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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 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 Juno VPAP ST-A System is a positive pressure device which design is based on the previously cleared ResMed S9 WANDA VPAP ST (K140159) platform. The device is used in a wider breathing circuit which typically comprises patient tubing and a mask (patient interface) to deliver the prescribed positive pressure treatment to patients.

Some of the key features of the platform include: in-line power supply; fully integrated humidifier; heater controller; colour LCD and simple controls for ease of use. An integrated wireless module for data transfer/connectivity is also included (note: Remote changes in a hospital setting may not be appropriate, as these setting changes may not be communicated to all hospital personnel treating the patient. Hospital staff should liaise with the patient's reqular care provider such that the desired therapy outcome is achieved).

Juno VPAP ST-A contains a Micro-processor controlled blower system that generates positive airway pressure (CPAP) between 4-20 cmHyO 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 device also incorporates an Alarm function as a fully integrated module.

The therapy modes available in the Juno VPAP ST-A come from the predicate ResMed S9 VPAP ST-A (K113288). These include CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS.

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 provided text does not contain detailed acceptance criteria or a study proving that the device meets these criteria in the manner you've requested (e.g., performance metrics, sample sizes, expert ground truth).

The document is a 510(k) summary for a medical device (Juno VPAP ST-A), which focuses on demonstrating substantial equivalence to a predicate device (ResMed S9 VPAP ST-A K113288), rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria.

The "Non Clinical data submitted" section (page 8) mentions "Bench test data is presented to demonstrate that the new device meets its published specifications and back-to-back testing shows substantial equivalence to the predicate device S9 VPAP ST-A (K113288)." It further states, "All bench tests confirmed that the product met the predetermined acceptance criteria. this included Pressure, Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests against the predicate devices using common protocols for both devices."

However, this section does not provide specific numerical acceptance criteria values or the reported device performance against those criteria. It also doesn't describe an AI/ML-based device that would typically involve a "test set" with ground truth established by experts, MRMC studies, or standalone algorithm performance.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device assessment (bench testing for substantial equivalence of a continuous ventilator) than what your questions imply (e.g., an AI/ML diagnostic device).

Here's what can be inferred or stated based on the document's content, and what cannot:

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

• Cannot provide. The document states that bench tests confirmed the product met "predetermined acceptance criteria" for parameters like pressure, flow, pressure support, trigger and cycling, hypopnea, and apnea tests. However, the specific numerical acceptance criteria (e.g., "pressure within +/- X cmH2O") and the actual performance results are not detailed in this summary.

2. Sample sized used for the test set and the data provenance:

• Cannot provide. The document refers to "bench tests" and "back-to-back testing" against a predicate device. This is not a "test set" in the context of clinical data for an AI/ML device. There are no details on sample size, data provenance, or whether the data was retrospective or prospective, as this was not a clinical study involving patients for direct performance evaluation against ground truth.

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

• Not applicable. This device is a continuous ventilator, and its performance was evaluated through engineering bench tests, not clinical evaluation against expert-adjudicated ground truth as would be done for a diagnostic AI/ML system.

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

• Not applicable. No expert adjudication was described.

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

• Not applicable. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance was not performed.

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

• Not applicable. This is a hardware medical device (ventilator) with integrated software/firmware, not a standalone diagnostic algorithm.

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

• Implied ground truth for bench testing: Engineering specifications and performance of the predicate device (S9 VPAP ST-A (K113288)). This is a "technical" ground truth, not a "clinical" one. The document states: "this included Pressure, Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests against the predicate devices using common protocols for both devices."

8. The sample size for the training set:

• Not applicable. This document is for a hardware device, not an AI/ML model that undergoes a training phase with a specific dataset.

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

• Not applicable. See point 8.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through bench testing against a predicate device's specifications and performance, rather than clinical study results of an AI/ML device against expert-established ground truth. Therefore, very little of the information typically sought for AI/ML device evaluation is available in this document.

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