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AirFit F20 Mask System:

The AirFit F20 mask has two product variants:

• AirFit F20 mask is intended for single-patent reuse in the home environment.
• AirFit F20 SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.

Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.

AirFit F20 NM Mask System:

The AirFit F20 Non Magnetic mask has two product variants:

• The AirFit F20 Non Magnetic variant is intended for single-patient reuse in the home environment.
• The AirFit F20 Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.

This mask is for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.

The AirFit F20 and AirFit F20 NM Mask Systems are both full-face masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices. CPAP & Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or ventilatory support. Both treatments deliver pressurized air from a flow generator to the patient. Such delivery of pressurized air relies on the Patient Interface; commonly known as the mask. Full face masks are a common type of Patient Interface (Mask) and are known to efficaciously support the delivery of pressurized air by providing a seal around the patient's nose and mouth.

The AirFit F20 mask system has two product variants:

• AirFit F20 Mask: This is the home use variant that is intended for single patient re-use.
• AirFit F20 SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.

AirFit F20 (K170924) had a "For Her" variant which was cleared with aesthetic colour pops, the AirFit F20 Mask and AirFit F20 SLM also have the same "For Her" variant.

The AirFit F20 NM mask system has two product variants:

• AirFit F20 NM Mask: This is the home use variant that is intended for single patient re-use.
• AirFit F20 NM SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.

The AirFit F20 and AirFit F20 NM Mask Systems share a common design architecture as the predicate AirFit F20 (K170924), except that the AirFit F20 NM Mask System has non-magnetic clips.

The AirFit F20 and AirFit F20 NM mask systems are made up of the following four main component assemblies: cushion, elbow, frame, and headgear. The cushion and headgear are available in various sizes to allow for adequate mask fit over the intended patient population.

The AirFit F20 and AirFit F20 NM mask systems are prescription devices supplied non-sterile.

The provided FDA 510(k) clearance letter and associated summary pertain to the AirFit F20 Mask Systems, which are non-continuous ventilators (CPAP/Bi-Level masks). This type of device does not typically involve complex diagnostic algorithms or AI components that would necessitate the study structure outlined in your request (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance for AI).

Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (AirFit F20, K170924) through non-clinical performance and safety testing, adherence to recognized standards, and biocompatibility evaluations.

Therefore, many of the specific questions you've asked cannot be directly answered from this document as they are not relevant to the type of device and clearance process involved.

Here's an attempt to extract the relevant information and address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a format typically used for diagnostic algorithm validation. Instead, it compares specific design parameters and performance characteristics of the new devices (AirFit F20 Mask System and AirFit F20 NM Mask System) against the predicate device (AirFit F20, K170924). The "Comments" column often indicates that the performance is "Equivalent" or "Identical," implying that the new devices meet or perform similarly to the established safety and performance profile of the predicate, which serves as the de facto acceptance benchmark.

Here's a summary derived from the comparison table (Pages 9-12 of the provided document):

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AirFit F30i Mask System
The AirFit F30i mask has two product variants:
· AirFit F30i mask is intended for single-patent reuse in the home environment.
• AirFit F30i SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.

AirFit F30i NM Mask System
The AirFit F30i Non Magnetic mask has two product variants:
· The AirFit F30i Non Magnetic variant is intended for single-patient reuse in the home environment.
· The AirFit F30i Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
This mask is for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multipatient reprocessing and must be reprocessed if reused between patients.

Arcadia Mask System
The Arcadia has two product variants:
· Arcadia mask is intended for single-patient reuse in the home environment.
· Arcadia SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
These masks are intended for patients weighing more than 66 lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.

The AirFit F30i, AirFit F30i NM and Arcadia mask systems are full-face conduit masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or non-life supporting ventilatory support. Both treatments deliver pressurized air from a flow generator to the patient. Such delivery of pressurized air relies on the Patient Interface; commonly known as the mask. Full face masks are a common type of Patient Interface (Mask) and are known to efficaciously support the delivery of pressurized air by providing a seal around the patient's nose and mouth.
The AirFit F30i, AirFit F30i NM and Arcadia mask systems each have two product variants:

• . AirFit F30i Mask/ AirFit F30i NM Mask/ Arcadia Mask: This is the home use variant that is intended for single patient re-use.
• . AirFit F30i SLM/ AirFit F30i NM SLM/ Arcadia SLM (sleep lab mask): This is intended for multipatient re-use and must be reprocessed if reused between patients using the disinfection guide
  The AirFit F30i, AirFit F30i NM and Arcadia mask systems are made up of the following four main component assemblies: Cushion, conduit frame, elbow and headgear. The cushion and conduit frame are available in various sizes to allow for adequate mask fit over the intended patient population.
  The AirFit F30i, AirFit F30i NM and Arcadia mask systems are prescription devices supplied non-sterile.

