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

The IntelliTrak option provides new triggering and cycling functionality that is intended for use only with adult and pediatric patients in invasive applications.

The V200 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. The IntelliTrak Software Option will add a new triggering and cycling mechanism based on the equation of motion for the purpose of improving patient-ventilator synchrony. The IntelliTrak software option is activated and is integrated into the V200 in the same way as other currently marketed V200 software options. It can either be installed in the factory or in the field as an upgrade to existing V200 ventilators. The IntelliTrak option is added to the currently commercially released software version and instrument. Downloading this option will add a "button" to the Graphical User Interface (GUI), which is used to turn IntelliTrak on and off.

The provided text describes a 510(k) premarket notification for a modification to a ventilator device, the V200 Ventilator with IntelliTrak Option. The submission focuses on demonstrating substantial equivalence to a predicate device (the unmodified V200 Ventilator) based on bench performance testing and software verification/validation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

The document doesn't explicitly list a table of acceptance criteria with specific numerical targets. Instead, it states that "bench performance testing was performed for the new option and performance was compared between the Respironics V200 with flow triggering set at 3 LPM and cycling set at 25% of peak flow and the Respironics V200 IntelliTrak option." This implies the acceptance criterion was that the IntelliTrak option performs comparably or acceptably in a bench setting to the predicate device's specified settings.

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

The document mentions "bench performance testing" but does not specify the sample size of these tests (e.g., number of test scenarios, duration of tests, number of physical devices tested). The provenance is implied to be internal testing ("Respironics California, Inc, policies and procedures") and is retrospective as it's part of a 510(k) submission showing the device meets certain standards before market approval. There is no information on the country of origin of the data beyond the company's location (Carlsbad, CA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not mention the use of experts to establish ground truth for the bench performance testing. The "ground truth" for this type of device modification would likely be the expected mechanical and physiological responses simulated during the bench tests, as defined by engineering specifications and potentially clinical guidelines.

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

There is no mention of an adjudication method, as the testing described is bench performance testing, not human-in-the-loop evaluation requiring expert consensus.

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 MRMC comparative effectiveness study was done or mentioned. This is a ventilator modification, not an imaging or diagnostic AI tool that would typically involve human "readers." The focus is on the device's operational performance.

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

The performance testing described is inherently "standalone" in the sense that it's testing the device's (or its software's) mechanical triggering and cycling functionality on a bench. There is no human intervention mentioned as part of the primary performance evaluation. The IntelliTrak option is an algorithm that modifies how the ventilator triggers and cycles breaths.

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

The "ground truth" implicitly used for the bench performance testing would be the expected and established mechanical and physiological responses of a ventilator under controlled conditions, based on engineering specifications and potentially industry standards for ventilator performance. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

The document does not mention a "training set." The IntelliTrak option is described as a software feature that provides new triggering and cycling functionality based on the "equation of motion." This suggests it's likely a model-based control algorithm rather than a machine learning algorithm that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established:
As no training set is mentioned or implied, this question is not applicable based on the provided text. The "ground truth" for the development of such an algorithm would be the principles of respiratory mechanics and the "equation of motion," which are established scientific and engineering principles.

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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 V60 ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with spontaneous respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

The Ventilator is intended to support pediatric patients weighing 20kg (44 lbs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The Ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.

The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories.

The V60™ ventilator is a microprocessor controlled positive pressure ventilatory assist system incorporating a user interface with multifunction keys, real-time graphic displays, and integral patient and system alarms. The ventilator provides noninvasive and invasive ventilatory support for spontaneously breathing adult and pediatric patients.

The provided text describes a 510(k) submission for the Respironics V60 Ventilator. The summary states that "Bench performance testing was performed comparing the new V60 and the predicate devices, and was found to be substantially equivalent." and "Performance testing and human factors testing demonstrate that the device is as safe, as effective and performs as well as or better than the predicate device."

However, the document does not provide specific acceptance criteria, reported device performance metrics, detailed study designs, sample sizes, information on ground truth establishment, or any details about multi-reader multi-case (MRMC) comparative effectiveness studies.

