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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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The ESPRIT 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 ESPRIT Ventilator is intended for use in either invasive or noninvasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically adjusts I-Triggers and E-Cycles breathing without the need for user adjustment of I-trigger (sensitivity) and E-cycle thresholds under changing leak conditions. The Auto-Trak option provides leak-compensated ventilation for leaks up to 60L/min.

The Respironics Esprit Ventilator is unchanged from K072450. The only change is to include the Respironics Performax Youth SE mask as an 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 SE Total Face Mask (K072588). 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 SE mask was designed to meet the 90" percentile for pediatrics age 7 and older and > 40 lbs.

The provided text describes a Special 510(k) submission for the Esprit Ventilator, primarily focusing on adding the Respironics Performax Youth SE mask as an option. As such, the study described is a compatibility test rather than a typical clinical performance study for an AI-powered device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "mask compatibility testing was performed. This testing included pressure performance, waveform performance, triggering, cycling and alarm functionality testing. All tests were verified to meet the required acceptance criteria." However, the specific quantitative acceptance criteria or detailed numerical performance results are not provided in this document excerpt.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document indicates "mask compatibility testing was performed" but does not specify the sample size (e.g., number of test sessions, number of masks tested, duration of tests).
• Data Provenance: The testing was "performed" by Respironics, Inc. ("This testing is provided in Tab 8 of this submission"). This implies the data is prospective and generated specifically for this submission, likely within a controlled lab or testing environment. The country of origin of the data is not explicitly stated beyond Respironics being based in the US (Monroeville, Pennsylvania).

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

This information is not applicable in this context. The study is a compatibility test for a medical device (ventilator and mask), not an AI diagnostic tool requiring expert interpretation to establish ground truth for a test set. The "ground truth" here would be the established functional specifications and performance characteristics of the ventilator and mask system, evaluated against engineering and physiological standards.

4. Adjudication Method for the Test Set

This information is not applicable. Since it's a compatibility test, not an expert-based diagnostic study, there's no need for adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC study was not done. This submission is for a ventilator and mask, not an AI system where human readers would interpret results.

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

No, this is not an AI algorithm. The device, the Esprit Ventilator, is a "microprocessor controlled, electrically powered, mechanical ventilator." The "Auto-Trak option" automatically adjusts parameters, which involves an algorithm, but the study described is about the physical compatibility of a new mask with the existing ventilator, not a performance study of the Auto-Trak algorithm itself.

7. The Type of Ground Truth Used

The ground truth used for this compatibility testing would be the engineering specifications, recognized standards, and physiological performance requirements for a ventilator and its compatible components (like a mask). The verification would be against these predefined technical and performance standards, not against "expert consensus, pathology, or outcomes data" in the typical sense of diagnostic AI studies. The statement "All tests were verified to meet the required acceptance criteria" implies testing against these pre-established standards.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI model requiring a training set.

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

This information is not applicable. This is not an AI model requiring a training set with established ground truth.

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