predicates, not usually a standalone performance trial against specific numerical targets.

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 present in the provided document. The 510(k) does not describe a clinical study with a "test set" in the context of evaluating a new algorithm's performance. The review focuses on design controls, verification, and validation testing (software, etc.) to ensure the modification is safe and effective compared to predicates, but details of such testing, including sample sizes for clinical data, are not provided.

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 present in the provided document, as no such "test set" and ground truth establishment are described.

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

This information is not present in the provided document, as no such "test set" and adjudication process are described.

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 information is not present in the provided document. This type of study is relevant for AI-powered diagnostic aids, which is not the nature of this ventilator modification.

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

This information is not present in the provided document. The device is a ventilator, not an AI-only algorithm. The "TC" feature is an integrated software function.

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

This information is not present in the provided document.

8. The sample size for the training set:

This information is not present in the provided document. The "TC" feature is described as an "additional functionality in software" using the existing user interface. It's not presented as a machine learning model requiring a discrete "training set" in the common sense of AI development.

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

This information is not present in the provided document.

Summary of what is known from the document:

• Device: Puritan-Bennett 840 Ventilator System with ET/Tracheostomy Tube Compensation (TC) Option.
• Modification: Addition of a new ET/Tracheostomy Tube Compensation, "TC", feature implemented via additional software functionality using the existing User Interface.
• Regulatory Pathway: 510(k) Pre-market Notification, asserting substantial equivalence to predicate devices (Puritan-Bennett 7200 Series Ventilator and Drager Evita 4 Ventilator).
• Basis for Equivalence: The intended use, materials, and design are similar to predicate devices. The technical characteristics of the modification do not introduce new questions of safety or effectiveness. Compensation for ET/Tracheostomy Tube resistance via positive pressure support is common clinical practice.
• Software Development: Followed FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 29, 1998) and internal company requirements for verification and validation testing.
• Intended Use: To provide continuous ventilation for infant, pediatric, and adult patients (tidal volume 25 - 2500 mL) requiring respiratory support in hospitals and hospital-type facilities. Not for transport between facilities or in the presence of flammable anesthetics. For use and servicing by trained and qualified clinicians/persons only, and by prescription.

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The Puritan-Bennett Helios Portable Liquid Oxygen System is intended to provide supplemental oxygen to oxygen therapy patients who may have difficulty extracting oxygen from the air that they breathe. It is intended to be used as an ambulatory source of oxygen both inside and outside the patient's home. It is not intended as life sustaining or life supporting device. The device has no contraindications.

The Helios portable liquid oxygen system consists of a vacuum insulated cryogenic container and plumbing that includes pressure relief valves, heat exchanger tubes and a pneumatic conserving device. The vacuum insulated container allows oxygen to be stored in its liquid state under pressure where the system pressure is controlled by the relief valve. When the patient opens the flow control valve, the liquid oxygen is withdrawn from the container into a vaporizing coil. Once in the vaporizing coil, ambient heat is absorbed by the liquid oxygen, converting it into a gas and warming it to near room temperature. The gas finally passes through the flow control valve and on to the patient at the prescribed metered rate. The device is intended to be used in conjunction with a larger liquid oxygen reservoir where it is filled by mating it to the fill connection on the top of the larger system. The Helios device is a purely mechanical device and contains no electrical or electronic components.

The provided text describes a 510(k) summary for the Puritan-Bennett Helios Portable Liquid Oxygen System. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, performance metrics, or study designs typically found in regulatory submissions for software-as-a-medical-device (SaMD) or AI-powered devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them because the provided text does not contain this type of information.

Specifically, the document states:

• "The Helios liquid oxygen system successfully passed tests in the following areas; - Mechanical/Climatic - Device Performance"

However, it does not provide:

1. A table of specific acceptance criteria (e.g., accuracy, sensitivity, specificity, or specific mechanical/climatic thresholds) or quantitative reported device performance against these criteria.
2. Sample sizes for a test set, data provenance, or details about training sets.
3. Information on experts, ground truth establishment, or adjudication methods, as these are relevant to studies involving human interpretation or AI model training.
4. Details about MRMC comparative effectiveness or standalone algorithm performance.

