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The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) or adult patients (> 66 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.

The Respironics BiPAP Synchrony 2 device is unchanged from K092043. The BiPAP Synchrony 2 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 only change to the Respironics BiPAP Synchrony 2 device is to include the small size Respironics AF531 EE Leak 1 Full Face Mask (no built-in exhalation) and the small size Respironics AF531 EE Leak 2 Full Face Mask (with built-in exhalation) as options for use by its pediatric users. These two masks consist of a silicon cushion, polycarbonate faceplate, and an integrated entrainment valve elbow made of polycarbonate with a silicone flapper. All of the materials used within these masks are predicate materials. The small size Respironics AF531 EE Leak 1 Full Face Mask has an entrainment elbow with no additional exhalation and will require a separate exhalation device. Whereas, the small size Respironics AF531 EE Leak 2 Full Face Mask has an entrainment elbow with built-in exhalation, negating the need for a separate exhalation device. Both masks are designed to be used with either the four point style headgear or the capstrap style headgear, allowing the patient an option.

Anthropometric analysis was performed on the small size of the Respironics AF531 EE Leak 1 Full Face Mask and the small size Respironics AF531 EE Leak 2 Full Face Mask. This analysis has determined that these two small masks will appropriately fit the pediatric population (> 7 years of age, > 40 lbs).

The provided text describes a 510(k) premarket notification for the Respironics BiPAP Synchrony 2. The submission is to include two additional pediatric full face masks for use with the device. The core device (BiPAP Synchrony 2) itself is unchanged from a previously cleared device (K092043). Therefore, the study focuses on proving the compatibility and substantial equivalence of the new masks with the existing device.

Here's an breakdown of the acceptance criteria and the study as described:

1. Table of acceptance criteria and the reported device performance

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

• Test Set Sample Size: Not explicitly stated in terms of the number of masks or individual tests performed. However, "mask compatibility testing was performed with each mask" refers to the two new pediatric masks (AF531 EE Leak 1 and AF531 EE Leak 2). The "anthropometric analysis" was also performed on "the small size of both" masks.
• Data Provenance: Not specified (e.g., country of origin). The testing seems to be internal verification testing by the manufacturer, Respironics, Inc. It's an internal, prospective study to validate the new mask additions.

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

Not applicable. This submission is for compatibility of new accessories (masks) with an existing medical device. The "ground truth" for the performance criteria (pressure, waveform, etc.) would be established by engineering specifications and regulatory standards for ventilator performance, not by expert medical opinion in this context. The anthropometric analysis implicitly relies on expert knowledge of pediatric anthropometry, but no specific external experts are mentioned.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical findings (e.g., multiple readers interpreting images). The "verification testing" implies comparison against predefined acceptance criteria.

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-based device or a diagnostic imaging study.

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

Not applicable. This is a medical device (ventilator and masks), not an algorithm.

7. The type of ground truth used

For Mask Compatibility: The ground truth would be established by predefined engineering specifications and regulatory standards for ventilator performance (e.g., specific pressure ranges, waveform characteristics, triggering sensitivity, alarm thresholds).

For Pediatric Fit: The ground truth is anthropometric data for the target pediatric population (> 7 years of age, > 40 lbs) coupled with design specifications for mask fit.

8. The sample size for the training set

Not applicable. This is not a machine learning model, so there is no "training set."

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

Not applicable.

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The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) or adult patients (> 66 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.

The Respironics BIPAP Synchrony 2 device is unchanged from K063533/K071509. The only change is to include the Respironics Performax Youth EE mask as a 3rd 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 Total Face Mask (K072592). 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 EE mask was designed to meet the 90" percentile for pediatrics age 7 and older and > 40 lbs.

The provided text is a 510(k) summary for a medical device called BiPAP Synchrony 2. This submission focuses on adding a new pediatric mask (Respironics Performax Youth EE mask) for use with an already cleared device. Therefore, the "acceptance criteria" and "device performance" discussed relate specifically to the compatibility and safety of this new mask with the existing ventilator system, rather than the core performance of the ventilator itself.

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

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

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 for the mask compatibility testing. It simply states that "mask compatibility testing was performed." It also does not provide details on the data provenance such as the country of origin or if the testing was retrospective or prospective. It is implied that the testing was performed by Respironics, Inc.

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 section is not applicable. The study described is an engineering and functional compatibility test of a medical device accessory, not a study requiring expert consensus for ground truth on clinical outcomes or diagnoses. The "ground truth" here is the pass/fail against predetermined engineering and performance specifications.

