Search Results

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.

Ask a specific question about this device

The small size AF531 SE Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.

The Respironics AF531 SE Full Face Mask consists of a silicone cushion, polycarbonate faceplate with a standard elbow with no exhalation, requiring the use of a separate exhalation device. This mask is an accessory for use with ventilators in the hospital/institutional environment only. The small size AF531 SE Full Face Mask will be used on patients 7 years or older (> 40 lbs/20kg).

The Respironics AF531 SE Full Face Mask is a medical device for noninvasive ventilation. The provided text describes its acceptance criteria and the study conducted to prove it meets them.

1. Acceptance Criteria and Device Performance

• Waveform Performance: Not explicitly detailed, but implied to be compliant with ventilation requirements.
• Triggering, Cycling, and Alarm Functionality: Implied to be compatible and functioning correctly with ventilators.
• Safety and Effectiveness: No new issues of safety or effectiveness identified. |
  | Material/Design | Silicone cushion, polycarbonate faceplate, standard elbow (requiring separate exhalation device), uses Four Points Headgear design (CapStrap headgear also compatible). |
  | Usage | Single use only. |

Reported Device Performance:
The document states: "The modified device has been performance tested with passing results. Test protocols including pressure performance, waveform performance, triggering, cycling and alarm functionality testing along with the results of these tests are provided in Tab 8 of this submission." And, "The small size AF531 SE Full Face Mask was performance tested and verified to meet the required acceptance criteria. Results of this testing concluded that the verification testing raises no new issues of safety or effectiveness."

2. Sample Size and Data Provenance

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described appears to be technical bench testing of the device's physical and functional properties rather than clinical data from human subjects.

3. Number and Qualifications of Experts for Ground Truth

This information is not provided in the document. Given that the testing focuses on the device's physical and functional performance (pressure, waveform, triggering, etc.), it's likely that engineers and technical experts in ventilation equipment would have been involved, rather than medical experts establishing ground truth for diagnostic accuracy.

4. Adjudication Method

The document does not specify any adjudication method for a test set. This type of method is typically used in studies involving subjective interpretation (e.g., image analysis for diagnosis), which is not the nature of the described testing for this device.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted involving human readers with or without AI assistance. This type of study is not relevant to the evaluation of a face mask for non-invasive ventilation.

6. Standalone Algorithm Performance

This device is a physical medical device (a face mask), not an algorithm or AI system. Therefore, the concept of a "standalone (i.e., algorithm only without human-in-the-loop performance)" study is not applicable.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by technical specifications and functional output (e.g., measured pressure, waveform characteristics, appropriate triggering/cycling, alarm functionality) as per engineering and regulatory standards for ventilator accessories. It is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on whether the device meets its defined technical performance parameters.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or AI algorithm development. Since this is a physical medical device and not an AI system, there is no training set in the conventional sense. The "training" for such devices involves design, prototyping, and iterative testing to ensure it meets specifications.

9. How Ground Truth for the Training Set was Established

As there is no "training set" for this physical device, the question of how its ground truth was established is not applicable. The design and development process for such a device relies on engineering principles, material science, and established standards for medical device safety and performance.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Esprit Ventilator with VCV Demand Flow Option 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 VCV Demand Flow Option is a software option for the currently marketed Esprit Ventilator. It represents an enhancement intended to provide additional flow/volume to patients when operator settings do not satisfy patient demand. VCV Demand Flow is available only in volume controlled mandatory and assist breaths. Once the software is enabled, the VCV Demand Flow feature is always available.

The provided text describes a 510(k) submission for a device modification (VCV Demand Flow Option) to an existing Esprit Ventilator. The document focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, comprehensive performance metrics, or the specific study design typically associated with a complete clinical trial or a full standalone performance evaluation of a new device.

Therefore, many of the requested categories cannot be fully answered based on the provided text. However, I will extract all available information that aligns with your request.

Acceptance Criteria and Device Performance (Limited Information Available)

The document states: "The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met." However, it does not provide a table of specific acceptance criteria (e.g., specific thresholds for flow rate accuracy, response time, etc.) nor does it report detailed device performance against such criteria. The focus is on demonstrating that the new software option for demand flow provides additional flow/volume when operator settings do not satisfy patient demand, and that this does not raise new questions of safety and effectiveness.

Study Details (Limited Information Available)

1. 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 "Software validation testing was performed," but does not specify a sample size for a test set, nor does it provide information on data provenance (country of origin, retrospective/prospective). This typically refers to patient data, which is not mentioned in the context of this software modification.

2. 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):

   • This information is not provided. The testing described appears to be software verification and validation, not a study involving expert-adjudicated ground truth on patient data.

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

   • This information is not provided, as the study described is not a clinical or image-based adjudication study.

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 MRMC comparative effectiveness study is mentioned. The device is a ventilator, not an AI diagnostic tool primarily evaluated by human readers.

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

   • The document implies standalone testing of the software modification ("Software validation testing was performed... The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met."). However, it does not isolate "algorithm only" performance from the overall system performance, nor does it quantify it explicitly. The VCV Demand Flow option is a software feature that enhances the ventilator's automatic response.

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

   • The concept of "ground truth" (in the sense of clinical accuracy against a definitive reference standard) is not explicitly discussed for this type of software modification. The ground truth for software validation would be defined by the design requirements and specifications themselves, against which the software's functionality is tested.

