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The ComfortGel Blue Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used by patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

The Respironics ComfortGel Blue Nasal Mask consists of a polycarbonate faceplate with a gel cushion encapsulated in a polyester seal for the face. The mask includes integrated exhalation features on the elbow. It is an accessory for use with CPAP and bi-level devices in the home (single patient use) and hospital/institution (multi-patient use).

The ComfortGel Blue Nasal mask covers the patient's nose only. It is strapped to the patient's face using headgear which connects to the mask via slots in the forehead bracket at the top, and via ball clip headgear attachments, which fit into sockets in the mask faceplate at the bottom. The mask is connected to the CPAP or bi-level flow generator via standard 22mm patient tubing. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.

The provided text describes a 510(k) summary for the ComfortGel Blue Nasal Mask. This document focuses on demonstrating substantial equivalence to predicate devices for a medical device rather than presenting a performance study with acceptance criteria and results in the typical sense of an AI/ML device study.

Therefore, many of the requested categories for AI/ML performance studies are not applicable to the information contained within this 510(k) summary. I will answer the questions to the best of my ability based on the provided text, indicating where information is not available or not relevant for this type of submission.

Here's a breakdown based on your request:

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

The 510(k) summary does not explicitly list "acceptance criteria" and "reported device performance" in the context of a statistical study with metrics like sensitivity, specificity, accuracy, etc., as would be common for AI/ML devices. Instead, it compares the technical characteristics and performance of the subject device to predicate devices to demonstrate substantial equivalence. The "acceptance criteria" in this context would implicitly be that the subject device's performance characteristics (e.g., leak rates, pressure drop, dead space) are comparable to or within acceptable limits of the predicate devices and do not raise new safety or effectiveness concerns.

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The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or noninvasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically adjusts I-Triggers and E-Cycles breathing without the need for user adjustment of I-trigger (sensitivity) and E-cycle thresholds under changing leak conditions. The Auto-Trak option provides leak-compensated ventilation for leaks up to 60L/min.

The Respironics Esprit Ventilator is unchanged from K072450. The only change is to include the Respironics Performax Youth SE mask as an option for use by its pediatric users. This mask is the same mask design as is used by the small size of the cleared Respironics Performax SE Total Face Mask (K072588). The mask consists of a silicon cushion, polycarbonate faceplate with an elbow that contains the exhalation feature. The anthropometric profile of the Respironics Performax Youth SE mask was designed to meet the 90" percentile for pediatrics age 7 and older and > 40 lbs.

The provided text describes a Special 510(k) submission for the Esprit Ventilator, primarily focusing on adding the Respironics Performax Youth SE mask as an option. As such, the study described is a compatibility test rather than a typical clinical performance study for an AI-powered device.

Here's an analysis based on the provided information, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "mask compatibility testing was performed. This testing included pressure performance, waveform performance, triggering, cycling and alarm functionality testing. All tests were verified to meet the required acceptance criteria." However, the specific quantitative acceptance criteria or detailed numerical performance results are not provided in this document excerpt.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document indicates "mask compatibility testing was performed" but does not specify the sample size (e.g., number of test sessions, number of masks tested, duration of tests).
• Data Provenance: The testing was "performed" by Respironics, Inc. ("This testing is provided in Tab 8 of this submission"). This implies the data is prospective and generated specifically for this submission, likely within a controlled lab or testing environment. The country of origin of the data is not explicitly stated beyond Respironics being based in the US (Monroeville, Pennsylvania).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable in this context. The study is a compatibility test for a medical device (ventilator and mask), not an AI diagnostic tool requiring expert interpretation to establish ground truth for a test set. The "ground truth" here would be the established functional specifications and performance characteristics of the ventilator and mask system, evaluated against engineering and physiological standards.

4. Adjudication Method for the Test Set

This information is not applicable. Since it's a compatibility test, not an expert-based diagnostic study, there's no need for adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC study was not done. This submission is for a ventilator and mask, not an AI system where human readers would interpret results.