Therefore, I cannot populate the table or answer most of the questions based on the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through general performance and human factors testing, rather than presenting a detailed clinical study with quantitative acceptance criteria.

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

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 mentions "Bench performance testing" and "human factors testing" but does not specify sample sizes for any test sets, nor does it provide details about data provenance (e.g., country of origin, retrospective or prospective nature).

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 specified in the provided text. The document does not describe the establishment of a "ground truth" using experts for the performance testing.

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

Not specified in the provided text.

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 MRMC study is mentioned. The device is a ventilator, and the testing described is performance and human factors testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

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

This question is not applicable in the context of a ventilator. The described "Performance testing" is inherently standalone in the sense that it tests the device's functionality.

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

The concept of "ground truth" as typically defined for diagnostic AI studies using expert consensus or pathology is not applicable to the performance testing of a ventilator as described in this document. The "ground truth" for a ventilator's performance would be engineering specifications and established physiological parameters it is designed to achieve.

8. The sample size for the training set

Not applicable. The document describes a medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. The document describes a medical device, not an AI/ML algorithm that requires 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 useradjustment 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 ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.

Here's a breakdown of the acceptance criteria and study information for the Respironics Esprit Ventilator Auto-Trak Sensitivity Option, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The document presents software testing results and performance testing results. The acceptance criteria for the software tests appear to be a simple "Pass/Fail" determination, where all listed parameters must pass. The performance testing section mentions a clinical trial for Auto-Trak performance and evaluation of other parameters, but it doesn't explicitly state quantitative acceptance criteria for these. The overall conclusion for the clinical investigation is qualitative: "at least equivalent performance and patient preference and no increase in adverse events over the predicate device."

Study Information

Due to the nature of the 510(k) summary, specific details about sample size for test and training sets, and expert qualifications are limited.

1. Sample Size and Data Provenance (Test Set):

   • Sample Size: The document does not explicitly state the sample size (number of patients) for the clinical trial. It refers to "the proportion of subjects."
   • Data Provenance: Not specified, but generally, clinical trials submitted for U.S. FDA 510(k) clearance are often conducted in the U.S. or international sites adhering to GCP. The document does not specify if the data was retrospective or prospective, but clinical investigation implies prospective.

2. Number of Experts and Qualifications (Ground Truth for Test Set):

   • The document does not provide information on the number or qualifications of experts used to establish the ground truth for the clinical trial.

3. Adjudication Method (Test Set):

   • The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical trial data.

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

   • No, an MRMC study was not explicitly described as such. The clinical investigation was a comparison between the "Auto-Trak (test)" and "Flow Triggering (control)" treatment groups to show equivalence. This is more of a comparative clinical trial of two device functionalities rather than an MRMC study assessing human reader improvement with AI assistance.
   • Effect Size: Not applicable, as an MRMC study was not described. The study aimed for equivalence rather than an effect size of human improvement with AI.

5. Standalone Performance (Algorithm Only without Human-in-the-loop):

   • Yes, a standalone study was done in the form of "Software testing" and "Performance Testing Results" tables (Table 1 and Table 2). These tests evaluated the device's algorithmic and mechanical functions independently of direct human interaction with the real-time AI. The "Auto-Trak Sensitivity option automatically triggers and cycles breathing without the need for user-adjustment of I-trigger (sensitivity) and E-cycle thresholds," which indicates its autonomous operation in those aspects.

6. Type of Ground Truth Used:

   • For the Software Testing and Performance Testing Results (mechanical parameters): The ground truth was based on pre-defined engineering and software specifications, and measured directly from the device's output against expected values (e.g., accuracy of flow-triggered breaths, bias flow).
   • For the Clinical Investigation: The ground truth for efficacy would be patient breathing patterns, comfort levels, and ventilator performance metrics (triggering, cycling). The ground truth for safety would be the occurrence and rate of adverse events. These would be derived from clinical observations and patient outcomes.

