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The Moore Park mask is intended to be used by patients weighing more than 66 lb (30 kg) who have been prescribed noninvasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The mask is intended for single patient re-use in the home and multi-patient re-use in the hospital/institutional environment.

The Moore Park mask is an externally placed vented respiratory mask. Positive air pressure (PAP) is directed to the patient's airway non-invasively, via the nose and/or mouth. The mask connects to the positive pressure flow source through conventional air tubing via an industry standard conical connector. The mask is held in place with adjustable headgear straps.

The Moore Park mask comprises 4 assemblies: headgear, frame, cushion and elbow. The exhaust ports are incorporated into the elbow and cushion assemblies. The anti-asphyxia valve is incorporated in the frame assembly. The cushion is available in various sizes to fit a wide patient population. The Moore Park mask is a prescription device supplied non-sterile.

Acceptance Criteria and Device Performance Study for Moore Park Mask

Based on the provided FDA 510(k) summary, here's a description of the acceptance criteria and the study conducted to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on non-clinical verification and validation testing, confirming compliance with relevant standards rather than stating specific quantitative performance metrics as acceptance criteria. However, the types of tests performed indicate the implicit acceptance criteria for safety and performance.

2. Sample Size for the Test Set and Data Provenance

The provided document describes non-clinical verification and validation testing (bench testing). Therefore, the concept of "test set" in the context of patient data (as might be applicable for an AI/diagnostic device) does not directly apply.

• Sample Size: Not applicable in the context of patient data for this device. The testing involved physical units of the mask and its components. The document does not specify the number of mask units or components used for each bench test.
• Data Provenance: Not applicable in the context of patient data. The data is generated from laboratory (bench) testing of the physical device components and assembled products. The company (ResMed Ltd) is based in Australia, suggesting the testing activities likely took place there or at affiliated test facilities.

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

This information is not applicable as the described studies are non-clinical, bench-top engineering and biocompatibility tests for a medical device (mask), not a diagnostic algorithm that requires expert-established ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as the described studies are non-clinical, bench-top engineering and biocompatibility tests for a medical device (mask), not a diagnostic algorithm requiring an adjudication method for ground truth.

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. The device is a PAP mask, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant.

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

This information is not applicable. The device is a PAP mask, not a standalone algorithm.

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

This information is not applicable in the sense of clinical "ground truth" for a diagnostic device. For the non-clinical tests described:

• Performance Tests: "Ground truth" is established by the specifications in the referenced ISO standards (e.g., ISO 17510:2015 for CO2 rebreathing limits, pressure-flow characteristics) or internal design specifications that ensure equivalence to the predicate device.
• Biocompatibility Tests: "Ground truth" is defined by the acceptance criteria within the referenced ISO 18562 and ISO 10993 series standards, which specify acceptable levels of biological response, emissions, or leachable substances.
• Reprocessing Validation: "Ground truth" is established by predetermined efficacy criteria for cleaning, disinfection, and maintenance of material properties.

8. The sample size for the training set

This information is not applicable. The device is a PAP mask, not an AI-powered device, and therefore does not have a "training set" in the context of machine learning.

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 medical device.

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The Scone Mask is intended to be used by patients weighing more than 66 lb (30 kg) who have been prescribed noninvasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The mask is intended for single patient re-use in the home and multi-patient re-use in the hospital/institutional environment.

The Scone Mask is an externally placed vented respiratory mask. Positive air pressure (PAP) source is directed to the patient's airway non-invasively, via the nose. The mask connects to the positive pressure flow source through conventional air tubing via an industry standard conical connector. The mask is held in place with adjustable head straps.

The Scone Mask comprises 4 subassemblies: headgear, frame, cushion and elbow. The exhaust ports are incorporated into the elbow and cushion assemblies. The cushion and frame are available in various sizes to fit a wide patient population.

The Scone Mask is a prescription device supplied non-sterile.

Here's a breakdown of the acceptance criteria and study details for the Scone Mask, based on the provided document. It's important to note that this is a medical device (mask), not an AI/algorithm-based device, so many of the typical AI/ML study questions (like MRMC, standalone algorithm performance, training set details) are not applicable to this submission. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Acceptance Criteria and Device Performance for Scone Mask

The provided document describes the FDA 510(k) submission for the Scone Mask, a non-invasive positive airway pressure (PAP) therapy mask. The "acceptance criteria" and "device performance" in this context refer to the mask's ability to meet established safety and performance standards for such devices, primarily by demonstrating substantial equivalence to a legally marketed predicate device (AirFit N20, K171212).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "sample size" in terms of subject counts for a clinical trial, as this was a non-clinical verification and validation study. The "samples" referred to are the actual Scone Mask prototypes and their components used for the various bench and laboratory tests. The number of masks/components tested for each specific test (e.g., CO2 rebreathing, flow resistance, mechanical integrity) is not detailed.
• Data Provenance: This was an internal validation study conducted by ResMed Ltd. The location of the test facility is not explicitly stated beyond ResMed Ltd's address being in Bella Vista, NSW, Australia. The data is non-clinical (bench testing), not collected from human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This submission is for a medical device (mask) based on non-clinical engineering and performance testing, not an AI/ML device requiring clinical expert review to establish ground truth from medical images/data. The "ground truth" here is objective physical and chemical measurements (e.g., CO2 levels, flow rates, material composition, mechanical properties) against established industry standards (ISO).

