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The Quartet Clinical System delivers continuous positive airway pressure (CPAP) and bi-level positive airway pressure therapies for the treatment of adult OSA. The Quartet Clinical System is intended for use by a qualified clinician (any individual trained to perform sleep study diagnoses) in clinical (hospital or sleep laboratory) settings where adult patients suffering from OSA are diagnosed and treated. The device is used in conjunction with masks, headgear, and various combinations of patient circuit accessories.

The Quartet Clinical System is intended to apply continuous positive airway pressure, known as CPAP, bi-level positive airway pressure, and self-titrating CPAP therapies to adult patients who suffer from OSA. The device can operate on either 115 or 230 Volts AC. As shown in Figure 12-1, the System consists of the Quartet device, a clinical remote control device called the Maestro CRC, and the recommended patient circuit that is used to direct the air to the patient. The tubing, exhalation port, and mask are referred to as the patient circuit.

The primary components of Quartet device are a blower motor assembly and a microprocessor control system. The blower motor is capable of generating positive airway pressures from 3 to 20 cm H2O. The level of pressure is dependent on motor speed, which is controlled by a microprocessor-controlled feedback system.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Respironics Quartet Clinical System:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided primarily relate to the maintenance of pressure within specified ranges and the clinical effectiveness of the Auto-CPAP mode in reducing AHI and ADI.

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

• Sample Size: 39 clinical subjects.
• Data Provenance: The study was "Respironics-sponsored clinical studies." No specific country of origin is mentioned, but "clinical subjects" implies human participants. Given the context of a 510(k) in the US, it's highly likely to be US data. The study was prospective in nature, as it involved conducting tests with active intervention (Auto-CPAP vs. manual CPAP) on these subjects.

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

The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth for AHI and ADI in the clinical study. However, the study involved "manually titrated CPAP" which would have been overseen by qualified clinicians (likely sleep specialists/pulmonologists). The "ground truth" for the effectiveness of the therapy (reduction in AHI/ADI) would have been determined through standard polysomnography conducted and interpreted by trained personnel in a clinical setting.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set data. The clinical study involved comparing outcomes (AHI, ADI, pressure) between two therapeutic approaches (manual CPAP and Auto-CPAP). The outcomes themselves would be measured via polysomnography, which has a standardized interpretation.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study described is a clinical trial comparing different therapeutic modes on subjects, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the clinical study essentially evaluates the standalone performance of the Auto-CPAP algorithm compared to manual CPAP settings. The "Virtuoso System Auto-CPAP" (which is identical to the Quartet's Auto-CPAP mode) functioned independently, adjusting pressure based on its internal algorithms. The performance metrics (AHI, ADI reduction) were directly attributed to the device's algorithmic function.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on clinical outcomes data, specifically:

• Polysomnography results: AHI (Apnea-Hypopnea Index) and ADI (Arterial Desaturation Index) are physiological measurements derived from polysomnography, which is the gold standard for diagnosing and assessing the severity of sleep apnea.
• Expert titration/diagnosis: While not explicitly called "ground truth," the comparison to "manually titrated CPAP" implies that the benchmark was set by human clinical experts determining optimal pressure.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set. The clinical study described served as a validation set for the Auto-CPAP mode that was already developed and present in the Virtuoso system.

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

Since no information on a training set is provided, the method for establishing its ground truth is also not described in this document. The Auto-CPAP mode was previously developed and validated in the K953930 submission for the Virtuoso Smart CPAP System. Therefore, any training activities or ground truth establishment would have occurred prior to this submission and are referenced implicitly through the predicate device.