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

This is not applicable as the study involves objective engineering measurements against defined performance criteria. There's no mention of a human adjudication process for the test results.

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

This is not applicable. This submission is for a ventilator and mask accessory, not an AI-powered diagnostic or assistive technology where a MRMC study would be relevant.

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

This is not applicable. The device is a ventilator, a mechanical medical device, not an algorithm.

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

The "ground truth" for this compatibility study was based on pre-defined engineering and performance specifications for the ventilator system and the new mask, as well as the safety and effectiveness requirements for medical devices. The objective was to confirm that the new mask did not negatively impact the existing cleared device's performance characteristics.

8. The sample size for the training set

This is not applicable. The submission describes a device modification and compatibility testing, not a machine learning model that would require a training set.

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

This is not applicable, as there is no training set for a machine learning model discussed in this document.

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The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) or adult patients (> 66 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.

The Respironics BiPAP Synchrony 2 device is unchanged from K063533. The only change is to include a Respironics pediatric mask as a second option for use by its pediatric users. This mask is the same mask design as is used by the cleared Respironics Reusable Contour Deluxe Nask (K991648). The mask consists of a silicon cushion, polycarbonate faceplate with an elbow that contains the exhalation feature. The anthropometric profile of the Respironics Pediatric Mask matches that of the Resmed Kidsta previously cleared in K063533.

This document describes a 510(k) premarket notification for the BiPAP Synchrony 2 Ventilatory Support System with the addition of a Respironics pediatric mask. The core device itself (BiPAP Synchrony 2) is unchanged from a previously cleared predicate device (K063533). The submission specifically addresses the compatibility of the new pediatric mask.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The general acceptance criteria and performance are reported qualitatively in the document. No specific numerical thresholds are provided, as the study focused on compatibility and function rather than a new "performance metric."

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

• Sample Size: Not explicitly stated in the provided text. The document refers to "mask compatibility testing" but does not detail the number of masks, devices, or test subjects used in this testing.
• Data Provenance: Not explicitly stated, however, the testing was performed by Respironics, Inc. and is part of a submission to the FDA in the United States. It's likely a controlled, in-house laboratory study. It would be considered prospective for the specific purpose of this submission (testing the new mask's compatibility).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The testing was conducted by the manufacturer, Respironics, likely by their engineering and R&D teams.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/specified. The testing described appears to be objective, functional performance testing (e.g., pressure, waveform analysis, discrete function activation) rather than subjective expert assessment. There is no indication of multiple readers or an adjudication process for these technical tests.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission focuses on the compatibility of a new mask with an existing device, involving technical performance testing, not the clinical effectiveness or human-in-the-loop performance with or without AI.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No, a standalone performance study in the context of an algorithm or AI was not done. This device is a ventilatory support system, not an AI/algorithm-based diagnostic or therapeutic device.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this testing was based on pre-defined engineering specifications and performance requirements for the ventilatory support system. The "acceptance criteria" for the mask compatibility testing (pressure, waveform, triggering, cycling, alarm functionality) refer to these established technical standards for proper device function.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This submission concerns a physical medical device and mask, not an AI or machine learning algorithm that would require a 'training set.'

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

• Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML model.

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The BiPAP Synchrony with Average Volume Assured Pressure Support (AVAPS) is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Synchrony may be used in the hospital or home.

The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.

The Respironics BiPAP Synchrony with AVAPS 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 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 AVAPS feature is professionally selected and rides on top of the existing modality provided by the BiPAP Synchrony. The BiPAP Synchrony with AVAPS pressure control that contains various controls which are used to configure positive pressure therapies.

The BiPAP Synchrony with AVAPS 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 Synchrony with AVAPS 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, a method of venting exhaled gases and a patient device (mask).

This submission describes the Respironics BiPAP Synchrony with AVAPS Ventilatory Support System, a continuous ventilator intended for non-invasive ventilatory support in adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The submission states that the device builds upon an existing cleared device platform, the Respironics BiPAP Synchrony (K992530, K012323, K020777).

1. Acceptance Criteria and Reported Device Performance:

The document mentions that "All tests were verified to meet the required acceptance criteria," but does not explicitly list the specific acceptance criteria or provide quantitative performance metrics. It generally states:

* The document states that bench testing included collecting this data for comparison and confirmed equivalence, implying these aspects met their respective (unspecified) acceptance criteria.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: Not specified for the clinical study. Bench testing details are also not quantified in terms of number of tests or samples.
• Data Provenance: The document does not specify the country of origin of the data. The clinical study is described as having been performed by Respironics, suggesting internal data. The nature of the study (clinical study and bench testing) suggests it could be prospective, but this is not explicitly stated.