4. Adjudication Method for the Test Set

• Not Applicable. As this is a non-clinical device performance study, there's no need for an adjudication method by medical experts. The results are derived from objective measurements and laboratory analyses, compared against predetermined acceptance limits derived from international standards (e.g., ISO 17510, ISO 10993 series).

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

• No. An MRMC study is relevant for diagnostic AI devices where human reader performance is being evaluated with and without AI assistance. This document describes the testing for a PAP mask, which is a physical medical device, not a diagnostic AI.

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

• Not Applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

• The "ground truth" for this device is based on engineering specifications, industry standards (ISO 17510 for masks, ISO 10993 for biocompatibility), and established scientific principles for device safety and performance. This includes:
  • Objective measurements: CO2 levels, airflow, pressure, mechanical strength, chemical composition.
  • Compliance with published standards: Meeting the specified requirements of ISO standards.
  • Performance equivalence: Demonstrating that the device performs similarly to a legally marketed predicate device under tested conditions.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set of data.

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

• Not Applicable. Given that this is not an AI/ML device, there is no "training set" or "ground truth" in that context.

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The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.

The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66lb (30kg).

The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and noninvasive ventilation.

The Astral ventilator system uses a micro-processor controlled blower, which, along with valves and pressure and flow sensors, achieves pressure, flow and time regulation of air is directed to the patient via one of three ventilator breathing circuits; double circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the inlet to the main turbine. The device provides both therapeutic alarms (e.g. tidal volume) and technical alarms (e.g. system fault), and a user interface allowing adjustment of clinical parameters and display of monitored clinical data. The Astral can use external AC or DC power supply and contains an integrated battery.

The Astral is capable of providing the following types of ventilatory support:

• Assist/Control and SIMV with either volume or pressure control -
• Continuous Spontaneous Ventilation in either Pressure Support or CPAP -
• -Volume Assurance and Apnea Ventilation

The provided text describes a 510(k) premarket notification for the ResMed Astral 100/150 ventilator, focusing on the addition of an AutoEPAP feature within its iVAPS therapy mode. This submission argues for substantial equivalence to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of "acceptance criteria" for the AutoEPAP feature in the same way one might find for diagnostic accuracy (e.g., sensitivity, specificity thresholds). Instead, it discusses the performance in terms of demonstrating non-inferiority to the predicate device's manual EPAP feature.

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

• Test Set Sample Size: The exact number of patients in the multi-center clinical trial is not explicitly stated in the provided text.
• Data Provenance: The data came from a multi-center, single-blind, randomized, cross-over clinical trial. This indicates a prospective study design. The country of origin is not specified, but the applicant (ResMed Ltd) is based in Australia, and the correspondent is in the USA.

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

The text describes a clinical trial comparing AutoEPAP to manual EPAP. For this type of study involving respiratory support, the "ground truth" isn't typically established by a panel of independent experts reviewing data for diagnostic accuracy. Instead, the ground truth is based on physiological measurements (like ODI4%) and clinical outcomes in patients under observation by medical professionals. The study design (clinical trial) itself serves as the method for assessing efficacy. Therefore, there's no mention of a specific number of experts establishing "ground truth" in the diagnostic sense, nor are their qualifications detailed in this context. Rather, the expertise lies within the medical professionals conducting and overseeing the clinical trial.

4. Adjudication Method for the Test Set

The study was a single-blind, randomized, cross-over clinical trial. In this setup, patients are switched between AutoEPAP and manual EPAP, and their outcomes (e.g., ODI4%) are compared within the same patient. The "adjudication" in this context refers to the assessment of clinical endpoints by the study investigators/medical team, rather than an independent expert review of specific cases for a diagnostic outcome. The text does not elaborate on a specific adjudication committee or process beyond the trial design itself.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. MRMC studies are typically used to evaluate the performance of diagnostic devices or algorithms where multiple readers interpret cases with and without AI assistance. This submission describes a clinical trial evaluating a therapeutic device (a ventilator with a new feature) where the performance is measured by physiological outcomes in patients.