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

No, this is not an AI algorithm. The device, the Esprit Ventilator, is a "microprocessor controlled, electrically powered, mechanical ventilator." The "Auto-Trak option" automatically adjusts parameters, which involves an algorithm, but the study described is about the physical compatibility of a new mask with the existing ventilator, not a performance study of the Auto-Trak algorithm itself.

7. The Type of Ground Truth Used

The ground truth used for this compatibility testing would be the engineering specifications, recognized standards, and physiological performance requirements for a ventilator and its compatible components (like a mask). The verification would be against these predefined technical and performance standards, not against "expert consensus, pathology, or outcomes data" in the typical sense of diagnostic AI studies. The statement "All tests were verified to meet the required acceptance criteria" implies testing against these pre-established standards.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI model requiring a training set.

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

This information is not applicable. This is not an AI model requiring a training set with established ground truth.

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The BiPAP AutoSV Advanced is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

The Respironics BiPAP AutoSV Advanced is a microprocessor controlled blower based Bi-level positive pressure system that delivers two positive pressure levels (IPAP/EPAP). The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. A flow sensor and redundant pressure sensors in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.

The BiPAP AutoSV Advanced pressure control contains various which are used to configure positive pressure therapies. With these controls, the device delivers minimum pressure support determined by the PSmin control. The device may automatically provide additional pressure support with inspiratory pressures between PSmin and PSmax to normalize patient ventilation during sleep disordered breathing events. Note: When PSmin = PSmax, this is equivalent to traditional bi-level therapy.

The BiPAP AutoSV Advanced is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.

The BiPAP AutoSV Advanced Ventilatory Support System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing and a method of venting exhaled gases.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the BiPAP AutoSV Advanced, focusing on its substantial equivalence to predicate devices and general performance modifications.

However, based on the text, I can extract the following relevant information:

Key Takeaways from the Text:

• Clinical Validation: The manufacturer performed "clinical validation to ensure the efficacy of the algorithm was not affected" due to modifications to the AutoSV algorithm.
• Bench Data: Other device modifications were validated using "bench data" including waveform performance, triggering data, and overall event detection and control data.
• Equivalence Claim: The testing "confirmed that the BiPAP AutoSV Advanced performs equivalently to the device predicate BiPAP AutoSV (K063540). All tests were verified to meet the required acceptance criteria."

Given the limited information, I cannot accurately fill out many of the requested fields. Here's a structured response based on what is available and what cannot be determined:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All tests were verified to meet the required acceptance criteria" and that the device "performs equivalently to the device predicate BiPAP AutoSV (K063540)." However, it does not provide a specific table of these criteria or quantitative reported performance values for each criterion.

2. Sample Size and Data Provenance:

• Sample Size for Test Set: Not specified. The document mentions "clinical validation" but does not give the number of patients or cases.
• Data Provenance: Not specified. It's unclear if the validation data was prospective or retrospective, or its country of origin.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method:

• Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study Done?: No information provided. The document focuses on performance equivalence to a predicate device, not on human reader improvement with AI assistance.

6. Standalone Performance Study:

• Standalone Study Done?: Likely yes, as implied by "bench data" and "clinical validation to ensure the efficacy of the algorithm was not affected." However, specific metrics for standalone performance (e.g., sensitivity, specificity for event detection) are not provided. The comparison is made against a predicate device.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not specified explicitly. For clinical validation of a ventilator algorithm, it would typically involve physiological measurements and potentially expert interpretation of physiological signals (e.g., polysomnography data for sleep disordered breathing events). For bench testing, it would be against known physical models or simulated conditions.

8. Sample Size for Training Set:

• Sample Size: Not specified. The document mentions modifications to an existing algorithm ("AutoSV algorithm") but does not detail a training set for a de novo algorithm development.

