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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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The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.

The ventilator is the same as described in the notification K010925. This application if for the following options to the Servo-i ventilator family.

The Bi-Vent mode is a Pressure controlled mode with added possibility to allow unrestricted spontaneous breathing, also at high level pressure.

The CO2 analyzer displays continuous CO2 curves of mainstream expired air and etCO2 figures. The aim is to measure the concentration of carbon dioxide to aid in determining the patient's ventilatory, circulatory, and metabolic status.

This document is a 510(k) summary for a Special 510(k) submission for the Siemens Servo Ventilator System, seeking clearance for two new options: Bi-Vent ventilation mode and a CO2 analyzer. The submission claims substantial equivalence to previously cleared devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria (e.g., accuracy percentages, error margins) for the CO2 analyzer or performance metrics for the Bi-Vent mode. Instead, it relies on claiming technological and clinical equivalence to predicate devices, implying that if the new options perform similarly to cleared devices, they meet implicit acceptance criteria.

The "reported device performance" is described through the lens of this equivalence:

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

• Sample Size: The document does not specify a numerical sample size for "test sets" in the typical sense of a clinical trial with a defined number of patients or samples.
• Data Provenance: The document mentions "verification and design validation on animals." This indicates that some form of pre-clinical testing data was used.
  • Country of Origin: Not specified for the animal studies.
  • Retrospective/Prospective: Animal studies are typically prospective by design.

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

• This information is not provided. The submission relies on technological and clinical equivalence to predicate devices. It doesn't describe a process of establishing ground truth on a new dataset by experts.

4. Adjudication Method

• Not applicable as the submission does not detail a study involving expert review or adjudication of a test set.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in this submission. The focus is on device function and equivalence, not on human reader performance with or without AI assistance (as this is a ventilator, not an AI-assisted diagnostic tool).

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

• Yes, for a ventilator and CO2 analyzer, the performance is inherently "standalone" in the sense that the device performs its functions and measurements independently. The clinical use involves a human operator (healthcare provider), but the performance metrics of the device itself (e.g., CO2 measurement accuracy, pressure delivery) are evaluated for the device alone. The "verification and design validation on animals" would assess this standalone performance.

7. Type of Ground Truth Used

• The ground truth is not explicitly defined as pathology, expert consensus, or outcomes data in the context of a new study on the Servo-i. Instead, the "ground truth" for the new options is essentially the performance of the legally marketed predicate devices. The new options are deemed to meet acceptance criteria if they exhibit "equivalent clinical performance" and "technological basis" to these established devices. For the animal study, the "ground truth" would be physiological measurements and observations in the animal model.

8. Sample Size for the Training Set

• This document does not refer to a "training set" as it would for a machine learning or AI algorithm. A ventilator's design and engineering are based on medical, physiological, and engineering principles rather than a data-driven training set in the AI sense.

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

• Not applicable, as there is no "training set" in the context of this device and submission type. The design and validation are based on established engineering principles, regulatory standards, and comparative performance to predicates.

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