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

Yes, the clinical trial described effectively evaluates the "standalone" performance of the AutoEPAP algorithm in conjunction with the iVAPS mode by comparing it directly to manual EPAP. While "human-in-the-loop" is always present in a therapeutic device setting (clinicians set parameters, monitor patients), the comparison focuses on the automatic adjustment provided by the AutoEPAP algorithm versus a constant manual setting, demonstrating the algorithm's performance in a real-world clinical application. Bench testing also verified the algorithm's response to simulated conditions, which is another form of standalone assessment.

7. The Type of Ground Truth Used

The primary "ground truth" or endpoint used in the clinical study was:

• Oxygen Desaturation Index (ODI4%) as a measure of upper airway obstruction.
• Safety outcomes (absence of serious adverse events or complications).

These are objective physiological measures and clinical safety data from patients.

8. The Sample Size for the Training Set

The text does not provide information on the sample size for the training set for the AutoEPAP algorithm. Algorithms typically undergo a development and training phase using data, but this submission focuses on the validation of the finalized algorithm through bench and clinical testing.

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

The document does not specify how the ground truth for the training set was established. Given that this is a therapeutic algorithm for a ventilator feature, the training would likely involve:

• Physiological models of respiratory mechanics.
• Data from patients with respiratory conditions and various levels of upper airway obstruction.
• Expert clinical knowledge and engineering principles to develop the algorithm to respond appropriately to changes in flow and apnea events, aiming to maintain optimal EPAP levels.

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The AirFit F20 is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous pressure (CPAP) or bilevel system.

The AirFit F20 is:

• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.

The AirFit F20 is an externally placed vented mask covering the mouth and the nose of the patient. It provides a seal such that pressure from a positive pressure source is directed to the patient's nose and/or mouth. The mask connects via a standard conical connector to a conventional air delivery hose, which in turn connects to the positive pressure source. The mask is held in place with an adjustable headgear that straps the mask to the face.

The AirFit F20 mask system comprises four subassemblies: cushion, frame, elbow and headgear. The elbow incorporates the vent array and anti-asphyxia valve safety features. The cushion and headgear are available in various sizes to fit a wide patient population.

AirFit F20 is a prescription device supplied non-sterile.

This document is an FDA 510(k) clearance letter for a medical device called AirFit F20, a non-invasive accessory for positive airway pressure (PAP) devices. It does not contain information about an AI/ML device or a study involving human readers and AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI, as the provided text pertains to a traditional medical device submission and does not involve AI or ML.

The document discusses the substantial equivalence of the AirFit F20 to a previously cleared predicate device (AirFit F20 (K153563)) based on:

• Intended Use: Same
• Operating Principle: Same
• Design and Materials: Similar
• Performance: Similar pressure-flow characteristics and flow impedance
• Operating Environments: Same (home and hospital/institution)
• Manufacturing Processes: Similar

The main differences from the predicate device relate to reprocessing claims for multi-patient reuse and material changes to certain components. Non-clinical data validation testing was conducted to demonstrate that these changes do not raise new questions of safety or effectiveness. This validation included:

• Bioburden efficacy tests
• Performance tests (visual inspection, total mask flow, AAV activation/deactivation, assembly integrity, mask-to-headgear connections) before and after reprocessing
• Residual toxicity tests
• Biocompatibility tests for material changes (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Acute systemic toxicity, Material-mediated Pyrogenicity, Implantation, Leachables testing)

In summary, the provided text describes a 510(k) clearance for a non-AI medical device and therefore does not contain the information needed to answer your specific questions about AI acceptance criteria and study details.

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The AirFit N20 channels airflow non-invasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.

The AirFit N20 is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure has been prescribed
• intended for single patient re-use in the home environment and multi-patient re-use in the hospital / institutional environment

The AirFit N20 is an externally placed vented respiratory mask covering the patient's nose. It provides a seal such that pressure from a positive air pressure (PAP) source is directed to the patient's airway non-invasively via the nose. The mask connects to the positive pressure source through a conventional air tubing via a standard conical connector. The mask is held in place with adjustable head straps.

The AirFit N20 comprises 4 subassemblies: headgear, frame, cushion and elbow/short tube. The exhaust port is incorporated into the elbow/short tube assembly. The cushion and headgear are available in various sizes to fit a wide patient population.

The AirFit N20 is a prescription device supplied non-sterile.

This document is a 510(k) premarket notification for the ResMed AirFit N20, a vented nasal mask, seeking clearance for expanded reprocessing claims. It is an FDA regulatory submission, not a study report describing an AI/ML device. Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets them cannot be provided as the document does not pertain to such a device.

The document discusses the substantial equivalence of the AirFit N20 with added reprocessing claims to a previously cleared predicate device. It details non-clinical testing performed to demonstrate that the expanded reprocessing claims do not affect the intended performance or raise new questions of safety or effectiveness.