7. Sample Size for Training Set:

   • The document does not provide any information on the sample size used for the training set (if any explicit machine learning 'training' was involved beyond deterministic algorithm development). The "Auto-Trak" option likely relies on rule-based algorithms or pre-programmed logic derived from extensive engineering and physiological knowledge, rather than a machine learning model trained on a large dataset in the modern sense.

8. How Ground Truth for Training Set Was Established:

   • As with the training set size, the document does not describe how ground truth was established for a training set. Given the context of a 2007 510(k) for a ventilator option, it's highly probable that the "training" involved:
     • Physiological models and simulations: Using established respiratory mechanics and patient models to design and refine the algorithms for triggering and cycling.
     • Bench testing & phantom lungs: Extensive testing with artificial lungs and leak generators to validate the algorithms' responses across various scenarios.
     • Clinical experience and expert input: The design of the algorithms would have incorporated extensive knowledge from respiratory therapists and physicians on effective ventilation strategies and patient interaction.

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The ESPRIT ventilatory 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 Speaking Mode software option allows tracheostomized adult and pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve.

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 and pediatric patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications. The Speaking Mode software option allows tracheostomized adult and pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve.

The provided document, K071212, describes the Esprit Ventilator Speaking Mode Option. It outlines the device's indications for use and demonstrates substantial equivalence to a predicate device through performance testing.

Here's the requested information structured around acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a table titled "Substantial equivalence was established by performance testing. The Table describing the performance testing follows:". This table outlines specific parameters and their purpose, with all outcomes reported as "Pass." This indicates that the device met the pre-defined acceptance criteria for each tested parameter.

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

The document does not explicitly state the sample size used for the performance testing. The provenance of the data is not specified (e.g., country of origin, retrospective or prospective). The testing appears to be a series of functional and alarm verification tests performed on the device itself, rather than a clinical study with patient data.

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

The document does not mention the use of experts to establish a "ground truth" for the test set, as the testing described focuses on functional aspects and alarm performance of the device's software option rather than subjective interpretation of medical data. The "Pass" results likely reflect objective verification against a documented set of design specifications or engineering requirements.

4. Adjudication Method for the Test Set

No adjudication method is described. Given the nature of the tests (functional verification of software and hardware interaction), results would likely be directly observable and measurable against specifications, without the need for expert adjudication.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described in this document. The focus is on the substantial equivalence of a new software feature for an existing ventilator, not on the comparative effectiveness of human readers with or without AI assistance. Therefore, no effect size for human reader improvement with AI is applicable or stated.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the performance testing described appears to be a standalone assessment of the Esprit Ventilator's Speaking Mode Option. The tests verify the algorithm's functional behavior, alarm performance, and interaction with the ventilator's existing systems, without explicit human-in-the-loop performance evaluation beyond potentially operating the device during testing.

7. The Type of Ground Truth Used

The "ground truth" for the described performance testing appears to be the device's functional specifications, design requirements, and intended operational behavior. The tests confirm that the ventilator's Speaking Mode Option operates as designed and meets the established safety and performance parameters. This is not
expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This document does not describe a training set. The "Speaking Mode Option" is a software feature for an existing ventilator, and the testing outlined is a verification of its functionality and integration, not an algorithm developed using machine learning or data-driven training.

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

As no training set is described or implied by the document, the establishment of ground truth for a training set is not applicable.

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The intended use of the Esprit Ventilator Neonatal Option is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes intubated neonatal patients with an ideal body weight range from 0.5 kg to 6.5 kg and an endotracheal tube I.D. range from 2.5 – 4.0 mm.

The Neonatal Option is a software modification to the currently marketed Esprit Ventilator. Once the software is enabled and the neonatal patient type is selected on the Esprit, it provides the following types of ventilatory support to neonatal patients in invasive applications only: Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CPAP) modes of ventilation. Pressure-Controlled (PC). Available in A/C and SIMV. Pressure Support (PS). Available in SIMV and SPONT. Apnea Ventilation

The provided text describes a software modification to the Esprit Ventilator, called the "Neonatal Option," but it does not contain acceptance criteria or a study proving that the device meets specific acceptance criteria in the format requested.

