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The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg).

The S9 VPAP Tx is intended to be used in a clinical environment.

The S9 VPAP Tx is similar to the predicate devices VPAP ST-A (K113288), VPAP ST (K102513), S9 VPAP Adapt (K113801) and S8 Aspen (K091947).

The S9 VPAP Tx provides CPAP, Auto-titrating, Bilevel, VAuto and ASV modes to treat OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing. This is achieved through the use of a micro-processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency.

The S9 VPAP Tx system comprises the flow generator, patient tubing, mask (patient interface) and optional H5i humidifier.

The performance and functional characteristics of the S9 VPAP Tx includes all the clinician and user friendly features of the predicate devices, VPAP ST-A (K113288), VPAP ST (K102513), S9 VPAP Adapt (K113801) and S8 Aspen (K091947).

Here's an analysis of the ResMed S9 VPAP Tx 510(k) submission based on the provided text, focusing on the absence of information regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of an AI/ML medical device submission.

The provided document is a 510(k) summary for the ResMed S9 VPAP Tx, a continuous ventilator. It does NOT describe an AI/ML device or any study that would typically be associated with performance criteria for an algorithmic diagnostic or prognostic tool. Instead, it describes a hardware medical device and its substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested points, such as "acceptance criteria and reported device performance" related to an AI/ML algorithm, sample sizes for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

The submission focuses on demonstrating compliance with recognized standards for medical electrical equipment and biocompatibility, as well as the substantial equivalence of the new device to existing predicate devices based on intended use, operating principle, technology, and manufacturing process.

Summary regarding Acceptance Criteria and Study for ResMed S9 VPAP Tx (K123511):

This 510(k) submission is for a continuous ventilator (S9 VPAP Tx), which is a hardware medical device, not an AI/ML device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" within the context of AI/ML performance (e.g., sensitivity, specificity, AUC) is not applicable to this submission.

The document states:

• "Design and Verification activities were performed on the S9 VPAP Tx as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria."
• "The S9 VPAP Tx has been tested to appropriate FDA consensus standards and other applicable requirements passing all test protocols."

This indicates that internal design verification and validation activities were conducted based on engineering specifications and compliance with relevant safety and performance standards for hardware medical devices. These are not performance metrics for an AI algorithm.

Addressing the specific points based on the provided text, noting irrelevance where appropriate for an AI/ML context:

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

   • Not Applicable in an AI/ML context. The document does not provide a table of performance metrics (like sensitivity, specificity) for an AI/ML component. The "acceptance criteria" here refers to the passing of various engineering and safety standards.
   • Relevant information from document: The device was tested according to:
     • IEC 60601-1-2:2007 (Electromagnetic compatibility)
     • IEC 60601-1:2005 (General requirements for safety and essential performance)
     • IEC 60601-1-8:2006 (Alarm systems)
     • ISO 10993 series (Biocompatibility)
   • Reported Device Performance: The document states "All tests confirmed the product met the predetermined acceptance criteria" and "passing all test protocols." No specific numerical performance results (e.g., for pressure delivery accuracy, flow rates) are provided in this summary, as these would typically be detailed in the full submission, not the summary.

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

   • Not Applicable. This device is a hardware ventilator. There is no "test set" of patient data for evaluating an AI/ML algorithm as described in the prompt. The testing involved bench testing of the physical device. The document states: "Clinical data for the S9 VPAP Tx is not required as the predicate devices have been subjected to clinical trial requirements or validated patient simulation models have been used during the bench testing phases." This refers to physical models or simulated patient conditions, not patient data for algorithm training/testing.

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)

   • Not Applicable. This is not an AI/ML device. Ground truth as typically understood for AI/ML validation (e.g., expert consensus on image interpretation) is not relevant here.

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

   • Not Applicable. This is not an AI/ML device.

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/ML device and therefore no MRMC study involving human readers and AI assistance was conducted or would be relevant.

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

   • Not Applicable. This device is a hardware ventilator, not an algorithm.

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

   • Not Applicable in an AI/ML context. The "ground truth" for this device's testing would be established by the functional specifications and performance standards (e.g., a pressure sensor correctly measures the output pressure, the device delivers a specified flow rate). The "validated patient simulation models" mentioned refer to physical or mathematical models representing patient physiology for bench testing, not clinical ground truth derived from patients for an AI.

8. The sample size for the training set

   • Not Applicable. This device does not have a "training set" in the context of AI/ML.