9. How Ground Truth for Training Set was Established:

• How Ground Truth Established: Not specified. As it's an update to an existing algorithm, it's possible that historical data and expert-defined criteria from the predicate device's development were used, but this is conjecture.

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The intended use of the Gas Transfill System is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting nor life sustaining.

The Respironics Gas Transfill System is comprised of a high pressure oxygen compressor and an external oxygen concentrator. The oxygen concentrator provides up to 2LPM of gaseous oxygen to the high pressure oxygen compressor for filling medical oxygen cylinders. In addition, the external oxygen concentrator provides up to 3LPM of gaseous oxygen for patient breathing. The external oxygen concentrator can be one of the Respironics series of FDA cleared devices or other manufacturers FDA cleared oxygen concentrators. The patient cannot breathe directly from the high pressure oxygen compressor. The purpose of the high pressure oxygen compressor is to fill medical oxygen cylinders only.

This looks like a 510(k) summary for a medical device. Based on the provided text, there is no information about acceptance criteria or a study proving the device meets said criteria. The document focuses on establishing substantial equivalence to predicate devices, the intended use, and general regulatory information.

Therefore, I cannot fulfill your request as the necessary data elements are not present in the provided text.

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The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home environment or multi-patient, multi-use in the hospital/institutional environment.

The Comfort Twin Nasal mask is a respiratory nasal mask using a dual cushion design with built-in bellows and an inner sealing flap for improving unintentional leak. It is a multi-patient, multi- use accessory for use with CPAP or bi-level devices. The Comfort Twin mask is strapped to the patient's face covering the nose, and connected to tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.

The provided text describes the 510(k) summary for the "Comfort Twin Nasal Mask - Multi-Patient, Multi-Use". It focuses on establishing substantial equivalence to predicate devices and detailing the device's design and intended use, rather than presenting a study with specific quantitative acceptance criteria or detailed performance metrics against those criteria.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for any of the performance tests.
• Data Provenance: Not specified, but the testing was internal ("Performance testing has been carried out to verify the safety & effectiveness...") and for mask efficacy testing, "tested by an independent laboratory". It does not mention country of origin or whether it was retrospective or prospective.

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

• Not applicable. The "ground truth" here refers to physical performance characteristics and cleaning efficacy, not interpretations made by experts in a diagnostic context.

4. Adjudication method for the test set:

• Not applicable. No expert adjudication process is described for physical performance and cleaning efficacy tests.

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 device is a medical accessory (nasal mask), not an AI-powered diagnostic tool, so an MRMC study is not relevant.

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

• Not applicable. This is not an algorithmic device. Performance testing focused on the physical device's characteristics and its ability to withstand cleaning.

7. The type of ground truth used:

• For performance with cleaning/disinfection: The "ground truth" would be established by objective measurements of material integrity and device function after exposure to Cidex, likely against pre-defined engineering specifications.
• For mask efficacy testing (cleaning method): The "ground truth" would be the demonstrated removal or inactivation of specified microorganisms or contaminants, measured by an independent laboratory.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."

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

• Not applicable.

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The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.

The Comfort Twin Nasal mask is a respiratory nasal mask using a dual cushion design with built-in bellows and an inner sealing flap for improving unintentional leak. It is a single patient use accessory for use with CPAP or bi-level devices. The Comfort Twin mask is strapped to the patient's face covering the nose, and connected to tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.

The provided text describes a 510(k) summary for the Comfort Twin Nasal Mask, which is a new device. The acceptance criteria and the study proving the device meets them are discussed in the context of demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states, "The new device was validated using bench data." This indicates that the testing was performed in a laboratory setting. The specific sample size for the test set is not provided. The provenance of the data is bench data, implying controlled experimental conditions rather than human or animal studies.

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

Not applicable. Since the validation was performed using "bench data," there was no need for human experts to establish ground truth in the way it would be required for clinical image analysis or diagnostic studies. The ground truth would be defined by the technical specifications and measurements of the device components and its interaction with test equipment.