The document is a 510(k) summary for a medical device modification, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria.

Here's an breakdown of what is and isn't available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Comment: The document states that "performance testing was successfully completed" and "all design and system level requirements...have been met," but it does not explicitly list what those acceptance criteria (e.g., specific metrics like accuracy, precision, or reliability thresholds) were, nor does it provide the quantitative results of the performance testing against such criteria. It's a high-level statement of success.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The testing described is "Software verification and validation testing," implying internal testing rather than clinical study data from a specific country or retrospective/prospective collection.

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

• Number of Experts: Not applicable. The document is about a ventilator's software modification, not an AI or diagnostic device that typically requires expert-established ground truth from medical images or clinical observations.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This type of testing (software verification and validation for a ventilator) does not typically involve expert adjudication of results in the way an AI diagnostic tool would.

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

• MRMC Study: No. This document does not describe an MRMC study. The device is a ventilator, not an imaging or diagnostic AI tool that would typically involve human readers.
• Effect Size of Human Readers: Not applicable.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: Yes, indirectly. The "Software verification and validation testing" is conducted on the device's software algorithms to ensure they meet design and system-level requirements. This inherently refers to the algorithm's performance in controlling ventilation parameters. However, specific metrics or a detailed standalone performance study report are not provided. The phrase "Breath delivery is controlled by software algorithms that are equivalent to those used on the currently marketed Respironics Esprit ventilator" suggests that the technical characteristics and performance of these algorithms were deemed equivalent to a previously cleared device.

7. Type of Ground Truth Used:

• Type of Ground Truth: "Design and system level requirements." For a ventilator, ground truth would typically be established based on engineering specifications, physiological models, and regulatory standards for delivering specific pressure, volume, and flow characteristics accurately and safely. It would not typically be pathology, expert consensus on images, or outcomes data in the way an AI diagnostic device would.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is a software modification for a ventilator, not a machine learning or AI model trained on a data set.

9. How Ground Truth for Training Set was Established:

• How Ground Truth was Established: Not applicable, as there is no training set in the context of an AI model for this device.

Summary of what the document does provide regarding performance:

• It states that the Neonatal Option is a software modification to an existing ventilator.
• It claims the addition does not result in the use of any new technological characteristics.
• It explicitly states: "Breath delivery is controlled by software algorithms that are equivalent to those used on the currently marketed Respironics Esprit ventilator."
• It indicates that "Software verification and validation testing was performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998)."
• It concludes that "Performance testing was successfully completed demonstrating that all design and system level requirements for the Esprit Ventilator with Neonatal Option have been met."
• The primary method for determining substantial equivalence relies on the similarity of performance characteristics, intended use, and patient populations to predicate devices, implying that the performance meets expectations set by already approved devices.

In essence, the document serves as a regulatory submission arguing for substantial equivalence based on the software's adherence to established design requirements and equivalency to existing technology, rather than detailing a specific experimental study with statistical results against explicit numerical acceptance criteria.

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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 to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.

The NICO-Esprit Interface is a software upgrade to the Esprit Ventilator, which allows the bi-directional communication of the devices to facilitate the transfer of NICO parameters to the Esprit Ventilator as well as the transfer of a patient's breath type information and FiO2 from the Esprit to the NICO Monitor.

The provided text describes a Special 510(k) for a device modification: the Esprit Ventilator with the NICO-Esprit Interface. This application focuses on demonstrating substantial equivalence to already marketed predicate devices, particularly regarding safety and effectiveness, for a software upgrade that allows bi-directional communication between the Esprit Ventilator and the NICO Monitor.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:
   The document does not specify a sample size for a test set or data provenance in the context of clinical performance or accuracy. The testing described is primarily focused on safety and software validation rather than a clinical performance study with patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided. The document describes engineering and software validation, not a study involving expert-established ground truth for patient data or diagnoses.