7. The sample size for the training set:

   • Not applicable. The document describes a software modification to an existing ventilator, not a machine learning or AI model trained on a dataset.

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

   • Not applicable, as there is no mention of a training set for a machine learning model.

Summary of Study Information Available in the Document:

The study described is primarily software verification and validation testing.

• Objective: To demonstrate that the VCV Demand Flow option, a software enhancement, meets all design and system requirements and does not raise new questions of safety and effectiveness compared to predicate devices.
• Methodology: "Software validation testing was performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998)."
• Outcome: "The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met." and "The technological characteristics... and the results of the performance testing do not raise new questions of safety and effectiveness."

This submission is a "Special 510(k): Device Modification," which typically focuses on demonstrating that the changes do not adversely affect safety or effectiveness, often through engineering analysis and in-house testing rather than extensive clinical trials or complex AI performance studies with broad datasets and expert adjudication.

Ask a specific question about this device

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.

Esprit Respiratory Mechanics is a diagnostic tool that enables a clinician to take dynamic and static measurements of a patient's lung parameters. The following maneuvers can be performed using Esprit Respiratory Mechanics: Vital Capacity, Maximum Inspiratory Pressure, PO.1 (Pressure change after the first 100 milliseconds of inspiratory effort), Static Compliance and Resistance. These tools are used by clinicians to monitor a patient's respiratory status and are displayed on the Esprit User Interface both graphically and in text format. Respiratory Mechanics also calculates the following: Ti/Ttot, Peak Lung Flow, Dynamic Compliance and Resistance.

The provided text is a 510(k) summary for the Esprit Ventilator with Respiratory Mechanics. It does not contain information about the acceptance criteria and study details for an AI/ML powered device as requested in the input.

Therefore, I cannot fulfill the request using the provided text. The document describes a traditional medical device modification and its substantial equivalence to predicate devices, without any mention of AI or machine learning, or performance metrics against specific acceptance criteria for such technologies.

Ask a specific question about this device

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 ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. The specific features of the product include:

• . Breathing system under microprocessor control.
• · User interface under microprocessor control. Uses "hyman interface" features associated with touch screen and graphical user interface technology. The specifics of the particular touch screen technology and its suitability to medical applications is covered in more detail in the principle of operation section.
• · Integral air source is built into the ventilator, eliminating the requirement for a central compressor and piped, medical grade wall air and/or an individual, stand alone compressor for each ventilator. The product will also be offered in a configuration without the blower in which case it will operate from a wall air supply.
• · Ability to provide variable oxygen concentrations (21% to 100% O2) from a 35 to 80 PSIG medical grade, oxygen gas source, including medical grade gas cylinders with suitable regulators.
• · Ability to operate on a re-chargeable primary battery for 30 minutes (nominal).
• · Ability to be powered by a secondary DC power source (24 VDC) for up to 3 hours.
• · Provide high product quality and reliability. ESPRIT has been designed using Highly Accelerated Life Testing (HALT), coupled with Environment Stress Screening (ESS) during manufacturing. Studies have shown that these techniques greatly eliminate reliability problems and are integral to the reliability of the product.

The Esprit Critical Care Ventilator (K981072) demonstrates substantial equivalence to predicate devices through a series of environmental and performance tests. The provided documentation does not detail specific acceptance criteria in numerical thresholds for clinical performance or any associated study proving the device meets those criteria with statistical significance. Instead, the focus is on engineering performance and safety standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on complying with various environmental and electrical safety standards, as well as meeting performance characteristics comparable to legally marketed predicate devices. The document does not provide specific numerical performance metrics but asserts that the device meets the requirements of the referenced standards and produces the flows and pressures detailed in the comparative analysis.

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

The document describes environmental and lab testing for the device. It does not refer to a "test set" in the context of patient data or clinical trials for evaluating diagnostic or predictive performance. The testing appears to be primarily engineering validation. Therefore, information on sample size for a test set, data provenance (country of origin, retrospective/prospective), is not applicable in the typical sense for AI/diagnostic devices. The testing is likely conducted on various units of the Esprit ventilator itself to ensure adherence to specified standards.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the studies described are engineering and performance validation tests, not clinical evaluations requiring expert consensus for ground truth establishment.

4. Adjudication Method

This information is not applicable for the type of testing described (environmental and performance validation). There is no mention of human adjudication for defining a ground truth.

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

A MRMC study was not performed or described. The submission focuses on device equivalence through engineering and performance comparisons, not on comparing human reader performance with or without AI assistance.

6. Standalone Performance

The device itself is a standalone mechanical ventilator. The described testing (environmental, performance, and comparison to predicate devices) effectively assesses the standalone performance of the ventilator in terms of its engineering and functional characteristics. There is no mention of an algorithm 'only' performance in the context of a diagnostic AI.

7. Type of Ground Truth Used

The "ground truth" in this context is adherence to established engineering standards, regulatory guidance for ventilators, and the performance characteristics of legally marketed predicate devices. This is based on objective measurements and comparisons against these defined benchmarks. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the declared studies.

8. Sample Size for the Training Set

This information is not applicable. The Esprit Ventilator is a mechanical device, not an AI or machine learning algorithm that requires a "training set" of data.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device