Here's a breakdown of the non-clinical testing mentioned, which serves as the "study" demonstrating the device meets its expanded claims, though it is not an AI/ML study:

1. Table of Acceptance Criteria and Reported Device Performance:

• Mask Pressure-Flow tests per ISO 17510:2015.
• Relevant mask mechanical integrity tests: visual inspection, assembly integrity, headgear connection integrity, simulated body weight crush test, and free fall drop test. |
  | Residual Toxicity: Device must remain safe after reprocessing. | Demonstrated using appropriate Cytotoxicity biocompatibility tests, performed in accordance with ISO 10993-5:2009. |

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

• Sample Size: Not explicitly stated in terms of number of devices/units tested. The document refers to "the subject device" implying a representative sample was used for the non-clinical tests.
• Data Provenance: The tests were conducted internally or by contracted labs as part of the regulatory submission process by ResMed Ltd. (Australia) for their device. This is prospective testing for regulatory clearance.

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

• This is not applicable as this is not an AI/ML device study. Ground truth in this context would refer to established standards and test methods (e.g., ISO standards, biocompatibility protocols) against which the physical device performance is measured. The "experts" would be the engineers, scientists, and technicians conducting and interpreting these non-clinical tests. Their specific numbers and qualifications are not provided in this regulatory summary.

4. Adjudication Method for the Test Set:

• Not applicable as this is not an AI/ML device study. Decisions are based on objective measurements against predefined acceptance criteria from international standards (e.g., ISO 17510:2015, ISO 10993-5:2009).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used:

• Established
  standards and validated test methods:
  • Bioburden efficacy test protocols (implicitly following relevant standards for cleanliness and disinfection).
  • ISO 17510:2015 for Mask Pressure-Flow tests.
  • Specific mechanical integrity test protocols (visual inspection, assembly integrity, etc.).
  • ISO 10993-5:2009 for Cytotoxicity biocompatibility tests.
• The ground truth is the performance of the predicate device and the specified limits/requirements within the applicable standards.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device; there is no "training set."

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

• Not applicable. This is not an AI/ML device.

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The Juno VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnoea (OSA).

The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg).

The Juno VPAP ST-A is intended for home and hospital use.

The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.

The subject device Juno VPAP ST-A retains all the same hardware, technologies and manufacturing characteristics as previously cleared in K153061. The device is used in a wider breathing circuit which typically comprises patient tubing and a mask (patient interface) to deliver a prescribed positive airway pressure treatment to patients.

Some of the kev features of the device include an in-line power supply: fully integrated humidifier: alarms module; heater controller; colour LCD and simple controls for ease of use. The device also allows data transfer/connectivity via an integrated wireless module (When used in a hospital setting, remote changes may not be appropriate for certain patients, as these setting changes may not be communicated to all hospital personnel treating the patient. Hospital staff should liaise with the patient's regular care provider such that the desired therapy outcome is achieved).

Juno VPAP ST-A utilizes a Micro-processor controlled blower system that generates positive airway pressure (CPAP) between 4-20 cmHJO as required to maintain an "air splint" for effective treatment of OSA and (Bilevel) pressures between 3-30 cmH2O for the treatment respiratory insufficiency.

The therapy modes available in the Juno VPAP ST-A include CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS. In this subject device now features an optional "AutoEPAP" function on iVAPS mode. AutoEPAP automatically adjusts EPAP pressure (within set values) in response to flow limitations of the upper airway.

Juno VPAP ST-A is intended to be used under the conditions and purposes indicated in the labelling provided with the product.

It is a prescription device, supplied non-sterile.

The document describes the Resmed Juno VPAP ST-A device (K161492), which is an update to a previously cleared device (K153061). The key change in the subject device is the addition of an optional "AutoEPAP" function to the iVAPS therapy mode.

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 acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, suitability for market is based on demonstrating substantial equivalence to the predicate device (Juno VPAP ST-A, K153061) and demonstrating that the new AutoEPAP algorithm provides equivalent therapy to the fixed EPAP setting of the predicate.

The reported device performance is that the AutoEPAP iVAPS therapy mode was as efficacious as iVAPS with fixed EPAP in terms of several clinical metrics.

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

• Sample size for the test set: Not explicitly stated. The document mentions "patients with respiratory insufficiency" but does not provide the number of participants.
• Data provenance: Not explicitly stated, but the study was a "clinical trial" which implies prospective data collection. The country of origin is not specified.

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

This information is not provided in the document. As this is a study evaluating the clinical efficacy of a ventilator mode, the "ground truth" would be established by direct physiological measurements and clinical assessments rather than expert review of images or data.

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, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC study was not done. This device is a ventilator, not an AI-assisted diagnostic tool that would typically involve human readers interpreting data or images. The study focuses on the direct efficacy of the ventilator's automated function.

