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N2 is intended to supply power to and serve as a base for dental devices and accessories. This includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

The N2 is a dental treatment unit in accordance with IEC 80601-2-60 and designed for dental treatment of children and adults. This product is used in dentistry only and may only be used by trained medical personnel and trained professional in the field of general dentistry.

The N2 is an AC-powered dental operative unit with accessories, intended to supply power to and server as a base for dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water unit functions.

The subject device has three types, Cart type, Mount type and Continental type which consists of chairs, unit, table, seat, stool, 3-way syringe, monitor arm, foot control and console.

The N2 dental operative unit is primarily evaluated against safety and performance standards for dental equipment and medical electrical equipment. As such, the acceptance criteria and study designs differ significantly from those for AI-powered diagnostic or prognostic devices.

Here's an analysis of the provided information, structured to address your specific points where applicable, and noting where the information is not relevant to this type of device:

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

For the N2 dental operative unit, the "acceptance criteria" are compliance with established international and FDA-recognized standards for electrical safety, electromagnetic compatibility, biocompatibility, cleaning/sterilization validation, and software validation. The reported device performance is that it complied with these standards.

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

For this type of device, "test set" and "data provenance" don't apply in the way they do for AI/diagnostic devices. The evaluation of N2 relies on bench testing and compliance with recognized standards.

• Bench Testing: This involves testing the physical device and its components in a controlled laboratory environment against specified parameters (e.g., electrical measurements, pressure limits, temperature control, mechanical movements). The "sample size" would typically be a representative number of units from a production batch or prototypes. The document doesn't specify the exact number of units tested for each standard, but it's understood to be sufficient for demonstrating compliance.
• Data Provenance: This is not relevant. The testing is performed in accordance with international standards, and the results are primarily engineering and performance measurements, not patient 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 is not applicable to the N2 device. "Ground truth" in the context of diagnostic performance (e.g., presence/absence of a disease) is established by expert consensus, pathology, or outcomes data. For a dental operative unit, the "ground truth" is adherence to engineering specifications and safety standards, which is verified through objective measurements and test procedures, not expert interpretation of clinical data.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret medical images or data and their decisions need to be reconciled to establish a consensus ground truth. For equipment like N2, compliance is determined by passing objective tests against defined standards, not by human interpretation.

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 is not applicable. The N2 is a dental operative unit (a piece of hardware for dental procedures), not an AI-assisted diagnostic or therapeutic device that would involve human readers or image interpretation. Therefore, an MRMC study is completely irrelevant.

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

This is not applicable. The N2 device is not an algorithm. Its "standalone performance" is its ability to function safely and effectively as a dental operative unit, which is demonstrated through component testing, system integration testing, and compliance with the listed standards. The software components are for controlling the unit's functions, not for standalone diagnostic or analytical tasks.

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

As mentioned in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not applicable to this device. The "truth" for this device's safety and effectiveness is its conformance to established engineering and medical device standards through objective measurements and validated processes.

8. The sample size for the training set

This is not applicable. "Training set" refers to data used to train machine learning models. The N2 device is a hardware unit with embedded software for control; it does not utilize machine learning in its described function.

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

This is not applicable for the same reasons as point 8.

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N2 is intended to supply power to and serve as a base for dental devices and accessories. This includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

The N2 is an AC-powered dental operative unit with accessories, intended to supply power to and serve as a base for dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronicallycontrolled chair movements with software and water unit functions.

This document describes the N2, a dental operative unit, and its substantial equivalence to a predicate device (K183347), K3. The submission focuses on non-clinical testing for safety and performance rather than AI-driven image analysis. Therefore, many of the requested fields regarding AI performance, such as sample size for test/training sets, data provenance, number and qualification of experts, adjudication methods, MRMC studies, and ground truth types, are not applicable in this context.

The document details the device's technical characteristics, intended use, and indicates that no clinical studies were deemed necessary. The acceptance criteria and "reported device performance" are primarily demonstrated through compliance with various international standards and specific bench tests, rather than metrics like sensitivity, specificity, or accuracy which would be typical for an AI-enabled diagnostic device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and 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)

This information is not applicable as the submission describes a physical dental operative unit, not an AI/software device that processes medical image data or other patient-specific data for diagnostic or prognostic purposes. The "testing" refers to bench testing and compliance with electrical, mechanical, and safety standards for the device itself.