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The Oasis Humidifier is an accessory for Respironics CPAP and BiPAP systems to provide moisture to the patient circuit. The Oasis is the only humidifier with the acoustical design that enables effective operation of Respironics' Auto-CPAP mode. As such, it is the only humidifier that can be used with Respironics' Auto-CPAP products (i.e., Virtuoso Smart CPAP System (K953930) and Quartet Clinical System (K963761, currently under review)). The Oasis can also be used with standard CPAP devices from other manufacturers which have maximum operating pressures of 20 cm H2O, and do not have bi-level or automatic pressure titration capabilities. Performance of non-Respironics CPAP systems with the Oasis humidifier should be verified before use.

The Oasis Humidifier (Figure 12-1) consists of a top ("lid"), bottom ("reservoir"), gasket, and a 24" reusable flexible tube that connects the Oasis to the pressuregenerating unit (Respironics CPAP or BiPAP unit). The lid and reservoir are held together by four release latches. The latches are connected to the reservoir. The Oasis has an inlet port and an outlet port on its lid. The inlet port is on the top of the lid. The inlet port is where water is poured into the reservoir and where flexible tube connects the Oasis to the pressure-generating unit. The outlet port is on the front of the lid. (The six-foot patient circuit tubing is attached to the Oasis outlet port.) A J-shaped tube molded in the top of this lid is an acousticallytuned passage. This passage gives the Oasis the acoustical characteristics that enable effective operation of Respironics' Auto-CPAP mode. As such, it allows the Oasis to be used as an accessory for Respironics' Auto-CPAP devices. The inlet port's 26 mm outside diameter corresponds with the larger end of the 24" flexible tubing (26 mm inside diameter). The smaller end of the tubing -- 22 mm inside diameter -- connects to the outlet port of the pressure-generating unit. Refer to K945782 for complete information on the 24" flexible tubing. The Oasis (excluding the gasket) is made of dishwasher-safe plastic.

The provided document describes the Oasis Humidifier (K964653), which is a medical device accessory for CPAP and BiPAP systems. This submission is a Premarket Notification (510(k)), indicating that the company is demonstrating substantial equivalence to a predicate device, not necessarily a new clinical study to establish novel performance criteria.

Therefore, many of the requested criteria for a clinical study on device performance (such as sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable (N/A) in this context, as this is a submission demonstrating equivalence through verification and validation (V&V) engineering tests against established standards and predicate device performance, not a clinical effectiveness trial for a new AI/imaging device.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of human data. The "test set" here refers to engineering verification and validation (V&V) testing performed on the Oasis Humidifier physical units. The document does not specify the number of units tested, but rather the performance parameters.
• Data Provenance: Not applicable as this relates to engineering and performance testing of the device itself, rather than human data. The testing was carried out by Respironics, Inc. in the United States. The data is prospective in the sense that the testing was performed specifically for this submission.

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

• Not Applicable. Ground truth, in the sense of expert review for diagnostic accuracy or clinical outcomes, is not established for this type of device submission. The "ground truth" for the engineering tests would be the established scientific and engineering principles, and the specifications of the predicate device and relevant standards. The testing itself is conducted by qualified engineers and technicians.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1) are common in clinical studies where expert consensus on controversial findings is needed. This is an engineering V&V process, where test results are compared directly against predefined acceptance criteria from specifications or standards.

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 physical medical device (humidifier), not an AI-powered diagnostic or imaging device. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

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

• Not Applicable. This is a physical medical device, not an algorithm, so "standalone" performance in the AI context does not apply. The device's performance characteristics (e.g., humidity output, pressure drop) are inherent to its design and functional operation without human intervention during its humidifying function.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: The "ground truth" is defined by the device's technical specifications (e.g., reservoir capacity, temperature ranges, humidity output targets), relevant medical device standards (implied by "certified to the standards referenced in the 'FDA Reviewer Guidance for Premarket Notifications'"), and the performance characteristics of the legally marketed predicate device (RI Humidifier, K945782). For example, for pressure drop, the "ground truth" is the scientifically measurable resistance to flow that determines if it's within acceptable limits and comparable to the predicate.

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not Applicable. As there is no "training set," there is no ground truth established for it.

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