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

Yes, the clinical trial described appears to be a standalone performance evaluation of the AutoEPAP iVAPS algorithm. It directly compares the efficacy of the new automated algorithm with the fixed EPAP mode, which also functions automatically (without real-time human intervention during therapy delivery).

7. The Type of Ground Truth Used

The ground truth was established using physiological measurements and clinical outcomes data such as:

• Apnea-Hypopnea Index (AHI)
• Oxygen Desaturation Index (ODI)
• Blood Oxygen Saturation (SPO2)
• Transcutaneous Carbon Dioxide (PtcCO2)
• Sleep Quality (presumably based on polysomnography or other clinical assessments)

8. The Sample Size for the Training Set

The document describes a clinical trial (double-blinded, randomized, crossover study) which evaluates the performance of the implemented algorithm. It does not mention a separate "training set" in the context of an AI/machine learning model development lifecycle. The AutoEPAP algorithm would have been developed and internally validated by the manufacturer, but the specific details of its training data (if any for a machine learning component) are not provided. The clinical trial serves as the validation or test set for the device's efficacy.

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

As explained above, a "training set" in the machine learning sense is not explicitly discussed. For the clinical trial (validation data), the ground truth was established through direct physiological measurements and clinical assessments as listed in point 7.

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The Menai self-adjusting system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). It is intended for home and hospital use.

Monte Carlo is a mobile application for patients to remotely operate a prescribed compatible ResMed machine and transfer, and display usage and therapeutic information. Monte Carlo also allows healthcare professionals to remotely configure compatible OSA therapy devices.

The Menai FFM is a non-invasive accessory used for channeling airflow to a patient from a compatible ResMed machine such as a continuous positive airway pressure (CPAP) system.

The Menai FFM is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home and hospital/institutional environment.

The Menai system CPAP device retains similar hardware and performance features of the predicate device(s). It is provided in a portable smaller footprint than the predicate for user convenience in the home environment. Key features include mask, tubing, humidification system, and software controls. The Menai System contains a Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for treatment of OSA. Included is an optional humidifier component for patients who experience dryness in the upper airways such as mouth or nasal areas.

The Menai system flow generator includes CPAP, AutoSet for Her (AfH) modes. These modes and their treatment parameters are only settable by the Clinician via the Clinician accessible menu of the software. In addition to Patient and Clinician settable features, the software can display patient sleep data and treatment pressures, similar to that found on the predicate S9 Elouera (K140124). The Menai system includes Cheynes Stokes Respiration (CSR) breathing pattern recognition and reporting, this feature remains unchanged as cleared S9 Elouera (K140124).

Here's a breakdown of the acceptance criteria and study information based on the provided text, keeping in mind that the document is a 510(k) summary and not a full clinical study report, so some details (like specific statistical results or full ground truth methods for all tests) may not be explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a consolidated table of acceptance criteria with numerical performance targets and reported results for all aspects of the device. Instead, it describes various tests and states that the device "met the predetermined acceptance criteria" or "demonstrated compliance."

However, we can infer some criteria and reported performance from the "Non-Clinical Testing" section for the core therapeutic performance:

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

• Test Set Sample Size:
  • Therapeutic Performance (Bench Testing): Not explicitly stated. It mentions "patient breathing patterns" and "digitized breathing patterns" for CSR detection, suggesting a collection of such patterns, but no number is given.
  • Biocompatibility, Electrical Safety, Mechanical, Acoustic, Software V&V: These are generally conducted on device units or software builds, not "patient test sets" in the same way clinical or diagnostic studies are. The sample size for these types of tests would typically refer to the number of devices or components tested, which is not specified.
  • Clinical Study (Humidifier): Not specified.
• Data Provenance: The document does not specify the country of origin for any data cited.
  • Therapeutic Performance (Bench Testing): Retrospective, as it used "digitized breathing patterns" and "patient script file" data.
  • Clinical Study (Humidifier): Prospective for the "clinical study" focusing on bio-burden and impedance.

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

• Therapeutic Performance (Bench Testing), CSR Detection: Not specified. The "Clinical Pass/Fail criteria" were predefined, implying expert input into their establishment, but the number or qualifications of experts used to establish the ground truth for the digitized breathing patterns themselves is not mentioned. Many such patterns are often derived from polysomnography interpreted by sleep specialists, but this is not stated here.
• Other Testing (Biocompatibility, Electrical, Mechanical, Software): Ground truth for these types of engineering and safety tests is established by adherence to recognized international standards and regulatory guidance, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for any specific test set. For the CSR detection, it states the Menai system's results were "compared to the predicate S9 Elouera (K140124)" and met "predefined Clinical Pass/Fail criteria." This implies a comparison to an established reference or a standard of performance, but not an independent expert adjudication process on the test cases themselves.

