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The Esprit and V200 Ventilators are microprocessor controlled, electrically powered, mechanical ventilators. They are 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 and V200 Ventilators are intended for use in either invasive or non-invasive applications.

The Esprit and V200 Ventilators with APRV Mode are intended for use for invasively ventilated adult and pediatric patients as prescribed by a physician

The intended use is the same as that of the predicate devices, except that the APRV Mode is for use on a subset of the patient population the original devices are cleared for (e.g. neonatal patients and non-invasive applications are excluded).

The Esprit and V200 Ventilators are microprocessor controlled, electrically powered, mechanical ventilators. This modification to the currently marketed Esprit Ventilator and V200 Ventilators is the addition of the APRV Mode.

The APRV Mode is an optional software upgrade. It is both a breath type and ventilation mode intended for invasively ventilated adult and pediatric patient populations. APRV enables the ventilator to deliver gas via an endotracheal tube or tracheostomy tube at two levels of pressure (Press High and Press Low), and allows for spontaneous or supported breathing at both levels.

The APRV Mode is activated via a software download through an I-button and is integrated into the Esprit and V200 Ventilators in the same way as other currently released software options. It can either be installed in the factory or in the field as an upgrade to existing Esprit and V200 ventilators. Downloading this option will add a "button" to the Graphical User Interface (GUI), which is used to turn APRV on and off.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Esprit Ventilator and V200 Ventilator with APRV Option.

It's important to note that the provided text is a 510(k) summary and FDA clearance letter, which typically summarizes the validation rather than detailing the full study protocols and results. As such, some specific details like exact acceptance criteria or raw performance data might not be explicitly stated in quantitative terms.

Acceptance Criteria and Reported Device Performance

The document states that "performance testing and a clinical simulation were conducted and support the assertion that the APRV Mode does not raise any new questions regarding safety and effectiveness."

Since this is a 510(k) for an addition of a mode (APRV) to existing cleared ventilators, the acceptance criteria are generally focused on demonstrating that this new mode performs as intended and does not negatively impact the overall safety and effectiveness of the existing device. The performance is assessed against the established specifications and safety profile of the predicate devices.

Study Details

Due to the nature of the provided document (510(k) summary), many of the specific details for a full study report are not present. Information below is extracted or inferred from the text.

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

   • Test Set Size: Not explicitly stated. The document mentions "performance testing and a clinical simulation." For a ventilator, performance testing typically involves bench testing on a ventilator, and a clinical simulation usually involves scenarios or mock patients rather than a large cohort of real patients.
   • Data Provenance: Not specified. Given the context of performance testing and clinical simulation, it would likely be laboratory or in-house data rather than patient data from specific countries. It's prospective in the sense that the testing was conducted on the modified device.

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

   • Not specified. For performance and clinical simulations of a ventilator, the "ground truth" would be the expected performance according to engineering specifications, physiological models, and clinical guidelines. This would typically be established by internal engineering, clinical, and regulatory experts within Respironics.

3. Adjudication Method for the Test Set:

   • Not specified. Given the nature of performance testing and clinical simulation for a medical device's functional mode, adjudication methods (like 2+1 reads) typical for diagnostic image analysis are not directly applicable. Performance is usually assessed against predefined technical and clinical thresholds.

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

   • No, an MRMC comparative effectiveness study was not explicitly mentioned or conducted as described. This type of study is more common for diagnostic imaging AI devices where human reader performance (with and without AI assistance) is being evaluated against ground truth. The current device is a ventilator with an added mode, not a diagnostic tool requiring reader interpretation in the same way. The evaluation focused on the device's functional performance and safety.

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

   • Yes, in essence. The "performance testing" and "clinical simulation" mentioned for the APRV Mode would constitute a standalone evaluation of the algorithm's (software's) performance within the ventilator system, independent of human interpretation or assistance during operation. The software's outputs (e.g., pressure, flow, volume delivery as per the APRV settings) are directly measured and compared against specifications.

6. Type of Ground Truth Used:

   • For performance testing: Engineering specifications, physiological models, and established clinical parameters for ventilation. These would define the expected output and behavior of the APRV mode under various simulated patient conditions.
   • For clinical simulation: Clinically acceptable ranges and responses as determined by medical professionals or established medical guidelines for ventilation.