4. Adjudication Method for the Test Set:

Not applicable. As the validation was based on "bench data," an adjudication method for reconciling expert opinions is not relevant. The "adjudication" would involve comparing measurements against predefined technical specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study focused on demonstrating substantial equivalence through bench data, comparing the performance characteristics of the new device to predicate devices. There is no mention of human readers or AI assistance in this context.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

Yes, in spirit, but not in the context of an algorithm. The study essentially evaluates the "standalone" performance of the physical device itself (the Comfort Twin Nasal Mask) in a controlled bench setting, without human intervention or interpretation that would typically be associated with an algorithm. It's an engineering performance evaluation, not an AI algorithm evaluation.

7. Type of Ground Truth Used:

The ground truth used was technical specifications and performance characteristics of the predicate devices (Respironics Reusable II Contour Nasal Mask and Resmed Mirage Activa), against which the new device's "bench data" was compared. The statement "All performance characteristics performed within specification and comparable to the cited device predicates" implies that the predicate devices' established performance benchmarks served as the ground truth for comparison.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical device (nasal mask), not an AI algorithm that requires a training set. The concept of a "training set" is not relevant to this type of product submission.

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

Not applicable. As a physical device, there is no training set in the context of machine learning.

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The Respironics Q Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

The Respironics REMstar Q Series Auto with AFLEX CPAP System is a microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Q Series Auto with AFLEX CPAP System includes the auto mode and the flex therapy feature cleared in K063830 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. In addition, the device includes the AFLEX therapy feature which provides added comfort for the user (also cleared in K063830). Like its predicate, the REMstar Q Series Auto with AFLEX CPAP System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 19mm tubing, an exhalation device, and a patient interface device.

This submission describes a 510(k) premarket notification for a modified CPAP system, not a study evaluating a novel device against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted directly from the provided text.

Based on the provided text, the submission focuses on demonstrating substantial equivalence to a predicate device due to a "modified design." The core statement regarding performance is:

"Design verification tests were performed on the Respironics REMstar Q-Series Auto with AFLEX CPAP System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

However, the specific acceptance criteria, the detailed results, and the study design that "proves" the device meets these criteria are not provided in the given document. The document only states that such tests were performed and met the criteria.

Therefore, I cannot populate the table or provide detailed answers to questions 2 through 9 for a specific performance study.

Here's an attempt to address your request based on the limited information available and acknowledging what is not present:

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

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

• Sample size for the test set: Not specified in the document.
• Data provenance: Not specified in the document. The tests performed are "design verification tests," which are typically laboratory-based and prospective, but no details are provided.

Section 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)

• Number of experts: Not applicable/not specified. Design verification tests for a CPAP system would typically involve engineering and possibly clinical experts for test protocol development and data interpretation, but the document does not detail this. The "ground truth" for these tests would likely be established by engineering specifications and industry standards rather than expert consensus on patient data.

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

• Adjudication method: Not applicable/not specified. The document describes engineering design verification, not a clinical study requiring adjudication of expert opinions.

Section 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

• MRMC study: No, an MRMC comparative effectiveness study was not done. This is a medical device, specifically a CPAP system, not an AI diagnostic tool.

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

• Standalone performance study: No, this is not an AI algorithm. The device's performance is inherent to its mechanical and software functions. The document refers to "design verification tests" for the device as a whole.

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

• Type of ground truth: The "ground truth" for the design verification tests would be established by
  • Engineering specifications and performance requirements derived from risk analysis.
  • Applicable standards (e.g., electrical safety, biocompatibility, performance standards for CPAP devices).
    These are not equivalent to expert consensus on clinical cases or pathology.

Section 8: The sample size for the training set

• Sample size for the training set: Not applicable. This document does not describe the development of an AI model with a training set.

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

• Ground truth for the training set: Not applicable. As this is not an AI model, there is no training set or associated ground truth.

