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the Carina home is a pressure controlled and volume controlled (pressure regulated) ventilator. The device is intended for use with patients with a tidal volume of 100 mL upwards. It is used for patients with respiratory insufficiency, using room air (also with additional oxygen). Federal law restricts this device to sale by or on the order of a physician.

the Carina home is a pressure controlled and volume controlled (pressure regulated) ventilator. The device is intended for use with patients with a tidal volume of 100 mL upwards. It is used for patients with respiratory insufficiency, using room air (also with additional oxygen).

The provided document is a 510(k) summary for the Carina™ home ventilator. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed performance study results, acceptance criteria, or ground truth information typically found in a clinical study report.

The document states: "The results of all verification and validation testing demonstrate that all system and design requirements for the Carina home device have been met. Qualification included hazard analysis, system level qualification and verification / validation tests." However, it does not provide the specifics of these tests in terms of performance metrics, acceptance criteria, sample sizes, or ground truth methods.

Therefore, many of the requested details cannot be extracted from this specific 510(k) summary. I can only provide information that is explicitly stated or can be inferred from the provided text.

Here's an attempt to answer based on the available information:

1. Table of acceptance criteria and the reported device performance

The document states that "The results of all verification and validation testing demonstrate that all system and design requirements for the Carina home device have been met." However, no specific acceptance criteria or quantitative performance metrics are reported in this summary. For example, it does not provide specific ranges for delivered tidal volume accuracy, respiratory rate accuracy, or pressure control stability that would typically be associated with a ventilator's performance and its acceptance criteria.

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

This information is not provided in the 510(k) summary. The document mentions "verification and validation testing," but it does not specify the sample size of any test sets (e.g., number of patients, test conditions, etc.) or the provenance of the 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)

This information is not applicable and therefore not provided in the 510(k) summary. This document pertains to a medical device (ventilator) engineering and regulatory submission, not a diagnostic algorithm that requires expert interpretation for ground truth establishment. The "ground truth" for a ventilator would typically relate to its physical performance measurements against established standards, not expert consensus on images or clinical data.

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

This information is not applicable and therefore not provided in the 510(k) summary. As stated above, this is not a diagnostic study requiring adjudication of expert opinions.

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

This information is not applicable and therefore not provided in the 510(k) summary. MRMC studies are used for evaluating diagnostic imaging systems or AI algorithms that assist human readers. The Carina home is a ventilator, not a diagnostic imaging or AI-assisted diagnostic device.

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

This information is not explicitly stated or applicable as described. The device itself is a ventilator, which operates an algorithm for controlling ventilation. Its performance is evaluated intrinsically, not as a standalone diagnostic algorithm in the context of human-in-the-loop performance. The document only mentions "system level qualification and verification / validation tests," which would inherently evaluate the device's algorithmic performance in controlling ventilation.

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

For a ventilator, the "ground truth" would typically be derived from established engineering standards, calibration measurements against highly accurate reference devices, and physiological models. The document does not specify the exact methods for ground truth establishment but implies these through references to "safety testing" and compliance with standards like IEC60601-1, IEC60601-1-2, and ASTM F1246. These standards define the acceptable performance characteristics and testing methodologies for medical devices.

8. The sample size for the training set

This information is not provided and is likely not applicable in the context of this device. Clinical studies for ventilator performance typically involve testing the device on a range of simulated lung models or, in later stages, on a limited number of patients to demonstrate safety and effectiveness. The term "training set" is generally used for machine learning algorithms, which is not the primary focus of this 510(k) for a ventilator.

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

This information is not provided and is not applicable. As mentioned above, the concept of a "training set" with established ground truth is typically associated with machine learning models, which is not the direct subject of this ventilator 510(k) summary. The ventilator's underlying control logic and algorithms are designed based on established physiological principles and engineering requirements, not "trained" on a dataset in the machine learning sense.

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Use of the KION Anesthesia Workstation is indicated in order to allow for the provision of anesthesia to the neonatal to adult patient populations in all ventilation modes except for Volume Control in the Circle System, where it is not intended for use on neonates. It is intended to be used in an environment where patient care is provided by Healthcare professionals, trained in the administration of anesthesia, when the professional determines that a device is required to assist the breathing of a patient undergoing anesthesia. The device can be used to administer anesthesia while controlling the entire ventilation for patients without any ability to breath, as well as supporting patients with reduced ability to breath.

The KION Anesthesia Workstation - Extended Modes Functionality, adds primarily new functions for Pressure Support and Non-rebreathing to the already cleared KION Anesthesia Workstation with Pressure Control Functionality.

The provided text is related to a 510(k) summary for the KION Anesthesia Workstation - Extended Modes Functionality. This document, like many 510(k) submissions for medical devices, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert-adjudicated ground truth data typically found in AI/ML device submissions.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the provided text because it describes a traditional medical device submission, not an AI/ML diagnostic system. The document does not describe a study involving algorithms, human readers, or performance metrics like sensitivity, specificity, or AUC against a ground truth dataset in the way an AI/ML device would.

Here's an analysis based on the information that is present:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this document is related to demonstrating substantial equivalence to legally marketed predicate devices, rather than meeting specific quantifiable performance metrics against a clinical ground truth as would be seen for an AI/ML device. The device's "performance" is assessed in terms of its clinical performance being "equivalent" to the predicate devices.

Study Details

The document describes a 510(k) submission for the KION Anesthesia Workstation - Extended Modes Functionality, claiming substantial equivalence to predicate devices. It does not describe a clinical study in the typical sense of evaluating diagnostic performance with a test set, ground truth, or human-AI comparison.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document does not describe a "test set" for performance evaluation in the context of an AI/ML device. The comparison is against predicate devices based on technological characteristics and intended use.
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): Not applicable. There is no mention of establishing ground truth by experts for a test set. This is a traditional medical device submission.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is an anesthesia workstation, 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: Not applicable. This is not an algorithmic diagnostic device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices, against which equivalence is claimed.
7. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided text concerns a traditional 510(k) submission for an anesthesia workstation, focusing on demonstrating substantial equivalence to predicate devices based on design, intended use, and technological characteristics. It does not provide the type of performance study details requested for an AI/ML diagnostic or assistive device.

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The VIP Bird Gold and VIP Sterling are ventilators intended to treat respiratory failure or respiratory insufficiency, in neonatal, infant and pediatric patients. The ventilators are intended for institutional use only, and not for emergency medical transport or home use.

The V.I.P Bird ventilator is a self-contained unit, combining an advanced pneumatic system with microprocessor -based technology. The result is a state-of-the-art ventilator system capable of providing excellent patient monitoring. Packaged in a compact lightweight unit, the V.I.P. Bird Gold/Sterling will incorporate all previous function of the V.I.P. Bird and the addition of Pressure Control mode of ventilation with Variable Rise Time, Volume Assured Pressure Support, Flow Triggering in Volume modes and a decelerating waveform. Other enhancements include expanded control setting range for Tidal Volume, improved resolution for the Inspiratory Time and Peak Flow controls. These specifications also include the volume monitoring functions of the Partner IIi.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, experimental studies, sample sizes, expert involvement, or ground truth establishment. The document is a 510(k) summary and an FDA clearance letter for a medical device (ventilator), primarily focused on declaring substantial equivalence to predicate devices and outlining regulatory compliance. It does not contain the kind of detailed technical study information that your request asks for.

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