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510(k) Data Aggregation
(212 days)
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.
| Acceptance Criteria (Claims) | Reported Device Performance (as stated in the document) |
|---|---|
| General | |
| Provides four modes of operation. | Confirmed: Manual CPAP Titration Mode, Bi-level Titration Mode, Auto-CPAP Titration Mode, Split Night with Auto-CPAP Titration Mode. |
| Provides data monitoring capabilities. | Confirmed: Maestro CRC provides alphanumeric and graphical representations of data. |
| Presents alphanumeric and graphical representation of data. | Confirmed: Maestro CRC provides alphanumeric and graphical representations of data. |
| Interfaces (optionally) with a polysomnograph. | Confirmed: Maestro CRC provides DC outputs that connect to a polysomnograph for data recording. |
| CPAP Mode | |
| Maintains constant pressure within ± 1.5 cm H2O at patient interface for flows of -35 to +85 L/min during both inspiratory and expiratory phase. | Not explicitly stated as "met" but implied through the statement "The Quartet Clinical System was found compliant and has been certified to the standards referenced in the 'FDA Reviewer Guidance for Premarket Notifications'" after performance-related testing, and the statement that it is 'equivalent' to predicate devices with similar claims. The provided document does not contain an explicit table or statement directly validating this for the Quartet itself within this submission, but rather relies on equivalency and general compliance for the non-Auto-CPAP modes. |
| Bi-level Mode | |
| Senses the patient's breathing efforts by monitoring airflow. | Claimed functionality. |
| Increases pressure upon sensing inspiratory effort. Decreases pressure upon sensing expiratory effort. | Claimed functionality. |
| Trigger sensitivity adjusts automatically. | Claimed functionality. |
| Compensates for most leaks. | Claimed functionality. |
| Maintains IPAP and EPAP within ± 1.5 cm H2O at patient interface for flows of -35 to +85 L/min. | Not explicitly stated as "met" but implied through equivalency to predicate devices and general compliance. |
| Auto-CPAP Mode | |
| Effective in treating OSA (reduces AHI to ≤ 10 events/hour). | Met: Virtuoso System Auto-CPAP (which is the same as Quartet's) reduced AHI from 51.81 to 8.39 (mean). |
| Reduces AHI and improves Arterial Desaturation Index (ADI). | Met: Virtuoso System Auto-CPAP reduced AHI from 51.81 to 8.39 and ADI from 61.59 to 16.39 (mean). |
| Improves sleep architecture (percentage of sleep time for four stages of sleep). | Claimed functionality, but no specific data presented to confirm this particular outcome. The study data focuses on AHI and ADI. |
| Maintains CPAP pressure within ± 1.5 cm H2O at patient interface for flows of -35 to +85 L/min. | Not explicitly stated as "met" but implied through equivalency and general compliance. Bench testing showing the Quartet responds to apneic events like the Virtuoso, and no significant differences in frequency response. |
| Split Night with Auto-CPAP Mode | |
| Delivers minimum CPAP pressure for a preset Delay Time. | Claimed functionality. |
| Provides opportunity to study patient at minimal pressures during Delay Time. | Claimed functionality. |
| Responds to airway instability by increasing/decreasing pressure to meet patient needs within designated limits once Delay Time ends. | Claimed functionality. This is essentially the Auto-CPAP mode after the Delay Time. The effectiveness is covered under the Auto-CPAP claims. |
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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(83 days)
The Respironics Solo CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA) only. The Solo CPAP System may be used in clinical settings (hospitals & sleep labs) and in home environments, and must be prescribed by a physician. It is not intended for life support or life sustaining applications. The device is used in conjunction with a mask (various styles and sizes available), headgear, and a combination of breathing circuit accessories.