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The Alice PDx is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician. It is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.

The Alice PDx is a wearable data recorder that collects and stores physiological signals. The role of the Alice PDx is only to record the data. The following physiological signals may be collected and stored by the Alice PDx device:

• EEG, EOG, EMG, ECG
• Nasal/oral Airflow
• Snore
• Thoracic and Abdominal Effort
• Body Position
• Pulse Oximetry, including:
  • Oxygen Saturation (SpO2)
  • Pulse Rate
  • Plethysmograph

The recorded data is stored on a secure digital (SD) card and may be passed on to a PC for analysis and reporting of the data by the Respironics Sleepware Software application. The Alice PDx data recorder is not in any way involved in the data management performed by the host.

The provided document, a 510(k) Premarket Notification for the Respironics Alice PDx, states that "Design verification tests were performed on the Alice PDx as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." However, it does not provide details about specific acceptance criteria or the results of these tests.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from the provided text.

Additionally, the document does not contain information regarding:

• Sample size used for the test set or its data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human readers with/without AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (e.g., expert consensus, pathology, outcome data).
• The sample size for the training set.
• How ground truth for the training set was established.

The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Respironics Galaxy K083874) based on shared intended use, operating principle, technology, and manufacturing process. It confirms that the device records data for various physiological signals and is intended for use with clinical software for polysomnography and sleep disorder studies.

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The Performax Total Face Mask is intended to provide an interface for application of CPAP or BiPAP therapy to patients. The mask is for multi-patient reuse on adult patients in the home or hospital/institutional environment.

The Respironics Performax Total Face Mask has the exact same design as the previously cleared Performax Total Face Mask (K072592). The Performax Mask consists of a polycarbonate faceplate with silicon cushion seal for the face. An integrated entrainment valve is provided for exhalation. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The function of the entrainment valve is unchanged from K992969. The mask when used with the integrated entrainment valve has two integrated exhalation features, which includes the one port on the faceplate and an exhalation site on the elbow. A separate exhalation device is not required for the integrated entrainment valve design. The mask faceplate contains headgear hooks upon which the premium headgear is attached. The mask is available in two sizes - small and large.

The Respironics Performax Total Face Mask is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases.

This document is a 510(k) summary for the "Respironics Performax Total Face Mask," which is a ventilator, non-continuous (respirator) under product code BZD. The submission is a "Special 510(k) Attachment 4" because it is a modification to add autoclaving as an approved method of disinfection.

Here's an analysis of the provided text, broken down by your requested categories:

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

Based on the provided text, the submission focuses on demonstrating substantial equivalence to a predicate device (Respironics Performax Total Face Mask, K072592) after a modification: the addition of autoclaving as an approved method of disinfection.

The text does not provide specific, quantifiable acceptance criteria (e.g., "airflow resistance shall not exceed X Pa/cm3/s") or detailed performance data (e.g., "after X autoclave cycles, the mask maintained Y seal integrity"). Instead, it states a high-level conclusion.

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

The document does not specify the sample size used for any testing. It also does not mention the data provenance (country of origin, retrospective or prospective). The statement "Based on the testing performed" implies that testing was conducted, but details are absent.

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 provided in the document. The type of submission (a 510(k) for a physical device modification) typically relies on engineering and sterility testing rather than expert-derived ground truth based on interpretation of data like medical images.

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

Adjudication methods like 2+1 or 3+1 are primarily relevant to studies involving human interpretation (e.g., diagnostic image reading), where disagreements need to be resolved. This document, describing a physical device modification and its substantial equivalence determination, does not involve such adjudication methods.

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

An MRMC study is not applicable to this type of device modification. This submission is for a physical medical device (a mask) and its disinfection method, not an AI-powered diagnostic or assistive tool. Therefore, there is no mention of an MRMC study or any effect size related to human readers' improvement with or without AI.

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

This submission is for a physical medical device. There is no algorithm involved, and therefore no standalone performance study in the context of AI.

