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The BiPAP AutoSV 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 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 pressure control that contains various which are used to configure positive pressure therapies. With these controls, the device delivers minimum pressure support determined by the EPAP and IPAP Min controls. The device may automatically provide additional pressure support with inspiratory pressures between IPAP Min and IPAP Max to normalize patient ventilation during sleep disordered breathing events. Note: When EPAP

The provided text describes a 510(k) premarket notification for a modified device, the Respironics BiPAP AutoSV. The submission claims substantial equivalence to previously cleared predicate devices. The "study" mentioned refers to design verification tests performed on the device to ensure it meets required acceptance criteria. However, the document does not contain detailed information about a clinical study with a detailed methodology, acceptance criteria, and specific performance results in the format you requested for "proving" the device meets acceptance criteria.

Based on the provided text, here's what can be extracted and what is missing:

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

Missing Information:

• Specific quantitative acceptance criteria (e.g., "pressure accuracy must be within +/- X cmH2O").
• Specific quantitative performance results from the design verification tests (e.g., "pressure accuracy was Y cmH2O").

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

• Sample Size: Not specified. The document mentions "design verification tests" but does not detail the number of devices or scenarios tested.
• Data Provenance: Not specified. It's internal testing conducted by Respironics.

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" for design verification tests is typically established through engineering specifications and regulatory standards, not expert consensus on patient data.

4. Adjudication method for the test set:

• Not applicable. This typically refers to clinical study data adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This type of study is not mentioned in the document. The device is a ventilator, not an AI-assisted diagnostic tool.

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

• The document implies that the device (which contains a microprocessor controller) underwent standalone testing as part of the design verification process. The "algorithm" here would be the control logic of the ventilator. However, specific details about protocol for standalone algorithm performance are not provided.

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

• For design verification tests, the "ground truth" would be the engineering specifications and regulatory standards that the device is required to meet.

8. The sample size for the training set:

• Not applicable in the context of this document. This refers to AI/ML model training, which is not the focus of this submission. The device is microprocessor-controlled but not described as using machine learning that would require a "training set" in the common sense of the term for AI products.

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

• Not applicable (see point 8).

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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 BiPAP AutoSV 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 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 pressure control that contains various which are used to configure positive pressure therapies. With these controls, the device delivers minimum pressure support determined by the EPAP and IPAP Min controls. The device may automatically provide additional pressure support with inspiratory pressures between IPAP Min and IPAP Max to normalize patient ventilation during sleep disordered breathing events. Note: When EPAP

The provided 510(k) summary for the BiPAP AutoSV device does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study that proves the device meets them. This document is a summary and primarily focuses on demonstrating substantial equivalence to predicate devices through
bench testing and general comparisons, rather than a detailed report of clinical study outcomes or specific acceptance criteria for performance metrics.

However, based on the provided text, here's what can be extracted and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states: "Bench testing has confirmed that the BiPAP AutoSV performs equivalently to the device predicate VPAP Adapt (K051364). All tests were verified to meet the required acceptance criteria."

This statement confirms that acceptance criteria exist and were met, but the document does not specify what those criteria are, nor does it provide a table of performance metrics. It only broadly mentions "waveform performance data, triggering data, alarms data, and overall event diction and control data."

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

The document refers to "comprehensive bench testing."

• Sample Size: The sample size for the test set is not specified. This typically refers to the number of devices or test conditions used in bench testing.
• Data Provenance: The data provenance is bench testing, meaning it's laboratory-generated data from Device A versus Device B comparison, rather than human subject data. The "country of origin" for the data is implicitly where the testing was conducted, likely the manufacturer's facilities (Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668, USA). This testing is retrospective in the sense that it compares a new device against an already cleared predicate device's performance characteristics.

3. Number of Experts and Their Qualifications for Ground Truth

• This device's submission relies on bench testing for proving equivalence, not clinical studies involving human patients where expert-established ground truth would be relevant for diagnostic or therapeutic accuracy. Therefore, information about the number or qualifications of experts used to establish ground truth is not applicable in this context as described in the summary.

4. Adjudication Method for the Test Set

• Since the testing described is primarily bench testing comparing device performance parameters, an "adjudication method" in the sense of resolving discrepancies between expert interpretations (e.g., 2+1, 3+1 for clinical evaluations) is not applicable. The "adjudication" would be based on objective measurements against pre-defined engineering or performance specifications.

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

• No, an MRMC comparative effectiveness study was not done according to this 510(k) summary. The document explicitly states the equivalence was demonstrated through "comprehensive bench testing." MRMC studies are typically used for diagnostic devices to assess the impact of AI on human reader performance, which doesn't fit the context of this ventilatory support system's submission as described.

6. Standalone (Algorithm Only) Performance

• The summary describes the device as a "microprocessor controlled blower based Bi-level positive pressure system that delivers two positive pressure levels." The "AutoSV algorithm" is mentioned as a component. While the algorithm is a key part of the device's functionality, the performance testing described is for the integrated device ("BiPAP AutoSV performs equivalently"). Therefore, a standalone algorithm-only performance study is not explicitly mentioned or implied. The performance is assessed at the device level.

7. Type of Ground Truth Used

• For the bench testing, the "ground truth" would be the established performance specifications and data from the predicate device (Resmed VPAP Adapt, K051364). The BiPAP AutoSV's performance data (waveform, triggering etc.) was compared against these established benchmarks to demonstrate "equivalence." It is not pathology, outcomes data, or expert consensus in a clinical diagnostic sense.

8. Sample Size for the Training Set

• This 510(k) submission is for a medical device (ventilator) that incorporates an algorithm. It is not an AI/ML diagnostic or prognostic software submission where a "training set" of patient cases for algorithm development would typically be disclosed as a distinct component. The document does not provide information on a "training set" for the AutoSV algorithm. Algorithm development often involves internal testing and refinement, but details about specific training data are not part of this 510(k) summary.

9. How Ground Truth for the Training Set Was Established

• As a "training set" for an explicit AI/ML algorithm is not described in this 510(k) summary, the method for establishing its ground truth is not applicable/not provided.

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