The document is a 510(k) summary for a purely mechanical medical device (a portable liquid oxygen system), not an AI/SaMD product. The information requested aligns with the evaluation of AI/SaMD, which is not applicable to this device.

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The Puritan-Bennett Aeris 590 oxygen concentrator with OCI is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. It is intended to be used with both pediatric and adult patients. It is not intended as life sustaining or life supporting device. The device has no contraindications.

An oxygen concentrator takes in room air, filters it and separates the nitrogen from the air under pressure, allowing only oxygen and trace gases to pass through to the oxygen outlet connection to the patient while exhausting a nitrogen-rich air mixture back into the room. The principle components of the Aeris 590 oxygen concentrator include a compressor, two molecular sieve containers, a valve system and a printed circuit board. The compressor draws in room air, pressurizes it and forces it through the pneumatic circuit of the device. As the air passes through one sieve container, the nitrogen bonds with the molecular sieve material within the pressurized container and allows only the oxygen and trace gases to flow out of the container. This oxygen rich mixture (+90% oxygen) is then delivered to the patient at a regulated pressure and flowrate. The valve system regulates the airflow through the sieve containers alternately. While one is pressurized and producing oxygen, the other is being depressurized and exhausting the nitrogen in preparation for the next cycle. A programmable logic device on the printed circuit board controls the timing of this cycling process. The OCI (Oxygen Concentration Indicator) provides an indication of the oxygen concentration of the output gas and includes alarm features.

Here's an analysis of the acceptance criteria and study information based on the provided text for the Puritan-Bennett Aeris 590 Oxygen Concentrator:

The provided document is a 510(k) Summary for the Puritan-Bennett Aeris 590 Oxygen Concentrator. It describes the device, its intended use, and claims substantial equivalence to a predicate device. It also briefly mentions performance testing.

The document does not contain the level of detail typically found in a robust study report for acceptance criteria, especially
when it comes to AI/ML device evaluations. It's a regulatory submission for a medical device that predates the common use of AI in such devices.

Therefore, many of the requested fields below will be marked as "Not Applicable" or "Not Provided" because this type of information is simply not present in a traditional 510(k) for a non-AI device.

Acceptance Criteria and Device Performance

The document states that the Aeris 590 oxygen concentrator successfully passed tests in several areas. It also mentions an improvement in oxygen concentration performance compared to its predicate device.

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

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

• Sample Size for Test Set: Not Provided. The document mentions "tests" but does not specify the number of units or any other sample size for these tests.
• Data Provenance: Not Provided. No information on the origin or type (retrospective/prospective) of data used for testing is given.

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)

• Number of Experts: Not Applicable for this type of device and testing. The "ground truth" for a device like an oxygen concentrator typically comes from engineering specifications, calibration standards, and validated measurement equipment, not expert human interpretation of complex data.
• Qualifications of Experts: Not Applicable.

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

• Adjudication Method: Not Applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which are not 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

• MRMC Study: No. This is not an AI/ML device, and no MRMC study comparing human readers (or users) with and without AI assistance was performed or is relevant to this device.
• Effect Size: Not Applicable.

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

• Standalone Performance: Not Applicable. This device is a hardware oxygen concentrator with embedded software; it is not an algorithm evaluated in a standalone manner in the context of an AI/ML device. Its "performance" is inherent to its functionality.

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

• Type of Ground Truth: Primarily engineering specifications, validated measurement standards, and performance against defined physical and electrical parameters. For oxygen concentration, the ground truth would be established by calibrated oxygen analyzers.

8. The sample size for the training set

• Sample Size for Training Set: Not Applicable. This is not an AI/ML device, so there's no "training set" in the machine learning sense. The device is designed and manufactured based on engineering principles.

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

• How Ground Truth was Established: Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established in that context. Device design and validation are based on engineering standards and performance targets.

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The 840 Ventilator System with BiLevel Option is used to provide continuous ventilation to patient's requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.