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

No MRMC comparative effectiveness study was mentioned. The device being reviewed is a noncontinuous ventilator (CPAP machine), not typically an imaging or diagnostic AI requiring an MRMC study to assess human reader improvement. The "Clinical Study" was focused on the humidifier component's characteristics (bioburden, impedance, replacement interval).

6. Standalone Performance Study (Algorithm Only)

Yes, standalone performance was implicitly studied for the core therapeutic functions and CSR detection:

• Therapeutic Performance (Bench Testing): "A breathing machine simulates patient breathing patterns, which results in the Flow Generator responding in a manner consistent with maintaining the CPAP treatment pressure... or adjusting the CPAP pressure..." This indicates the algorithm's performance in responding to simulated physiological conditions.
• CSR Detection and Reporting: "Side-by-side testing using the same digitised breathing patterns was used for both predicate and Menai system. This test executes patient script file is treated as an individual scenario, which the Menai reports either: No CSR, CSR, CSR + OSA, OSA." This is a standalone test of the algorithm's ability to detect and report these patterns.

7. Type of Ground Truth Used

• Therapeutic Performance (Bench Testing): The ground truth for these tests would be the expected or ideal physiological response to the simulated breathing patterns, as defined by the device's specification and comparison to the predicate device's known performance. This is essentially an engineering-defined "ground truth."
• CSR Detection and Reporting: The ground truth for this was established by the "same digitized breathing patterns" used for both the predicate and new device, which were likely derived from actual patient data previously interpreted and labeled, forming the "patient script files." This would be closer to an "expert consensus" or "polysomnography-derived" ground truth for the underlying physiological events.
• Clinical Study (Humidifier): Laboratory analysis (for bacterial accumulation/proliferation) and direct measurement (for impedance).

8. Sample Size for the Training Set

The document does not provide details about a training set for any algorithms. This is a 510(k) summary, often focused on verification and validation against pre-defined requirements and predicate devices, rather than the developmental aspects of AI/ML algorithms which would typically involve training sets. While there's a "Software Verification and Validation Testing" section, it focuses on general software lifecycle processes rather than machine learning specifics.

9. How Ground Truth for the Training Set Was Established

Since no training set details are provided, the method for establishing its ground truth is also not described.

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The AirFit N20 channels airflow non-invasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.

The AirFit N20 is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure has been prescribed
• intended for single patient re-use in the home environment and multi-patient re-use in the hospital / institutional environment.

The modified ResMed AirFit N20 is a non-invasive vented respiratory mask that provides a silicone air seal around the patient's nose and upper lip. The mask is held in place with adjustable head straps. Air flow from a positive air pressure (PAP) source is directed to the patient's airway non-invasively. It connects to a conventional PAP device air delivery hose via a standard 22mm swivel.

The modified AirFit N20 comprises 4 subassemblies: headgear, frame, cushion and elbow/short tube. The exhaust port is incorporated into the elbow/short tube assembly. For home use, the mask may be cleaned in warm soapy water.

The AirFit N20 is a prescription device supplied non-sterile.

This document describes the regulatory submission for the ResMed AirFit N20, a non-invasive vented respiratory mask. The submission, K161978, is a modification of a previously cleared predicate device, AirFit N20 (K153673), aiming to demonstrate substantial equivalence.

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state sample sizes for specific tests (e.g., number of masks tested for CO2 rebreathing, or number of cleaning/reprocessing cycles). It mentions "testing to simulated normal use and reasonable abuse scenarios," suggesting laboratory-based testing.

• Data Provenance: The testing was conducted by ResMed Ltd, an Australian company, for a device intended for international markets (indicated by FDA submission). The data is retrospective in the sense that it's bench testing and verification/validation conducted by the manufacturer, not a prospective clinical trial. There is no mention of data from human subjects in the testing phase beyond what is implicitly covered by biocompatibility standards.

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

Not applicable. This is a medical device submission primarily relying on bench testing and engineering verification/validation against international standards (e.g., ISO 17510:2015, ISO 10993 series) and comparison to a predicate device, rather than human expert-established ground truth for a diagnostic output. The "ground truth" here is the adherence to established engineering specifications and safety standards.

4. Adjudication Method for the Test Set

Not applicable for this type of submission. The evaluation is based on objective measurements against pre-defined engineering and performance criteria and adherence to recognized standards.

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

No. This document explicitly states: "Clinical data was not relied upon to demonstrate Substantial Equivalence to the predicate device. Bench testing demonstrates that the modified AirFit N20 mask device performs in an equivalent manner and is as safe and as effective as the previously cleared predicate AirFit N20 device (K153673)." Therefore, an MRMC study is not relevant to this submission.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)

Yes, in the sense that the device's functional and mechanical performance was evaluated in isolation ("bench testing") against pre-defined specifications and standards. This is not an AI algorithm, but a physical medical device; its "standalone performance" refers to its intrinsic characteristics and operation.