3. Number and Qualifications of Experts for Ground Truth (Test Set):

Not applicable. The study primarily relies on comparing the AVAPS feature to existing therapy and comprehensive bench testing. There is no mention of experts establishing a "ground truth" in the diagnostic or interpretative sense for the test set. The clinical study aimed to establish therapeutic effectiveness.

4. Adjudication Method for Test Set:

Not applicable. There is no mention of an adjudication process as would be typical for studies involving human interpretation or subjective assessments.

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

No. The document describes a clinical study to assure therapy provided with AVAPS was equivalent to or better than existing therapy provided without AVAPS. It does not describe an MRMC study comparing human readers with and without AI assistance. The device is a ventilatory support system, not an interpretive AI tool for imaging or diagnostics.

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

Yes, in essence. The clinical study evaluated the effectiveness of the AVAPS feature as delivered by the device, independent of direct human intervention during the process of ventilation delivery itself. The bench testing also assessed the device's technical performance in a standalone manner. The device is controlled by a microprocessor and delivers therapy based on its internal algorithms.

7. Type of Ground Truth Used:

For the clinical study, the "ground truth" was likely clinical outcomes or measures of therapeutic effectiveness, as the study aimed to determine if AVAPS was "as effective as that of therapy without AVAPS." The specific metrics are not detailed, but would typically involve physiological parameters related to ventilation and patient well-being for OSA/Respiratory Insufficiency. For bench testing, the ground truth was derived from engineering specifications and performance expectations for waveform, triggering, and alarm data.

8. Sample Size for the Training Set:

Not applicable. The device is built on an existing platform and the AVAPS feature is an added functionality. There is no mention of a machine learning model that would require a distinct "training set" in the context of this submission. The device is stated to be microprocessor-controlled, but the development process doesn't explicitly refer to a machine learning training phase.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no explicitly defined "training set" in the context of this submission. The development of the AVAPS algorithm would have been based on physiological principles and engineering design, potentially informed by clinical expertise and data from previous device iterations or relevant medical literature.

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The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) and adult patients (> 66 Ibs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.

The Respironics BiPAP Synchrony 2 Ventilatory Support System 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 Synchrony 2 also has a CPAP mode in which a fixed pressure is delivered and four bilevel operating modes which determine how the changes between IPAP and EPAP pressures are made, Spontaneous, Spontaneous/Timed, Timed and Pressure Control.

The BiPAP Synchrony 2 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 Synchrony 2 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, a method of venting exhaled gases, and the Mirage Kidsta mask (K060105).

Acceptance Criteria and Performance Study for BiPAP Synchrony 2

The provided document describes the predicate device comparison and bench testing performed for the BiPAP Synchrony 2 Ventilatory Support System, particularly for its expanded indication for pediatric patients. Since this is an abbreviated 510(k) submission, the full details of the specific acceptance criteria tables and complete study reports are not always provided in this summary. However, based on the text, we can infer the type of criteria and the nature of the study.

Note: The document explicitly states that the device is a "Non-Continuous ventilator" and "non-life supporting." This context is important as the rigor of testing and acceptance criteria can differ significantly from life-supporting devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission focuses on demonstrating equivalence to predicate devices and expanding a pediatric indication primarily through bench testing, the acceptance criteria are generally established against the performance of the predicate devices or relevant industry standards for ventilator performance.

2. Sample Size for the Test Set and Data Provenance

The study described primarily involves bench testing.

• Sample Size: The document does not specify the exact number of units or test cycles used in the bench testing. It refers to "additional testing" and "bench testing" which implies a sufficient number of tests were conducted to cover the various performance parameters.
• Data Provenance: The testing was conducted by Respironics, Inc., presumably at their facilities. The data is thus prospective, generated specifically for this submission. The country of origin of the data is the United States.

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

N/A. This was not a clinical study involving human patients or ground truth established by medical experts in the context typically seen for diagnostic AI/ML devices. The "ground truth" for this device's performance was established through engineering specifications, regulatory standards, and comparison to predicate device performance, which would have been validated by Respironics' internal engineering and quality assurance teams.

