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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 S-A is indicated to provide noninvasive ventilation for patients weighing more than 30 lbs (13 kg) with respiratory insufficiency such as that associated with hypercapnic Chronic Obstructive Pulmonary Disease (COPD) or obstructive sleep apnea (OSA). The VPAP S-A is intended for home and hospital use.

VPAP S-A System (VPAP S-A with H5i) is similar to the predicate device, using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is the Same as the S9 VPAP ST-A (K113288) 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 caused by COPD. The system comprises the flow generator, patient interface), alarm functions and integrated humidifier. Therapy modes contained in the VPAP S-A are CPAP and Spontaneous. Therapy modes come from the S9 VPAP ST-A (K113288) and remain unchanged.

The provided document for K122324, the VPAP S-A, is a 510(k) summary for a non-life-supporting continuous ventilator. It primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than reporting on a clinical study with detailed acceptance criteria and performance metrics for a specific algorithm or AI component.

Therefore, many of the requested sections below cannot be fully completed based on the provided text, as the submission relies on bench testing and similarity to a predicate device, not a novel AI/algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All bench tests confirmed the product met the predetermined acceptance criteria." However, it does not provide a table with specific acceptance criteria values and corresponding reported device performance values. It lists the types of tests conducted.

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

The document explicitly states: "Clinical data for the VPAP S-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 activities."

Therefore, there isn't a "test set" in the sense of a patient dataset for evaluating an algorithm's performance. The testing involved bench tests with patient simulation models. The sample size for these simulation models is not specified, nor is the provenance directly applicable.

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

Not applicable. As no clinical test set using human data was employed, there was no need for experts to establish ground truth in the context of diagnostic accuracy. The "ground truth" for the bench tests would be the known, controlled parameters of the simulation models.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set.

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

No MRMC study was performed or reported. This submission focused on substantial equivalence through bench testing to a predicate device, not on improving human reader performance with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The device is a medical device (ventilator), not a diagnostic algorithm. Its performance is evaluated through its functional capabilities, and those were assessed via bench testing in a standalone manner (device performance alone) against predetermined engineering criteria and compliance with standards. It does not involve "algorithm only" performance in the context of an AI/ML diagnostic tool.

7. The Type of Ground Truth Used

The ground truth used for the bench testing was the known, controlled parameters of the validated patient simulation models and the specifications outlined in the relevant IEC standards (e.g., IEC 60601-1-2, IEC 60601-1, IEC 60601-1-8). The device's outputs (Pressure, Flow, etc.) were compared against these known simulation parameters and standard requirements.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its functionality is based on established engineering principles and control systems.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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