7. Sample Size for the Training Set:

   • Not applicable / Not specified. This device is a software-controlled mechanical ventilator, not a machine learning or AI algorithm that 'learns' from a training dataset in the typical sense (e.g., image recognition). The "training" for such a system involves software development, coding, and internal validation against design specifications, not a dataset of examples.

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

   • Not applicable. As above, there isn't a "training set" in the sense of data used to train a machine learning model. The software's logic and behavior are designed based on established medical science, engineering principles for mechanical ventilation, regulatory requirements, and internal development methodologies. The "ground truth" during development and testing refers to what the device is designed to do and what it should achieve safely and effectively.

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The V200 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 ventilator is intended for use in either invasive or non-invasive applications.

The intended use is identical to that of the predicate the currently marketed Esprit Ventilator.

The V200 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 V200 Ventilator is intended for use in either invasive or noninvasive applications and contains the following modes of ventilation:

• . Assist/Control (A/C)
• Synchronized Intermittent Mandatory Ventilation (SIMV) .
• Continuous Positive Airway Pressure (CPAP)
• Spontaneous (Spont) .
• . Spontaneous/Timed (Spont/T)
• Apnea (Backup Mode) .

The V200 Ventilator is a hardware modification to the currently marketed Esprit that upgrades the look of the Esprit through minor changes to some of the external hardware components, as follows:

• The position of the encoder knob changed, as well as the attachment method .
• Material changes were made to the top and bottom enclosure .
• Dimensional, material, and attachment method changes were made to the bezel . assembly
• The resins and color of the Heated Filter Assembly were changed ●
• Dimensional changes were made to the Overlay, as well as positioning of the hard . keys, indicator lights, and icons

Ventilators with this updated look are sold under the brand name of the V200 Ventilator.

All electrical components, internal hardware components, firmware, and software are physically and functionally identical to those on the currently marketed Esprit Ventilator.

The V200 Ventilator technological characteristics with respect to the control mechanism, operating principle, energy type, ergonomics of the patient interface, firmware, software, environmental specifications, and performance specifications are identical to that of the currently marketed Esprit Ventilator.

The V200 ventilator contains the identical software as the currently marketed Esprit Ventilator. The software options are enabled by downloading the operational software and installing the software option. They are integrated into the V200 Ventilator in the same manner as they are on the currently marketed Esprit Ventilator. The options can be installed either in the factory or in the field as an upgrade to existing V200 Ventilators.

All available options on the Esprit cleared subsequent to the original 510(k) (K981072) are also available on the V200 Ventilator.

This 510(k) summary explains that the V200 Ventilator is a hardware modification of the already-marketed Esprit Ventilator. The submission focuses on demonstrating substantial equivalence rather than presenting new performance data against specific acceptance criteria for a novel device. Therefore, many standard elements of acceptance criteria and a study proving those criteria are not explicitly present in the provided text.

Here's a breakdown based on the information available:

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

Since the V200 Ventilator is presented as a hardware modification of an existing device (Esprit Ventilator) with identical technological characteristics, the acceptance criteria are implicitly that the V200 Ventilator performs identically to the Esprit Ventilator in all functional and safety aspects.

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 a "sample size" for a clinical test set in the traditional sense, nor does it mention data provenance (country, retrospective/prospective). This is because the submission primarily relies on demonstrating that the hardware modifications did not alter the performance of the existing, cleared device. The testing mentioned in "Substantial Equivalence/Performance Testing" relates to engineering and regulatory compliance testing rather than clinical performance testing with patient data.

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 submission concerns hardware changes to a medical device, not a diagnostic algorithm that requires expert ground truth for a test set.

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

Not applicable. This submission concerns hardware changes to a medical device, not a diagnostic algorithm that requires expert adjudication for a test set.

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. The V200 Ventilator is a mechanical ventilator, not an AI-assisted diagnostic tool.

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

Not applicable. The V200 Ventilator is a mechanical ventilator, not an algorithm.

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

Not applicable in the typical sense for a diagnostic device. For the V200 Ventilator, "ground truth" likely refers to the established performance specifications and safety profile of the predicate Esprit Ventilator. The "study" (testing) aims to show that the V200 maintains this "ground truth" and that the hardware changes did not introduce deviations.

8. The sample size for the training set:

Not applicable. The V200 Ventilator is a mechanical ventilator with identical firmware and software to its predicate. There is no mention of a "training set" as would be relevant for machine learning algorithms.

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

Not applicable, as there is no mention of a training set.

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