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

For this device modification, the "ground truth" would be established through a combination of:

• Engineering testing: To confirm the mask's physical integrity, seal effectiveness, pressure performance, and material properties after autoclaving.
• Sterility/biocompatibility testing: To demonstrate that the autoclaving process effectively disinfects the device and that the materials remain biocompatible.
• Previous clearance data (K072592): The original performax mask (K072592) served as the "ground truth" for the baseline design, safety, and effectiveness. The current submission's "ground truth" is that the modified device's performance after autoclaving remains equivalent to this established baseline.

The document does not explicitly state these ground truth types but they are implied by the nature of the device and the submission (e.g., "no effect on the safety or effectiveness").

8. The sample size for the training set

This information is not applicable as there is no AI/machine learning model being trained in this submission.

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

This information is not applicable as there is no AI/machine learning model being trained in this submission.

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The Respironics REMstar M-Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.

The Respironics REMstar M-Series Auto with AFLEX CPAP System is a microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar M-Series Auto with AFLEX System also includes the auto mode and the flex therapy feature cleared in K063830 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. In addition the device includes an AFLEX therapy feature which provides added comfort for the user. As stated in the submission, the purpose of this modification is to provide enhanced event detection and algorithm response to these new event types. Like its predicate, this device is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, an exhalation device, and a patient interface device.

The provided text does not contain detailed information about specific acceptance criteria for a device's performance, nor does it describe a study proving the device meets said criteria with the requested level of detail. The document is a 510(k) summary for a CPAP system, primarily focusing on its substantial equivalence to a predicate device and its intended use.

However, based on the statement: "Design verification tests were performed on the Respironics REMstar M-Series Auto with AFLEX System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device." we can infer that acceptance criteria and verification tests were indeed conducted.

Given the available information, I can only provide a general interpretation based on the statements made:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify a table of acceptance criteria or numerical performance metrics for the device. The only performance-related statement is a general assertion that "All tests were verified to meet the required acceptance criteria."

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

This information is not provided in the document.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided in the document, as the "ground truth" concept as typically applied in AI/ML performance evaluation studies (e.g., expert consensus on medical images) is not relevant to this type of device modification submission.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned or implied. The device is a CPAP system, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance Study

While "enhanced event detection and algorithm response" are mentioned as a purpose of modification, the document does not describe a standalone performance study with specific metrics, methodology, or results. The focus is on the device as a whole and its substantial equivalence to a predicate device, not on isolated algorithm performance.

7. Type of Ground Truth Used

Given that this is a CPAP device and the context of a 510(k) for a modified device, the "ground truth" would likely refer to objective engineering and clinical performance metrics measured against established standards and internal specifications, rather than expert consensus on diagnostic interpretations or pathology. Examples of such "ground truth" would be:

• Engineering Specifications: Pressure accuracy, flow rate, leak detection, alarm functionality, power consumption, sound levels.
• Clinical Performance (inferred): The device's ability to effectively deliver positive airway pressure for Obstructive Sleep Apnea, as measured through clinical trials or simulated use conditions against established physiological parameters.
• Risk Analysis Outcomes: Verification that identified risks are mitigated and safety requirements are met.

However, the document does not explicitly describe how this "ground truth" was established or measured with specific details.

8. Sample Size for the Training Set

This information is not provided. Given that the document refers to "design verification tests" and "risk analysis and product requirements" rather than an AI/ML development process, the concept of a "training set" in the context of machine learning is not directly applicable here. The device likely underwent traditional engineering design and testing, not a machine learning model training process that would require a distinct "training set."

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

As above, the concept of a "training set" with established ground truth in the AI/ML sense is not directly applicable to this document. The "ground truth" for verifying the device's performance (as inferred from point 7) would have been established through a combination of industry standards, regulatory requirements, internal design specifications, and potentially pre-clinical or clinical testing protocols for CPAP devices.

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