The provided text does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria in the format requested. The document is a 510(k) summary and FDA clearance letter, which outlines the device's substantial equivalence to a predicate device based on various performance and safety tests. However, it does not provide the specific "acceptance criteria" (e.g., minimum sensitivity, specificity, or accuracy thresholds) or the detailed methodology and results of a single study with the requested metrics.

Instead, the document lists several non-clinical data submitted, which include performance and safety tests in accordance with ISO standards and other bench tests. The conclusion states that "Non-clinical verification and validation assessment/testing demonstrated that AirFit F30i NM and Arcadia mask systems met all intended performance requirements." and "Verification confirmed that the new device met the predetermined acceptance criteria and the performance is substantially equivalent to the previously cleared predicate AirFit F30i mask system (K183512)."

Therefore, I can extract the types of tests performed and the comparison to the predicate device, but I cannot fill in the table or answer all sub-questions as the specific numerical acceptance criteria and a single "study" proving it with the requested detail are not present.

Here's what can be extracted based on the provided text, with an explanation for missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative (e.g., "met all intended performance requirements") and tied to ISO standards or established performance of the predicate device. Specific numerical thresholds for acceptance are not explicitly listed in the 510(k) summary, except for some comparative parameters.

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The Oran Park mask is intended for use in the home or hospital/institutional environment on patients weighing more than 661b (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy.

Only the Sleep Lab Mask (SLM) variant is intended and validated for multi-patient reuse and must be reprocessed if reused between patients.

The Oran Park Mask is an accessory to deliver air flow and positive air pressure generated by positive airway pressure (PAP) devices such as CPAP or bi-level flow generator systems to the patient's airway, for the treatment of Obstructive Sleep Apnea (OSA) or ventilator support (non-life support). It delivers the treatment pressure from the source device to the patient's upper airway by providing an air seal between the PAP device and under the patient's nose and mouth.

There are 2 variants to the Oran Park Mask:

• . Oran Park Mask (Home Use) Intended for single patient re-use (SPMU) for home use. It is configured with a diffused venting port located on the elbow, known as the QuietAir elbow.
• . Oran Park SLM (Sleep Lab Mask)

Intended for multi-patient re-use (MPMU) and must be reprocessed if reused between patients. It is configured with a non-diffused venting port located on the elbow, known as the Multihole elbow.

The Oran Park mask comprises of 4 sub-assemblies: headgear, frame, cushion and elbow. The venting ports and anti-asphyxia valve are incorporated into the elbow assembly. There are four magnets incorporated in the Oran Park mask – two magnets in the frame assembly and 2 magnets in the lower headgear clips – with a magnetic field strength up to 400 mT. The mask help facilitate attaching and detaching the headgear to the mask frame when regularly fitting the mask for use. The cushion and headgear are available in various sizes to fit a wide patient population. Soft wraps, which are attached to the Oran Park mask frame, are available as an optional accessory for patient's comfort.

The Oran Park mask is a prescription device and is supplied non-sterile.

The Oran Park Mask is a medical device accessory used to deliver airflow and positive air pressure from PAP devices for the treatment of Obstructive Sleep Apnea or ventilator support. The device underwent non-clinical testing to demonstrate its performance and safety, aiming to prove substantial equivalence to the predicate device, AirFit F20 (K153563).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents a comparison table between the predicate device (AirFit F20, K153563) and the subject device (Oran Park Mask System) for various design parameters and features. The "Comments" column often indicates the acceptance criteria for the subject device by stating "Equivalent," "Identical," or referencing compliance with specific ISO standards.