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 is not applicable. Ground truth, in the context of expert consensus, is typically established for diagnostic tasks where human interpretation is the gold standard. For this device, "ground truth" would relate to the physical and functional parameters meeting engineered specifications and safety standards, validated through direct measurement and compliance testing (e.g., measuring current, pressure, chair movement ranges).

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

This is not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations, which is not relevant for the testing described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. MRMC studies are conducted for systems that assist human readers in tasks like image interpretation. The N2 is a dental operative unit, not an AI-assisted diagnostic or interpretative tool.

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

This is not applicable. The N2 is a physical device with some electronic controls (firmware), not a standalone algorithm.

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

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

• Engineering Specifications: The pre-set criteria for bench tests, electrical safety, and mechanical performance are based on design specifications and industry standards.
• Regulatory Standards: Compliance with international standards such as IEC 60601-1, IEC 80601-2-60, ISO 10993, ISO 17665, and ISO 16954 forms the basis of "truth" for safety and essential performance.
• Manufacturer Recommendations: For cleaning/sterilization, the validation is against the manufacturer's recommended protocols.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of machine learning for this device. The software validation refers to standard software development, verification, and validation (V&V) processes for firmware, not AI model training.

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

This is not applicable for the reasons stated above.

In summary, the provided document describes a 510(k) submission for a dental operative unit, which is a physical device. The "study" mentioned refers to non-clinical bench testing and compliance with various international electrical, mechanical, safety, and biocompatibility standards to demonstrate substantial equivalence to a predicate device. It is not an AI-enabled diagnostic or assistive device, so many of the requested fields regarding AI performance evaluation are irrelevant.

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BeneVision N12/N15/N17/N19/N22

The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

· BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only:

· C.O. monitoring and A-Fib are intended for adult patients only;

• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.

· rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport. hospital ambulance, or home use.

BeneVision N1 Patient Monitor:

The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• PAWP, PNP, and PNC are intended for adult and pediatric patients only;
• A-Fib is intended for adult patients only;

The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

The subject BeneVision N Series Patient Monitors includes six monitors:

• BeneVision N12 Patient Monitor
• BeneVision N15 Patient Monitor
• BeneVision N17 Patient Monitor ●
• . BeneVision N19 Patient Monitor
• . BeneVision N22 Patient Monitor
• BeneVision N1 Patient Monitor ●

Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.

The provided document describes the BeneVision N Series Patient Monitors and their clearance by the FDA based on substantial equivalence to predicate devices, particularly focusing on changes and new features. The document details the device's intended use, technological comparisons, and performance data from various tests. However, it does not explicitly provide a table of acceptance criteria and reported device performance in the format requested. Instead, it states that "the results of the bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device."

Specifically regarding "Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm)" which is the relevant regulation name for the product code MHX (used by the BeneVision N Series Patient Monitors), the document states:
"Add arrhythmia detection for neonatal patients when used with the MPM 3.0 module." (Page 9, Table 2 ECG section; Page 22, Table 3 ECG section).
And references "K200015 - ePM series Patient Monitors...: provided as reference devices for ECG algorithm supporting arrhythmia detection in neonate that has been added to the subject BeneVision N Series Patient Monitors." (Page 6, Section 4).

Given the information in the document, here's a structured response:

Acceptance Criteria and Device Performance Study for Arrhythmia Detection in Neonates

The provided FDA 510(k) summary (K202405) for the BeneVision N Series Patient Monitors primarily focuses on demonstrating substantial equivalence to a predicate device (K192972) and a reference device (K200015) for the new feature of neonatal arrhythmia detection. While it explicitly states that the device meets its accuracy specifications, it does not provide a specific table of acceptance criteria or detailed reported performance metrics for neonatal arrhythmia detection. Instead, it relies on general statements about meeting specifications and compliance with standards.

However, based on the document's information and common regulatory expectations for such devices, we can infer the type of acceptance criteria and the nature of the study.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table for the acceptance criteria and reported device performance for neonatal arrhythmia detection. It states that the device "meets its accuracy specification." For arrhythmia detection systems, typical performance metrics and acceptance criteria, often derived from standards like IEC 60601-2-27, would generally include:

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The BeneVision N12/N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• The arrhythmia detection, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only;
• C.O. monitoring is intended for adult patients only;
• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
• rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use.