3. Adjudication method for the test set:
   This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed here.

4. 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 comparative effectiveness study was not done. The device modification is a software upgrade for ventilator communication, not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The provided text describes "Software validation testing," which evaluates the algorithm's performance against its design and system requirements. This could be interpreted as a form of "standalone" evaluation of the software's functionality and correctness, but it's not a standalone clinical performance study in the way it might be for a diagnostic AI algorithm. The device itself (ventilator) is always used with human-in-the-loop operation by medical personnel.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the safety and software validation, the "ground truth" would be the defined engineering specifications, regulatory standards (like IEC 60601-1-2, UL 2601), and the FDA's software guidance (1998). The software was validated to ensure it met these predetermined requirements, not against clinical outcomes or expert consensus on patient data.

7. The sample size for the training set:
   This information is not applicable/provided. The document describes a software upgrade for an existing medical device, not a machine learning or AI model that typically requires a training set. The validation performed seems to be traditional software testing against defined requirements.

8. How the ground truth for the training set was established:
   This information is not applicable/provided as there is no mention of a training set for an AI model.

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The intended use of the PLV Continuum II ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 lbs). The PLV Continuum II ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.

The PLV Continuum ventilator is a microprocessor controlled, compressor-based, ventilator that provides ventilatory support by delivering room air to the patient. PLV Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software. The PLV Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings. The PLV Continuum is capable of providing the following types of ventilatory support:

• Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece).
• Assist Control, Synchronized Intermittent Mandatory Ventilation (SIMV) or Spontaneous Pressure (CPAP) modes of ventilation.
• Volume-Controlled (VC). Available in A/C and SIMV.
• Pressure-Controlled (PC). Available in A/C and SIMV.
• Pressure Support (PS). Available in SIMV and SPONT.

The provided document is a 510(k) Premarket Notification for a modification to the PLV Continuum Ventilator, now referred to as the PLV Continuum II Ventilator. This document concerns a medical device (ventilator) and its regulatory approval process, rather than a clinical study evaluating an AI/ML powered device. As such, many of the requested fields (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of submission.

The document primarily focuses on establishing substantial equivalence to predicate devices rather than proving the performance against specific acceptance criteria in the context of an AI/ML algorithm.

However, I can extract information related to the performance testing conducted for the device.

Here's a summary of the information that can be extracted, with notes for the fields that are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as a series of performance tests, rather than a single clinical study.

• Study Name/Description: "Summary of Performance Testing" (Section 16.5)
• Study Objective: To demonstrate that all design and system requirements for the modified PLV Continuum have been met and to support substantial equivalence to predicate devices.
• Key Finding: "The results of all testing demonstrate that all design and system requirements for the modified PLV Continuum have been met." (Section 16.5) and "The technological characteristics of the modified PLV Continuum ventilator and the results of the performance testing do not raise new questions of safety and effectiveness when compared to the legally marketed predicate devices." (Section 16.6)

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

• Not Applicable. This is a hardware/software medical device modification submission, not an AI/ML study with a distinct "test set" of patient data. The "testing" refers to engineering and regulatory compliance testing of the device itself.

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. Ground truth, in the context of patient data adjudicated by experts, is not relevant to this type of device submission. Performance was assessed against engineering standards and specifications.

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

• Not Applicable. See point 3.

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-powered device, nor is it a diagnostic device being evaluated with human readers.

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

• Not Applicable. While the device is microprocessor-controlled with software algorithms, the "standalone" performance requested typically refers to the performance of an AI algorithm in isolation from a human user, which is not the subject of this document. The device's performance was evaluated as a complete system.

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

• Not Applicable as traditionally defined for AI/ML studies. The "ground truth" here is adherence to engineering specifications and regulatory standards (e.g., flow rates, pressure delivery, safety alarms, EMC compliance).

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm development described in this document. The software algorithms are described as "equivalent to those used on the currently marketed Respironics PLV Continuum ventilator (K022750)".

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

• Not Applicable. See point 8.

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The intended use of the PLV Continuum ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 lbs). The PLV Continuum ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.