4. Adjudication Method for the Test Set

N/A. As this was primarily bench testing against engineering specifications and predicate device performance, there was no adjudication method in the traditional sense involving multiple human readers/experts. Performance verification was likely based on measured values falling within predefined tolerance bands relative to specifications or predicate device performance.

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

No. An MRMC comparative effectiveness study was not performed. This type of study is typically conducted for diagnostic devices where human readers interpret results, and the AI system aims to assist or improve their performance. The BiPAP Synchrony 2 is a therapeutic device (ventilator) and the submission focuses on its mechanical performance and safety.

6. Standalone (Algorithm only without human-in-the-loop performance) Study

N/A. This device is not an algorithm-only device. It is a physical medical device (ventilator) with integrated software/firmware for controlling its mechanical functions. The performance described is inherently that of the device operating as intended, without a direct "human-in-the-loop" evaluative component in the same way an AI diagnostic tool would be assessed.

7. Type of Ground Truth Used

The ground truth used for this submission's testing was:

• Engineering Specifications: Performance parameters (pressure, waveform, triggering, cycling, alarms) were likely measured against predefined internal engineering specifications and relevant industry standards for non-invasive ventilators.
• Predicate Device Performance: Performance data from the legally marketed predicate devices (Respironics BiPAP Synchrony HC, S/T, Harmony, and Resmed VPAP III ST-A / Kidsta system) served as a benchmark for demonstrating equivalence.
• Risk Analysis Outcomes: The pediatric indication added considerations from a risk analysis, which would have informed specific test requirements to ensure safety and efficacy in that population based on clinical understanding.

8. Sample Size for the Training Set

N/A. This device is not an AI/ML device in the sense that it requires a "training set" for an algorithm. It is a microprocessor-controlled mechanical device. Its control algorithms are developed through engineering design, not machine learning from a data set.

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

N/A. See point 8.

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The Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony may be used in the hospital/institutional environment.

The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.

The Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex is a microprocessor controlled blower based bi-level positive pressure system that delivers two different 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. Respironics is adding an additional therapy feature to the existing Spontaneous "S" mode in the BiPAP Synchrony Ventilatory Support System Software. This feature will ease the transition from the end of inspiration to the beginning of exhalation. The BiPAP Synchrony Ventilatory Support System with Bi-Flex 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, and a patient interface device.

The provided document is a 510(k) premarket notification for a medical device (Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex). It focuses on demonstrating substantial equivalence to a predicate device and does not contain the kind of detailed performance study information typically required for characterizing acceptance criteria, sample sizes for test/training sets, expert qualifications, or ground truth establishment relevant to AI/ML device evaluations.

Therefore, most of the requested information regarding acceptance criteria, study details, expert qualifications, adjudication methods, and sample sizes for training/test sets cannot be extracted from this document.

Here's what can be gathered:

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

The document states: "Design verification tests were performed on the Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex 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 (e.g., specific pressure ranges, flow rates, response times) and the reported device performance against these criteria are not detailed in this submission. This document summarizes that tests were conducted and criteria were met, but it doesn't provide the criteria or performance data itself.

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

This information is not provided in the document. The submission pertains to design verification, which typically involves engineering tests, not clinical data sets in the way an AI/ML study would.

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 applicable/provided. The device is a ventilatory support system, not an interpretive device that requires expert-established ground truth in the context of diagnostic performance studies.

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

This information is not applicable/provided. Adjudication methods are typically relevant for establishing ground truth in diagnostic studies, which is not the primary focus of this submission.

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

This information is not applicable/provided. This device is a ventilatory support system, not an AI-assisted diagnostic tool that would involve human readers.

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

This information is not applicable/provided. The device's performance relates to its mechanical and software functions to deliver ventilation, not an "algorithm only" performance in the context of an AI/ML model.

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

This is not explicitly stated in the document, as the "ground truth" concept in this context would likely refer to engineering specifications and physical measurements, rather than clinical outcomes or expert consensus on diagnoses. The document mentions "risk analysis and product requirements" as the basis for design verification.

8. The sample size for the training set

This information is not applicable/provided. This device is not an AI/ML product developed using training sets in the typical sense.

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

This information is not applicable/provided.

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The Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony may be used in the hospital or home.

The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.

The Respironics BiPAP Synchrony Ventilatory Support System is a microprocessor controlled blower based Bi-level positive pressure system that delivers two different 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. Respironics is modifying the existing device with the addition of 3 alarms, expanding the EPAP setting to 30 cmH2O and adding a remote control accessory for use in a clinical setting. The BiPAP Synchrony 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, a method of venting exhaled gases, and a patient interface device.