The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• The arrhythmia detection and PAWP is intended for adult and pediatric patients only
  The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

The subject BeneVision N Series Patient Monitors includes six monitors:

• BeneVision N12 Patient Monitor
• BeneVision N15 Patient Monitor
• BeneVision N17 Patient Monitor
• BeneVision N19 Patient Monitor
• BeneVision N22 Patient Monitor
• BeneVision N1 Patient Monitor

The BeneVision N Series Patient Monitors are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of monitoring.

The provided document is a 510(k) Summary for the Mindray BeneVision N Series Patient Monitors. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with statistical endpoints.

Therefore, many of the requested elements for a detailed study description (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with specific metrics, and ground truth establishment for training data) are not present in the provided text.

The document primarily highlights changes from predicate devices and states that functional and system-level testing, along with compliance with consensus standards, demonstrate equivalence.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically seen for a new device's efficacy study. Instead, it compares the specifications of the subject device with those of predicate devices, implicitly indicating that the subject device's performance meets or exceeds the predicate's established performance or relevant cleared standards.

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

The document does not specify sample sizes for test sets. The testing mentioned is referred to as "functional and system level testing" and "bench testing." It also states Mindray conducted "clinical testing to demonstrate that the Mindray and Nellcor SpO2 modules meet relevant consensus standards."
There is no mention of data provenance (e.g., country of origin of data, retrospective or prospective).

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

Not applicable. The document does not describe the use of experts to establish ground truth for testing. The evaluation focused on meeting specifications and consensus standards, and demonstrating equivalence to predicate devices.

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

Not applicable. There is no mention of adjudication methods.

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 a patient monitor, not an AI-assisted diagnostic device, and no MRMC studies are mentioned.

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

The document describes performance in terms of functionality and adherence to technical specifications and consensus standards, not in terms of "algorithm-only" performance as would be relevant for an AI device. The tests performed are for the integrated device.

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

The term "ground truth" is not used. The performance evaluation is based on meeting engineering specifications, comparing against predicate device performance, and compliance with recognized consensus standards (e.g., IEC, ISO, AAMI standards for physiological measurement accuracy).

8. The sample size for the training set

Not applicable. A "training set" is relevant for machine learning algorithms. This document describes a patient monitor, and no machine learning model training is discussed.

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

Not applicable, as no training set for a machine learning model is mentioned.

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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 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 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:

• o 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 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 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.

The provided document is a 510(k) summary for the ResMed AirFit N20, a vented nasal mask. It primarily focuses on demonstrating substantial equivalence to a predicate device (AirFit N10) rather than presenting a detailed study proving the device meets specific performance acceptance criteria for a novel AI or diagnostic algorithm.

Therefore, many of the requested items, particularly those related to a study proving new device performance against acceptance criteria for an AI or diagnostic algorithm, are not present in this document. The document describes non-clinical testing for performance characteristics rather than a study with a test set, ground truth, experts, or a comparison to human readers.

Here's an analysis based on the information available:

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

The document does not provide a formal table of quantitative acceptance criteria alongside actual reported performance values for each criterion. It broadly states that "Testing confirmed that the new device met the predetermined acceptance criteria."

However, it lists the types of non-clinical testing conducted, which imply the areas where performance was assessed:

• CO2 rebreathing
• Total mask flow
• Flow resistance
• Through impedance
• Mechanical integrity (simulated normal use and reasonable abuse, home cleaning, multi-patient reprocessing, transportation, storage)
• Biocompatibility

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 applicable or provided in the context of this 510(k) summary for a respiratory mask. The "test set" here refers to the physical devices undergoing engineering and biocompatibility testing, not a dataset for an algorithm. There is no mention of data provenance in the sense of patient 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 is not applicable as the document describes non-clinical engineering and biocompatibility testing of a physical medical device, not an AI or diagnostic algorithm requiring expert-established ground truth from images or patient records.

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

This is not applicable for the type of testing described (engineering and biocompatibility of a respiratory mask).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was done or is mentioned. This document pertains to a physical medical device (mask), not an AI-assisted diagnostic or an algorithm that would involve human readers.

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

This is not applicable. The device is a respiratory mask, not an algorithm.