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

   • Not Applicable. This device does not have a "training set" or associated ground truth in the context of AI/ML.

In conclusion, the ResMed S9 VPAP Tx 510(k) submission is for a conventional medical device (ventilator) and does not contain information pertinent to the performance criteria or studies typically associated with AI/ML-enabled devices. The "predetermined acceptance criteria" and "test protocols" refer to engineering and safety standards, not AI algorithm performance metrics.

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The VPAP ST-A is indicated to provide non-invasive ventilation for patients weighing more than 30 lbs (13kg) or more than 66 lbs (30kg) in iVAPS mode with respiratory insufficiency or obstructive sleep apnea (OSA). The VPAP ST-A is intended for use in the hospital or home.

VPAP ST-A System (VPAP ST-A with H5) is similar to the predicate device(s), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is similar to the S9 VPAP ST (K102513) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure (CPAP) between 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA and (Bilevel) pressures between 3-30 cmHzO for the treatment respiratory insufficiency. The system comprises the flow generator, patient tubing, mask (patient interface), alarm functions and integrated humidifier. Therapy modes contained in the VPAP ST-A are CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS. Therapy modes come from the S9 VPAP ST (K102513) and Stellar 150 (K103167). The functional characteristics of the VPAP ST-A system includes all the clinician and user friendly features of the predicate devices.

The provided document is a 510(k) summary for the ResMed VPAP ST-A. It discusses the device's substantial equivalence to predicate devices and outlines non-clinical testing. However, it does not contain information about a study that used a test set with established ground truth, MRMC studies, or training sets.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a study with a test set, nor can I answer questions related to sample sizes for test/training sets, expert involvement for ground truth, adjudication methods, or MRMC studies, as this information is not present in the document.

Based on the provided text, here's what can be inferred and what cannot:

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

• Cannot be provided directly. The document states: "All bench tests confirmed the product met the predetermined acceptance criteria, this included Pressure. Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests against the predicate devices using common protocols for both devices." However, the specific acceptance criteria values and the quantitative reported device performance for these criteria are not detailed in the summary.

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

• Cannot be provided. The document describes "bench tests" and "validated patient simulation models" but does not detail a "test set" in the context of patient data with a specific sample size or provenance. It explicitly states: "Clinical data for the VPAP ST-A is not required as the predicate devices have been subjected to clinical trial requirements or validated patient simulation models have been used during the bench testing phases."

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)

• Not applicable/Cannot be provided. As there is no mention of a clinical test set requiring expert ground truth establishment for patient outcomes, this information is not present.

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

• Not applicable/Cannot be provided. Similar to point 3, without a clinical test set subject to human interpretation, adjudication methods are not relevant here.

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, an MRMC study was not done. The document explicitly states: "Clinical data for the VPAP ST-A is not required". The device described is a medical device (ventilator) and not an AI or imaging diagnostic tool that would typically involve human readers.

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

• Yes, in essence, standalone testing was done. The "bench tests" and testing "against the predicate devices using common protocols" along with the use of "validated patient simulation models" can be considered a form of standalone performance assessment against engineering and functional specifications, rather than human-in-the-loop performance. However, this is for the device's core functions, not an 'algorithm' in the typical AI sense.

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

• Objective engineering/functional specifications and predicate device performance. For the bench tests, the "ground truth" would be the pre-defined engineering design specifications for parameters like pressure, flow, trigger, cycling, and apnea/hypopnea detection, as well as the performance characteristics of the predicate devices. These are objective, measurable parameters rather than clinical outcomes or pathology.

8. The sample size for the training set

• Not applicable/Cannot be provided. The device is a ventilator, not an AI model that undergoes "training" in the machine learning sense from a dataset.

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

• Not applicable/Cannot be provided. As there is no training set for an AI model, this question is not relevant.

Summary of what the document does state regarding testing:

• Type of Testing: Non-clinical bench tests and simulation models.
• Confirmation: "All bench tests confirmed the product met the predetermined acceptance criteria."
• Criteria Areas: Pressure, Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests.
• Comparison Basis: Against predicate devices.
• Protocols: Common protocols for both devices (new and predicate).
• Clinical Data: "Clinical data for the VPAP ST-A is not required."
• Standards: Tested to appropriate FDA consensus standards and other applicable requirements, including IEC 60601-1-2:2007, IEC 60601-1:2005, and IEC 60601-1-8:2006.

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