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The Luna® G3 BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/ institutional environment on adult patients. It is to be used on patients > 66 lbs / 30 kg for whom CPAP therapy has been prescribed.

The Luna® G3 BPAP system is a microprocessor controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. Its hardware design is identical to the previously cleared Luna® G3 BPAP 25A (K201620). The subject device includes two models, with different pressure ranges. They both have four therapy modes, which are CPAP, Spontaneous (S), Timed (T) and Spontaneous/Timed (S/T).

This 510(k) summary (K212263) describes a device modification to an existing Bi-level PAP system (Luna G3 BPAP System). The core of the submission revolves around demonstrating substantive equivalence to a predicate device (Luna G3 BPAP 25A, K201620) and referencing a device (Juno VPAP ST-A, K153061) for new functionalities.

It is crucial to understand that this document describes a device intended for treatment of Obstructive Sleep Apnea (OSA), providing positive airway pressure. It is not an AI/ML powered diagnostic device that would typically involve a multi-reader multi-case (MRMC) study or complex ground truth establishment from expert consensus or pathology, as might be seen for an imaging AI.

Therefore, many of the typical "acceptance criteria" and "study types" for AI/ML-powered devices, such as those related to standalone performance (e.g., sensitivity, specificity, AUC), MRMC studies, and expert ground truth establishment for a diagnostic output, are not applicable to this type of medical device submission.

Instead, the acceptance criteria and supporting studies are focused on engineering and performance characteristics of the medical device itself, ensuring it functions safely and effectively as intended and is equivalent to previously cleared devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a single aggregated table of "acceptance criteria" versus "reported performance" for a diagnostic output as would be seen for AI/ML diagnostic tools. Instead, it details specific performance tests and standards met, comparing the subject device's characteristics to its predicate and reference devices. The "acceptance criteria" are implied by adherence to recognized standards and demonstrated equivalence to the cleared predicate.

Here's an interpretation of relevant performance characteristics that serve as de facto acceptance criteria and their reported performance:

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The device provides positive pressure therapy for the treatment of adult obstructive sleep apnea syndrome in self breathing patients weighing over 30kg (66lbs). This product can be used in the home as well as in clinical/hospital environments.

The proposed device is a non-invasive, continuous positive airway pressure ventilator, incorporating a heated respiratory humidifier. The device is intended to treat obstructive sleep apnea by delivering a flow of positive airway pressure at a level prescribed by a physician to splint open the airway and prevent airway collapse. The proposed device is available in three types, which are Aurora, Resware and Zizmer. Each type is available in different models designed with different therapy modes and pressure ranges. The therapy modes are available in four types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T) and Timed (T). The pressure range for the proposed devices is available in three types, which are 4-20cm H2O, 4-25cm H2O and 4-30cm H2O. Alarm module is incorporated in the device. The device will generate audio and visual alarm for airway leakage, motor malfunction and high motor temperature. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use. The proposed device can be reused by single patient.

The provided text is a 510(k) Premarket Notification for a medical device (SysMed S/T, a noncontinuous ventilator for treating obstructive sleep apnea). It describes the device, its intended use, and states that non-clinical tests were conducted to demonstrate substantial equivalence to predicate devices based on compliance with various engineering, safety, and biocompatibility standards.

However, this document does NOT describe the acceptance criteria and the study that proves the device meets the acceptance criteria in terms of clinical performance, specifically an AI/ML type of study. The information requested, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are typically found in clinical validation reports for AI/ML-driven medical devices.

The provided document focuses on demonstrating substantial equivalence based on physical and functional characteristics, and compliance with well-established performance and safety standards for medical ventilators. It does not involve AI/ML performance evaluation as would be described for an AI/ML-driven diagnostic or therapeutic device.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document confirms that non-clinical tests were done to verify compliance with standards, but not a study demonstrating clinical performance against specific acceptance criteria relevant to AI/ML.

Here's why the document doesn't contain the requested information:

• Device Type: The SysMed S/T is a non-continuous ventilator. Its primary function involves delivering positive airway pressure. While it might incorporate some automated features (like therapy modes), the provided document does not indicate it's an AI/ML-driven device that makes diagnostic or treatment recommendations requiring complex clinical validation studies with human readers or AI-specific performance metrics like sensitivity, specificity, or AUC against a ground truth established by experts.
• 510(k) Process: The 510(k) pathway for medical device clearance primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This often involves engineering bench testing, biocompatibility testing, and comparison of technical specifications, rather than a full-scale clinical trial or AI/ML performance study unless the device introduces novel technology or significant changes affecting safety or effectiveness.
• Lack of Clinical Data/AI Performance Metrics: The "Non-Clinical Test Conclusion" section lists various industry standards (e.g., IEC, ISO) that the device complies with, relating to electrical safety, electromagnetic compatibility, alarm systems, home healthcare environment use, sleep apnea therapy equipment, humidifying equipment, and biocompatibility. These are typical engineering and safety tests, not clinical performance studies for an AI/ML algorithm.

If this were an AI/ML device, the "Non-Clinical Test Conclusion" or a separate "Clinical Study" section would detail how the AI's performance was measured against a clinically relevant ground truth, including metrics like sensitivity, specificity, or area under the ROC curve, and would address the points in your query.

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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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