The 840 Ventilator System is a Class II device, "Continuous Ventilator", per 21 CFR Part 868.5895. This device is designated a Class I Type B equipment per IEC 601-1. The 840 Ventilator's gas delivery system consists of two proportional solenoid valves (PSOLs) and an active expiratory valve. Previosly cleared modes of ventilation include Assist Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV), and Spontaneous (SPONT). The 840 Ventilator System supplies mandatory or spontaneous breaths with a preset level of positive end expiratory pressure (PEEP), trigger sensitivity, and oxygen concentration. A mandatory breath can be pressure- or volume-controlled, except in the optional BiLevel mode, when it is always pressure-controlled. A spontaneous breath mode allows the patient inspiratory flows of up to 200 L/min, with or without pressure support. The 840 Ventilator modification is the addition of two new features for this device, the BiLevel Option and Inspiratory Pause. The BiLevel mode and Inspiratory Pause features are implemented on the 840 Ventilator through additional functionality in software and by using the existing User Interface panel. "BiLevel" has been added as a mode choice in the touch screen MODE menu. The INSP PAUSE key on the user interface, is activated to perform the inspiratory pause function. The pneumatic design and the electrical circuitry (apart from the User Interface printed circuit board) has remained unchanged functionally.

This document describes a 510(k) premarket notification for the Puritan-Bennett 840 Ventilator System with a new BiLevel Option and Inspiratory Pause features. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, many of the requested sections (Table of acceptance criteria, sample size, number of experts, adjudication method, MRMC study, standalone performance, sample size for training, ground truth for training) cannot be extracted from the provided text as they are not present in this type of regulatory submission for a modification to an existing device.

Here's what can be extracted and inferred based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document as it is a 510(k) submission for a modification to an existing device, focusing on substantial equivalence rather than primary functional performance testing against novel acceptance criteria.

The submission states: "Puritan-Bennett Corp. asserts that a) the intended use of the 840 Ventilator with BiLevel Option, as described in its labeling, has not changed from that of the cleared device, the 840 Ventilator, and b) the fundamental scientific technology of the 840 Ventilator with BiLevel Option has not changed from that of the 840 Ventilator."

It also mentions that "The BiLevel mode and Inspiratory Pause features are currently included in cleared predicate devices, providing justification for substantial equivalence." This implies that the 'acceptance criteria' are implicitly met if the device functions equivalently to these predicate devices for the new features.

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

This information is not provided in the document. The submission references "verification and validation testing, test and software quality procedures" but does not detail the size or nature of the test sets used for these activities, nor the provenance of data. This type of detail is typically internal to the company's design control documentation rather than explicitly stated in a 510(k) summary.

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

This information is not provided in the document. The assessment described is based on engineering verification and validation against design specifications and comparison to predicate devices, not typically through expert-adjudicated ground truth as would be common for diagnostic AI algorithms.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study was not mentioned or relevant to this 510(k) submission. This type of study is more common for diagnostic imaging or AI devices where human reader performance is augmented or compared. The 840 Ventilator is medical equipment; the submission focuses on its functional equivalence and safety.

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

This concept is not directly applicable to a ventilator. While the device contains software algorithms, the "standalone performance" is integrated into the device's overall function and directly assessed as part of its verification and validation. The submission does not describe a separate "algorithm only" performance study in the context of typical AI device evaluations.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, functional testing against those specifications, and demonstrated equivalence to previously cleared predicate devices. For example, the device must accurately deliver a preset tidal volume or maintain a target pressure. This would be verified through direct measurement with calibrated equipment during testing, rather than through expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic devices.

8. The Sample Size for the Training Set

This information is not provided in the document. The device's operation is based on deterministic algorithms and control systems, not learning models that require a "training set" in the machine learning sense.

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

This information is not provided in the document, as it doesn't describe a machine learning model with a training set. The "ground truth" for its development would be the fundamental principles of respiratory mechanics, engineering design standards, and pre-defined performance parameters derived from clinical requirements for ventilators.

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