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The Whitsundays Mask System has two product variants:
• Whitsundays mask
· Whitsundays SLM (Sleep Lab Mask)
Both masks are intended for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Whitsundays mask is intended for single-patient reuse in the home environment and the Whitsundays SLM is intended for multi-patient reuse in the hospital/institutional environment. The Sleep Lab Mask (SLM) is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.

The Whitsundays Mask System is an accessory to deliver airflow and positive air pressure generated by positive airway pressure (PAP) devices such as CPAP or bi-level flow generator systems to the patient's airway, for the treatment of Obstructive Sleep Apnea (OSA) or ventilatory support (non-life support). It delivers the treatment pressure from the source to the patient's upper airway by providing an air seal between the PAP device and the bottom of the patient's nose.
The Whitsundays mask system has two product variants:

• Whitsundays mask This is the home use variant that is intended for single patient re-use.
• . Whitsundays SLM (Sleep Lab Mask) This is the SLM variant that is intended for multi-patient re-use and must be reprocessed if reused between patients.
  The Whitsundays Mask System is made up of 4 main component assemblies: nasal cushion, conduit frame, elbow, and headgear. The nasal cushion and conduit frame are available in various sizes to allow for adequate mask fit in the intended patient population.
  The Whitsundays Mask System is a prescription device supplied non- sterile.

The provided text describes the ResMed Whitsundays Mask System and its substantial equivalence to a predicate device, the Scone mask (K180497). The document focuses on non-clinical data and acceptance criteria based on recognized standards.

Here's the breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

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The S10 Kirra is indicated to provide CPAP and Bi-level therapy 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). ASV and ASVAuto modes are also indicated for the treatment of central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use.

The S10 Kirra is a prescription only Positive Airway Pressure (PAP) ventilator device intended to treat individuals that are diagnosed with sleep apnea conditions. The S10 Kirra uses a micro-processor controlled blower, along with pressure and flow sensors, to achieve pressure, flow and time regulation of air delivery. It includes optional humidification, with air delivery to the patient via heated or non-heated breathing circuits. The device provides both therapeutic (e.g. tidal volume) and technical data (e.g. system fault), and a user interface allowing adjustment of device parameters. The device uses an external AC power supply, and allows the addition of low flow supplemental oxygen.

The provided text describes the S10 Kirra, a non-continuous ventilator, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer all parts of your request about acceptance criteria and a specific study proving the device meets them.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices (S9 Greenhills, S9 Wanda, S9 Elouera), rather than detailing a new study with acceptance criteria for a novel device.

Here's a breakdown of what can be extracted and what is missing:

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

The document states:
"Verification confirmed the S10 Kirra met the predetermined acceptance criteria as defined in the relevant compliance standards and as defined in the system verification protocols."

However, it does not provide a table listing specific acceptance criteria values and the reported performance for each criterion. It broadly mentions areas of testing:

• Pressure performance
• Breath events (flow limitations, snore, apneas)
• Response to periodic breathing
• Humidification

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

This information is not available in the provided text. The document refers to "verification bench testing" and "comparative predicate testing" but does not specify sample sizes for test sets or data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available. The document focuses on bench testing and comparison to predicate devices, not human expert evaluations for ground truth.

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

This information is not available. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed 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

The document explicitly states:
"Clinical performance data is not required as the subject device uses established therapeutic technology and bench testing is sufficient to demonstrate substantial equivalence."

Therefore, no MRMC comparative effectiveness study was done as the device relies on established technology, and its performance was evaluated through non-clinical bench testing.

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

The entire non-clinical data section describes performance of the device itself (hardware and software), which can be considered a standalone performance assessment in a bench testing environment. The listed performance areas (pressure, breath events, humidification) are intrinsic to the device's function.

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

For the non-clinical bench testing, the "ground truth" would be established by engineering specifications, compliance standards, and the performance characteristics of the predicate devices. The tests evaluate if the S10 Kirra performs according to these pre-defined, measurable engineering and physiological parameters. It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for clinical evaluations.

8. The sample size for the training set

This information is not applicable/available. The S10 Kirra is a medical device (ventilator) with microprocessor control, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's "training" involves design, engineering, and calibration to meet its specifications, rather than data-driven model training.

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

This information is not applicable/available for the same reason as point 8.

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