7. Type of Ground Truth Used

The "ground truth" for this device, as described in the submission, is based on:

• International Standards: Primarily ISO 17510:2015 (Medical devices – Sleep apnoea breathing therapy Masks and application accessories) and ISO 10993 series for biocompatibility.
• Engineering Specifications: Predetermined acceptance criteria derived from the device's design requirements and performance characteristics of the legally marketed predicate device (K153673).
• Predicate Device Performance: The original AirFit N20 (K153673) serves as a benchmark for "similar performance."

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As noted above, there is no AI/ML training set.

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The S9 VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The S9 VPAP Adapt is intended for home and hospital use.

The AirCurve 10 ASV device is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.

The VPAP Adapt is indicated for the treatment of patients weighing more than 66lb (30kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The VPAP Adapt is intended for home and hospital use.

The S9 VPAP Adapt is identical to the predicate device S9 VPAP Adapt (K102586), using a blower based positive pressure system with an integrated heated humidfier and heater controller. The device platform is identical to the S9 VPAP Adapt (K102586) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmHJO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier. The S9 VPAP ADAPT is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation.

The VPAP Adapt is identical to the predicate device (K113801), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the VPAP Adapt (K113801) and contains a Micro-processor controlled blower system that qenerates controlled positive airway pressure between 3-25 cmH2O as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier. The VPAP Adapt is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation.

The AirCurve 10 ASV is identica to the predicate device, S9 Greenhills (K140279), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the S9 Greenhills (K140279) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmH2O. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier. The AirCurve 10 ASV is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV mode) or (ASVAuto mode) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average minute ventilation. It then adjusts the degree of pressure support to servo-control the patilation to at least equal the target ventilation. The same is true for ASVAuto mode except the EPAP is adjusted to address any obstructive apneas detected.

The provided text describes a 510(k) premarket notification for several ResMed devices (S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV). The submission is a labeling change only to include a contraindication related to Adaptive Servo-Ventilation (ASV) therapy.

Therefore, the acceptance criteria and device performance information typically associated with a medical device study (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC) are not applicable or provided in this document. The purpose of this 510(k) is to demonstrate substantial equivalence to predicate devices based on the absence of changes to the device's fundamental safety and effectiveness despite the new contraindication.

The study referenced, SERVE-HF, is not a study proving the device meets acceptance criteria in the traditional sense of validating a device's performance metrics. Instead, it is a clinical trial that informed the contraindication for the ASV therapy provided by the devices.

Here's an breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission is for a labeling change and asserts that the "new device has not altered the safety and effectiveness" compared to the predicate, traditional performance acceptance criteria (e.g. sensitivity, specificity for a diagnostic device) are not detailed as they were not required to be re-evaluated for the 510(k). The "acceptance criteria" here implicitly refer to demonstrating that the device itself (hardware, underlying software logic for therapy delivery) remains functionally identical and equally safe and effective as its predicate before the new contraindication.

The document essentially states:

The justification for substantial equivalence for all three devices (S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV) explicitly states:

• "Same intended use"
• "Same operating principle"
• "Similar technologies"
• "Same manufacturing process"

And crucially: "As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device..."

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

The document does not describe a "test set" for validating the device's technical performance in the current submission. The SERVE-HF study, which informed the contraindication, acted as the primary data provenance.

• Sample Size (SERVE-HF): 1325 patients
• Data Provenance (SERVE-HF): "randomized, parallel, event-driven, international multicenter study." This implies a prospective, multi-country study. Specific countries are not detailed in this document.

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

Not applicable for this 510(k) submission, as it's a labeling change based on a clinical trial (SERVE-HF) rather than a de novo device performance study requiring expert ground truth in a test set. The SERVE-HF study's outcomes (survival and cardiovascular events) were the 'ground truth' for establishing the contraindication, validated via standard clinical trial methodologies rather than expert consensus on individual cases for a device's performance.

4. Adjudication method for the test set

Not applicable. For the SERVE-HF study, clinical trial protocols would typically include adjudication methods for primary and secondary outcomes, often by an independent committee. This level of detail is not present in the 510(k) summary.

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 therapeutic ventilator, not an AI-assisted diagnostic tool.

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

Not applicable. This is a therapeutic device. The "algorithm" for ASV therapy operates as part of the device's function, not as a standalone diagnostic. The SERVE-HF study assessed the clinical outcome of the therapy delivered by such devices.

7. The type of ground truth used

The "ground truth" for the new contraindication derived from the outcomes data of the SERVE-HF study. These outcomes included "survival and cardiovascular outcomes" rather than expert consensus, pathology, or specific diagnostic accuracy.