The PLV Continuum ventilator is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PLV Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PLV Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PLV Continuum is capable of providing the following types of ventilatory support:

• Positive Pressure Ventilation, delivered either invasively (via endotracheal or . tracheostomy tube) or non-invasively (via mask or mouthpiece).
• Assist/Control. Spontaneous Intermittent Mandatory Ventilation (SIMV) or . Continuous Positive Airway Pressure (CPAP) modes of ventilation.
• Volume-Controlled (VC). Available in A/C and SIMV. .
• Pressure-Controlled (PC). Available in A/C and SIMV. .
• Pressure Support (PS). Available in SIMV and SPONT. ●

Here's an analysis of the provided text regarding the acceptance criteria and study for the PLV Continuum Ventilator:

Acceptance Criteria and Device Performance for PLV Continuum Ventilator

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the results "demonstrate that all design and system requirements...have been met," implying successful adherence to the standards. Specific numerical performance data against acceptance thresholds from ASTM F 1100-90 and F 1246-91 are not explicitly detailed in this summary.

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

The provided summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The document refers to "Performance testing," "EMC testing," "Electrical, mechanical and environmental testing," and "Software validation testing" as being conducted, but typical details like the number of devices tested, number of patients, or specific test scenarios are not included in this high-level summary.

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

This information is not provided in the summary. Performance testing for a ventilator typically involves engineering and functional tests against specifications, rather than expert-established ground truth in the same way a diagnostic imaging AI might.

4. Adjudication Method for the Test Set

This information is not applicable or provided. The document describes performance testing against established standards and guidance, not an adjudication process of expert opinions.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic AI devices where human readers interpret medical images or data. The PLV Continuum Ventilator is a mechanical ventilator, and its evaluation focuses on its functional performance, safety, and equivalence to predicate devices, not on human-in-the-loop diagnostic accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Given that the device is a mechanical ventilator, the "standalone" performance would encompass the various performance tests mentioned (e.g., breath delivery accuracy, alarm functionality, power consumption) without direct human intervention in its core mechanical operation. The summary states: "Breath delivery is controlled by software algorithms." This implies algorithmic function is evaluated as part of the overall device performance. However, there isn't a separate "algorithm only" study specifically described as it would be for an AI diagnostic device. The performance testing evaluates the device's functions, which are driven by its algorithms.

7. The Type of Ground Truth Used

The "ground truth" for the PLV Continuum Ventilator's performance testing is based on established engineering standards and regulatory guidance. This includes:

• ASTM F 1100-90 and F 1246-91: These are standards for ventilators, providing the criteria against which the device's mechanical and functional performance (e.g., volume delivery, pressure control, alarm thresholds) would be measured.
• FDA Draft Reviewer Guidance for Premarket Notification Submissions (1993): This guidance dictates the requirements for electrical, mechanical, and environmental testing.
• FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998): This guidance sets the "ground truth" for software validation.

Essentially, the "ground truth" is defined by compliance with these recognized safety and performance standards for medical devices.

8. The Sample Size for the Training Set

The concept of a "training set" is usually applicable to machine learning or AI models that learn from data. The PLV Continuum Ventilator is described as a "microprocessor controlled" device with "software algorithms" that are "equivalent to those used on the currently marketed Respironics Esprit ventilator." This suggests that the software algorithms were developed based on established engineering principles for ventilator function, possibly iteratively tested and refined, rather than being "trained" on a large dataset in the sense of a deep learning model. Therefore, a "training set" in the context of an AI model driven by data is not explicitly mentioned or directly applicable here.

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

As the device relies on established software algorithms and engineering principles rather than a data-driven AI model, the concept of a "training set" with established ground truth as it applies to AI/ML is not relevant here. The ground truth for the development of such a device's software would stem from physiological requirements for ventilation, mechanical engineering principles, and the performance characteristics of predicate devices, which were then codified into algorithms. The testing described then verifies that these algorithms, as implemented in the device, meet the specified performance and safety requirements.

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