The Solo CPAP System is an electromechanical device that produces Continuous Positive Airway Pressure (CPAP) and delivers it to a patient. As shown in Figure 12-1, the system consists of the Solo CPAP device and a patient circuit that is used to direct the air to the patient. The Solo CPAP device consists of a blower assembly and a microprocessor control system. The blower assembly generates positive airway pressures from 4 to 15 cm H2O. The level of pressure is dependent on motor speed. Two control buttons (Pressure ON/OFF and Ramp) and an LED are located on the control panel at the top of the unit. Motor speed is controlled by a microprocessorcontrolled feedback system. The device can operate on either 115 or 230 Volts AC, or 12 volts DC using the DC accessories included with the system. The Solo CPAP System offers DC power as an alternative power source; it is not intended to be used as a battery back-up source. The Solo CPAP System is not intended to be used in a mobile environment. Pressurized air travels from the Solo CPAP device to the patient via 22 mm flexible tubing. The flexible tubing connects with an exhalation port to exhaust carbon dioxide from the circuit, which in turn connects to a mask. The tubing, exhalation port, and mask are referred to as the patient circuit.
The provided document is a 510(k) premarket notification for the Solo CPAP System. It states that the submission demonstrates the system's substantial equivalence to predicate devices (Respironics Aria CPAP System and Nellcor Puritan-Bennett Companion 314 Nasal CPAP System) through performance-related testing.
Here's an analysis based on your request, highlighting the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics for the Solo CPAP System in terms of diagnostic accuracy or clinical outcomes. Instead, it broadly states:
"Testing was performed to demonstrate that the performance of the Solo CPAP System in its intended environment is as safe and effective as that of the legally marketed predicate devices. The safety and effectiveness of the Solo CPAP System were verified through performance-related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing. The Solo CPAP System was tested and found compliant with the standards referenced in the "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993."
This indicates that the "acceptance criteria" were compliance with established safety and performance standards for these types of electromechanical devices, rather than clinical efficacy metrics.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Compliant with standards |
| Electromagnetic Compatibility | Compliant with standards |
| Mechanical Testing | Compliant with standards |
| Environmental Testing | Compliant with standards |
| Overall Safety & Effectiveness | As safe and effective as predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any clinical test set involving patients or human subjects. The testing described is focused on the device's engineering performance (electrical, EMC, mechanical, environmental). Therefore, there is no sample size for a "test set" in the context of clinical data, nor is there information about data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since there was no clinical study described with a test set requiring ground truth established by experts, this information is not applicable and not present in the document.
4. Adjudication Method for the Test Set
As no clinical test set is described, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this document. The submission focuses on demonstrating substantial equivalence through technical performance testing, not direct comparison of human reader performance with or without AI assistance. The device is a CPAP machine, not an AI diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The Solo CPAP System is an electromechanical device with an embedded software control system that regulates pressure. It's not an "algorithm" in the sense of an AI model making diagnostic or prescriptive decisions that would require a "standalone" performance evaluation against human performance. The software controls motor speed and monitors functions, which are integral to the device's operation. Its performance is assessed as part of the overall device's electrical, mechanical, and safety testing. Therefore, this question is not applicable in the context of this device.
7. The Type of Ground Truth Used
The "ground truth" for the testing described is primarily engineering specifications and regulatory standards for electrical safety, electromagnetic compatibility, mechanical integrity, and environmental performance. For example, a "ground truth" for electrical safety would be meeting specific current leakage limits or insulation resistance values.
8. The Sample Size for the Training Set
The document discusses an "embedded software control system" and assembly language routines. This software controls motor speed and monitors various conditions. There is no mention of a training set in the context of machine learning or AI models. The software is likely developed using traditional programming and control systems engineering, not a data-driven training approach.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned in the context of machine learning, there is no information on how ground truth for a training set was established. The software's "ground truth" would be its functional specifications and correct execution of control logic, verified through software testing and validation processes. The document states: "Its software has been designed and developed in accordance with the FDA Reviewer's Guidance for Computer Controlled Medical Devices." This implies adherence to established software development and verification principles, rather than a data-driven ground truth for a training set.
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