8. The sample size for the training set

Not applicable. The SERVE-HF study's data was used to establish a clinical contraindication for the device's therapy, not to train a machine learning model. The device itself (S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV) is established technology, and the 510(k) asserts its functional identity to predicate devices.

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

Not applicable, as no training set for a machine learning model is described. The "ground truth" for the contraindication came from the clinical trial results of the SERVE-HF study: patients randomized to ASV therapy (compared to optimal medical management alone) showed an increased risk of cardiovascular mortality.

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The VPAP ADAPT SV is intended to provide non-invasive ventilatory support to treat adult patients with obstructive sleep apnea (OSA) and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

The VPAP TX is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. The VPAP TX is intended to be used in a clinical environment.

The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg). The S9 VPAP Tx is intended to be used in a clinical environment.

The VPAP Adapt SV is identical to the predicate device VPAP Adapt SV (K051364), using a blower based positive pressure system. The device platform is identical to the VPAP Adapt SV (K051364) and contains a blower (motorfan assembly), flow and pressure sensors, and processing electronics. The blower supplies pressurized air to the patient via a mask and air tubing. The VPAP Adapt SV is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy to stabilize a patient's ventilation. The device continually measures instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation.

The VPAP Tx is identical to the predicate device VPAP Tx (K092186), using a blower based positive pressure system. The device platform is identical to the VPAP Tx (K092186) and contains a Micro- processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency. The VPAP Tx system comprises the flow generator, patient interface) and optional humidifier.

The S9 VPAP Tx is identical to the predicate device S9 VPAP Tx (K123511), using a blower based positive pressure system. The device platform is identical to the S9 VPAP Tx (K092186) and contains a Micro- processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency. The S9 VPAP Tx comprises the flow generator, patient interface) and optional humidifier.

This document is primarily a 510(k) summary for three ResMed devices (VPAP Adapt SV, VPAP Tx, and S9 VPAP Tx), indicating that the submission is for a labeling change to include a contraindication. It states that no further clinical testing was required to show substantial equivalence to the predicate devices because it was a labeling change only. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a performance study for a new device or software.

However, the contraindication is supported by a large-scale clinical study:

SERVE-HF Study Information (relevant to the contraindication):

• Study Design: Randomized, parallel, event-driven, international multicenter study.
• Sample Size: 1325 patients.
• Patient Population: Chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.
• Intervention: Addition of ASV (Adaptive Servo-Ventilation) to guideline-based medical management.
• Outcome Investigated: Effects on survival and cardiovascular outcomes.
• Finding: The addition of ASV did not improve outcomes and showed an increased risk of cardiovascular mortality despite effective control of central sleep apnea. This finding supports the need for a contraindication rather than demonstrating the device's performance against specific acceptance criteria for its intended use outside of this specific high-risk patient group.

Given the nature of the submission (a labeling change based on a clinical trial that identified a contraindication), the following points from your request cannot be directly extracted from the provided text for the device's performance meeting acceptance criteria:

1. A table of acceptance criteria and the reported device performance: Not available, as no new performance study was conducted. The tables provided compare characteristics of the new device to the predicate, stating they are "Equivalent," which is about substantial equivalence, not acceptance criteria performance.
2. Sample size used for the test set and the data provenance: For the contraindication study (SERVE-HF), the sample size was 1325 patients, from an international multicenter study. Data provenance for the device's original clearance is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this submission's context, as it's a labeling change based on a large clinical trial, not a performance study compared to expert ground truth for a diagnostic AI.
4. Adjudication method: Not applicable here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the SERVE-HF study, the "ground truth" was clinical outcomes data (survival and cardiovascular mortality).
8. The sample size for the training set: Not applicable, as this is a device and a labeling change, not an AI/ML algorithm development with a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary in relation to your request:

The document describes a labeling change for three continuous ventilators (VPAP Adapt SV, VPAP Tx, S9 VPAP Tx). This change is to add a contraindication for ASV therapy in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.

This contraindication is directly supported by findings from the SERVE-HF study, a large-scale, randomized, parallel, event-driven, international multicenter study involving 1325 patients. The study found that adding ASV to guideline-based medical management in this specific patient population did not improve outcomes and led to an increased risk of cardiovascular mortality. The "ground truth" for the SERVE-HF study was clinical outcomes data (survival and cardiovascular outcomes).

The document explicitly states that no further clinical testing was required for this 510(k) submission because it was only a labeling change, and the device itself (its operating principle, technology, manufacturing process) remains substantially equivalent to its respective predicate devices (K051364, K092186, K123511). Therefore, there are no new acceptance criteria or device performance data against them presented in this document for the device's efficacy in its cleared indications.

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