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

For the non-clinical testing, the "ground truth" or reference for performance would be established engineering standards (e.g., ISO 17510-2, ISO 10993 series) and design specifications. For example, CO2 rebreathing would be measured against limits defined by standards, and biocompatibility would be assessed against the requirements of ISO 10993.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device, not an algorithm that requires a training set.

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

This is not applicable.

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The iVolve® Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The iVolve "Mask is: to be used by adult patients (>66lb/30 kg) for whom positive airway pressure has been prescribed. intended for single-patient re-use in the home, hospital, and sub-acute environment.

The iVolve® N2 and Nasal Masks are respiratory nasal mask interfaces that directs airflow from a positive pressure device to the patient's nose. The iVolve® Full-Face Mask is a mask interface that directs air flow from a positive pressure device to the patient's nose or mouth. The iVolve® Mask Series is held in place with adjustable headgear that straps the mask to the face. The iVolve® is safe when used under the conditions and purposes intended as indicated the labeling provided with the product. The iVolve® is a prescription device supplied non-sterile.

The iVolve® Nasal Mask Series (iVolve® Nasal Mask, iVolve® Full Face Mask, iVolve® N2) is a respiratory mask intended to channel airflow non-invasively to patients from a positive airway pressure device. The device was seeking substantial equivalence to existing predicate devices (Mirage Activa LT Nasal Mask (Resmed, K030798), Mirage Quattro Full Face Mask (Resmed, K113127), and Willow Nasal Mask (BMC, K112271)).

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

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the iVolve® Mask Series were based on functional performance metrics relative to predicate devices, with the objective for the device to meet intended product specifications and fall within a ±15% range of the predicate devices for key characteristics.

Additional Performance Characteristics (Comparison to predicates):

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

• Sample Size: For each performance test (Flow/Pressure Curve, Pressure Drop/Resistance, Dead Space), 3 samples of each mask type (iVolve Nasal Mask, iVolve N2 Nasal Mask, iVolve Full-Face Mask) were tested. For Dead Space, all sizes (S, M, L) were tested. For Flow/Pressure Curve and Pressure Drop/Resistance, a medium size (M*) was tested.
• Data Provenance: The document does not specify the country of origin. The data is from non-clinical performance bench testing, implying it's laboratory-generated data rather than patient-derived (retrospective or prospective).

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

• Not applicable. This study relies on bench testing for physical and mechanical performance, not expert-derived ground truth from clinical images or diagnoses.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods are typically associated with human expert review in clinical studies. This study involved direct measurement against established physical/mechanical parameters and comparison to predicate device specifications.

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

• No, an MRMC comparative effectiveness study was not done. This submission focuses on non-clinical performance bench testing for substantial equivalence of a medical device (respiratory mask), not on AI-assisted diagnostic or interpretative tasks that would involve human readers.

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

• Not applicable. This device is a physical medical device (a respiratory mask), not an algorithm or AI system. Its performance evaluation is based on its physical characteristics and functionality.

7. The Type of Ground Truth Used:

• The ground truth in this submission is based on intended product specifications and the performance range of legally marketed predicate devices, specifically:
  • Biocompatibility Standards: ISO 10993 for materials (cytotoxicity, animal skin irritation, implantation, genotoxicity, Kligman maximization).
  • Performance Standards: Internal product specifications for Flow/Pressure, Resistance/Pressure Drop, and Dead Space, and the established ranges of predicate devices (ResMed Mirage Activa LT Nasal Mask (K030798), ResMed Mirage Quattro Full Face Mask (K113127), and BMC Willow Nasal Mask (K112271)).
  • Durability: 200 cycles of home cleaning validated the mask's material integrity.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI or machine learning model. There is no "training set."

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

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

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The DC-N2/DC-N2S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid and testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.

DC-N2/DC-N2S is asoftware controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, Color, Power , iScape, Smart 3D or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.5 MHz to 10.0 MHz.

The provided 510(k) summary for the DC-N2/DC-N2S Diagnostic Ultrasound System states "Clinical Studies: Not applicable. The subject of this submission, DC-N2/DC-N2S Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Therefore, it does not contain information regarding acceptance criteria, study design, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC comparative effectiveness studies, or standalone performance studies.

The submission focuses on demonstrating substantial equivalence through non-clinical tests and comparison with predicate devices, rather than through clinical performance data.

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