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The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs).

The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

The Newport HT70 is a state of the art ventilator that combines ruggedness, exceptional mobility, and ease of use with clinical proficiency to provide ventilatory support for infant, pediatric and adult patients. It has a durable exterior and robust overall design that stands up to the harsh environments found in emergency response, transport and homecare environments. The HT70's unique design provides maximum mobility and safety for short or long distance transport of critically ill patients and also for patients who are going about their normal activities of daily life.

The HT70 is user friendly with all controls easily found on the front touchscreen and panel; there are no complicated menus or difficult sequences to follow in order to make necessary adjustments for common operations. It may be operated from AC or DC external power sources or from the "hot-swappable" Integrated Battery System. Any time the ventilator is connected to external power, the Integrated Battery System is charged, including while the ventilator is in use.

The Newport HT70™ Family of Ventilators is a device intended to provide continuous or intermittent positive pressure mechanical ventilatory support.

Here's an analysis based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for specific tests. The document refers to "a series of tests" but does not quantify the number of units or test iterations.
• Data Provenance: The tests are non-clinical and would have been conducted by the manufacturer, Newport Medical Instruments, Inc., likely at their facilities in Costa Mesa, CA, USA. The data is retrospective in that it's prior to the 510(k) submission, but it's new data generated for this specific device.

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

• This information is not applicable to this 510(k) submission. The Newport HT70 Ventilator is a medical device designed to perform a physical function (mechanical ventilation) and its performance is evaluated against engineering, electrical, and software specifications, rather than against an expert-derived ground truth based on interpretation (e.g., image analysis for disease detection).

4. Adjudication Method for the Test Set

• Not applicable. As the performance assessment is based on objective measurements against predefined specifications, an adjudication method for reconciling expert opinions is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance

• No. An MRMC study is not applicable here. This device is a ventilator, not an AI-assisted diagnostic or decision-support tool where human readers interact with AI.

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

• Not applicable in the context of AI algorithms. While the ventilator's software and hardware perform functions independently of continuous human-in-the-loop operation, this is not an "algorithm-only" performance as understood in AI/ML contexts. The device's performance is tested as a complete system of hardware and software.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests were the engineering design specifications, performance requirements, and safety standards (e.g., electromagnetic compatibility standards, electrical safety standards, internal performance metrics for ventilation parameters). For substantial equivalence, the "ground truth" was the performance and operating principles of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This submission is for a conventional medical device (ventilator) and does not involve AI/Machine Learning, therefore there is no "training set."

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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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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