This 510(k) submission (K012323) is for a modification to the Respironics BiPAP Synchrony Ventilatory Support System, specifically adding 3 alarms, expanding the EPAP setting to 30 cmH2O, and adding a remote control accessory. It is a modification to an existing device, not a new device requiring extensive clinical studies with human readers or AI.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Design verification tests were performed on the Respironics BiPAP Synchrony Ventilatory Support 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 and the detailed performance results (e.g., alarm thresholds, EPAP accuracy, remote control reliability) are NOT explicitly provided in the public summary. The 510(k) summary typically contains a high-level overview. Detailed test reports would be part of the full 510(k) submission, which is not publicly released in its entirety.

Table Placeholder (based on general understanding of device modifications):

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

The document does not specify the sample size for the test set or the data provenance. Design verification tests generally involve testing multiple units of the modified device. Given this is a device modification (not a clinical study of diagnostic accuracy), the "test set" would refer to the units of the device being tested, not patient data.

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

This information is not applicable to this 510(k) submission as it describes a modification to a medical device's hardware/software features, not a diagnostic or prognostic algorithm that requires expert consensus on ground truth from clinical data. The "ground truth" for this type of submission is defined by engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical data, where there might be disagreement among experts. For device design verification, a pass/fail criterion based on pre-defined specifications is typical.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission is about a device modification, not a diagnostic AI tool.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

No, a standalone (algorithm only) performance study was not done. This concept is for AI algorithms separate from a human operator. The modifications here are integrated features of the BiPAP Synchrony device.

7. The Type of Ground Truth Used:

The ground truth used for these design verification tests would be engineering specifications and performance requirements for the alarms, EPAP delivery, and remote control functionality, as well as adherence to relevant regulatory standards (e.g., for safety, EMC). It is not clinical ground truth like pathology, expert consensus on images, or outcomes data, as this is not a diagnostic or treatment outcome study.

8. The Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train machine learning models. This 510(k) describes a traditional medical device modification, not an AI/ML-driven device that requires a training set.

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

This information is not applicable for the same reasons as #8.

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The BiPAP® Synchrony™ HC is a non-invasive, pressure support ventilator used to

• i) Augment the breathing of patients suffering from acute or chronic respiratory insufficiency
• ii) Maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea.
  It is not intended to provide the total ventilatory requirements of the patient.
  The BiPAP® Synchrony™ HC is intended for use with nasal masks and full-face masks as recommended by Respironics.

The BiPAP Synchrony is intended to provide non-invasive ventilation in adult patients (>30kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony ventilator is intended for use with nasal masks and fullface masks as recommended by Respironics.

The BiPAP® Synchrony™ HC is a noninvasive pressure support ventilator and is classified under product code MNS (continuous ventilator, non-life supporting).
The BiPAP Synchrony HC provides therapy in the Continuous Positive Airway Pressure (CPAP) Spontaneous/Timed (S/T), Pressure Assist, and Timed modes.

The provided text describes a medical device, the BiPAP® Synchrony™ HC, and its substantial equivalence to a predicate device. It details the device's functions, intended use, and various tests performed to demonstrate its safety and effectiveness. However, the document does not contain the specific information required to answer your questions about acceptance criteria and a study that proves the device meets those criteria.

Here's why and what's missing:

• No Acceptance Criteria Table: The document states that "Testing was performed to demonstrate that the performance of the BiPAP® Synchrony™ HC in its intended environment is as safe and effective as that of the legally marketed predicate device." It also mentions compliance with "standards referenced in the 'Draft FDA Reviewer Guidance for Ventilators,' July 1995 as well as with the 'Draft Reviewer Guidance for Premarket Notifications, 'November 1993." However, it does not provide a table outlining specific acceptance criteria (e.g., minimum accuracy percentages, maximum deviation values) for its performance and then reporting the device's measured performance against those criteria.
• No Study Details: While the document confirms that "performance-related testing in addition to electrical safety, electromagnetic compatibility, mechanical and environmental testing" was conducted, it does not provide any details about a specific study (e.g., clinical trial, validation study) that would assess the device's performance against predefined acceptance criteria. Therefore, information regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies is absent.

In summary, based on the provided text, I cannot answer your request as the necessary study details and acceptance criteria are not present. The document focuses on regulatory approval (510(k) submission) by demonstrating substantial equivalence, which is a different scope than detailing specific performance studies with acceptance criteria.

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